Division
HEAL Study
Investigator(s)
Title
Phase 2, Double-Blind, Placebo-Controlled Trial Of Modafinil For The Treatment Of Cocaine Dependence
Short Description
To evaluate the efficacy and safety of modafinil relative to placebo in reducing cocaine use in subjects with cocaine dependence as assessed by self-report confirmed with urine assays for benzoylecgonine (BE).
Release Date
Sep 02, 2015
Description

The primary objective of this study is to evaluate the efficacy of modafinil relative to placebo in increasing the weekly mean proportion of cocaine non-use days over the treatment period as determined by self-report of cocaine use confirmed with urine assays for BE.

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Division
HEAL Study
Investigator(s)
Title
Phase 2, Double-Blind, Placebo-Controlled Trial Of Reserpine For The Treatment Of Cocaine Dependence
Short Description
The purpose of this study is to assess the efficacy and safety of reserpine for the treatment of cocaine dependence.
Release Date
Dec 04, 2014
Description

The primary objective of this study is to assess the efficacy of reserpine in reducing cocaine use in subjects with cocaine dependence (DSM-IV criteria). The hypothesis is that reserpine will increase the weekly mean proportion of cocaine non-use days over the treatment period when compared to placebo as determined by self-report of cocaine use confirmed with urine assays for BE.

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Division
HEAL Study
Investigator(s)
Title
A Randomized Controlled Evaluation of Buspirone for Relapse-Prevention in Adults with Cocaine Dependence (BRAC)
Short Description
A randomized study to evaluate the efficacy of buspirone, relative to placebo, in preventing relapse in cocaine-dependent adults in inpatient/residential treatment.
Release Date
May 14, 2014
Description

This was a randomized, controlled pilot trial in which 62 inpatient/residential participants were recruited from six sites to participate in a study comparing buspirone to placebo. The purpose of this study was to evaluate buspirone's efficacy, relative to placebo, in blocking reinstatement of cocaine use as assessed by the maximum days of continuous cocaine abstinence, as assessed by twice-weekly UDS and self-report, during study weeks 4-15. The study also evaluated the impact of buspirone, relative to placebo, on other drug-abuse outcomes and on factors that may mediate buspirone’s efficacy as a relapse-prevention treatment.

Division
HEAL Study
Investigator(s)
Title
Cocaine Use Reduction with Buprenorphine (CURB)
Short Description
A randomized study to test the safety and effectiveness of buprenorphine in the presence of naltrexone for the treatment of cocaine dependence.
Release Date
Apr 24, 2015
Description

This was a randomized, controlled trial that enrolled 302 cocaine-dependent participants who had either past-year opioid dependence or past-year opioid abuse or past-year opioid use with a history of opioid dependence during the lifetime. Participants were randomized to one of three treatment arms: 1) placebo plus naltrexone, 2) 4mg buprenorphine plus naltrexone, and 3) 16mg buprenorphine plus naltrexone. Participants received 8 weeks of pharmacotherapy, with thrice weekly clinic visits. The primary aim of the study was to compare the number of cocaine use days during the 30-day evaluation period (the final 30 days of active medication administration prior to taper; days 25-54) amongst the treatment groups. The study also evaluated a number of secondary outcome measures.

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Division
HEAL Study
Title
Smoking-Cessation and Stimulant Treatment (S-CAST): Evaluation of the Impact of Concurrent Outpatient Smoking-Cessation and Stimulant Treatment on Stimulant-Dependence Outcomes
Short Description
A randomized study to evaluate the impact of substance-abuse treatment as usual plus smoking-cessation treatment (TAU+SCT), relative to substance-abuse treatment as usual (TAU), on drug-abuse outcomes
Release Date
Nov 19, 2013
Description

This was a randomized, controlled trial in which 538 participants were recruited from 12 sites to participate in a study comparing treatment as usual plus smoking-cessation (TAU+SCT) to substance abuse treatment as usual alone (TAU). The purpose of this study was to evaluate whether concurrent smoking-cessation treatment improves, worsens, or has no effect on stimulant-use outcomes in smokers who are in outpatient substance-abuse treatment for cocaine or methamphetamine dependence. The study also evaluated: 1. the impact of TAU+SCT, relative to TAU, on other drug-abuse outcomes; 2. the efficacy of TAU+SCT, relative to TAU, in improving smoking outcomes; and 3. whether achieving complete smoking abstinence is associated with improved stimulant use outcomes.

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Deidentification Notes
Division
HEAL Study
Investigator(s)
Title
Web-delivery of Evidence-Based, Psychosocial Treatment for Substance Use Disorders
Short Description
A randomized study to evaluate the effectiveness of including an interactive, web-based version of the Community Reinforcement Approach (CRA) intervention plus incentives targeting drug abstinence and treatment participation as part of community-based, outpatient substance abuse treatment.
Release Date
May 14, 2014
Description

This was a randomized, controlled trial in which 507 participants in outpatient treatment for substance use disorders were recruited from ten sites to participate in a study comparing 1) treatment as usual (TAU) to 2) a modification of TAU, which included access to the Therapeutic Education System (TES), a computerized psychosocial intervention which combines skill building modules based on the Community Reinforcement Approach (CRA) with incentives contingent upon abstinence from drugs and completion of TES modules. The purpose of this study was to evaluate the relative effectiveness of the interventions on the primary outcomes of a) drug abstinence during active treatment and b) treatment retention. The study also evaluated a number of secondary outcome measures.

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Division
HEAL Study
Investigator(s)
Title
Stimulant Reduction Intervention using Dosed Exercise (STRIDE)
Short Description
A randomized study to test the effectiveness of the addition of exercise to treatment as usual in improving drug treatment outcomes.
Release Date
Apr 24, 2015
Description

This was a randomized, controlled trial that enrolled 302 participants diagnosed with stimulant abuse or dependence that began substance use treatment in a residential setting. Participants were randomized to one of two treatment arms: 1) usual care augmented with Vigorous Intensity High Dose Exercise (VIHD) and 2) usual care augmented with Health Education Intervention (HEI). Participants received three months of acute phase intervention followed by an additional six months of intervention with less frequent supervision. The primary aim of the study was to compare percent days of abstinence between the VIHD and HEI groups based on stimulant use during the 12-week acute phase. The study also evaluated a number of secondary outcome measures.

Keywords
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Division
HEAL Study
Title
Project Aware: HIV Rapid Testing & Counseling in STD Clinics in the U.S. – an Adaptation of CTN-0032
Short Description
A randomized study to assess the relative effectiveness and cost-effectiveness of 1) on-site HIV rapid testing with brief, participant-tailored prevention counseling vs. 2) on-site HIV rapid testing with information only in individuals seeking medical or health services at STD clinics.
Release Date
Jul 03, 2014
Description

This was a randomized, controlled trial in which 5012 participants seeking medical or health services from nine STD clinics were enrolled in a study comparing 1) on-site HIV rapid testing with brief, participant-tailored prevention counseling vs. 2) on-site HIV rapid testing with information only. The purpose of this study was to explore whether the provision of counseling reduced risk behavior and sexually transmitted infections over time. In addition to HIV, participants were screened for sexually transmitted infections at the baseline visit and the 6-month follow-up visit.

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Division
HEAL Study
Investigator(s)
Title
HIV Rapid Testing and Counseling in Drug Abuse Treatment Programs in the U.S.
Short Description
To evaluate the more effective strategy to increase receipt of HIV test results and decrease sexual risk behaviors that lead to HIV transmission and acquisition among individuals receiving drug treatment within community-based drug abuse treatment programs in the United States.
Release Date
Nov 02, 2011
Description

This was a randomized, controlled clinical trial in which 1,281 adults receiving drug abuse treatment were recruited from 12 sites to participate in an HIV testing and counseling study. The purpose of this study was to assess the relative effectiveness of three HIV testing strategies on increasing receipt of test results: (1) on-site HIV rapid testing with brief, participant-tailored prevention counseling, (2) on-site HIV rapid testing with information only, and (3) referral for off-site HIV testing. The study also assessed the effectiveness of the three testing strategies in reducing HIV risk behaviors. Injection drug risk behavior was also assessed.

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Deidentification Notes
Division
HEAL Study
Title
An Evaluation of Neurocognitive Function, Oxidative Damage, and Their Association With Treatment Outcomes in Methamphetamine and Cocaine Abusers
Short Description
An ancillary study to CTN-0031 to replicate the finding that performance on the STROOP color-word interference task is predictive of treatment completion in participants with cocaine use disorders and to extend this finding to participants with methamphetamine use disorders.
Release Date
Nov 26, 2013
Description

This was an ancillary study to CTN-0031, a randomized controlled trial of Stimulant Abuser Groups to Engage in 12-Step (STAGE-12). 219 participants from 3 sites who were randomized in the CTN-0031 study were eligible for the ancillary study, in which neurocognitive testing was performed and a blood sample was obtained for the assessment of oxidative stress/damage. The purpose of the ancillary study was to replicate the finding that performance on the Stroop color-word interference task is predictive of treatment completion in participants with cocaine use disorders and to extend this finding to participants with methamphetamine use disorders. The study also evaluated performance on additional neurocognitive measures and the level of oxidative damage and the impact of each of these on stimulant use outcomes.

Keywords
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Deidentification Notes