NIDA Clinical Trials Network CTN-0051, Extended-Release Naltrexone vs. Buprenorphine for Opioid Treatment (X:BOT): Study design and rationale.

Introduction: For opioid-dependent patients in the US and elsewhere, detoxification and counseling-only aftercare are treatment mainstays. Long-term abstinence is rarely achieved; many patients relapse and overdose after detoxification. Methadone, buprenorphine-naloxone (BUP-NX) and extended-release naltrexone (XR-NTX) can prevent opioid relapse but are underutilized.

Predictors of 12-Step Attendance and Participation for Individuals With Stimulant Use Disorders.

Objective: Few studies have examined the effectiveness of 12-step peer recovery support programs with drug use disorders, especially stimulant use, and it is difficult to know how outcomes related to 12-step attendance and participation generalize to individuals with non-alcohol substance use disorders (SUDs).

Method: A clinical trial of 12-step facilitation (N=471) focusing on individuals with cocaine or methamphetamine use disorders allowed examination of four questions: Q1) To what extent do treatment-seeking stimulant users use 12-step programs and, which ones? Q2) Do factors previously found to predict 12-step participation among those with alcohol use disorders also predict participation among stimulant users? Q3) What specific baseline "12-step readiness" factors predict subsequent 12-step participation and attendance? And Q4) Does stimulant drug of choice differentially predict 12-step participation and attendance?

Results: The four outcomes variables, attendance, speaking, duties at 12-step meetings, and other peer recovery support activities, were not related to baseline demographic or substance problem history or severity. Drug of choice was associated with differential days of Alcoholics Anonymous (AA) and Narcotics Anonymous (NA) attendance among those who reported attending, and cocaine users reported more days of attending AA or NA at 1-, 3- and 6-month follow-ups than did methamphetamine users.

Buprenorphine + naloxone plus naltrexone for the treatment of cocaine dependence: the Cocaine Use Reduction with Buprenorphine (CURB) study.

Aims: To 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.

Methods: This 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.

Decision-making processes as predictors of relapse and subsequent use in stimulant-dependent patients.

Background: Decision-making processes have been posited to affect treatment outcome in addicted patients.

Objective: The present multi-site study assessed whether two measures of decision-making predicted relapse and subsequent use in stimulant-dependent patients.

Methods: A total of 160 methamphetamine- or cocaine-dependent patients participating in a multi-site clinical trial evaluating a modified 12-step facilitation intervention for stimulant-dependent patients (STAGE-12) were assessed.

Achieving cannabis cessation -- evaluating N-acetylcysteine treatment (ACCENT): design and implementation of a multi-site, randomized controlled study in the National Institute on Drug Abuse Clinical Trials Network.

Despite recent advances in behavioral interventions for cannabis use disorders, effect sizes remain modest, and few individuals achieve long-term abstinence. One strategy to enhance outcomes is the addition of pharmacotherapy to complement behavioral treatment, but to date no efficacious medications targeting cannabis use disorders in adults through large, randomized controlled trials have been identified. The National Institute on Drug Abuse Clinical Trials Network (NIDA CTN) is currently conducting a study to test the efficacy of N-acetylcysteine (NAC) versus placebo (PBO), added to contingency management, for cannabis cessation in adults (ages 18-50).

Multisite, randomized, double-blind, placebo-controlled pilot clinical trial to evaluate the efficacy of buspirone as a relapse-prevention treatment for cocaine dependence.

Objective: To evaluate the potential efficacy of buspirone as a relapse-prevention treatment for cocaine dependence.

Method: A randomized, double-blind, placebo-controlled, 16-week pilot trial was conducted at 6 clinical sites between August 2012 and June 2013. Adult crack cocaine users meeting DSM-IV-TR criteria for current cocaine dependence who were scheduled to be in inpatient/residential substance use disorder (SUD) treatment for 12-19 days when randomized and planning to enroll in local outpatient treatment through the end of the active treatment phase were randomized to buspirone titrated to 60 mg/d (n = 35) or placebo (n = 27).

A randomized pilot clinical trial to evaluate the efficacy of Community Reinforcement and Family Training for Treatment Retention (CRAFT-T) for improving outcomes for patients completing opioid detoxification.

Background: Detoxification with psychosocial counseling remains a standard opioid-use disorder treatment practice but is associated with poor outcomes. This study tested the efficacy of a newly developed psychosocial intervention, Community Reinforcement Approach and Family Training for Treatment Retention (CRAFT-T), relative to psychosocial treatment as usual (TAU), for improving treatment outcomes.

Methods: A randomized, 14-week trial with follow-up visits at 6 and 9 months post-randomization conducted at two substance use disorder (SUD) treatment programs.

Parenting under the influence: the effects of opioids, alcohol and cocaine on mother-child interaction.

Nearly 20% of adults receiving treatment for a substance use disorder live with their minor children (Stanger et al., 1999) and women in drug use treatment are twice as likely as men to have children in their household (Wechsberg et al., 1998).

A randomized trial of concurrent smoking-cessation and substance use disorder treatment in stimulant-dependent smokers.

Objective: To evaluate the impact of concurrent treatments for substance use disorder and nicotine-dependence for stimulant-dependent patients.

Method: A randomized, 10-week trial with follow-up at 3 and 6 months after smoking quit date conducted at 12 substance use disorder treatment programs between February 2010 and July 2012. Adults meeting DSM-IV-TR criteria for cocaine and/or methamphetamine dependence and interested in quitting smoking were randomized to treatment as usual (n = 271) or treatment as usual with smoking-cessation treatment (n = 267).

A tale of two stimulants: mentholated cigarettes may play a role in cocaine, but not methamphetamine, dependence.

Background: Research suggests that mentholated cigarettes may play a role in cocaine dependence. The purpose of the present study was to expand upon the research on mentholated cigarettes and cocaine dependence and to evaluate the role of mentholated cigarettes in methamphetamine dependence.

Methods: Secondary analysis of a multisite, randomized trial evaluating the impact of smoking-cessation treatment in stimulant-dependent outpatients (N=538).

Intervention with substance-abusing runaway adolescents and their families: results of a randomized clinical trial.

Objectives: To examine the efficacy of 3 theoretically distinct interventions among substance-abusing runaway adolescents and to explore individual differences in trajectories of change.

Method: Adolescents (N = 179) between the ages of 12 and 17 were recruited from a runaway shelter in a midwestern city. The sample included 94 females (52.

Stimulant abuser groups to engage in 12-step: a multisite trial in the National Institute on Drug Abuse Clinical Trials Network.

Aims: The study evaluated the effectiveness of an 8-week combined group plus individual 12-step facilitative intervention on stimulant drug use and 12-step meeting attendance and service.

Design: Multisite randomized controlled trial, with assessments at baseline, mid-treatment, end of treatment, and 3- and 6-month post-randomization follow-ups (FUs).

Setting: Intensive outpatient substance treatment programs.

Helping alliance, retention, and treatment outcomes: a secondary analysis from the NIDA Clinical Trials Network Women and Trauma Study.

We examined the association between the therapeutic alliance and treatment outcomes among 223 women with posttraumatic stress disorder (PTSD) and substance use disorders who participated in a multisite clinical trial of group treatments for trauma and addictions in the United States throughout 2004 and 2005. General linear models indicated that women who received Seeking Safety, a cognitive-behavioral treatment, had significantly higher alliance ratings than those in Women's Health Education, a control group. Alliance was related to significant decreases in PTSD symptoms and higher attendance in both interventions.

How practice and science are balanced and blended in the NIDA Clinical Trials Network: the bidirectional process in the development of the STAGE-12 protocol as an example.

Background: Bidirectional, collaborative partnerships between academic researchers and practitioners have been a fundamental vehicle to achieve the National Institute on Drug Abuse (NIDA) Clinical Trials Network (CTN) goal of improving outcomes of community-based drug treatment. These partnerships blend clinical perspectives of practitioners and methodological expertise of researchers working together to address clinically meaningful issues through randomized clinical trials conducted in community treatment settings.

Objectives: Bidirectionality is a guiding principle of the CTN, but its operationlization at the practical level in protocol development and implementation has not been articulated.

Primary outcome indices in illicit drug dependence treatment research: systematic approach to selection and measurement of drug use end-points in clinical trials.

Aims: Clinical trials test the safety and efficacy of behavioral and pharmacological interventions in drug-dependent individuals. However, there is no consensus about the most appropriate outcome(s) to consider in determining treatment efficacy or on the most appropriate methods for assessing selected outcome(s). We summarize the discussion and recommendations of treatment and research experts, convened by the US National Institute on Drug Abuse, to select appropriate primary outcomes for drug dependence treatment clinical trials, and in particular the feasibility of selecting a common outcome to be included in all or most trials.

Impact of attention-deficit/hyperactivity disorder (ADHD) treatment on smoking cessation intervention in ADHD smokers: a randomized, double-blind, placebo-controlled trial.

Objective: High smoking rates in adults with attention-deficit/hyperactivity disorder (ADHD) and nicotine's amelioration of ADHD suggest that effective ADHD treatment might facilitate abstinence in smokers with ADHD. The present study evaluated if using osmotic-release oral system methylphenidate (OROS-MPH) to treat ADHD enhances response to smoking cessation treatment in smokers with ADHD.

Method: A randomized, double-blind, placebo-controlled, 11-week trial with a 1-month follow-up was conducted at 6 clinical sites between December 2005 and January 2008.

Do treatment improvements in PTSD severity affect substance use outcomes? A secondary analysis from a randomized clinical trial in NIDA's Clinical Trials Network.

Objective: The purpose of the analysis was to examine the temporal course of improvement in symptoms of posttraumatic stress disorder (PTSD) and substance use disorder among women in outpatient substance abuse treatment.

Method: Participants were 353 women randomly assigned to 12 sessions of either trauma-focused or health education group treatment. PTSD and substance use assessments were conducted during treatment and posttreatment at 1 week and after 3, 6, and 12 months.

Multisite randomized trial of behavioral interventions for women with co-occurring PTSD and substance use disorders.

The authors compared the effectiveness of the Seeking Safety group, cognitive-behavioral treatment for substance use disorder and posttraumatic stress disorder (PTSD), to an active comparison health education group (Women's Health Education [WHE]) within the National Institute on Drug Abuse's Clinical Trials Network. The authors randomized 353 women to receive 12 sessions of Seeking Safety (M = 6.2 sessions) or WHE (M = 6.

Choosing a control group in effectiveness trials of behavioral drug abuse treatments.

Effectiveness trials are an important step in the scientific process of developing and evaluating behavioral treatments. The focus on effectiveness research presents a different set of requirements on the research design when compared with efficacy studies. The choice of a control condition has many implications for a clinical trial's internal and external validity.

12-step participation as a pathway to recovery: the Maryhaven experience and implications for treatment and research.

Maryhaven, a comprehensive, community-based drug abuse treatment facility, combines a core commitment to 12-step principles and practices with the use of scientifically derived treatment interventions. Treatment goals at Maryhaven include abstinence from substance abuse, patient engagement and progress in 12-step activities, and strong patient affiliation with 12-step organizations within the community. The author discusses the reasons why Maryhaven takes this approach, describes the program's use of empirically derived treatment tools to further 12-step objectives, argues that there are natural affinities between 12- step and some empirical treatment tools such as the Stages of Change model, and suggests research projects that he believes can improve treatment and illuminate the mechanisms by which 12-step activities help patients overcome addiction.

Addressing smoking in community drug abuse treatment programs: practical and policy considerations.

Smoking is the leading cause of preventable death in the United States. This public health problem is of particular concern among individuals with substance use disorders in that they smoke at a greater rate than the general public. Smoking-related illness represents a major source of preventable death in persons with drug dependencies.

Using buprenorphine short-term taper to facilitate early treatment engagement.

The U.S. Federal Food and Drug Administration approved buprenorphine for drug abuse treatment in 2002, and it became available for clinical use in early 2003.

Disseminating evidence-based practices in substance abuse treatment: a review with suggestions.

Although substance abuse professionals are generally open to new and better therapeutic methods, most evidence-based treatments do not easily find their way into practice. Natural diffusion processes for innovations in substance abuse treatments are relatively informal and have yielded a widely acknowledged gap between science and community practice. This review focuses on methods for effectively disseminating new treatment methods into practice.