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The purpose of this study was to investigate the blood levels of methadone in participants receiving methadone for the treatment of opioid dependence. After stabilization on methadone for four weeks, blood samples from 95 participants were collected between treatment weeks 4 and 12, before and after receiving doses of methadone, and its blood levels were measured. A multiple linear regression model was used to examine the association between methadone blood levels and the outcomes of methadone maintenance treatment (MMT). Outcome differences between participants who had high (≥2) or low (2 was significantly poorer than those whose ratio was

AimsTo examine the safety and effectiveness of buprenorphine + naloxone sublingual tablets (BUP, as Suboxone(®) ) provided after administration of extended-release injectable naltrexone (XR-NTX, as Vivitrol(®) ) to reduce cocaine use in participants who met DSM-IV criteria for cocaine dependence and past or current opioid dependence or abuse.MethodsThis multi-centered, double-blind, placebo-controlled study, conducted under the auspices of the National Drug Abuse Treatment Clinical Trials Network, randomly assigned 302 participants at sites in California, Oregon, Washington, Colorado, Texas, Georgia, Ohio, New York and Washington DC, USA to one of three conditions provided with XR-NTX: 4 mg/day BUP (BUP4, n = 100), 16 mg/day BUP (BUP16, n = 100, or no buprenorphine (placebo; PLB, n = 102). Participants received pharmacotherapy for 8 weeks, with three clinic visits per week. Cognitive behavioral therapy was provided weekly. Follow-up assessments occurred at 1 and 3 months post-intervention. The planned primary outcome was urine drug screen (UDS)-corrected, self-reported cocaine use during the last 4 weeks of treatment. Planned secondary analyses assessed cocaine use by UDS, medication adherence, retention and adverse events.ResultsNo group differences were found between groups for the primary outcome (BUP4 versus PLB, P = 0.262; BUP16 versus PLB, P = 0.185). Longitudinal analysis of UDS data during the evaluation period using generalized linear mixed equations found a statistically significant difference between BUP16 and PLB [P = 0.022, odds ratio (OR) = 1.71] but not for BUP4 (P = 0.105, OR = 1.05). No secondary outcome differences across groups were found for adherence, retention or adverse events.ConclusionsBuprenorphine + naloxone, used in combination with naltrexone, may be associated with reductions in cocaine use among people who meet DSM-IV criteria for cocaine dependence and past or current opioid dependence or abuse.

BackgroundDespite the growing prevalence of opioid use among offenders, pharmacotherapy remains an underused treatment approach in correctional settings. The aim of this 4-year trial is to assess the clinical utility, effectiveness, and cost implications of extended-release naltrexone (XR-NTX, Vivitrol®; Alkermes Inc.) alone and in conjunction with patient navigation for jail inmates with opioid use disorder (OUD).MethodsOpioid-dependent inmates will be randomly assigned to one of three treatment conditions before being released to the community to include: 1) XR-NTX only; 2) XR-NTX plus patient navigation (PN), and 3) enhanced treatment-as-usual (ETAU) with drug education and a community treatment referral. Before release from jail, participants in the XR-NTX and XR-NTX plus PN conditions will receive their first XR-NTX injection. Those in the XR-NTX plus PN condition also will meet with a patient navigator. Participants in both XR-NTX conditions will be scheduled for medical management sessions twice monthly for months 1-3, monthly medical management sessions for months 4-6, with monthly injections for 5months post-release (which, given the pre-release injection, results in a 6-month medication phase). Follow-up data collection will occur at 1, 3, 6, and 12months post release.ResultsWe discuss the study's rationale, aims, methods, and anticipated findings. The primary outcome is the presence of a DSM 5 OUD diagnosis 1year after randomization (6months after the end of the active treatment phase).DiscussionWe hypothesize that providing XR-NTX prior to release from jail will be particularly beneficial for this extremely high-risk population by reducing opioid use, associated criminal behavior, and injection-related disease risk. ClinicalTrials.Gov: NCT02110264.

ObjectivesThis 2-stage open-label pilot study evaluated the safety and potential efficacy of naltrexone + bupropion as a pharmacotherapy for methamphetamine (MA) use disorder.MethodsThe study was conducted in 2 stages of recruitment across 3 sites; 20 participants were enrolled in stage 1 and 29 participants were enrolled in stage 2. Eight weeks of open-label pharmacotherapy with a combination of extended-release injectable naltrexone (XR-NTX; Vivitrol) plus extended-release oral bupropion (BRP; Wellbutrin XL) were provided with a smartphone-assisted medication adherence platform. Participants met Diagnostic and Statistical Manual of Mental Disorders, 5th Edition criteria for severe MA use disorder, self-reported ≥20 days of MA use in the 30 days prior to consent, and submitted 3 MA-positive urine drug screens (UDS) out of 4 collected during screening. Participants attended clinic twice weekly for observed BRP dosing, UDS testing, assessments, and medical management; XR-NTX was administered at weeks 1 and 5. A BRP taper and follow-up visit occurred in week 9.ResultsAnalyses evaluated effects of XR-NTX + BRP to determine the number of "responders" according to a statistically predefined response criterion (6 of 8 MA-negative UDS during the last 4 weeks of medication). The 2-stage design required that stage 1 yield ≥3 responders to continue to stage 2; 11 of the 49 participants met responder criteria across both stages (5 in stage 1, 6 in stage 2).ConclusionsUnder the statistical analysis plan, study "success" required ≥9 responders. With 11 responders, the study demonstrated sufficient potential of naltrexone plus bupropion as a combination pharmacotherapy for MA use disorder to warrant further study.

Background and aimsNo effective pharmacotherapy for methamphetamine (MA) use disorder has yet been found. This study evaluated sustained-release methylphenidate (MPH-SR) compared with placebo (PLA) for treatment of MA use disorder in people also undergoing behavioral support and motivational incentives.DesignThis was a randomized, double-blind, placebo-controlled design with MPH-SR or PLA provided for 10 weeks (active phase) followed by 4 weeks of single-blind PLA. Twice-weekly clinic visits, weekly group counseling (CBT) and motivational incentives (MI) for MA-negative urine drug screens (UDS) were included.SettingTreatment sites were in Los Angeles, California (LA) and Honolulu, Hawaii (HH), USA.ParticipantsA total of 110 MA-dependent (via DSM-IV) participants (LA = 90; HH = 20).MeasurementsThe primary outcome measure is self-reported days of MA use during the last 30 days of the active phase. Included in the current analyses are drug use (UDS and self-report), retention, craving, compliance (dosing, CBT, MI), adverse events and treatment satisfaction.FindingsNo difference was found between treatment groups in self-reported days of MA use during the last 30 days of the active phase (P = 0.22). In planned secondary outcomes analyses, however, the MPH group had fewer self-reported MA use days from baseline through the active phase compared with the PLA group (P = 0.05). The MPH group also had lower craving scores and fewer marijuana-positive UDS than the PLA group in the last 30 days of the active phase. The two groups had similar retention, other drug use, adverse events and treatment satisfaction.ConclusionsMethylphenidate may lead to a reduction in concurrent methamphetamine use when provided as treatment for patients undergoing behavioral support for moderate to severe methamphetamine use disorder, but this requires confirmation.

ObjectivesCompare HIV injecting and sex risk in patients being treated with methadone (MET) or buprenorphine-naloxone (BUP).MethodsSecondary analysis from a study of liver enzyme changes in patients randomized to MET or BUP who completed 24 weeks of treatment and had 4 or more blood draws. The initial 1:1 randomization was changed to 2:1 (BUP:MET) after 18 months due to higher dropout in BUP. The Risk Behavior Survey measured HIV risk before 30 days at baseline and weeks 12 and 24.ResultsAmong 529 patients randomized to MET, 391 (74%) were completers; among 740 randomized to BUP, 340 (46%) were completers; 700 completed the Risk Behavior Survey. There were significant reductions in injecting risk (P < 0.0008) with no differences between groups in mean number of times reported injecting heroin, speedball, other opiates, and number of injections; or percent who shared needles; did not clean shared needles with bleach; shared cookers; or engaged in front/back loading of syringes. The percent having multiple sex partners decreased equally in both groups (P < 0.03). For males on BUP, the sex risk composite increased; for males on MET, the sex risk decreased resulting in significant group differences over time (P < 0.03). For females, there was a significant reduction in sex risk (P < 0.02) with no group differences.ConclusionsAmong MET and BUP patients who remained in treatment, HIV injecting risk was equally and markedly reduced; however, MET retained more patients. Sex risk was equally and significantly reduced among females in both treatment conditions, but it increased for males on BUP and decreased for males on MET.

AimsTo examine patient and medication characteristics associated with retention and continued illicit opioid use in methadone (MET) versus buprenorphine/naloxone (BUP) treatment for opioid dependence.Design, settings and participantsThis secondary analysis included 1267 opioid-dependent individuals participating in nine opioid treatment programs between 2006 and 2009 and randomized to receive open-label BUP or MET for 24 weeks.MeasurementsThe analyses included measures of patient characteristics at baseline (demographics; use of alcohol, cigarettes and illicit drugs; self-rated mental and physical health), medication dose and urine drug screens during treatment, and treatment completion and days in treatment during the 24-week trial.FindingsThe treatment completion rate was 74% for MET versus 46% for BUP (P

To describe the prevalence of childhood adverse events (CAEs) among methamphetamine-dependent men and women, and assess the relationship of cumulative CAEs to health problems. Data for 236 men and 351 women were analyzed assessing CAEs. Dependent variables included 14 self-reported health problems or psychiatric symptom domains. Mental health was assessed via the Mini-International Neuropsychiatric Interview. Medical conditions were collected using the Health Status Survey. Women reported more cumulative exposure to CAEs than men (28% vs. 13%, p less than 0.01). Regressions showed the impact of CAEs on health is strong for both men and women. Yet, women were more likely than men to have 7 out of 14 health problems, independent of their reported abuse (ranging from a positive OR for suicidality = 1.63 to a positive OR for bladder/bowel disease = 6.09). Substance abuse treatment programs should prioritize individual treatment plans and enhance multi-agency collaborations to provide referrals and community networks that offer clients appropriate trauma-based psychiatric and/or medical treatment.

The dramatic rise in the number of 12-step programs and participants raises questions concerning client participation in drug treatment and 12-step programs, and their separate and combined effects on recovery. The results of a treatment outcomes study indicate that rather than recovery alternatives, drug treatment and 12-step programs are utilized by the client as integrated recovery activities. Treatment participants with pretreatment 12-step involvement stayed in treatment longer, and were more likely to complete the 24-week program. Both pretreatment 12-step involvement and duration of participation in drug treatment are associated with subsequent 12-step involvement. Most importantly, there is an additive effect of these recovery activities in that those who participated concurrently in both drug treatment and 12-step programs had higher rates of abstinence than those who participated only in treatment or in 12-step programs.

Objectives: This article describes how smartphones were used to monitor and encourage medication adherence in a pilot study evaluating the potential efficacy of a combination pharmacotherapy for methamphetamine use disorder. We examine the feasibility, utility, and acceptability of using smartphones to capture dosing videos from the perspectives of participants and staff. Methods: The study was an 8-week, open-label evaluation of extended-release injectable naltrexone combined with once-daily oral extended-release bupropion (BRP, Welbutrin XL, 450 mg/day). Participants attended visits twice-weekly for observed BRP dosing, assessments, and medical management. BRP was dispensed once weekly for dosing on nonclinic days. Medication adherence was assessed objectively (by observation in the clinic and smartphone videos for dosing at home) and subjectively (self-reports of dosing). Surveys assessing the smartphone component were completed by participants and study staff. Results: Participants (N = 49) reported taking 93.6% of the dispensed BRP doses while 86.6% of dispensed doses were confirmed via dosing video and in-person observations. Most participants who completed the survey agreed that the smartphone was easy to use (92.6%) and that taking the dosing videos helped to remember to take the study medication (80.5%). Staff agreed that the smartphone helped collect accurate dosing data for most (77.5%) participants. Conclusions: The use of smartphones for video-based oral medication dosing in this study provided a feasible and acceptable mechanism to encourage, monitor, and confirm medication adherence. Video-confirmed dosing adherence provides an objective numerical indicator of the lowest medication adherence rate participants achieve, allowing investigators to more confidently interpret results. [ABSTRACT FROM AUTHOR]

Although 12-Step is increasingly utilized as a recovery resource and is viewed by many addiction specialists as an integral component of treatment and long-term recovery, questions regarding participation and effectiveness of 12-Step programs for women and ethnic minorities have been raised. Utilizing data from the Los Angeles Target Cites Evaluation Project (n = 356), participants in adult outpatient alcohol and drug treatment were followed for 24 months and rates of 12-Step participation and effectiveness were assessed for all gender and ethnic groups. Contrary to reports that 12-Step is more appropriate for European-American males, statistical analyses reveals that women and ethnic minorities are equally likely to attend 12-Step programs, and to recover in conjunction with such participation as European-American males. Although 12-Step may not appeal to all seeking to cease alcohol and drug use, the clinical implications for treatment providers and other addiction specialists points to the benefits of integrating 12-Step components into traditional treatment programs and recommending 12-Step participation for clients of all gender and ethnic groups.

This investigation examines whether the Addicted-Self Model of cessation of alcohol and drug dependent behavior (Fiorentine & Hillhouse, 2000b; in press) is able to predict unassisted or 'natural' recovery. Four hypotheses are tested using a prospective investigation of individuals who drop out in the first week of outpatient treatment, do not re-enter any type of treatment or aftercare, and attend no Twelve-step meetings during the study period (n =78). Consistent with the assumptions of the model, acknowledgement of loss of control over alcohol and drug use, or low controlled use self-efficacy, predicts greater acceptance of the need for life-long abstinence. A decrease in controlled use self-efficacy is associated with an increase in abstinence acceptance. High and increasing abstinence acceptance predicts higher levels of alcohol and drug abstinence. Consistent with the Addicted-Self Model, but contrary to the Relapse Prevention Approach (Marlatt & Gordon, 1980, 1985), high controlled use self-efficacy does not predict less severe relapse or lower levels of alcohol and drug use for those who continue to use these substances. Clinical implications and directions for future research are discussed.

The Addicted-Self Model of the cessation of alcohol- and drug-dependent behaviors is outlined briefly, and five hypotheses consistent with the predictions of the model are examined. All five hypotheses are confirmed, broadening the support for the Addicted-Self Model of recovery. These findings also suggest modifications of the assumptions underlying alcohol and drug expectancy research. These modifications are discussed, and directions for further research are suggested. Key Words. Alcohol and drug recovery; Alcohol and drug relapse; Dependent behavior cessation; Expectancies; Self-efficacy; Transtheoretical model of self-change, This study provides additional support for the Addicted-Self Model of cessation of alcohol- and drug-dependent behavior by examining the relationship between controlled use self-efficacy, negative expectancies, abstinence acceptance, and abstinence, [...]

This study examined the possible effects of client-counselor gender and ethnic congruency on perceived counselor empathy, client engagement in treatment and the maintenance of abstinence during and after out-patient drug treatment. The findings indicate that client-counselor gender and ethnic congruence were significantly associated with higher levels of perceived counselor empathy for all gender, ethnic, and age groups. Contrary to expectation, however, client-counselor gender and ethnic congruence were not consistently associated with higher levels of treatment engagement and abstinence for all gender, ethnic, and age groups. The findings support a recommendation of routinely matching clients to counselors of the same gender for women, Latinos, and clients 35 years or older, but they do not support a recommendation of matching clients to ethnically-congruent counselors, with the possible exception of female clients. The findings also indicate that, with the exception of Latino clients, a policy of matching a client to an empathic counselor regardless of gender or ethnicity of the counselor would lead to a more favorable treatment outcome than would a policy of matching clients solely to gender and ethnically-congruent counselors. This study highlights the need for additional studies examining the client-counselor relationship. Further understanding of this relationship could lead to a greater understanding of the drug treatment process and suggest ways to generally improve the delivery of drug treatment.

The article discusses research which was conducted to compare buprenorphine taper outcomes between prescription opioid and heroin users. Researchers evaluated the differences in outcomes of 90 heroin users and 90 opioid users. They found that a higher percentage of the prescription opioid users provided an opioid free urine sample at the end of the taper.

The article reports on research conducted to investigate the use of the drug buprenorphine plus naloxone with buprenorphine alone for the treatment of pain. Researchers evaluated 12 patients with noncancer pain who received medication intravenously for five days. They found that there were no order effects and no differences between medications in pre-to-post pain ratings, side effects or adverse reactions and that a combination of drugs was not more effective than buprenorphine alone.

Abstract: Evidence suggests that patients on opiate maintenance therapy for the treatment of addiction present with opioid-induced hyperalgesia. This study compared the experimental (cold-pressor, electrical stimulation) pain responses of 82 treatment-seeking heroin-dependent adults, randomized to methadone (METH, n = 11) or buprenorphine (BUP, n = 64) therapy, with matched drug free controls (n = 21). Heroin-dependent participants were evaluated at baseline (treatment entry), medication (METH or BUP) stabilization (4–8 weeks), and chronic administration (12–18 weeks), at trough (just prior to dosing) and peak (3 hours after dosing) plasma levels. Collection of the control group’s pain responses occurred twice during a single session, 3 hours apart. Baseline comparisons indicate that heroin-dependent individuals demonstrate significantly shorter latencies to threshold and tolerance for cold-pressor pain than the control group. Across pain stimuli and time points, little change in pain responses was found over time, the exception being cold pressor pain tolerance, for which hyperalgesia significantly increased at trough METH/BUP levels in both groups as they stabilized in treatment. We conclude that heroin-dependent individuals are hyperalgesic, and that once stabilized in treatment, are not different in pain responses regardless of treatment agent. The effects of nonpharmacologic therapy and previous heroin use may explain increased hyperalgesia found with treatment. Perspective: To better understand the clinical phenomenon of opioid-induced hyperalgesia, this article describes experimental pain responses of heroin-dependent participants both prior to and over the course of maintenance therapy with methadone or buprenorphine. Hyperalgesia is present with illicit and treatment opioid use, and does not appear to appreciably improve over the course of treatment. [Copyright &y& Elsevier]