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1.  Take-Home Emergency Naloxone to Prevent Heroin Overdose Deaths after Prison Release: Rationale and Practicalities for the N-ALIVE Randomized Trial 
The naloxone investigation (N-ALIVE) randomized trial commenced in the UK in May 2012, with the preliminary phase involving 5,600 prisoners on release. The trial is investigating whether heroin overdose deaths post-prison release can be prevented by prior provision of a take-home emergency supply of naloxone. Heroin contributes disproportionately to drug deaths through opiate-induced respiratory depression. Take-home emergency naloxone is a novel preventive measure for which there have been encouraging preliminary reports from community schemes. Overdoses are usually witnessed, and drug users themselves and also family members are a vast intervention workforce who are willing to intervene, but whose responses are currently often inefficient or wrong. Approximately 10% of provided emergency naloxone is thought to be used in subsequent emergency resuscitation but, as yet, there have been no definitive studies. The period following release from prison is a time of extraordinarily high mortality, with heroin overdose deaths increased more than sevenfold in the first fortnight after release. Of prisoners with a previous history of heroin injecting who are released from prison, 1 in 200 will die of a heroin overdose within the first 4 weeks. There are major scientific and logistical challenges to assessing the impact of take-home naloxone. Even in recently released prisoners, heroin overdose death is a relatively rare event: hence, large numbers of prisoners need to enter the trial to assess whether take-home naloxone significantly reduces the overdose death rate. The commencement of pilot phase of the N-ALIVE trial is a significant step forward, with prisoners being randomly assigned either to treatment-as-usual or to treatment-as-usual plus a supply of take-home emergency naloxone. The subsequent full N-ALIVE trial (contingent on a successful pilot) will involve 56,000 prisoners on release, and will give a definitive conclusion on lives saved in real-world application. Advocates call for implementation, while naysayers raise concerns. The issue does not need more public debate; it needs good science.
doi:10.1007/s11524-013-9803-1
PMCID: PMC3795186  PMID: 23633090
2.  Depression and Anxiety Symptoms in Children and Adolescents with Autism Spectrum Disorders without Intellectual Disability 
Recent studies have shown that rates of depression and anxiety symptoms are elevated among individuals with autism spectrum disorders (ASDs) of various ages and IQs and that depression/anxiety symptoms are associated with higher IQ and fewer ASD symptoms. In this study which examined correlates of depression and anxiety symptoms in the full school-age range of children and adolescents (age 6-18) with ASDs and IQs ≥ 70 (n=95), we also observed elevated rates of depression/anxiety symptoms, but we did not find higher IQ or fewer ASD symptoms among individuals with ASDs and depression or anxiety symptoms. These findings indicate an increased risk for depression/anxiety symptoms in children and adolescents with ASDs without intellectual disability, regardless of age, IQ, or ASD symptoms.
doi:10.1016/j.rasd.2011.06.015
PMCID: PMC3355529  PMID: 22615713
autism; children; adolescents; depression; anxiety; IQ
3.  Injecting drug use via femoral vein puncture: preliminary findings of a point-of-care ultrasound service for opioid-dependent groin injectors in treatment 
Background
Within the UK, injecting in the femoral vein (FV), often called 'groin injecting', is a serious cause of risk and harm. This study aimed to use ultrasound scanning as a means to engage groin injectors (GIs), examine their femoral injecting sites and assess their venous health, with the intention of developing improved responses.
Methods
Between September 2006 and March 2009, GIs attending a network of community drug treatment centres in South East England were invited to attend an ultrasound 'health-check' clinic. This paper provides a narrative account of the scanning procedure and operation of the service, with descriptive statistical analysis of GIs who attended. The analysis uses a structured, specially-developed clinical data set that incorporates a categorisation for the severity of FV damage. Case studies using ultrasound images and a link to a video are provided to illustrate the range of presentations encountered and the categorisations used for severity.
Results
A total of 160 groin scans (76 bilateral and 8 unilateral) were performed in 84 GIs. The majority were men (69.0%) and the mean age of the sample was 36.8 years. The mean duration of drug use and injecting drug use was 19.7 years and 13.8 years, respectively. FV damage at the injecting site in the right groin was graded as minimal in 20 patients (25%), moderate in 27 (33.8%), severe in 16 (20.0%) and very-severe in 17 (21.3%). Corresponding figures for left FV were 24 (30.0%), 22 (27.5%), 18 (22.5%) and 16 (20.0%). Wide variation was observed in the time to the development of these grades of FV damage.
Conclusions
Modern, portable ultrasound scanners make it possible to examine the venous health of GIs in community treatment settings. Ultrasound scanning identified extensive FV damage, much hitherto-unrecognised in this population. These findings should further alert clinicians, policy-makers and patients to the urgent need for effective harm reduction responses to GI behaviour. Images of damaged FV in this paper might prove to be a useful resource for discussions about GI risks.
doi:10.1186/1477-7517-9-6
PMCID: PMC3305527  PMID: 22264343
Injecting drug use; groin injecting; femoral vein damage; ultrasonography; harm reduction
5.  Tissue elasticity properties as biomarkers for prostate cancer 
In this paper we evaluate tissue elasticity as a longstanding but qualitative biomarker for prostate cancer and sonoelastography as an emerging imaging tool for providing qualitative and quantitative measurements of prostate tissue stiffness. A Kelvin-Voigt Fractional Derivative (KVFD) viscoelastic model was used to characterize mechanical stress relaxation data measured from human prostate tissue samples. Mechanical testing results revealed that the viscosity parameter for cancerous prostate tissue is greater than that derived from normal tissue by a factor of approximately 2.4. It was also determined that a significant difference exists between normal and cancerous prostate tissue stiffness (p < 0.01) yielding an average elastic contrast that increases from 2.1 at 0.1 Hz to 2.5 at 150 Hz. Qualitative sonoelastographic results show promise for cancer detection in prostate and may prove to be an effective adjunct imaging technique for biopsy guidance. Elasticity images obtained with quantitative sonoelastography agree with mechanical testing and histological results. Overall, results indicate tissue elasticity is a promising biomarker for prostate cancer.
PMCID: PMC3144495  PMID: 18957712
Cancer biomarkers; elasticity imaging; sonoelastography; ultrasound; viscoelasticity
6.  Risk of death during and after opiate substitution treatment in primary care: prospective observational study in UK General Practice Research Database 
Objective To investigate the effect of opiate substitution treatment at the beginning and end of treatment and according to duration of treatment.
Design Prospective cohort study.
Setting UK General Practice Research Database
Participants Primary care patients with a diagnosis of substance misuse prescribed methadone or buprenorphine during 1990-2005. 5577 patients with 267 003 prescriptions for opiate substitution treatment followed-up (17 732 years) until one year after the expiry of their last prescription, the date of death before this time had elapsed, or the date of transfer away from the practice.
Main outcome measures Mortality rates and rate ratios comparing periods in and out of treatment adjusted for sex, age, calendar year, and comorbidity; standardised mortality ratios comparing opiate users’ mortality with general population mortality rates.
Results Crude mortality rates were 0.7 per 100 person years on opiate substitution treatment and 1.3 per 100 person years off treatment; standardised mortality ratios were 5.3 (95% confidence interval 4.0 to 6.8) on treatment and 10.9 (9.0 to 13.1) off treatment. Men using opiates had approximately twice the risk of death of women (morality rate ratio 2.0, 1.4 to 2.9). In the first two weeks of opiate substitution treatment the crude mortality rate was 1.7 per 100 person years: 3.1 (1.5 to 6.6) times higher (after adjustment for sex, age group, calendar period, and comorbidity) than the rate during the rest of time on treatment. The crude mortality rate was 4.8 per 100 person years in weeks 1-2 after treatment stopped, 4.3 in weeks 3-4, and 0.95 during the rest of time off treatment: 9 (5.4 to 14.9), 8 (4.7 to 13.7), and 1.9 (1.3 to 2.8) times higher than the baseline risk of mortality during treatment. Opiate substitution treatment has a greater than 85% chance of reducing overall mortality among opiate users if the average duration approaches or exceeds 12 months.
Conclusions Clinicians and patients should be aware of the increased mortality risk at the start of opiate substitution treatment and immediately after stopping treatment. Further research is needed to investigate the effect of average duration of opiate substitution treatment on drug related mortality.
doi:10.1136/bmj.c5475
PMCID: PMC2965139  PMID: 20978062
7.  Impact of supervision of methadone consumption on deaths related to methadone overdose (1993-2008): analyses using OD4 index in England and Scotland 
Objective To evaluate the impact of introduction of supervision of methadone dosing on deaths related to overdose of methadone in Scotland and England between 1993 and 2008 while controlling for increased prescribing of methadone.
Design Analysis of annual trends in deaths related to overdose of methadone in relation to defined daily doses of methadone prescribed.
Setting Scotland and England.
Population Deaths in which methadone was coded as the only drug involved or as one of the drugs implicated.
Main outcome measure Annual OD4-methadone index (number of deaths with methadone implicated per million defined daily doses of methadone prescribed in that year).
Results OD4-methadone declined substantially over the four epochs of four years between 1993 and 2008. It decreased significantly (P<0.05) in 10 of 12 epoch changes: in Scotland from 19.3 (95% confidence interval 15 to 24) to 4.1 (2.8 to 5.4) and finally to 3.0 (2.4 to 3.5) for methadone only deaths (and from 58 to 29 to 14 for deaths with any mention of methadone); in England from 27.1 (25 to 29) to 24.8 (23 to 27) and finally to 5.8 (5.3 to 6.3) for methadone only deaths (and from 46 to 42 to 12 for deaths with any mention of methadone). The decreases in OD4-methadone were closely related to the introduction of supervised dosing of methadone in both countries, first in Scotland (1995-2000) and later in England (1999-2005). These declines occurred over periods of substantial increases in prescribing of methadone (18-fold increase in defined daily doses per million population annually in Scotland and sevenfold increase in England).
Conclusions Introduction of supervised methadone dosing was followed by substantial declines in deaths related to overdose of methadone in both Scotland and England. OD4-methadone index analyses, controlled for substantial increases in methadone prescribing in both countries, identified at least a fourfold reduction in deaths due to methadone related overdose per defined daily dose (OD4-methadone) over this period.
doi:10.1136/bmj.c4851
PMCID: PMC2941573  PMID: 20847018
9.  Heroin-assisted Treatment (HAT) a Decade Later: A Brief Update on Science and Politics 
Since the initial Swiss heroin-assisted treatment (HAT) study conducted in the mid-1990s, several other jurisdictions in Europe and North America have implemented HAT trials. All of these studies embrace the same goal—investigating the utility of medical heroin prescribing for problematic opioid users—yet are distinct in various key details. This paper briefly reviews (initiated or completed) studies and their main parameters, including primary research objectives, design, target populations, outcome measures, current status and—where available—key results. We conclude this overview with some final observations on a decade of intensive HAT research in the jurisdictions examined, including the suggestion that there is a mounting onus on the realm of politics to translate the—largely positive—data from completed HAT science into corresponding policy and programming in order to expand effective treatment options for the high-risk population of illicit opioid users.
doi:10.1007/s11524-007-9198-y
PMCID: PMC2219559  PMID: 17562183
Heroin-assisted treatment; Science; Politics; Opioid dependence; Clinical trials
11.  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
13.  The prescribing of methadone and other opioids to addicts: national survey of GPs in England and Wales 
Background
GPs occupy a pivotal position in relation to providing services to opiate misusers in the UK, and this is now cited to support initiatives in other countries.
Aims
To investigate GP involvement in the management of opiate misusers; and to examine the nature of this prescribing of methadone and other opioids.
Design
GP data collected via self-completion postal questionnaire from a 10% random sample of the 30 000 GPs across England and Wales. Patient prescription data obtained on opiate misusers treated during the preceding 4 weeks.
Setting
Primary healthcare practice in England and Wales in mid-2001.
Method
A questionnaire was mailed to a random 10% sample of GPs stratified by number of partners in the practice, with three follow-up mailshots. Data on drugs prescribed by these practitioners were also studied, including drug prescribed, form, dose and dispensing arrangements.
Results
The response rate was 66%. Opiate misusers had been seen by 51% of GPs in the preceding 4 weeks (mean of 4.1 such patients), of whom 50% had prescribed opiate-substitution drugs. This provided a study sample of 1482 opiate misusers to whom GPs were prescribing methadone (86.7%), dihydrocodeine (8.5%) or buprenorphine (4.4%). Of 1292 methadone prescriptions, mean daily dose was 36.9 mg — 47.9% being for 30 mg or less. Daily interval dispensing was stipulated by 44.6%, while 42.9% permitted weekly take-away supply.
Conclusions
In 2001 nearly three times as many GPs were seeing opiate misusers than was the case in 1985. Half were prescribing substitute-opiate drugs such as methadone (to an estimated 30 000 patients). However, there are grounds for concern about the quality of this prescribing. Most doses were too low to constitute optimal methadone maintenance; widespread disregard of the availability of supervised or interval dispensing increases the risks of diversion to the blackmarket and deaths from methadone overdose. Increased quantity of care has been achieved. Increased quality is now required.
PMCID: PMC1472740  PMID: 15970068
addiction; buprenorphine; methadone; narcotics; heroin; opiate-related disorders
14.  Cannabis use and the GP: brief motivational intervention increases clinical enquiry by GPs in a pilot study. 
This preliminary test of a brief intervention designed to stimulate GP incorporation of cannabis enquiry was followed up after 2-3 months. Intervention comprised face-to-face discussion based on principles of motivational interviewing, with informational adjunct. Substantially more positive attitudes and greater clinical activity were observed following receipt of intervention.
PMCID: PMC1314679  PMID: 14601341
20.  Absinthe: what's your poison?  
BMJ : British Medical Journal  1999;319(7225):1590-1592.
PMCID: PMC1127080  PMID: 10600949

Results 1-25 (31)