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1.  Opioid Dependence during Pregnancy: Relationships of Anxiety and Depression Symptoms to Treatment Outcomes 
Addiction (Abingdon, England)  2012;107(0 1):74-82.
To examine the relationship of anxiety and depression symptoms with treatment outcomes (treatment discontinuation, rates of ongoing use of illicit drugs, and likelihood of preterm delivery) in opioid-dependent pregnant women and describe their use of psychotropic medications.
Design and setting
Secondary data analysis from a randomized controlled trial of treatment for opioid dependence during pregnancy.
175 opioid-dependent pregnant women, of whom 131 completed treatment.
Symptoms of anxiety and depression were captured with the 15-item Mini International Neuropsychiatric Interview (MINI) screen. Use of illicit drugs was measured by urine drug screening. Preterm delivery was defined as delivery prior to 37 weeks gestation. Self-reported use of concomitant psychotropic medication at any point during the study was recorded.
Women reporting only anxiety symptoms at study entry were more likely to discontinue treatment (adjusted OR = 4.56, 95% CI = 1.91–13.26, P = 0.012) while those reporting only depression symptoms were less likely to discontinue treatment (adjusted OR = 0.14, 95% CI = 0.20 – 0.88, P = 0.036) compared to women who reported neither depression nor anxiety symptoms. No statistically significant between group differences were observed for ongoing illicit drug use or preterm delivery. A majority (61.4%) of women reported use of concomitant psychotropic medication at some point during study participation.
Opioid-agonist-treated pregnant patients with co-occurring symptoms of anxiety require additional clinical resources to prevent premature discontinuation.
PMCID: PMC4315620  PMID: 23106929
2.  Induction of Pregnant Women onto Opioid-agonist Maintenance Medication: An Analysis of Withdrawal Symptoms and Study Retention 
Drug and alcohol dependence  2013;132(0):329-334.
Induction onto buprenorphine during pregnancy may be more challenging than induction onto methadone. This study explores factors predicting withdrawal intensities and compares trajectories of withdrawal during the induction phase between opioid-dependent women randomly assigned to methadone or buprenorphine.
A secondary analysis was conducted on data from 175 opioid-dependent pregnant women inducted onto buprenorphine or methadone subsequent to stabilization on morphine sulfate. ANOVA analyses were conducted to determine differences between mean peak CINA scores by medication and completion status. General linear mixed models were fitted to compare trajectories of CINA scores between methadone and buprenorphine conditions, and between study dropouts and completers within the buprenorphine condition.
Both buprenorphine and methadone patients experienced withdrawal categorized as minimal by the CINA scoring system. Significant differences in mean peak CINA scores for the first 72 hours of induction were found between the methadone (4.5; SD=0.4) and buprenorphine conditions (6.9; SD=0.4), with buprenorphine patients exhibiting higher mean peak CINA scores [F (3, 165) =9.70, p<0.001]. The trajectory of CINA scores showed buprenorphine patients exhibiting a sharper increase in mean CINA scores than methadone patients [F (1, 233) =8.70, p=0.004]. There were no differences in mean peak CINA scores [F (3, 77) =0.08, p=0.52] or in trajectory of CINA scores [F (1, 166) =0.42, p=0.52] between buprenorphine study dropouts and completers.
While mean peak CINA score was significantly higher in the buprenorphine condition than the methadone condition, neither medication condition experienced substantial withdrawal symptoms. Further research on factors related to successful induction to buprenorphine treatment in pregnant women is needed.
PMCID: PMC3732530  PMID: 23523131
pregnancy; opioid dependence; buprenorphine induction; CINA; opioid withdrawal; methodone induction
3.  Age-related aspects of addiction 
Gerontology  2012;58(6):540-544.
Research has shown that substance use, abuse and addiction are not limited to a specific age group. Problems related to substance addiction are an important cause of morbidity in the population aged 65 and above, especially the abuse of prescription drugs and legal substances. A lack of evidence-based studies and tailored treatment options for the aging population is evident. Appropriate and effective health-care is an important goal to improve health-related quality of life of elderly people. Research in the increasingly aging population needs to include an age- and gender-sensitive approach.
PMCID: PMC3540205  PMID: 22722821
Addiction; Substance use; Substance abuse; Substance dependence; Prescribed medication; Alcohol; Age; Gerontology
4.  Peripartum pain management in opioid dependent women 
Increased pain sensitivity and the development of opioid tolerance complicate the treatment of pain experienced by opioid maintained pregnant women during delivery and the perinatal period. The aim of the present study was to investigate differences in pain management of opioid maintained compared to non-dependent pregnant women during delivery and the postpartum period. 40 deliveries of 37 opioid dependent women enrolled in a double-blind, double-dummy randomized controlled trial (RCT) examining the safety and efficacy of methadone (mean dose at the time of delivery = 63.89 mg) and buprenorphine (mean dose at the time of delivery = 14.05 mg) during pregnancy were analyzed and participants were matched to a non-dependent comparison group of 80 pregnant women. Differences in pain management (opioid and non-opioid analgesic medication) during delivery and perinatal period were analyzed. Following cesarean delivery opioid maintained women received significantly less opioid analgesics (day of delivery p = 0.038; day 1: p = 0.02), NSAIDs were administered more frequently to opioid dependent patients than to the comparison group during cesarean section and on the third day postpartum. Significantly higher nicotine consumption in the group of opioid dependent women had a strong influence on the retrieved results, and might be considered as an independent factor of altered pain experience. Differences in pain treatment became evident when comparing opioid maintained women to healthy controls. These differences might be based on psychosocial consequences of opioid addiction along with the lack of an interdisciplinary consensus on pain treatment protocols for opioid dependent patients.
PMCID: PMC3290684  PMID: 22396085
pain; opioid dependence; pregnancy; NSAIDs; methadone; buprenorphine
5.  A Comparison of Buprenorphine + Naloxone to Buprenorphine and Methadone in the Treatment of Opioid Dependence during Pregnancy: Maternal and Neonatal Outcomes 
Given that buprenorphine + naloxone is prescribed for opioid-dependent pregnant women, it is important to examine the extent to which it differs from buprenorphine alone, methadone, or methadone-assisted withdrawal on neonatal and maternal outcomes. Summary statistics on maternal and neonatal outcomes were collected from 7 previously published studies examining treatment for opioid-dependent pregnant women that represented a range of research methodologies. Outcomes from these studies were compared to the same outcomes for 10 women treated with the combined buprenorphine + naloxone product. There were no significant differences in maternal outcomes for buprenorphine + naloxone compared to buprenorphine, methadone, or methadone-assisted withdrawal. Preliminary findings suggest no significant adverse maternal or neonatal outcomes related to the use of buprenorphine + naloxone for the treatment of opioid dependence during pregnancy. However, further research should examine possible differences between buprenorphine + naloxone and buprenorphine alone or methadone in fetal physical development.
PMCID: PMC3603528  PMID: 23531704
buprenorphine; methadone; opioid dependence; pregnancy; neonates
6.  Should pregnant women with substance use disorders be managed differently? 
Neuropsychiatry  2012;2(1):29-41.
Pregnant women with substance use disorders have multiple special needs, which might be best managed within a multiprofessional treatment setting involving medical, psychological and social care. Adequate treatment provision remains a challenge for healthcare professionals, who should undergo special training and education when working with this patient population. Careful assessment and screening is necessary to tailor interventions individually to the woman's needs in order to achieve beneficial clinical outcomes for mothers and newborns, whereas the choice of treatment options highly depends on the type of substance of abuse and evidence-based treatment interventions available. Economic considerations have shown that early multiprofessional treatment might yield better clinical outcomes and save healthcare costs over the lifespan.
PMCID: PMC3521595  PMID: 23243466
7.  Are male neonates more vulnerable to neonatal abstinence syndrome than female neonates? 
Gender medicine  2011;8(6):355-364.
Prior studies have shown an increased vulnerability among males, to adverse outcomes during the postnatal period. The majority of children exposed to opioids and other medication in utero develop a neonatal abstinence syndrome (NAS), yet individual predisposition for NAS is poorly understood. This investigation examines the role of neonatal sex in the postnatal period, for neonates exposed to standardized opioid maintenance treatment in utero with a focus on the neonatal abstinence syndrome (NAS) regarding severity, medication requirements and duration.
Patients and Methods
This is a secondary analysis of data collected in a prospective randomized, double-blind, double-dummy multi-center trial examining the comparative safety and efficacy of methadone and buprenorphine during pregnancy (Maternal Opioid Treatment: Human Experimental research MOTHER – study). 131 neonates born to opioid-dependent women randomized at six US sites (n=74) and one European site (n=37) were analyzed. Sex-based differences in birth weight, length, head circumference, NAS duration, NAS severity, and treatment parameters of full-term neonates were assessed.
Males had a significantly higher birth weight (p=0.027) and head circumference (p=0.017) than females, with no significant sex difference in rates of preterm delivery. No significant sex-related differences were found for NAS development, severity, duration, or medication administered with non significant differences in concomitant drug consumption during pregnancy (p =0.959).
This unique prospective study shows similar postnatal vulnerability for both sexes, suggesting that factors other than sex are the major determinants of clinically significant NAS.
PMCID: PMC3241965  PMID: 22088886
opioid dependence; methadone; buprenorphine; pregnancy; neonatal abstinence syndrome; sex differences
8.  Randomized Controlled Trials in Pregnancy: Scientific and Ethical Aspects Exposure to different opioid medications during pregnancy in an intra-individual comparison 
Addiction (Abingdon, England)  2011;106(7):1355-1362.
Chronic medical conditions such as opioid dependence require evidence-based treatment recommendations. However, pregnant women are underrepresented in clinical trials. We describe the first within-subject comparison of maternal and neonatal outcomes for methadone vs. buprenorphine exposed pregnancies. Though methadone is the established treatment of pregnant opioid dependent women, recent investigations have shown a trend for a milder neonatal abstinence syndrome (NAS) under buprenorphine. However, it is not only the choice of maintenance medication that determines the occurrence of NAS, other factors such as maternal metabolism, illicit substance abuse and nicotine consumption also influence its severity and duration and represent confounding factors in the assessment of randomized clinical trials.
Case series description
Three women who were part of the European cohort of a randomized, double-blind multicenter trial with a contingency management tool [the Maternal Opioid Treatment: Human Experimental Research (MOTHER) study], each had two consecutive pregnancies and were maintained on either methadone or buprenorphine for their first and then the respective opposite, still-blinded medication for their second pregnancy. Birth measurements, the total neonatal abstinence score, the total amounts of medication used to treat NAS and the days of NAS treatment duration were assessed.
Both medications were effective and safe in reducing illicit opioid relapse and avoiding preterm labour. Methadone maintenance yielded to a significantly higher neonatal birth weight. Data patterns suggest that buprenorphine-exposure was associated with lower neonatal abstinence syndrome (NAS) scores. Findings from this unique case series are consistent with earlier reports using between-group analyses.
Buprenorphine has the potential to become an established treatment alternative to methadone for pregnant opioid dependent women. Under special consideration of ethical boundaries, psychopharmacological treatment during pregnancy must be addressed as an integral part of clinical research projects in order to optimize treatment for women and neonates.
PMCID: PMC3107876  PMID: 21438938
opioid dependence; methadone; buprenorphine; pregnancy; neonatal abstinence syndrome
9.  Unintended Pregnancy in Opioid-abusing Women 
The aim of the present study was to estimate the prevalence of unintended pregnancy and its three subtypes (mistimed, unwanted, ambivalent) among opioid-abusing women. In the general population, 31–47% of pregnancies are unintended; data on unintended pregnancy in opioid- and other drug-abusing women are lacking. Pregnant opioid-abusing women (N=946) screened for possible enrollment in a multi-site randomized controlled trial comparing opioid maintenance medications completed a standardized interview assessing sociodemographic characteristics, current and past drug use, and pregnancy intention. Almost 9 of every 10 pregnancies were unintended (86%), with comparable percentages mistimed (34%), unwanted (27%), and ambivalent (26%). Irrespective of pregnancy intention, more than 90% of the total sample had a history of drug abuse treatment, averaging more than 3 treatment episodes. Interventions are sorely needed to address the extremely high rate of unintended pregnancy among opioid-abusing women. Drug treatment programs are likely to be an important setting for such interventions.
PMCID: PMC3052960  PMID: 21036512
Pregnancy; intention; family planning; opioid; drug abuse
10.  Opioid Dependent and Pregnant: What Are the Best Options for Mothers and Neonates? 
Pregnancy in opioid-dependent women is a major public health issue. Women who are afflicted by opioid addiction are a highly vulnerable group of patients frequently becoming pregnant unplanned and at risk of adverse pregnancy outcomes and peri-natal complications. Opioid agonist maintenance treatment is the best option for the majority of women. Ideally, early and closely monitored treatment in an interdisciplinary team approach including social workers, nurses, psychologists, psychiatrists, gynecologists, anesthesiologists, and pediatricians should be provided. The treatment of comorbid psychiatric conditions, the resolution of financial, legal, and housing issues, and the psychosocial support provided have a significant effect on optimizing pregnancy outcomes. This paper aims to update health professionals in the field of gynecology and obstetrics on the latest optimal treatment approaches for mothers suffering from opioid dependence and their neonates.
PMCID: PMC3306958  PMID: 22496696
11.  Co-occurring Psychiatric Symptoms are Associated with Increased Psychological, Social and Medical Impairment in Opioid Dependent Pregnant Women 
The interaction of psychiatric symptoms with drug dependence during pregnancy is not well understood. This study examines the relationship of psychiatric symptoms to severity of drug use and drug related problems among participants in a clinical trial of pharmacologic treatment of opioid dependence during pregnancy (N=174). 64.6% reported additional psychiatric symptoms (48.6% mood symptoms, 40.0% anxiety symptoms, and 12.6% suicidal thinking). Women who endorsed co-occurring psychiatric symptoms showed more severe impairment on the Addiction Severity Index (ASI). Further investigation is warranted to understand the effect of psychiatric symptoms on long-term maternal and neonatal outcomes.
PMCID: PMC2924760  PMID: 20716304
12.  Shortening of treatment duration in patients with chronic hepatitis C genotype 2 and 3 - impact of ribavirin dose - a randomized multicentre trial 
BMC Research Notes  2011;4:220.
Chronic hepatitis C (CHC) Patients, infected with genotype (GT) 2 or 3 are treated with Peg-IFN and ribavirin (RBV) (800 mg/day) for 24 weeks. Treatment duration can be shortened to 12-16 weeks if a higher dose of RBV (1.000/1.200 mg/day) was used without considerable loss of responsiveness or increased risk of relapse. Previously we have shown that in patients with CHC, GT 2/3 RBV can be reduced to 400 mg/day if administered for 24 weeks without an increase in relapse rates. Therefore we investigated the efficacy of a reduced RBV dosage of 400 mg/day with shorter treatment duration (16 weeks).
Treatment naïve patients with CHC, GT 2/3 were randomized to receive 180 μg peginterferonα2a/week in combination with either 800 (group C) or 400 mg/d (group D) for 16 weeks. The primary endpoint was SVR.
12 months after the first patient was randomized a inferior outcome of group D as compared to group C was noted, therefore the study was terminated. At study termination 89 patients were enrolled (group C: 31, D: 51). The SVR rate was statistically different in the two study groups with 51.6% in group C and 28.4% in group D (p = 0.038). Patients with low viral load had higher SVR rates (C: 67%, D: 33%) than those with high viral load (C: 33%, D: 21%).
Both treatment duration and the dose of RBV play a major role to optimize outcome of patients with GT3. If one intends to shorten the treatment weight based RBV dose should be used, if lower RBV doses are used patients should be treated for at least 24 weeks as. A treatment regimen with a reduced RBV dosage and shortened treatment duration is associated with low SVR rates due to high relapse rates.
Trial registration
PMCID: PMC3141520  PMID: 21714878
Hepatitis C;  treatment duration;  Ribavirin dose; genotype 2 and 3;  randomized controlled trial
13.  Neonatal Abstinence Syndrome after Methadone or Buprenorphine Exposure 
The New England journal of medicine  2010;363(24):2320-2331.
Methadone, a full mu-opioid agonist, is the recommended treatment for opioid dependence during pregnancy. However, prenatal exposure to methadone is associated with a neonatal abstinence syndrome (NAS) characterized by central nervous system hyperirritability and autonomic nervous system dysfunction, which often requires medication and extended hospitalization. Buprenorphine, a partial mu-opioid agonist, is an alternative treatment for opioid dependence but has not been extensively studied in pregnancy.
We conducted a double-blind, double-dummy, flexible-dosing, randomized, controlled study in which buprenorphine and methadone were compared for use in the comprehensive care of 175 pregnant women with opioid dependency at eight international sites. Primary outcomes were the number of neonates requiring treatment for NAS, the peak NAS score, the total amount of morphine needed to treat NAS, the length of the hospital stay for neonates, and neonatal head circumference.
Treatment was discontinued by 16 of the 89 women in the methadone group (18%) and 28 of the 86 women in the buprenorphine group (33%). A comparison of the 131 neonates whose mothers were followed to the end of pregnancy according to treatment group (with 58 exposed to buprenorphine and 73 exposed to methadone) showed that the former group required significantly less morphine (mean dose, 1.1 mg vs. 10.4 mg; P<0.0091), had a significantly shorter hospital stay (10.0 days vs. 17.5 days, P<0.0091), and had a significantly shorter duration of treatment for the neonatal abstinence syndrome (4.1 days vs. 9.9 days, P<0.003125) (P values calculated in accordance with prespecified thresholds for significance). There were no significant differences between groups in other primary or secondary outcomes or in the rates of maternal or neonatal adverse events.
These results are consistent with the use of buprenorphine as an acceptable treatment for opioid dependence in pregnant women. (Funded by the National Institute on Drug Abuse; number, NCT00271219.)
PMCID: PMC3073631  PMID: 21142534
14.  Gender issues in the Pharmacotherapy of Opioid-Addicted Women: Buprenorphine 
Journal of addictive diseases  2010;29(2):217-230.
Gender, a biological determinant of mental health and illness, plays a critical role in determining patients’ susceptibility, exposure to mental health risks, and related outcomes. Regarding sex differences in the epidemiology of opioid dependence, one third of the patients are women of childbearing age. Women have an earlier age of initiation of substance use and a more rapid progression to drug involvement and dependence than men. Generally few studies exist which focus on the special needs of women in opioid maintenance therapy. The aim of this paper is to provide an overview of treatment options for opioid-dependent women, with a special focus on buprenorphine, and to look at recent findings related to other factors that should be taken into consideration in optimizing the treatment of opioid-dependent women. Issues addressed include the role of gender in the choice of medication assisted treatment, sex differences in pharmacodynamics and pharmacokinetics of buprenorphine drug interactions, cardiac interactions, induction of buprenorphine in pregnant patients, the neonatal abstinence syndrome and breastfeeding. This paper aims to heighten the awareness for the need to take gender into consideration when making treatment decisions in an effort to optimize services and enhance the quality of life of women suffering from substance abuse.
PMCID: PMC2858865  PMID: 20407978
Gender; buprenorphine; opioid dependence; neonatal abstinence syndrome
15.  Characteristics of Opioid-Using Pregnant Women Who Accept or Refuse Participation in a Clinical Trial: Screening Results from the MOTHER Study 
Although concerns arise about the generalizability of results from Randomized Controlled Trials (RCTs), few studies systematically examine this issue.
This study compared the characteristics of 427 opioid-using pregnant women who did (n =208) and did not consent (n=219) to enrollment in a multi-center clinical trial of agonist medications (i.e., the MOTHER study).
Logistic regression models were used to compare consenters and non-consenters to examine the effect of screening variables on the likelihood of consenting.
Of nine characteristics examined, most differences did not reach statistical significance. Consenting participants were less likely than non-consenting women to be currently enrolled in a methadone maintenance program (74.5% vs. 84.5%, p=.01).
Conclusion and Scientific Significance
These data show that the recruited sample of drug-dependent pregnant women enrolled in an intensive RCT is representative of the larger population of treated opioid-dependent patients and supports the generalizability of randomized controlled trials in this population.
PMCID: PMC2925421  PMID: 20014912
Substance use; opiates; opioids; substance abuse; pregnant women; treatment acceptance; methadone; buprenorphine
16.  Psychopharmacologic Management of Opioid-Dependent Women during Pregnancy 
Illicit drug use during pregnancy presents complex clinical challenges, including reducing drug use and treating psychiatric disorders. Pharmacologic treatment of psychiatric disorders in a pregnant woman requires an evaluation of the balance between potential clinical benefit and the risk of potential neonatal consequences. This study describes psychiatric symptoms in 111 opioid-dependent pregnant women and their prescribed psychotropic medications. Hypomania, generalized anxiety disorder and depression were the most common disorders for which psychiatric symptoms were endorsed. Over half of women studied were prescribed some form of psychoactive medication during pregnancy. Pharmacologic vs. non-pharmacologic treatment approaches in this patient population are discussed.
PMCID: PMC2777700  PMID: 19283567
17.  Substance abuse in patients with schizophrenia 
The comorbidity of schizophrenia and substance abuse has attracted increasing attention in the past years, with multiple potential links, including genetic vulnerability, neurobiological aspects, side effects of medications, and psychosocial factors being under discussion. The link between the use of substances and the development of psychoses is demonstrated by the high prevalence of substance abuse in schizophrenia. Apart from alcohol misuse, substances commonly abused in this patient group include nicotine, cocaine, and cannabis. In particular, heavy cannabis abuse has been reported to be a stressor eliciting relapse in schizophrenic patients. In general, substance use in psychosis is associated with poorer outcomes, including increased psychotic symptoms and poorer treatment compliance. Since both disorders have been observed to be closely interdependent, a particular treatment for schizophrenic patients with comorbidity of substance abuse is needed in order to provide more effective care. In this article, we discuss various potential modes of interaction and interdependence, and the possibility of embarking on new therapeutic paths for treating this particular population.
PMCID: PMC3181760  PMID: 16640112
schizophrenia; substance abuse; comorbidity; epidemiology; neurobiological aspects; intervention

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