Results of a pilot randomized controlled trial of buprenorphine for opioid dependent women in the criminal justice system

Aims

Recent studies have demonstrated the efficacy of both methadone and buprenorphine when used with opioid dependent men transitioning from prison to the community, but no studies have been conducted with women in the criminal justice (CJ) system. The aim of this study was to determine the efficacy of buprenorphine for relapse prevention among opioid dependent women in the CJ system transitioning back to the community.

Methods

36 women under CJ supervision were recruited from an inpatient drug treatment facility that treats CJ individuals returning back to the community. Nine were enrolled in an open label buprenorphine arm then 27 were randomized to buprenorphine (n = 15) or placebo (n = 12; double-blind). All women completed baseline measures and started study medication prior to release. Participants were followed weekly, provided urine drug screens (UDS), received study medication for 12 weeks, and returned for a 3-month follow-up. Intent-to-treat analyses were performed for all time points through 3 month follow-up.

Results

The majority of participants were Caucasian (88.9%), young (M ± SD = 31.8 ± 8.4 years), divorced/separated (59.2%) women with at least a high school/GED education (M ± SD = 12 ± 1.7 years). GEE analyses showed that buprenorphine was efficacious in maintaining abstinence across time compared to placebo. At end of treatment, 92% of placebo and 33% of active medication participants were positive for opiates on urine drug screen (Chi-Square = 10.9, df = 1; p < 0.001). However, by the three month follow-up point, no differences were found between the two groups, with 83% of participants at follow-up positive for opiates.

Conclusions

Women in the CJ system who received buprenorphine prior to release from a treatment facility had fewer opiate positive UDS through the 12 weeks of treatment compared to women receiving placebo. Initiating buprenorphine in a controlled environment prior to release appears to be a viable strategy to reduce opiate use when transitioning back to the community.     

The effectiveness comparison of Jitai tablets versus methadone in community-based drug treatment: A 1-year follow-up study

Objective

The aim of the study was to compare the effectiveness of Jitai tablets (JTT) versus methadone in a community drug treatment program.

Methods

A cohort study was conducted with 386 eligible subjects from 7 districts to 65 communities in Shanghai. The subjects were placed into the JTT group (n = 206) or the methadone group (n = 180). The data were collected at 8-, 26- and 52-week follow-ups.

Results

The retention rates of the methadone group at the 8-, 26-, and 52-week follow-ups were 97.78%, 91.67%, and 85.00%, respectively. The retention rates of the JTT group at these follow-ups were 90.78%, 83.50%, and 74.27%, respectively. A Chi-square test indicated a significant difference, and the P values were 0.0037, 0.0161, and 0.0095 for each follow-up. The relapse rates for the JTT group were 3.88%, 6.31% and 11.17% for each follow-up, and those for the methadone group were 1.11%, 2.78%, and 7.78% for each follow-up. The Chi-square test indicated no significance, and the P values were 0.1128, 0.1005 and 0.2594. A survival analysis indicated that the relapse survival curve had no significant difference between the two groups (log-rank test, P = 0.188).

Conclusion

Methadone and JTT combined with psychological intervention and social support provided effective maintenance treatment and relapse prevention in a community drug treatment program. The retention rate in the methadone group was higher, but the JTT group had the same relapse prevention as the methadone group. JTT can be recommended to clinical doctors and drug addicts.     

A Stage I pilot study of acceptance and commitment therapy for methadone detoxification

Background

While agonist replacement therapies are effective for managing opioid dependence, community treatment programs are increasingly choosing detoxification. Unfortunately, success rates for opioid detoxification are very low, in part, due to physical and psychological symptoms associated with opioid withdrawal. Few behavior therapies specifically address the distressing experiences specific to opioid withdrawal. A novel behavioral treatment, acceptance and commitment therapy (ACT), works from the premise that the avoidance of unpleasant private experiences (thoughts, feelings, bodily sensations) is ubiquitous yet may be pathogenic, resulting in treatment drop-out and further drug use.

Methods

This Stage I pilot study developed and tested an ACT-based opioid detoxification behavioral therapy. Opioid dependent patients (N = 56) who were attending a licensed methadone clinic were randomized to receive either 24 individual therapy sessions of ACT or drug counseling (DC) in the context of a 6-month methadone dose reduction program.

Results

While no difference was found on opioid use during treatment, 37% of participants in the ACT condition were successfully detoxified at the end of treatment compared to 19% of those who received DC. Fear of detoxification was also reduced across time in the ACT condition relative to DC.

Conclusion

This first study of ACT to assist opioid detoxification indicates promise. Research is needed to refine specific treatment strategies for this population to further strengthen effects.     

Self-perceived problem with alcohol use among opioid substitution treatment clients

Background and aim

Excessive alcohol use increases mortality and morbidity among opioid substitution therapy (OST) clients. Regular attendance for OST dosing presents key opportunities for screening and treatment. However, individuals' perception of their alcohol consumption as problematic or otherwise may impact their willingness to change. This study examines patterns of alcohol consumption among OST clients, perceptions of their own use and correlates of excess consumption.

Methods

Confidential, structured interviews were conducted with 264 clients of two Sydney OST clinics. Alcohol consumption was assessed using the Alcohol Use Disorders Identification Test (AUDIT); and illicit drug dependence with the Severity of Dependence Scale.

Results

Forty-one percent of the participants scored ≥ 8 on the AUDIT (‘AUDIT-positive’), indicating excessive alcohol use. The higher a participant's AUDIT score, the more likely they were to demonstrate insight into the potential problems associated with their drinking (linear trend, p < 0.01). However, only half of AUDIT-positive participants believed they drank too much and/or had a problem with alcohol. One-third had discussed their drinking with OST staff, and a similar proportion reported a history of alcohol treatment. AUDIT-positive participants were more likely than others to be classified as dependent on an illicit drug in the last six months (AOR = 1.76, 95% CI:1.00–3.09), report a history of alcohol treatment (AOR = 5.70, 95% CI:2.83–11.48) and believe it is safe to drink 4 + standard drinks in one session (AOR = 5.30, 95% CI:2.79–10.06).

Conclusions

OST clients with AUDIT scores ≥ 8 appear to underestimate the risks associated with their alcohol consumption. Regular assessments of alcohol use and targeted brief alcohol interventions may improve health outcomes among OST clients.     

Cigarette smoking in opioid-dependent pregnant women: Neonatal and maternal outcomes

Background

The relationship between cigarette smoking and neonatal and maternal clinical outcomes among opioid-agonist-treated pregnant patients is sparse.

Objectives

(1) Is smoking measured at study entry related to neonatal and maternal outcomes in pregnant women receiving opioid-agonist medication? (2) Is it more informative to use a multi-item measure of smoking dependence or a single-item measure of daily smoking? (3) Is the relationship between smoking at study entry and outcomes different between methadone and buprenorphine?

Methods

Secondary analyses examined the ability of the tobacco dependence screener (TDS) and self-reported past 30-day daily average number of cigarettes smoked, both measured at study entry, to predict 12 neonatal and 9 maternal outcomes in 131 opioid-agonist-maintained pregnant participants.

Results

Past 30-day daily average number of cigarettes smoked was significantly positively associated with total amount of morphine (mg) needed to treat neonatal abstinence syndrome (NAS), Adjusted Odds Ratio (AOR) = 1.06 (95% CI: 1.02, 1.09), number of days medicated for NAS, AOR = 1.04 (95% CI: 1.01, 1.06), neonatal length of hospital stay in days, AOR = 1.03 (95% CI: 1.01, 1.05), and negatively associated with 1-AOR = .995 (95% CI: .991,.999) and 5-min Apgar scores, AOR = .996 (95% CI: .994,.998). Simple effect tests of the two significant TDS × medication condition effects found TDS was unrelated to non-normal presentation and amount of voucher money earned in the methadone [AORs = .90 (95% CI: .74, 1.08, p > .24) and 1.0 (95% CI: .97, 1.03, p > .9)] but significant in the buprenorphine condition [AORs = 1.57 (95% CI: 1.01, 2.45, p < .05) and 1.08 (95% CI: 1.04, 1.12, p < .01)].

Conclusions

Regardless of prenatal methadone or buprenorphine exposure, heavier cigarette smoking was associated with more compromised birth outcomes.     

Retention in methadone maintenance treatment in mainland China, 2004–2012: A literature review

Background

Methadone maintenance treatment (MMT) was implemented in mainland China since 2004. Numerous individual studies have investigated MMT retention but the overview still remains unclear. The aim of the study was to review MMT retention rates and predicting factors in mainland China during 2004–2012.

Methods

Chinese and English databases of literature were searched for studies reporting on retention rates and predicting factors in non-transfer MMT patients of fixed-site clinics in mainland China (2004–2012). Qualitative methods were used to synthesize the results.

Results

Nineteen studies were eligible for review, with sample size ranging from 29 to 3758. Retention rates varied between 30.0% at 6 months in Shanghai and 70.3% at 12 months in Xi'an. Predicting factors were non-treatment including sociodemographics (n = 14), support system and social function (n = 9), economic status (n = 2) and psychological status (n = 1), and treatment-related including drug use (n = 15), methadone use (n = 12), MMT clinics (n = 9), MMT participation (n = 7), awareness on MMT (n = 5) and HIV serostatus (n = 3). Methadone dose (n = 12) and age (n = 7) were the first two important specific factors.

Conclusions

In mainland China, MMT retention rates are heterogeneous and relatively lower, and predicting factors mainly focus on objective aspects. Future work should further explore subjective predicting factors regarding MMT retention.     

Factors associated with dropout among patients in opioid maintenance treatment (OMT) and predictors of re-entry. A national registry-based study

Background

Retention in treatment is often highlighted as one of the key indicators of success in opioid maintenance treatment (OMT).

Aims

To identify factors associated with long-term retention in opioid maintenance treatment and to analyse predictors of subsequent treatment episodes.

Methods

Treatment retention and re-entry were examined for a national cohort of patients admitted to OMT in Norway in the period 1997–2003. Multivariate Cox regression models were used to investigate factors associated with treatment dropout 18 months after treatment entry.

Results

The 18 month retention rate among patients admitted to OMT in Norway (n = 2431) was 65.8% (n = 1599). Dropout from OMT within 18 months was associated with younger age (HR 0.97 [0.96–0.98]), high levels of general pre-treatment criminal offences (HR 1.66 [1.32–2.09]) and having drug-related offences during the 30 days prior to dropout (HR 1.80 [1.36–2.38]). Of the patients who dropped out (n = 832), 42.7% (n = 355) were re-engaged in subsequent treatment episodes. Pre-treatment criminal offences were associated with increased odds for treatment re-entry, whereas being younger and having drug-related offences during the first OMT episode were associated with lower odds for re-engagement in OMT. Gender was not associated with treatment dropout and re-entry.

Conclusion

High levels of pre-treatment criminal offences and drug offences during the 30 days prior to dropout were associated with treatment dropout. Efforts to increase support services to these patients may contribute to higher rates of retention in OMT.     

The construct and measurement equivalence of cocaine and opioid dependences: A National Drug Abuse Treatment Clinical Trials Network (CTN) study

Introduction

Although DSM-IV criteria are widely used in making diagnoses of substance use disorders, gaps exist regarding diagnosis classification, use of dependence criteria, and effects of measurement bias on diagnosis assessment. We examined the construct and measurement equivalence of diagnostic criteria for cocaine and opioid dependences, including whether each criterion maps onto the dependence construct, how well each criterion performs, how much information each contributes to a diagnosis, and whether symptom-endorsing is equivalent between demographic groups.

Methods

Item response theory (IRT) and multiple indicators–multiple causes (MIMIC) modeling were performed on a sample of stimulant-using methadone maintenance patients enrolled in a multisite study of the National Drug Abuse Treatment Clinical Trials Network (CTN) (N = 383). Participants were recruited from six community-based methadone maintenance treatment programs associated with the CTN and major U.S. providers. Cocaine and opioid dependences were assessed by DSM-IV Checklist.

Results

IRT modeling showed that symptoms of cocaine and opioid dependences, respectively, were arrayed along a continuum of severity. All symptoms had moderate to high discrimination in distinguishing drug users between severity levels. “Withdrawal” identified the most severe symptom of the cocaine dependence continuum. MIMIC modeling revealed some support for measurement equivalence.

Conclusions

Study results suggest that self-reported symptoms of cocaine and opioid dependences and their underlying constructs can be measured appropriately among treatment-seeking polysubstance users.     

A randomized trial of intensive outpatient (IOP) vs. standard outpatient (OP) buprenorphine treatment for African Americans

Background

Buprenorphine is increasingly being used in community-based treatment programs, but little is known about the optimal level of psychosocial counseling in these settings. The aim of this study was to compare the effectiveness of OP and IOP level counseling when provided as part of buprenorphine treatment for opioid-dependent African Americans.

Methods

Participants were African American men and women starting buprenorphine treatment at one of two community-based clinics (N = 300). Participants were randomly assigned to OP or IOP. Measures at baseline, 3- and 6-month included the primary outcome of DSM-IV opioid and cocaine dependence criteria, as well as additional outcomes of illicit opioid and cocaine use (urine test and self-report), criminal activity, retention in treatment, Quality of Life, Addiction Severity Index composite scores, and HIV risk behaviors.

Results

Participants assigned to OP received, on average, 3.67 (SD = 1.30) h of counseling per active week in treatment. IOP participants received an average of 5.23 (SD = 1.68) h of counseling per active week (less than the anticipated 9 h per week of counseling). Both groups showed substantial improvement over a 6-month period on nearly all measures considered. There were no significant differences between groups in meeting diagnostic criteria for opioid (p = .67) or cocaine dependence (p = .63). There were no significant between group differences on any of the other outcomes. A secondary analysis restricting the sample to participants meeting DSM-IV criteria for baseline cocaine dependence also revealed no significant between-group differences (all ps > .05).

Conclusions

Buprenorphine patients receiving OP and IOP levels of care both show short-term improvements.     

Cannabis use and neurocognitive functioning in a non-clinical sample of users

Objective

With the recent debates over marijuana legalization and increases in use, it is critical to examine its role in cognition. While many studies generally support the adverse acute effects of cannabis on neurocognition, the non-acute effects remain less clear. The current study used a cross-sectional design to examine relationships between recent and past cannabis use on neurocognitive functioning in a non-clinical adult sample.

Method

One hundred and fifty-eight participants were recruited through fliers distributed around local college campuses and the community. All participants completed the Brief Drug Use History Form, the Structured Clinical Interview for DSM-IV Disorders, and neurocognitive assessment, and underwent urine toxicology screening. Participants consisted of recent users (n = 68), past users (n = 41), and non-users (n = 49).

Results

Recent users demonstrated significantly (p < .05) worse performance than non-users across cognitive domains of attention/working memory (M = 42.4, SD = 16.1 vs. M = 50.5, SD = 10.2), information processing speed (M = 44.3, SD = 7.3 vs. M = 52.1, SD = 11.0), and executive functioning (M = 43.6, SD = 13.4 vs. M = 48.6, SD = 7.2). There were no statistically significant differences between recent users and past users on neurocognitive performance. Frequency of cannabis use in the last 4 weeks was negatively associated with global neurocognitive performance and all individual cognitive domains. Similarly, amount of daily cannabis use was negatively associated with global neurocognitive performance and individual cognitive domains.

Conclusions

Our results support the widespread adverse effects of cannabis use on neurocognitive functioning. Although some of these adverse effects appear to attenuate with abstinence, past users' neurocognitive functioning was consistently lower than non-users.     

Participation in opioid substitution treatment reduces the rate of criminal convictions: Evidence from a community study

Objective

Positive outcomes associated with opioid substitution treatment include reduced illicit opioid use and lower risk of HIV and other blood-borne infections. The effect on the reduction of criminal activity remains unclear. Our aim was to investigate the impact of treatment on criminal activity using conviction register data.

Method

This observational retrospective study included all new patients (N = 169) enrolled in an opioid substitution treatment program in the Helsinki University Central Hospital Clinic for Addiction Psychiatry between 2000 and 2005. Psychiatric and psychosocial services were provided as part of the program. Patient treatments were followed up for 18 months. Data on criminal convictions were collected for approximately 3 years before and after the start of treatment.

Results

Mean rates of convictions decreased significantly during treatment. The effects were similar for total convictions, drug convictions, and property crime convictions. Although the numbers of violence and drunk driving convictions were too small to be analysed separately, on a bivariate level there was no indication of reduction in these crime types. Patients with amphetamine co-dependence fared best. Sex, age, other co-dependences or psychiatric diagnoses, negative urine analyses during the treatment, and dropping out from treatment had little impact on the outcomes.

Conclusions

Opioid substitution treatment seems to reduce criminal activity effectively. However, more information is needed to determine how treatment influences different types of criminality and which types of patients benefit most.     

Change in symptoms of erectile dysfunction in depressed men initiating buprenorphine therapy

Aims

The aim of this study is to describe the change in erectile dysfunction (ED) symptoms in the first 12 weeks of outpatient buprenorphine therapy.

Background

Erectile dysfunction is highly prevalent in men who use illicit opioids when compared with the general population. To date, no study has examined ED symptoms over time in men initiating buprenorphine therapy for opioid dependence.

Methods

A randomized, double blind, placebo-controlled trial was conducted to determine whether escitalopram treatment of depressive symptoms begun 1 week prior to buprenorphine induction would improve treatment retention. Male patients completed the International Index of Erectile Function scale at baseline prior to induction and monthly thereafter. A score of 25 or less on the erectile function domain (range 1–30) is considered indicative of erectile dysfunction.

Findings

A total of 111 male subjects enrolled: mean age 38.5 (± 9.7) years, 80.1% non-Hispanic Caucasian; 67.3% reported heroin as their opioid of choice. Mean IIEF at baseline was 20.4 (± 10.5). At baseline, 44.1% of the entire cohort had erectile dysfunction; among those who identified as sexually active at baseline, 26.1% had ED. Baseline erectile function was inversely and significantly correlated with age (r = − .27, p = .006), but was not associated significantly with race, heroin use, years of opioid use, smoking, or hazardous use of alcohol. Compared to baseline, mean erectile function was significantly improved (p = .001) at 3 months, and sexual desire (p = .002) improved significantly at both 2- and 3-month assessments.

Conclusion

Erectile dysfunction is highly prevalent in depressed males using illicit opioids. Men who remain in buprenorphine treatment for 3 months show improvement in erectile function and sexual desire.     

Time to initiation of treatment for neonatal abstinence syndrome in neonates exposed in utero to buprenorphine or methadone

Background

The recommended standard of care calls for treating opioid-dependent pregnant women with methadone and observing neonates exposed in utero for five to seven postnatal days to see if treatment for neonatal abstinence syndrome (NAS) is needed. Data from a large multi-site randomized clinical trial comparing buprenorphine vs. methadone for the treatment of opioid dependence during pregnancy suggest buprenorphine-exposed neonates had less severe NAS, but may require pharmacologic treatment for NAS later than methadone-exposed neonates. The present study examined whether time to pharmacologic treatment initiation differed in a relatively large non-blinded clinical sample of buprenorphine- vs. methadone-exposed neonates treated for NAS.

Methods

Medical records for 75 neonates exposed to buprenorphine (n = 47) or methadone (n = 28) in utero who required treatment for NAS were examined. Time elapsed between birth and initiation of pharmacologic treatment was calculated for each neonate and time to treatment initiation compared between groups.

Results

Median time to treatment initiation (hours:minutes, IQR) was significantly later in buprenorphine- vs. methadone-exposed neonates (71:02, 44:21–96:27 vs. 34:12, 21:00–55:41, respectively, p < .001). Estimates of mean time to treatment initiation from parametric analyses that adjusted for maternal and neonatal characteristics were very similar (73:10 (95% CI: 61:00–87:18) vs. 42:36 (95% CI: 33:06–53:30), respectively, p = .0005). This difference was not dependent on maternal age or neonatal sex, gestational age, or birth weight.

Conclusions

These findings confirm results from randomized clinical trials, adding generality to the observation that buprenorphine-exposed neonates require treatment significantly later than methadone-exposed neonates.     

Is opioid substitution treatment beneficial if injecting behaviour continues?

Background

Opioid substitution treatment (OST) is recognised as an effective treatment for opioid dependence. Still, a subgroup of OST users continues to inject drugs. This study examines health risks and criminal activity in a population of needle exchange programme (NEP) participants by comparing those identified as current OST users to (i) those identified as former OST users and (ii) those with no OST experience.

Methods

This was a semi-annual cross-sectional study conducted from 2002 to 2011. NEP participants were interviewed in Oslo, Norway (n = 1760); 341 were identified as current OST users, 356 as former OST users and 1063 had no OST experience. The associations between OST status and health risk and criminal activity were assessed through univariate and multiple logistic regression analyses.

Results

Among NEP participants, those currently in OST had fewer non-fatal overdoses (OR = 0.5 [95% CI 0.3, 0.9]) compared to former OST users and those never in OST. Additionally, they were less likely to have injected frequently (OR = 0.4 [95% CI 0.3, 06]), to have used heroin daily or almost daily (OR = 0.3 [95% CI 0.2, 0.4]), and to have committed theft (OR = 0.6 [95% CI 0.4, 1.0]) and engaged in drug dealing (OR = 0.7 [95% CI 0.5, 0.9]) in the past month. Overall, there was a high level of polysubstance use and no group differences on this measure.

Conclusions

NEP participants who are currently in OST have substantially reduced health risks and criminal activity than other NEP participants. The high level of polysubstance use nevertheless poses a public health challenge.     

Impact of training for healthcare professionals on how to manage an opioid overdose with naloxone: effective, but dissemination is challenging

Background

Opioid overdose has a high mortality, but is often reversible with appropriate overdose management and naloxone (opioid antagonist). Training in these skills has been successfully trialled internationally with opioid users themselves. Healthcare professionals working in substance misuse are in a prime position to deliver overdose prevention training to drug users and may themselves witness opioid overdoses. The best method of training dissemination has not been identified. The study assessed post-training change in clinician knowledge for managing an opioid overdose and administering naloxone, evaluated the ‘cascade method’ for disseminating training, and identified barriers to implementation.

Methods

A repeated-measures design evaluated knowledge pre-and-post training. A sub-set of clinicians were interviewed to identify barriers to implementation. Clinicians from addiction services across England received training. Participants self-completed a structured questionnaire recording overdose knowledge, confidence and barriers to implementation.

Results

One hundred clinicians were trained initially, who trained a further 119 clinicians (n = 219) and thereafter trained 239 drug users. The mean composite score for opioid overdose risk signs and actions to be taken was 18.3/26 (±3.8) which increased to 21.2/26 (±4.1) after training, demonstrating a significant improvement in knowledge (Z = 9.2, p < 0.001). The proportion of clinicians willing to use naloxone in an opioid overdose rose from 77% to 99% after training. Barriers to implementing training were clinician time and confidence, service resources, client willingness and naloxone formulation.

Conclusions

Training clinicians how to manage an opioid overdose and administer naloxone was effective. However the ‘cascade method’ was only modestly successful for disseminating training to a large clinician workforce, with a range of clinician and service perceived obstacles. Drug policy changes and improvements to educational programmes for drug services would be important to ensure successful implementation of overdose training internationally.     

Evaluation of metabolite/drug ratios in blood and urine as a tool for confirmation of a reduced tolerance in methadone-related deaths in Denmark

Background

Methadone blood concentrations in fatal cases are highly variable and there is an appreciable overlap between therapeutic methadone concentrations and the concentrations detected in fatalities. As with other opioids, the background of these methadone-related deaths is unclear. The aim of this study was to investigate if short-time abstinence was contributing to the cause of death in methadone-related deaths by evaluation of the EDDP/methadone ratio in blood and urine.

Methods

Samples of blood and urine were collected from 103 autopsy cases and analysed for the concentrations of methadone and its main metabolite EDDP. The cases were divided into three groups according to the cause of death: cases where methadone was the cause of death (N = 67), cases where poly-drug poisoning including methadone was the cause of death (N = 24) and cases where death were caused by other factors (N = 12). Urine samples from 11 living persons receiving methadone were also included.

Results

In general, a substantial overlap of the methadone concentrations in blood and urine was seen between the groups. There was a tendency of lower median EDDP/methadone urinary ratios in the methadone poisoning group (median: 1.0), poly-drug poisoning group (median: 0.94) and in the fatalities not related to methadone (median: 1.1) compared to the living subjects in methadone treatment (median: 1.6), although the differences were not significant.

Conclusion

It was not possible to reveal a possible abstinence period prior to death by using the EDDP/methadone ratio in blood and urine in methadone-related deaths.