Division
HEAL Study
Investigator(s)
Title
Phase 2, Double-Blind Placebo-Controlled Trial Of Bupropion for the Treatment of Methamphetamine Dependence
Short Description
The purpose of this study is to assess the efficacy and safety of bupropion in reducing methamphetamine use in subjects with methamphetamine dependence.
Release Date
May 07, 2018
Description

A double-blind, placebo-controlled, parallel-group design study in which 100 subjects will be randomly assigned to placebo or bupropion for 12 weeks with follow-up assessments 4 weeks following treatment. Adaptive randomization will be used to balance treatment groups based on gender.

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Positive and Negative Affect Schedule

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Abbreviation
PANAS
Description

The Positive and Negative Affect Schedule (PANAS) measures the two primary dimensions of mood: Positive affect reflects the extent to which a person feels enthusiastic, active, and alert; negative affect is a general dimension of subjective distress and unpleasurable engagement that subsumes a variety of aversive mood states. The PANAS consists of 10 positive affects (interested, excited, strong, enthusiastic, proud, alert, inspired, determined, attentive, and active) and 10 negative affects (distressed, upset, guilty, scared, hostile, irritable, ashamed, nervous, jittery, and afraid). Participants are asked to rate items on a scale from 1 to 5, based on the strength of emotion where 1 = "very slightly or not at all," and 5 = "extremely."

Category
Mental Health
Subcategory
General/Multiple Disorders

Wisconsin Smoking Withdrawal Scale

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Abbreviation
WSWS
Description

This 28-item scale was developed to contain reliable subscales tapping the major symptom elements of the nicotine withdrawal syndrome. It uses seven internally consistent subscales: anger, anxiety, sadness, concentration, sleep, hunger, and craving. Respondents rate each statement on a scale ranging from 0 (strong disagree) to 4 (strongly agree). The WSWS is sensitive to smoking withdrawal and predictive of smoking cessation outcomes, and its brevity makes it useful in both the clinical and research context.

Category
Substance Use
Subcategory
Tobacco
Division
HEAL Study
Title
Phase 2, Double-Blind, Placebo-Controlled Trial Of Selegiline Transdermal System (STS) As An Aid For Smoking Cessation
Short Description
The objectives of this study are to determine the efficacy and safety of selegiline transdermal system (STS) and brief behavioral intervention for smoking cessation in heavy smokers.
Release Date
May 07, 2018
Description

Determine the efficacy of STS with brief behavioral therapy (the investigational intervention) for smoking cessation in heavy smokers. It is hypothesized that the quit rate at the end of treatment for subjects who receive STS with behavioral intervention will be greater than the quit rate for subjects in the placebo patch control group with behavioral intervention.  Determine the safety of the investigational intervention for smoking cessation in heavy smokers as assessed by adverse events, weight gain/loss, vital signs, ECG, and clinical laboratory assessments.

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Division
HEAL Study
Investigator(s)
Title
Double-Blind, Placebo-Controlled Multi-Center Trial Of Baclofen For The Treatment Of Cocaine Dependence
Short Description
To assess the efficacy and safety of baclofen in reducing cocaine use in subjects with cocaine dependence. It is hypothesized that baclofen treatment, compared to placebo, will be associated with fewer days of cocaine use as assessed by self-report confirmed with urine assays for benzoylecgonine (BE).
Release Date
May 07, 2018
Description

The primary objective of this study is to assess the efficacy of baclofen in reducing cocaine use in subjects with cocaine dependence (DSM-IV criteria). The hypothesis is that baclofen will reduce cocaine use over the treatment period as compared to placebo as determined by selfreport confirmed with urine assays for BE.

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Study Data
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Study Documents
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Deidentification Notes