Division
HEAL Study
Title
Screening, Motivational Assessment, Referral, and Treatment in Emergency Departments (SMART-ED)
Short Description
A randomized study to assess the impact of screening, referral to treatment, and brief intervention on substance use and substance-related outcomes among participants endorsing problematic substance use during an emergency department (ED) visit.
Release Date
Sep 02, 2014
Description

This was a randomized, controlled trial that enrolled 1285 participants who were identified with problematic substance use during an ED visit. Participants were randomized to one of three treatment arms: 1) minimal screening only (MSO), 2) screening, assessment, and referral to treatment (SAR), and 3) screening, assessment, and referral plus a brief intervention (BI) with two telephone follow-up booster sessions (BI-B). Follow-up assessments of all three groups were conducted at 3, 6, and 12 months post-randomization. The primary aim of the study was to compare the days of use of the patient-defined primary problem drug, assessed by the Time-Line Follow-Back, for the 30-day period preceding the 3-month follow-up between the three treatment arms. The study also evaluated a number of secondary outcome measures.

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Division
HEAL Study
Investigator(s)
Title
Reducing HIV/STD Risk Behaviors: A Research Study for Men in Drug Abuse Treatment
Short Description
To study a program for men in drug abuse treatment designed to build safer sexual skills and reduce unprotected sexual risk behavior.
Release Date
Oct 02, 2008
Description

Drug treatment, itself, can have a powerful positive effect on HIV drug use risk behavior, especially needle use behaviors. However, sexual risk behavior has received less attention and has been shown to be more difficult to change. Research suggests that skills-based HIV risk reduction interventions with peer group discussion and single sex sessions can reduce risky sexual behavior. This study evaluates a five-session HIV risk reduction group therapy designed specifically for heterosexual men. This therapy is compared to one session of HIV education, which is typically provided as standard care in drug treatment clinics. The researchers hypothesize that men in the gender-specific therapy group will report less risky sexual behavior than men in standard therapy. They are also expected to have a more positive attitude towards condom use, be more likely to have condoms, be more likely to have taken condoms from clinic.

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Division
HEAL Study
Investigator(s)
Title
Phase 2, Double-Blind, Placebo-Controlled Trial Of Bupropion For Methamphetamine Dependence
Short Description
This study is to assess the efficacy of bupropion in reducing methamphetamine use in subjects with methamphetamine dependence who report using methamphetamine 29 or less days during the 30 days prior to the start of signing consent.
Release Date
Dec 04, 2014
Description

The primary objective of this study is to assess the efficacy of bupropion in reducing methamphetamine use in subjects with methamphetamine dependence who report using methamphetamine 29 or less days during the 30 day prior to signing consent. It is hypothesized that bupropion, compared to placebo, will be associated with an increase in the proportion of subjects who achieve abstinence (confirmed by at least two methamphetamine negative urines) each week during the last two weeks (Weeks 11 and 12) for non-daily users as the primary outcome.

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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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Protocol
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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