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1.  Cost utility analysis of co-prescribed heroin compared with methadone maintenance treatment in heroin addicts in two randomised trials 
BMJ : British Medical Journal  2005;330(7503):1297.
Objective To determine the cost utility of medical co-prescription of heroin compared with methadone maintenance treatment for chronic, treatment resistant heroin addicts.
Design Cost utility analysis of two pooled open label randomised controlled trials.
Setting Methadone maintenance programmes in six cities in the Netherlands.
Participants 430 heroin addicts.
Interventions Inhalable or injectable heroin prescribed over 12 months. Methadone (maximum 150 mg a day) plus heroin (maximum 1000 mg a day) compared with methadone alone (maximum 150 mg a day). Psychosocial treatment was offered throughout.
Main outcome measures One year costs estimated from a societal perspective. Quality adjusted life years (QALYs) based on responses to the EuroQol EQ-5D at baseline and during the treatment period.
Results Co-prescription of heroin was associated with 0.058 more QALYs per patient per year (95% confidence interval 0.016 to 0.099) and a mean saving of €12 793 (£8793, $16 122) (€1083 to €25 229) per patient per year. The higher programme costs (€16 222; lower 95% confidence limit €15 084) were compensated for by lower costs of law enforcement (- €4129; upper 95% confidence limit - €486) and damage to victims of crime (- €25 374; upper 95% confidence limit - €16 625). The results were robust for the use of national EQ-5D tariffs and for the exclusion of the initial implementation costs of heroin treatment. Completion of treatment is essential; having participated in any abstinence treatment in the past is not.
Conclusions Co-prescription of heroin is cost effective compared with treatment with methadone alone for chronic, treatment resistant heroin addicts.
PMCID: PMC558200  PMID: 15933353
2.  Randomised trial of heroin maintenance programme for addicts who fail in conventional drug treatments 
BMJ : British Medical Journal  1998;317(7150):13-18.
Objective: To evaluate an experimental heroin maintenance programme.
Design: Randomised trial.
Setting: Outpatient clinic in Geneva, Switzerland.
Subjects: Heroin addicts recruited from the community who were socially marginalised and in poor health and had failed in at least two previous drug treatments.
Intervention: Patients in the experimental programme (n=27) received intravenous heroin and other health and psychosocial services. Control patients (n=24) received any other conventional drug treatment (usually methadone maintenance).
Main outcome measures: Self reported drug use, health status (SF-36), and social functioning.
Results: 25 experimental patients completed 6 months in the programme, receiving a median of 480 mg of heroin daily. One experimental subject and 10 control subjects still used street heroin daily at follow up (difference 44%; 95% confidence interval 16% to 71%). Health status scores that improved significantly more in experimental subjects were mental health (0.58 SD; 0.07 to 1.10), role limitations due to emotional problems (0.95 SD; 0.11 to 1.79), and social functioning (0.65 SD; 0.03 to 1.26). Experimental subjects also significantly reduced their illegal income and drug expenses and committed fewer drug and property related offences. There were no benefits in terms of work, housing situation, somatic health status, and use of other drugs. Unexpectedly, only nine (38%) control subjects entered the heroin maintenance programme at follow up.
Conclusions: A heroin maintenance programme is a feasible and clinically effective treatment for heroin users who fail in conventional drug treatment programmes. Even in this population, however, another attempt at methadone maintenance may be successful and help the patient to stop using injectable opioids.
Key messages A heroin maintenance programme may be a useful treatment option for patients who do not succeed in conventional drug treatment programmes Patients randomly allocated to the Geneva heroin maintenance programme fared better that patients in conventional drug treatments in terms of street drug use, mental health, social functioning, and illegal activities Results of the trial apply only to a subgroup of severely addicted people who failed repeatedly in conventional drug treatments This evaluation does not distinguish between the effects of heroin itself and the effects of other medical and psychosocial services that were provided as part of the programme There was less demand for the heroin maintenance programme than anticipated and most control subjects declined entry into the programme at the end of the study
PMCID: PMC28595  PMID: 9651260
3.  Methodology for the Randomised Injecting Opioid Treatment Trial (RIOTT): evaluating injectable methadone and injectable heroin treatment versus optimised oral methadone treatment in the UK 
Whilst unsupervised injectable methadone and diamorphine treatment has been part of the British treatment system for decades, the numbers receiving injectable opioid treatment (IOT) has been steadily diminishing in recent years. In contrast, there has been a recent expansion of supervised injectable diamorphine programs under trial conditions in a number of European and North American cities, although the evidence regarding the safety, efficacy and cost effectiveness of this treatment approach remains equivocal. Recent British clinical guidance indicates that IOT should be a second-line treatment for those patients in high-quality oral methadone treatment who continue to regularly inject heroin, and that treatment be initiated in newly-developed supervised injecting clinics.
The Randomised Injectable Opioid Treatment Trial (RIOTT) is a multisite, prospective open-label randomised controlled trial (RCT) examining the role of treatment with injected opioids (methadone and heroin) for the management of heroin dependence in patients not responding to conventional substitution treatment. Specifically, the study examines whether efforts should be made to optimise methadone treatment for such patients (e.g. regular attendance, supervised dosing, high oral doses, access to psychosocial services), or whether such patients should be treated with injected methadone or heroin.
Eligible patients (in oral substitution treatment and injecting illicit heroin on a regular basis) are randomised to one of three conditions: (1) optimized oral methadone treatment (Control group); (2) injected methadone treatment; or (3) injected heroin treatment (with access to oral methadone doses). Subjects are followed up for 6-months, with between-group comparisons on an intention-to-treat basis across a range of outcome measures. The primary outcome is the proportion of patients who discontinue regular illicit heroin use (operationalised as providing >50% urine drug screens negative for markers of illicit heroin in months 4 to 6). Secondary outcomes include measures of other drug use, injecting practices, health and psychosocial functioning, criminal activity, patient satisfaction and incremental cost effectiveness. The study aims to recruit 150 subjects, with 50 patients per group, and is to be conducted in supervised injecting clinics across England.
doi:10.1186/1477-7517-3-28
PMCID: PMC1613238  PMID: 17002810
4.  Heroin and cocaine co-use in a group of injection drug users in Montréal 
Objective
To describe the pattern of co-use of heroin and cocaine in individuals who were not receiving methadone maintenance treatment.
Design
Structured interviews.
Setting
Community hospital.
Participants
Individuals (n = 1111) selected from a cohort of out-of-treatment injection drug users in Montréal, Que.
Outcome measure
Frequency (injections per day) and quantity (number of days of use) of heroin, cocaine and speedball (the simultaneous administration of heroin and cocaine) use reported in the month preceding the interview.
Results
About 50% of the sample reported using only cocaine intravenously (C group), about 8% reported using only heroin (H group) intravenously and about 15% reported using both heroin and cocaine (HC group) intravenously. Reported cocaine consumption was similar in the HC and C groups. Heroin was used on fewer days by the HC than by the H group, but the number of injections per day was similar. Speedball use, which was quantified independently from heroin and cocaine use, was reported almost exclusively by the HC group, and speedball was used less often than either heroin or cocaine alone. Finally, a similar proportion of individuals in the C and the HC groups consumed alcohol in the 24 hours preceding the interview, but a larger proportion of individuals in the HC group reported the use of marijuana.
Conclusion
In a cohort of injection drug users in Montréal, cocaine was the most prevalent illicit drug. Furthermore, about 70% of the heroin users also injected cocaine, but not in the form of speedball. Thus, the sequential co-use of heroin and cocaine is highly prevalent in Montréal and deserves particular clinical attention.
PMCID: PMC305269  PMID: 14719049
cocaine; heroin; substance abuse, intravenous
5.  A randomized clinical trial of methadone maintenance for prisoners: findings at 6 months post-release 
Addiction (Abingdon, England)  2008;103(8):1333-1342.
Aims
This study examined the effectiveness of methadone maintenance initiated prior to or just after release from prison at 6 months post-release.
Design
A three-group randomized controlled trial was conducted between September 2003 and June 2005.
Setting
A Baltimore pre-release prison.
Participants
Two hundred and eleven adult pre-release inmates who were heroin-dependent during the year prior to incarceration.
Intervention
Participants were assigned randomly to the following: counseling only: counseling in prison, with passive referral to treatment upon release (n = 70); counseling + transfer: counseling in prison with transfer to methadone maintenance treatment upon release (n = 70); and counseling + methadone: methadone maintenance and counseling in prison, continued in a community-based methadone maintenance program upon release (n = 71).
Measurements
Addiction Severity Index at study entry and follow-up. Additional assessments at 6 months post-release were treatment record review; urine drug testing for opioids, cocaine and other illicit drugs.
Findings
Counseling + methadone participants were significantly more likely than both counseling only and counseling + transfer participants to be retained in drug abuse treatment (P = 0.0001) and significantly less likely to have an opioid-positive urine specimen compared to counseling only participants (P = 0.002). Furthermore, counseling + methadone participants reported significantly fewer days of involvement in self-reported heroin use and criminal activity than counseling only participants.
Conclusions
Methadone maintenance, initiated prior to or immediately after release from prison, increases treatment entry and reduces heroin use at 6 months post-release compared to counseling only. This intervention may be able to fill an urgent treatment need for prisoners with heroin addiction histories.
doi:10.1111/j.1360-0443.2008.002238.x
PMCID: PMC2582162  PMID: 18855822
Heroin addiction; methadone maintenance; prisoners; randomized clinical trial; substance abuse treatment
6.  Enhancing motivation within a rapid opioid substitution treatment feasibility RCT: a nested qualitative study 
Background
Opioid substitution treatment (OST) has multiple benefits for heroin injectors and is an evidence-based major component of international treatment. The current qualitative study sought to explore participants’ attitudes to and reasons for participating in a feasibility randomised trial in primary care offering ‘same day’ OST (methadone) for injecting heroin users compared to usual care.
Methods
Twenty injecting heroin users (8 intervention and 12 controls; 16 males and 4 females) were interviewed; purposive sampling was used to select a maximum variation sample from those who agreed; and analysis used thematic methods.
Results
Motivation to join the trial included the need to secure treatment set against some ambivalence due to previous negative experiences of trying to obtain OST. Positive effects of securing methadone via the trial, included self-reported improvements in health and self-care; reduction in crime, stress and drug use. Completing the baseline questionnaires at recruitment appeared to enhance motivation for treatment for all participants. For some control participants, this motivation seemed to increase a sense of self-efficacy and cognitive dissonance generated was resolved by seeking treatment from their GP. Self-determination theory suggests that behaviour change may have been initiated during the recruitment appointment, resulting in an increased determination to seek treatment amongst control participants.
Conclusions
Taking part in the ‘script in a day’ trial enabled participants in the intervention arm to gain same-day access to methadone and reduce their drug use. For those in the control arm, completing the baseline questionnaires at recruitment appeared to create cognitive dissonance between their current health state and own aspirations, so increasing motivation for treatment. Over 50% obtained and were still in receipt of OST (methadone or buprenorphine) at the 3 month follow-up. We suggest that a regular ‘health evaluation’ for injecting heroin users not in treatment, paired with low-barrier access to treatment, may be a way of exploring this and encouraging more into obtaining OST more quickly and at the best time for them. This intervention should be delivered without pressure for change.
Clinical trial registration
This trial is registered with International Standard Randomised Controlled Trial Number Register: SCript In a Day for injecting drug users: feasibility trial: ISRCTN16846554.
doi:10.1186/1747-597X-9-44
PMCID: PMC4240819  PMID: 25407020
Opioid substitution treatment; Motivational interviewing; Cognitive dissonance; Self-determination theory; Qualitative interviews
7.  Randomized Trial of Standard Methadone Treatment Compared to Initiating Methadone without Counseling: 12-month Findings 
Addiction (Abingdon, England)  2012;107(5):943-952.
Aims
This study aimed to determine the relative effectiveness of 12-months of Interim Methadone (IM; supervised methadone with emergency counseling only for the first 4 months of treatment), Standard Methadone treatment (SM; with routine counseling) and Restored Methadone treatment (RM: routine counseling with smaller caseloads).
Design
A randomized controlled trial was conducted comparing: IM, SM, and RM treatment. IM lasted for 4 months after which participants were transferred to SM.
Setting
The study was conducted in two methadone treatment programs in Baltimore, MD, USA.
Participants
The study included 230 adult methadone patients newly-admitted through waiting lists.
Measurements
We administered the Addiction Severity Index and a supplemental questionnaire at baseline, 4-, and 12-months post- baseline.
Measurements included retention in treatment, self-reported days of heroin and cocaine use, criminal behavior and arrests, and urine tests for heroin and cocaine metabolites.
Findings
At 12 months, on an intent-to-treat basis, there were no significant differences in retention in treatment among the IM, SM and RM groups (60.6%, 54.8% and 37.8%, respectively). Positive urine tests for the three groups declined significantly from baseline (ps<0.001 and 0.003, for heroin and cocaine metabolistes respectively) but there were no significant Group x Time interactions for these measures. Thirty-one percent of the sample reported at least one arrest during the year, but there were no significant between-group effects.
Conclusions
Limited availability of drug counseling services should not be a barrier to providing supervised methadone to adults dependent on heroin - at least for the first 4 months of treatment.
doi:10.1111/j.1360-0443.2011.03700.x
PMCID: PMC3319854  PMID: 22029398
Interim methadone; methadone treatment; counseling; heroin addiction treatment
8.  NAOMI: The trials and tribulations of implementing a heroin assisted treatment study in North America 
Background
Opioid addiction is a chronic, relapsing disease and remains a major public health challenge. Despite important expansions of access to conventional treatments, there are still significant proportions of affected individuals who remain outside the reach of the current treatment system and who contribute disproportionately to health care and criminal justice costs as well as to public disorder associated with drug addiction.
The NAOMI study is a Phase III randomized clinical trial comparing injectable heroin maintenance to oral methadone. The study has ethics board approval at its Montréal and Vancouver sites, as well as from the University of Toronto, the New York Academy of Medicine and Johns Hopkins University.
The main objective of the NAOMI Study is to determine whether the closely supervised provision of injectable, pharmaceutical-grade opioid agonist is more effective than methadone alone in recruiting, retaining, and benefiting chronic, opioid-dependent, injection drug users who are resistant to current standard treatment options.
Methods
The case study submitted chronicles the challenges of getting a heroin assisted treatment trial up and running in North America. It describes: a brief background on opioid addiction; current standard therapies for opioid addiction; why there is/was a need for a heroin assisted treatment trial; a description of heroin assisted treatment; the beginnings of creating the NAOMI study in North America; what is the NAOMI study; the science and politics of the NAOMI study; getting NAOMI started in Canada; various requirements and restrictions in getting the study up and running; recruitment into the study; working with the media; a status report on the study; and a brief conclusion from the authors' perspectives.
Results and conclusion
As this is a case study, there are no specific results or main findings listed. The case study focuses on: the background of the study; what it took to get the study started in Canada; the unique requirements and conditions of getting a site, and the study, approved; working with the media; recruitment into the study; a brief status report on the study; and a brief conclusion from the authors' perspectives.
Trail Registration
ClinicalTrials.gov registration number: NCT00175357
doi:10.1186/1477-7517-6-2
PMCID: PMC2639576  PMID: 19159475
9.  Heroin Dependence Treatment in Malaysia: A randomized, double-blind placebo-controlled comparison of buprenorphine and naltrexone maintenance treatment 
Lancet  2008;371(9631):2192-2200.
Background
Expanding access to effective treatments for heroin dependence is a global health priority that will also reduce HIV transmission. This study compares the efficacy for maintaining heroin abstinence, preventing relapse, and reducing HIV risk behaviors of three common treatments: detoxification followed by drug counseling only or drug counseling combined with opioid antagonist (naltrexone) or agonist (buprenorphine) maintenance treatment.
Methods
126 detoxified heroin dependent patients in Malaysia were randomly assigned to 24 weeks of medication maintenance with naltrexone, buprenorphine, or placebo, provided double-blind and double-dummy. All patients received manual-guided drug counseling. Primary outcomes, assessed by three times per week urine testing, were days to first heroin use, days to heroin relapse (3 consecutive opioid-positive urine tests), maximum consecutive days heroin abstinence, and, assessed by self-report at baseline, 3- and 6-months, reductions in HIV risk behaviors. The study was terminated after 22 months of enrolment, based on findings of superior buprenorphine efficacy in an interim safety analysis and the recommendation of the Data and Safety Monitoring Board. This study is registered with ClinicalTrials.gov, with the number NCT00383045.
Findings
We observed consistent, significant linear contrasts in days to first heroin use (p<0.001), days to heroin relapse (p<0.001), maximum consecutive days heroin abstinence (p<0.01), and retention (p<0.001), with all results best for buprenorphine, intermediate for naltrexone, and worst for placebo. Buprenorphine was associated with significantly greater time to first heroin use and retention compared to naltrexone (p<0.01 for both measures) or placebo (p<0.001 for both measures) and also significantly greater time to heroin relapse (p<0.01) and maximum consecutive weeks abstinent (p<0.01) compared to placebo. There were no significant differences between naltrexone and placebo on these measures. HIV risk behaviors were significantly reduced from baseline across all 3 treatments (p<0.001), but the reductions did not differ significantly among the 3 treatments.
Interpretation
The effectiveness of buprenorphine for maintaining prolonged periods of abstinence, delaying the time to resumption of heroin use or relapse, and retaining patients in treatment supports widespread dissemination of opioid agonist maintenance treatment.
doi:10.1016/S0140-6736(08)60954-X
PMCID: PMC4041792  PMID: 18586174
Heroin Dependence; Buprenorphine; Naltrexone; Randomized Clinical Trial; HIV/AIDS
10.  A randomized trial of six-month methadone maintenance with standard or minimal counseling versus 21-day methadone detoxification 
Drug and alcohol dependence  2008;94(1-3):199.
Background
Important questions remain regarding the necessary duration and intensity for methadone treatment to be effective.
Methods
As part of a clinical trial of tuberculosis chemoprophylaxis (Batki et al., 2002), patients with opioid dependence were recruited from an outpatient 21-day methadone detoxification program and were randomly assigned to one of three treatment conditions: 1) continuation in 21-day methadone detoxification; 2) transfer to six-month methadone maintenance with only minimal counseling; or 3) transfer to six-month methadone maintenance with standard twice monthly counseling and as-needed social work and psychiatric services. Both of the six-month maintenance treatments were followed by 1.5 months of detoxification. Urine drug tests and self-report measures were collected at baseline, months 1 through 6, and month 8.5.
Results
Compared to 21-day methadone detoxification, six-month methadone maintenance with either minimal or standard counseling resulted in fewer opiate positive urine tests and days of self-reported heroin and alcohol use. There was no change in cocaine use or other outcome measures. The increased counseling available in the standard counseling condition did not appear to reduce heroin use further than the minimal counseling condition, in contrast to the effect found for more structured counseling in long-term methadone maintenance (McLellan et al., 1993).
Conclusions
Six months of methadone maintenance, even with minimal counseling, reduces heroin and alcohol use more than 21-day methadone detoxification.
doi:10.1016/j.drugalcdep.2007.11.021
PMCID: PMC2821580  PMID: 18243585
opioid dependence; methadone maintenance; counseling; contingency management
11.  A Randomized Clinical Trial of Methadone Maintenance for Prisoners: Results at One-Month Post- Release 
Drug and alcohol dependence  2007;91(2-3):220-227.
Background
Despite its effectiveness, methadone maintenance is rarely provided in American correctional facilities. This study is the first randomized clinical trial in the US to examine the effectiveness of methadone maintenance treatment provided to prisoners with pre-incarceration heroin addiction.
Methods
A three-group randomized controlled trial was conducted between September 2003 and June 2005. Two hundred-eleven Baltimore pre-release inmates who were heroin dependent during the year prior to incarceration were enrolled in this study. Participants were randomly assigned to the following: Counseling Only: counseling in prison, with passive referral to treatment upon release (n = 70); Counseling + Transfer: counseling in prison with transfer to methadone maintenance treatment upon release (n = 70); and Counseling + Methadone: methadone maintenance and counseling in prison, continued in a community-based methadone maintenance program upon release (n = 71).
Results
Two hundred participants were located for follow-up interviews and included in the current analysis. The percentages of participants in each condition that entered community-based treatment were, respectively, Counseling Only 7.8%, Counseling + Transfer 50.0%, and Counseling + Methadone 68.6%, p < .05. All pairwise comparisons were statistically significant, (all ps < .05). The percentage of participants in each condition that tested positive for opioids at one month post-release were, respectively, Counseling Only 62.9%, Counseling + Transfer 41.0%, and Counseling + Methadone 27.6%, p < .05, with the Counseling Only group significantly more likely to test positive than the Counseling + Methadone group.
Conclusions
Methadone maintenance initiated prior to or immediately after release from prison appears to have beneficial short-term impact on community treatment entry and heroin use. This intervention may be able to fill an urgent treatment need for prisoners with heroin addiction histories.
doi:10.1016/j.drugalcdep.2007.05.022
PMCID: PMC2423344  PMID: 17628351
methadone maintenance; drug abuse treatment; prisoners; heroin addiction
12.  The impact of cocaine and heroin on the placental transfer of methadone 
Background
Methadone is the therapeutic agent of choice for the treatment of opiate addiction in pregnancy. The co-consumption (heroin, cocaine) which may influence the effects of methadone is frequent. Therefore, the impact of cocaine and heroin on the placental transfer of methadone and the placental tissue was investigated under in vitro conditions.
Methods
Placentae (n = 24) were ex-vivo perfused with medium (m) (control, n = 6), m plus methadone (n = 6), m plus methadone and cocaine (n = 6) or m plus methadone and heroin (n = 6). Placental functionality parameters like antipyrine permeability, glucose consumption, lactate production, hormone production (hCG and leptin), microparticles release and the expression of P-glycoprotein were analysed.
Results
Methadone accumulated in placental tissue. Methadone alone decreased the transfer of antipyrine from 0.60 +/- 0.07 to 0.50 +/- 0.06 (fetal/maternal ratio, mean +/- SD, P < 0.01), whereas the combination with cocaine or heroin increased it (0.56 +/- 0.08 to 0.68 +/- 0.13, P = 0.03 and 0.58 +/- 0.21 to 0.71 +/- 0.24; P = 0.18). Microparticles (MPs) released from syncytiotrophoblast into maternal circuit increased by 30% after cocaine or heroin (P < 0.05) and the expression of P-glycoprotein in the tissue increased by ≥ 49% after any drug (P < 0.05). All other measured parameters did not show any significant effect when methadone was combined with cocaine or heroine.
Conclusion
The combination of cocaine or heroin with methadone increase antipyrine permeability. Changes of MPs resemble findings seen in oxidative stress of syncytiotrophoblast.
doi:10.1186/1477-7827-7-61
PMCID: PMC2703629  PMID: 19519880
13.  Patients in long-term maintenance therapy for drug use in Italy: analysis of some parameters of social integration and serological status for infectious diseases in a cohort of 1091 patients 
BMC Public Health  2006;6:216.
Background
Heroin addiction often severely disrupts normal social functioning. The aims of this multi-centre study of heroin users in long-term replacement treatment were: i) to provide information on aspects of social condition such as employment, educational background, living status, partner status and any history of drug addiction for partners, comparing these data with that of the general population; ii) to assess the prevalence of hepatitis, syphilis and HIV, because serological status could be a reflection of the social conditions of patients undergoing replacement treatment for drug addiction; iii) to analyse possible relationships between social conditions and serological status.
Methods
A cross-sectional study was carried out in sixteen National Health Service Drug Addiction Units in northern Italy. The data were collected from February 1, 2002 to August 31, 2002. Recruitment eligibility was: maintenance treatment with methadone or buprenorphine, treatment for the previous six months, and at least 18 years of age. In the centres involved in the study no specific criteria or regulations were established concerning the duration of replacement therapy. Participants underwent a face-to-face interview.
Results
The conditions of 1091 drug treatment patients were evaluated. The mean duration of drug use was 14.5 years. Duration was shorter in females, in subjects with a higher educational background, and in stable relationships. Most (68%) had completed middle school (11–14 years of age). Seventy-nine percent were employed and 16% were unemployed. Fifty percent lived with their parents, 34% with a partner and 14% alone. Males lived more frequently with their parents (55%), and females more frequently with a partner (60%). Sixty-seven percent of male patients with a stable relationship had a partner who had never used heroin. HCV prevalence was 72%, HBV antibodies were detected in 42% of patients, while 30% had been vaccinated; 12.5% of subjects were HIV positive and 1.5% were positive for TPHA.
Conclusion
A significant percentage of heroin users in treatment for opiate addiction in the cohort study have characteristics which indicate reasonable integration within broader society. We posit that the combination of effective treatment and a setting of economic prosperity may enhance the social integration of patients with a history of heroin use.
doi:10.1186/1471-2458-6-216
PMCID: PMC1570141  PMID: 16928267
14.  Does Cannabis Use Predict Poor Outcome for Heroin-Dependent Patients on Maintenance Treatment? A Review of Past Findings, and More Evidence Against 
Addiction (Abingdon, England)  2003;98(3):269-279.
Aims
To determine whether cannabinoid-positive urine specimens in heroin-dependent outpatients predict other drug use or impairments in psychosocial functioning, and whether such outcomes are better predicted by cannabis-use disorders than by cannabis use itself.
Design
Retrospective analyses of three clinical trials; each included a behavioral intervention (contingency management) for cocaine or heroin use during methadone maintenance. Trials lasted 25–29 weeks; follow-up evaluations occurred 3, 6, and 12 months posttreatment. For the present analyses, data were pooled across trials where appropriate.
Setting
Urban outpatient methadone clinic.
Participants
408 polydrug abusers meeting methadone-maintenance criteria.
Measurements
Participants were categorized as nonusers, occasional users, or frequent users of cannabis based on thrice-weekly qualitative urinalyses. Cannabis-use disorders were assessed with the Diagnostic Interview Schedule III-R. Outcome measures included proportion of cocaine- and opiate-positive urines and the Addiction Severity Index (at intake and follow-ups).
Findings
Cannabis use was not associated with retention, use of cocaine or heroin, or any other outcome measure during or after treatment. Our analyses had a power of .95 to detect an r2 of .11 between cannabis use and heroin or cocaine use; the r2 we detected was less than .03 and nonsignificant. A previous finding that cannabis use predicted lapse to heroin use in heroin-abstinent patients did not replicate in our sample. However, cannabis-use disorders were weakly associated with psychosocial problems at posttreatment follow-up.
Conclusions
Cannabinoid-positive urines need not be a major focus of clinical attention during treatment for opiate dependence, unless patients report symptoms of cannabis-use disorders.
PMCID: PMC2943839  PMID: 12603227
cannabis; methadone maintenance; treatment outcome
15.  Optimum Methadone Compliance Testing 
Executive Summary
Objective
The objective of this analysis was to determine the diagnostic utility of oral fluid testing collected with the Intercept oral fluid collection device.
Clinical Need: Target Population and Condition
Opioids (opiates or narcotics) are a class of drugs derived from the opium poppy plant that typically relieve pain and produce a euphoric feeling. Methadone is a long-acting synthetic opioid used to treat opioid dependence and chronic pain. It prevents symptoms of opioid withdrawal, reduces opioid cravings and blocks the euphoric effects of short-acting opioids such as heroin and morphine. Opioid dependence is associated with harms including an increased risk of exposure to Human Immunodeficiency Virus and Hepatitis C as well as other health, social and psychological crises. The goal of methadone treatment is harm reduction. Treatment with methadone for opioid dependence is often a long-term therapy. The Ontario College of Physicians and Surgeons estimates that there are currently 250 physicians qualified to prescribe methadone, and 15,500 people in methadone maintenance programs across Ontario.
Drug testing is a clinical tool whose purpose is to provide objective meaningful information, which will reinforce positive behavioral changes in patients and guide further treatment needs. Such information includes knowledge of whether the patient is taking their methadone as prescribed and reducing or abstaining from using opioid and other drugs of abuse use. The results of drug testing can be used with behavior modification techniques (contingency management techniques) where positive reinforcements such as increased methadone take-home privileges, sustained employment or parole are granted for drug screens negative for opioid use, and negative reinforcement including loss of these privileges for drug screens positive for opioid used.
Body fluids including blood, oral fluid, often referred to as saliva, and urine may contain metabolites and the parent drug of both methadone and drugs of abuse and provide a means for drug testing. Compared with blood which has a widow of detection of several hours, urine has a wider window of detection, approximately 1 to 3 days, and is therefore considered more useful than blood for drug testing. Because of this, and the fact that obtaining a urine specimen is relatively easy, urine drug screening is considered the criterion measure (gold standard) for methadone maintenance monitoring. However, 2 main concerns exist with urine specimens: the possibility of sample tampering by the patient and the necessity for observed urine collection. Urine specimens may be tampered with in 3 ways: dilution, adulteration (contamination) with chemicals, and substitution (patient submits another persons urine specimen). To circumvent sample tampering the supervised collection of urine specimens is a common and recommended practice. However, it has been suggested that this practice may have negative effects including humiliation experienced by patient and staff, and may discourage patients from staying in treatment. Supervised urine specimen collection may also present an operational problem as staff must be available to provide same-sex supervision. Oral fluid testing has been proposed as a replacement for urine because it can be collected easily under direct supervision without infringement of privacy and reduces the likelihood of sample tampering. Generally, the results of oral fluid drug testing are similar to urine drug testing but there are some differences, such as lower concentrations of substances in oral fluid than urine, and some drugs remain detectable for longer periods of time in urine than oral fluid.
The Technology Being Reviewed
The Intercept Oral Specimen Collection Device (Ora-Sure Technologies, Bethlehem, PA) consists of an absorbent pad mounted on a plastic stick. The pad is coated with common salts. The absorbent pad is inserted into the mouth and placed between the cheek and gums for 3 minutes on average. The pad absorbs the oral fluid. After 3 minutes (range 2min-5 min) the collection device is removed from the mouth and the absorbent pad is placed in a small vial which contains 0.8mL of pH-balanced preservative, for transportation to a laboratory for analysis. It is recommended that the person undergoing oral fluid drug testing have nothing to eat or drink for a 10- minute period before the oral fluid specimen is collected. This will remove opportunity for adulteration. Likewise, it is recommended that the person be observed for the duration of the collection period to prevent adulteration of the specimen. An average of 0.4 mL of saliva can be collected. The specimen may be stored at 4C to 37C and tested within 21 days of collection (or within 6 weeks if frozen).
The oral fluid specimen must be analyzed in a laboratory setting. There is no point-of-care (POC) oral fluid test kit for drugs of abuse (other than for alcohol). In the laboratory the oral fluid is extracted from the vial after centrifugation and a screening test is completed to eliminate negative specimens. Similar to urinalysis, oral fluid specimens are analyzed first by enzyme immunoassay with positive specimens sent for confirmatory testing. Comparable cut-off values to urinalysis by enzyme immunoassay have been developed for oral fluids
Review Strategy
 
Research Question
What is the diagnostic utility of the Intercept oral specimen device?
Inclusion criteria:
Studies evaluating paired urine and oral fluid specimens from the same individual with the Intercept oral fluid collection device.
The population studied includes drug users.
Exclusion criteria:
Studies testing for marijuana (THC) only.
Outcomes:
Sensitivity and Specificity of oral fluid testing compared to urinalysis for methadone (methadone metabolite), opiates, cocaine, benzodiazepines, and alcohol.
Quality of the Body of Evidence
The Grading of Recommendations Assessment, Development and Evaluation (GRADE) system was used to evaluate the overall quality of the body of evidence (defined as 1 or more studies) supporting the research questions explored in this systematic review. A description of the GRADE system is reported in Appendix 1.
Summary of Findings
A total of 854 potential citations were retrieved. After reviewing titles and abstracts, 2 met the inclusion and exclusion criteria. Two other relevant studies were found after corresponding with the author of the 2 studies retrieved from the literature search. Therefore a total of 4 published studies are included in this analysis. All 4 studies carried out by the same investigator meet the definition of Medical Advisory Secretariat level III (not a-randomized controlled trial with contemporaneous controls) study design. In each of the studies, paired urine and oral fluid specimens where obtained from drug users. Urine collection was not observed in the studies however, laboratory tests for pH and creatinine were used to determine the reliability of the specimen. Urine specimens thought to be diluted and unreliable were removed from the evaluation. Urinalysis was used as the criterion measurement for which to determine the sensitivity and specificity of oral fluid testing by the Intercept oral fluid device for opiates, benzodiazepines, cocaine and marijuana. Alcohol was not tested in any of the 4 studies. From these 4 studies, the following conclusions were drawn:
The evidence indicates that oral fluid testing with the Intercept oral fluid device has better specificity than sensitivity for opiates, benzodiazepines, cocaine and marijuana.
The sensitivity of oral fluids testing with the Intercept oral fluid device seems to be from best to worst: cocaine > benzodiazepines >opiates> marijuana.
The sensitivity and specificity for opiates of the Intercept oral fluid device ranges from 75 to 90% and 97- 100% respectively.
The consequences of opiate false-negatives by oral fluid testing with the Intercept oral fluid device need to be weighed against the disadvantages of urine testing, including invasion of privacy issues and adulteration and substitution of the urine specimen.
The window of detection is narrower for oral fluid drug testing than urinalysis and because of this oral fluid testing may best be applied in situations where there is suspected frequent drug use. When drug use is thought to be less frequent or remote, urinalysis may offer a wider (24-48 hours more than oral fluids) window of detection.
The narrow window of detection for oral fluid testing may mean more frequent testing is needed compared to urinalysis. This may increase the expense for drug testing in general.
POC oral fluid testing is not yet available and may limit the practical utility of this drug testing methodology. POC urinalysis by immunoassay is available.
The possible applications of oral fluid testing may include:
Because of its narrow window of detection compared to urinalysis oral fluid testing may best be used during periods of suspected frequent or recent drug use (within 24 hours of drug testing). This is not to say that oral fluid testing is superior to urinalysis during these time periods.
In situations where an observed urine specimen is difficult to obtain. This may include persons with “shy bladder syndrome” or with other urinary conditions limiting their ability to provide an observed urine specimen.
When the health of the patient would make urine testing unreliable (e,g., renal disease)
As an alternative drug testing method when urine specimen tampering practices are suspected to be affecting the reliability of the urinalysis test.
Possible limiting Factors to Diffusion of Oral Fluid Technology
No oral fluid POC test equivalent to onsite urine dips or POC analyzer reducing immediacy of results for patient care.
Currently, physicians get reimbursed directly for POC urinalysis. Oral fluid must be analyzed in a lab setting removing physician reimbursement, which is a source of program funding for many methadone clinics.
Small amount of oral fluid specimen obtained; repeat testing on same sample will be difficult.
Reliability of positive oral fluid methadone (parent drug) results may decrease because of possible contamination of oral cavity after ingestion of dose. Therefore high methadone levels may not be indicative of compliance with treatment. Oral fluid does not as yet test for methadone metabolite.
There currently is no licensed provincial laboratory that analyses oral fluid specimens.
Abbreviations
2-ethylidene- 1,5-dimethyl-3,3-diphenylpyrrolidine
enzyme immunoassay
Enzyme Linked Immunosorbent Assay (ELISA),
Enzyme Multiplied Immunoassay Test (EMIT)
Gas chromatography
gas chromatography/mass spectrometry
High-performance liquid chromatography
Limit of Detection
Mass spectrometry
Methadone Maintenance Treatment
Oral fluid testing
Phencyclidine
Point of Care Testing
tetrahydrocannabinol
11-nor-delta-9-tetrhydrocannabinol-9-carboxylic acid
urine drug testing
PMCID: PMC3379523  PMID: 23074492
16.  Maintenance treatment for opioid dependence with slow-release oral morphine: a randomized cross-over, non-inferiority study versus methadone 
Addiction (Abingdon, England)  2014;109(4):617-626.
Aims
To compare the efficacy of slow-release oral morphine (SROM) and methadone as maintenance medication for opioid dependence in patients previously treated with methadone.
Design
Prospective, multiple-dose, open label, randomized, non-inferiority, cross-over study over two 11-week periods. Methadone treatment was switched to SROM with flexible dosing and vice versa according to period and sequence of treatment.
Setting
Fourteen out-patient addiction treatment centres in Switzerland and Germany.
Participants
Adults with opioid dependence in methadone maintenance programmes (dose ≥50 mg/day) for ≥26 weeks.
Measurements
The efficacy end-point was the proportion of heroin-positive urine samples per patient and period of treatment. Each week, two urine samples were collected, randomly selected and analysed for 6-monoacetyl-morphine and 6-acetylcodeine. Non-inferiority was concluded if the two-sided 95% confidence interval (CI) in the difference of proportions of positive urine samples was below the predefined boundary of 10%.
Findings
One hundred and fifty-seven patients fulfilled criteria to form the per protocol population. The proportion of heroin-positive urine samples under SROM treatment (0.20) was non-inferior to the proportion under methadone treatment (0.15) (least-squares mean difference 0.05; 95% CI = 0.02, 0.08; P > 0.01). The 95% CI fell within the 10% non-inferiority margin, confirming the non-inferiority of SROM to methadone. A dose-dependent effect was shown for SROM (i.e. decreasing proportions of heroin-positive urine samples with increasing SROM doses). Retention in treatment showed no significant differences between treatments (period 1/period 2: SROM: 88.7%/82.1%, methadone: 91.1%/88.0%; period 1: P = 0.50, period 2: P = 0.19). Overall, safety outcomes were similar between the two groups.
Conclusions
Slow-release oral morphine appears to be at least as effective as methadone in treating people with opioid use disorder.
doi:10.1111/add.12440
PMCID: PMC4226326  PMID: 24304412
Dose–response; maintenance treatment; methadone; opioid addiction; retention rate; slow-release oral morphine
17.  Initiation to heroin injecting among heroin users in Sydney, Australia: cross sectional survey 
Background
Heroin injection is associated with health and social problems including hepatitis C virus (HCV) transmission. Few studies have examined the circumstances surrounding initiation to heroin injecting, especially current users initiating others. The current study aimed to examine the age of first heroin use and injection; administration route of first heroin use; relationship to initiator; the initiation of others among a group of heroin users; and to examine these factors in relation to HCV status and risk.
Method
Heroin users in Sydney were recruited through needle and syringe programs, a methadone clinic and snowballing. Participants were interviewed about their own initiation to heroin use, blood-borne virus risk and knowledge, and whether they had initiated others to heroin injecting. Information on HCV status was collected via self-report. Data was analysed using univariate and multivariate statistical techniques for Normally distributed continuous and categorical data.
Results
The study recruited 399 heroin users, with a mean age of 31 years, 63% were male, 77% reported heroin as their primary drug and 59% were HCV positive (self-report). Mean age at first heroin use and injection was 19 and 21 years, respectively. The majority of heroin users commenced heroin use via injecting (65%), younger users (<25 years, 25–30 years) were less likely than older users (>30 years) to commence heroin use parenterally. Participants were initiated to injection mainly by friends (63%). Thirty-seven percent reported initiating others to heroin injection, but few factors were related to this behaviour. Those with longer heroin using careers were more likely to report initiating others to heroin injection, but were no more likely to have done so in the preceding 12 months. Participants who had initiated others were more likely to have shared injecting equipment (12 vs 23%), but were no more likely to be HCV positive (self-report) than those who did not.
Conclusion
Interventions to prevent heroin users initiating others to injecting are necessary. Peer groups may be well positioned to implement such interventions.
doi:10.1186/1477-7517-2-2
PMCID: PMC550668  PMID: 15713226
heroin; injecting; initiation; risk behaviour
18.  Concurrent heroin use among methadone maintenance clients in China 
Addictive Behaviors  2011;37(3):264-268.
Background
The study examined concurrent illicit heroin use among methadone maintenance clients in China and its association with clients’ demographic characteristics, treatment experience, and personal social network.
Methods
Face-to-face surveys were conducted with 178 clients randomly recruited from six methadone maintenance treatment (MMT) clinics in Sichuan, China. Concurrent heroin use was measured based on self-report of heroin use during the past 30 days and a confirmatory urine morphine test. The participants’ demographic characteristics and treatment factors were measured and examined. The drug use status of their family members and friends was also assessed.
Results
A total of 80 participants (44.9%) who either reported illicit heroin use in the past 30 days or had a positive urine test were defined as using heroin concurrently. Having drug-using friends was significantly associated with increased concurrent heroin use. Longer length of treatment (2 years or longer) was associated with increased concurrent heroin use. Among those who had both drug-using family members and friends, more women (71.4%) than men (50.0%) used heroin. For those who had no drug-using family members or friends, more men (34.8%) than women (20.8%) used heroin.
Discussion
Study findings indicate an urgent need to address concurrent illicit heroin use among MMT clients. Further examination of the influence of social networks on concurrent drug abuse behavior is encouraged. Results also highlight the importance of understanding gender differences in treatment seeking and behavioral changes, which is crucial to the development of gender-specific treatment strategies.
doi:10.1016/j.addbeh.2011.11.004
PMCID: PMC3258322  PMID: 22100548
Drug use; Methadone maintenance therapy; China
19.  Differences in sociodemographic, drug use and health characteristics between never, former and current injecting, problematic hard-drug users in the Netherlands 
Background
Injecting drug users are at increased risk for harmful effects compared to non-injecting drug users. Some studies have focused on differences in characteristics between these two groups (e.g., housing, overall health). However, no study has investigated the specific Dutch situation which in the last years has seen a decrease in homelessness among problematic hard-drug users and an increasing focus on physical health in low-threshold addiction care. The purpose of this study was to determine differences in sociodemographic, drug use and health characteristics between never-injecting (NIDUs), former-injecting (FIDUs) and current-injecting drug users (IDUs) and describe injecting practices.
Methods
A total of 202 problematic hard-drug users (NIDU = 64; FIDU = 76; IDU = 62) were recruited from 22 low-threshold care facilities, including drug consumption rooms, methadone maintenance treatment, heroin-assisted therapy, day shelter and/or night shelter, supported housing and day activity centres. Data were collected on-site through structured face-to-face interviews.
Results
Results indicate that IDUs represented a separate group of problematic hard-drug users, with distinct sociodemographic and drug use characteristics. Overall, IDUs appeared to be the group with least favourable characteristics (unstable housing/homelessness, illegal activities, polydrug use) and NIDUs appeared to have the most favourable characteristics (stable housing, help with debts, less polydrug use). The FIDU group lies somewhere in between. The three groups did not differ significantly in terms of health. Regarding injecting practices, results showed that majority of IDUs had injected drugs for over 10 years and IDUs injected heroin, cocaine, amphetamine and/or methadone in the past 6 months. Sharing syringes was not common. A quarter reported public injecting.
Conclusions
Unstable housing and homelessness are related to (former) injecting drug use, and stable housing is related to never-injecting drug use. Our study suggests that the number of ‘new’ IDUs is low. However, public injecting among IDUs is not uncommon and is associated with unstable housing. This emphasizes the potential of housing projects as a component of harm reduction measures. Therefore, prevention of (risks associated with) injecting drug use and supported housing programmes for problematic hard-drug users deserve the continuous attention of policymakers and professionals in low-threshold addiction care.
doi:10.1186/1477-7517-11-6
PMCID: PMC3926265  PMID: 24524263
Injecting drug use; Non-injecting drug use; Housing; Homelessness; Opiate use; Health; Low-threshold care
20.  Efficacy of prescribed injectable diacetylmorphine in the Andalusian trial: Bayesian analysis of responders and non-responders according to a multi domain outcome index 
Trials  2009;10:70.
Background
The objective of this research was to evaluate data from a randomized clinical trial that tested injectable diacetylmorphine (DAM) and oral methadone (MMT) for substitution treatment, using a multi-domain dichotomous index, with a Bayesian approach.
Methods
Sixty two long-term, socially-excluded heroin injectors, not benefiting from available treatments were randomized to receive either DAM or MMT for 9 months in Granada, Spain. Completers were 44 and data at the end of the study period was obtained for 50. Participants were determined to be responders or non responders using a multi-domain outcome index accounting for their physical and mental health and psychosocial integration, used in a previous trial. Data was analyzed with Bayesian methods, using information from a similar study conducted in The Netherlands to select a priori distributions. On adding the data from the present study to update the a priori information, the distribution of the difference in response rates were obtained and used to build credibility intervals and relevant probability computations.
Results
In the experimental group (n = 27), the rate of responders to treatment was 70.4% (95% CI 53.2-87.6), and in the control group (n = 23), it was 34.8% (95% CI 15.3-54.3). The probability of success in the experimental group using the a posteriori distributions was higher after a proper sensitivity analysis. Almost the whole distribution of the rates difference (the one for diacetylmorphine minus methadone) was located to the right of the zero, indicating the superiority of the experimental treatment.
Conclusion
The present analysis suggests a clinical superiority of injectable diacetylmorphine compared to oral methadone in the treatment of severely affected heroin injectors not benefiting sufficiently from the available treatments.
Trial Registration
Current Controlled Trials ISRCTN52023186
doi:10.1186/1745-6215-10-70
PMCID: PMC2739523  PMID: 19682360
21.  Buprenorphine Outpatient Outcomes Project: can Suboxone be a viable outpatient option for heroin addiction? 
Background
Opioid dependence treatment traditionally involves methadone clinics, for which dispensing schedules can be cumbersome. Buprenorphine, a partial agonist of the mu receptor and antagonist of the kappa receptor, is a potential outpatient alternative to methadone. Funded by a grant from the State of Maryland's Community Health Resources Commission (CHRC), the Buprenorphine Outpatient Outcomes Project (BOOP) evaluates the outcome of Suboxone (buprenorphine/naloxone) treatment on abstinence from heroin use, rates of emergency room visits and hospitalizations, legal issues, and quality of life.
Methods
Active heroin users were recruited between June 2007 and June 2010 and induction therapy with Suboxone was instituted during hospitalization. Once discharged, patients were followed as outpatients for maintenance treatment and counseling. Data were collected from electronic medical records, Maryland state legal records, and SF-36® Health Surveys regarding several parameters and patients were categorized according to duration of treatment with Suboxone into one of three groups: <1 month, 1–3 months, and >3 months.
Results
A total of 220 participants were included in the study. The age range of participants was 18–67 years with most being African American males. Eighty-three (38%) remained in the study for at least 1 month, with 37 of the 83 (45%) remaining in treatment for >3 months. Ten of the 37 (27%) never relapsed after their longest period of abstinence from heroin. During the first year after initiating treatment with Suboxone, hospitalization and emergency room visit rates for all 220 participants decreased by 45 and 23%, respectively, as compared to the year prior to starting treatment. The number of legal charges for drug possession decreased from 70 to 62. Anecdotally, the quality of life seemed to improve in those who were treated with Suboxone for longer periods of time and received regular counseling.
Conclusion
Overall, Suboxone is an effective treatment method for heroin addiction and is a viable outpatient therapy option. Individualized treatment plans and counseling must be implemented for maximum benefits to be seen. Retention of patients for a long duration of therapy was difficult, but for those who did remain, benefits were seen in overall health, abstinence from heroin use, cognition, and quality of life.
doi:10.3402/jchimp.v4.22902
PMCID: PMC3992357  PMID: 24765257
Suboxone; heroin abuse; substance abuse treatment; quality of life
22.  Differential long-term outcomes for voluntary and involuntary transition from injection to oral opioid maintenance treatment 
Background
The most widely used maintenance treatment for opioid dependency is substitution with long-acting oral opioids. Treatment with injectable diacetylmorphine provides an opportunity for patients to stabilize and possibly transition to oral treatment, if clinically indicated. The aim of this study was to explore outcomes of individuals that received injectable diacetylmorphine and voluntarily transitioned to oral methadone.
Design and methods
The North American Opiate Medication Initiative was a randomized controlled trial that compared the effectiveness of injectable diacetylmorphine (or hydromorphone) to oral methadone for long-term opioid-dependency. Treatment was provided for 12-months with an additional 3 months for transition and weaning. Participants were followed until 24-months from randomization. Among the participants randomized to injectable treatments, a sub-group voluntarily chose to transition to oral methadone (n = 16) during the treatment period. Illicit heroin use and treatment retention were assessed at 24-months for those voluntarily and involuntarily transitioning (n = 95) to oral methadone.
Results
At 24-months, the group that voluntarily transitioned to oral methadone had higher odds of treatment retention (adjusted odds ratio = 5.55; 95% confidence interval [CI] = 1.11, 27.81; Chi-square = 4.33, df = 1, p-value = 0.037) than the involuntary transition group. At 24-months, the adjusted mean difference in prior 30 days of illicit heroin use for the voluntary, compared to the involuntary group was -5.58 (95% CI = -11.62, 0.47; t-value = -1.83, df = 97.4, p-value = 0.070).
Conclusions
Although the results of this study were based on small groups of self-selected (i.e., non-randomized) participants, our data underlines the critical importance of voluntary and patient-centered decision making. If we had continued offering treatment with diacetylmorphine, those retained to injectable medication may have sustained the achieved improvements in the first 12 months. Diversified opioid treatment should be available so patients and physicians can flexibly choose the best treatment at the time.
Trial registration
Clinical Trial Registration: NCT00175357
doi:10.1186/1747-597X-9-23
PMCID: PMC4064505  PMID: 24908387
Opioid dependency; Diacetylmorphine, Injectable; Oral methadone; Opioid maintenance treatment
23.  Impact of One-Year Methadone Maintenance Treatment in Heroin Users in Jiangsu Province, China 
Context
Although the effectiveness of methadone maintenance treatment (MMT) is well-established in many countries, it is a relatively new therapy for heroin users in China. Jiangsu Province, a relatively wealthy province, set up 4 MMT clinics in February 2006. No previous studies have evaluated the impact of MMT in a wealthy Chinese province.
Objective
The aim of this study is to evaluate the impact of a 1-year MMT among heroin users in Jiangsu Province. We investigated the impact of the treatment by examining the following outcomes: 1) reduction of heroin use, 2) increase of appropriate sexual intercourse, 3) reduction of antisocial behavior, 4) increase of better social and family relationships, and 5) HIV prevalence among heroin users in MMT clinics.
Design and Setting
Repeated cross-sectional surveys were conducted before and after heroin users in Jiangsu Province received at least 1-year of treatment in the MMT clinics. A questionnaire survey was implemented for those who agreed to participate from March to April 2006, before the initiation of MMT (N = 554). The second survey was from August to September 2007 and was administered to those who received MMT for more than 1 year (N = 804). One hundred and ninety-six patients who were investigated in both surveys were included in a longitudinal study to evaluate the factors attributable to behavior change.
Results
MMT helped in reducing the percentage of heroin injection and also improved social and familial relationships. Antisocial behavior, including theft, prostitution, and dealing in heroin, decreased after 1-year treatment in the MMT clinics. However, the percentage of patients using condoms was not statistically significant. No case was found to be HIV-positive among those who received more than 1 year MMT. In the longitudinal study of 196 patients who participated in both surveys, no specific demographic variables were found to be associated with heroin use, anti-social behaviors after 1-year MMT.
Conclusions
MMT was thought to reduce heroin use, antisocial behaviors and HIV prevalence, and increased appropriate sexual intercourse behaviors and better social and family relationships among heroin users in a wealthy province in China, which was true regardless of gender, age, marital status, or working status.
PMCID: PMC3864915  PMID: 24357931
impact; methadone maintenance treatment; HIV infection; heroin users
24.  The Leeds Evaluation of Efficacy of Detoxification Study (LEEDS) Prisons Project Study: protocol for a randomised controlled trial comparing methadone and buprenorphine for opiate detoxification 
Trials  2009;10:53.
Background
In the United Kingdom (UK), there is an extensive market for the class 'A' drug heroin and many heroin users spend time in prison. People addicted to heroin often require prescribed medication when attempting to cease their drug use. The most commonly used detoxification agents in UK prisons are currently buprenorphine and methadone, both are recommended by national clinical guidelines. However, these agents have never been compared for opiate detoxification in the prison estate and there is a general paucity of research evaluating the most effective treatment for opiate detoxification in prisons. This study seeks to address this paucity by evaluating the most routinely used interventions amongst drug users within UK prisons.
Methods/Design
This study uses randomised controlled trial methodology to compare the open use of buprenorphine and methadone for opiate detoxification, given in the context of routine care, within three UK prisons. Prisoners who are eligible and give informed consent will be entered into the trial. The primary outcome will be abstinence status eight days after detoxification, as determined by a urine test. Secondary outcomes will be recorded during the detoxification and then at one, three and six months post-detoxification.
Trial registration
Current Controlled Trials ISRCTN58823759
doi:10.1186/1745-6215-10-53
PMCID: PMC2715402  PMID: 19602218
25.  Reinterpreting Ethnic Patterns among White and African American Men Who Inject Heroin: A Social Science of Medicine Approach 
PLoS Medicine  2006;3(10):e452.
Background
Street-based heroin injectors represent an especially vulnerable population group subject to negative health outcomes and social stigma. Effective clinical treatment and public health intervention for this population requires an understanding of their cultural environment and experiences. Social science theory and methods offer tools to understand the reasons for economic and ethnic disparities that cause individual suffering and stress at the institutional level.
Methods and Findings
We used a cross-methodological approach that incorporated quantitative, clinical, and ethnographic data collected by two contemporaneous long-term San Francisco studies, one epidemiological and one ethnographic, to explore the impact of ethnicity on street-based heroin-injecting men 45 years of age or older who were self-identified as either African American or white. We triangulated our ethnographic findings by statistically examining 14 relevant epidemiological variables stratified by median age and ethnicity. We observed significant differences in social practices between self-identified African Americans and whites in our ethnographic social network sample with respect to patterns of (1) drug consumption; (2) income generation; (3) social and institutional relationships; and (4) personal health and hygiene. African Americans and whites tended to experience different structural relationships to their shared condition of addiction and poverty. Specifically, this generation of San Francisco injectors grew up as the children of poor rural to urban immigrants in an era (the late 1960s through 1970s) when industrial jobs disappeared and heroin became fashionable. This was also when violent segregated inner city youth gangs proliferated and the federal government initiated its “War on Drugs.” African Americans had earlier and more negative contact with law enforcement but maintained long-term ties with their extended families. Most of the whites were expelled from their families when they began engaging in drug-related crime. These historical-structural conditions generated distinct presentations of self. Whites styled themselves as outcasts, defeated by addiction. They professed to be injecting heroin to stave off “dopesickness” rather than to seek pleasure. African Americans, in contrast, cast their physical addiction as an oppositional pursuit of autonomy and pleasure. They considered themselves to be professional outlaws and rejected any appearance of abjection. Many, but not all, of these ethnographic findings were corroborated by our epidemiological data, highlighting the variability of behaviors within ethnic categories.
Conclusions
Bringing quantitative and qualitative methodologies and perspectives into a collaborative dialog among cross-disciplinary researchers highlights the fact that clinical practice must go beyond simple racial or cultural categories. A clinical social science approach provides insights into how sociocultural processes are mediated by historically rooted and institutionally enforced power relations. Recognizing the logical underpinnings of ethnically specific behavioral patterns of street-based injectors is the foundation for cultural competence and for successful clinical relationships. It reduces the risk of suboptimal medical care for an exceptionally vulnerable and challenging patient population. Social science approaches can also help explain larger-scale patterns of health disparities; inform new approaches to structural and institutional-level public health initiatives; and enable clinicians to take more leadership in changing public policies that have negative health consequences.
Bourgois and colleagues found that the African American and white men in their study had a different pattern of drug use and risk behaviors, adopted different strategies for survival, and had different personal histories.
Editors' Summary
Background.
There are stark differences in the health of different ethnic groups in America. For example, the life expectancy for white men is 75.4 years, but it is only 69.2 years for African-American men. The reasons behind these disparities are unclear, though there are several possible explanations. Perhaps, for example, different ethnic groups are treated differently by health professionals (with some groups receiving poorer quality health care). Or maybe the health disparities are due to differences across ethnic groups in income level (we know that richer people are healthier). These disparities are likely to persist unless we gain a better understanding of how they arise.
Why Was This Study Done?
The researchers wanted to study the health of a very vulnerable community of people: heroin users living on the streets in the San Francisco Bay Area. The health status of this community is extremely poor, and its members are highly stigmatized—including by health professionals themselves. The researchers wanted to know whether African American men and white men who live on the streets have a different pattern of drug use, whether they adopt varying strategies for survival, and whether they have different personal histories. Knowledge of such differences would help the health community to provide more tailored and culturally appropriate interventions. Physicians, nurses, and social workers often treat street-based drug users, especially in emergency rooms and free clinics. These health professionals regularly report that their interactions with street-based drug users are frustrating and confrontational. The researchers hoped that their study would help these professionals to have a better understanding of the cultural backgrounds and motivations of their drug-using patients.
What Did the Researchers Do and Find?
Over the course of six years, the researchers directly observed about 70 men living on the streets who injected heroin as they went about their usual lives (this type of research is called “participant observation”). The researchers specifically looked to see whether there were differences between the white and African American men. All the men gave their consent to be studied in this way and to be photographed. The researchers also studied a database of interviews with almost 7,000 injection drug users conducted over five years, drawing out the data on differences between white and African men. The researchers found that the white men were more likely to supplement their heroin use with inexpensive fortified wine, while African American men were more likely to supplement heroin with crack. Most of the white men were expelled from their families when they began engaging in drug-related crime, and these men tended to consider themselves as destitute outcasts. African American men had earlier and more negative contact with law enforcement but maintained long-term ties with their extended families, and these men tended to consider themselves as professional outlaws. The white men persevered less in attempting to find a vein in which to inject heroin, and so were more likely to inject the drug directly under the skin—this meant that they were more likely to suffer from skin abscesses. The white men generated most of their income from panhandling (begging for money), while the African American men generated most of their income through petty crime and/or through offering services such as washing car windows at gas stations.
What Do These Findings Mean?
Among street-based heroin users, there are important differences between white men and African American men in the type of drugs used, the method of drug use, their social backgrounds, the way in which they identify themselves, and the health risks that they take. By understanding these differences, health professionals should be better placed to provide tailored and appropriate care when these men present to clinics and emergency rooms. As the researchers say, “understanding of different ethnic populations of drug injectors may reduce difficult clinical interactions and resultant physician frustration while improving patient access and adherence to care.” One limitation of this study is that the researchers studied one specific community in one particular area of the US—so we should not assume that their findings would apply to street-based heroin users elsewhere.
Additional Information.
Please access these Web sites via the online version of this summary at http://dx.doi.org/10.1371/journal.pmed.0030452.
The US Centers for Disease Control (CDC) has a web page on HIV prevention among injection drug users
The World Health Organization has collected documents on reducing the risk of HIV in injection drug users and on harm reduction approaches
The International Harm Reduction Association has information relevant to a global audience on reducing drug-related harm among individuals and communities
US-focused information on harm reduction is available via the websites of the Harm Reduction Coalition and the Chicago Recovery Alliance
Canada-focused information can be found at the Street Works Web site
The Harm Reduction Journal publishes open-access articles
The CDC has a web page on eliminating racial and ethnic health disparities
The Drug Policy Alliance has a web page on drug policy in the United States
doi:10.1371/journal.pmed.0030452
PMCID: PMC1621100  PMID: 17076569

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