Division
HEAL Study
Title
Double-Blind, Placebo-Controlled Trial Of Selegiline Transdermal System For The Treatment Of Cocaine Dependence
Short Description
To assess the efficacy and safety of the Selegiline Transdermal System (STS) in reducing cocaine use in subjects with cocaine dependence. It is hypothesized that selegiline 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 randomized controlled trial is the assessment of the efficacy of STS in reducing cocaine use in subjects with cocaine dependence (DSM-IV criteria). The hypothesis is that STS will reduce the weekly mean proportion of cocaine non-use days relative to placebo as determined by self report of use confirmed with urine assays for BE.  Secondary objectives include assessing the reduction in the overall proportion of non-use days and the proportion of subjects that achieve measured reductions in cocaine and other drugs use, the reduction in the severity of cocaine dependence and craving, and severity of depression (HAM-D), and the safety of STS in the study population.

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Division
HEAL Study
Investigator(s)
Title
Extended-Release Naltrexone vs. Buprenorphine for Opioid Treatment
Short Description
Assess the comparative effectiveness of extended release injectable naltrexone (XR-NTX, Vivitrol®), an opioid antagonist recently approved and indicated for the prevention of relapse to opioid dependence, versus buprenorphine-naloxone (BUP-NX, Suboxone®), a high affinity partial agonist indicated for maintenance treatment of opioid dependence, as pharmacotherapeutic aids to recovery.
Release Date
Jan 12, 2018
Description

The primary goal of the study is to estimate the difference, if one exists, between XR-NTX and BUP-NX in the distribution of the time to relapse (i.e.., loss of persistent abstinence) during the 6-month trial. Secondary objectives are to: (1) compare outcome on XR-NTX versus BUP-NX across a range of clinical safety and secondary efficacy domains, and (2) explore demographic and, clinical, and genetic predictors of successful treatment and moderators of differential effectiveness (i.e., what variables may help clinicians choose which of these treatments is best for a given patient), and (3) collect a limited dataset to permit analyses of economic costs and benefits of the two treatments. The study is conducted in 8 NIDA Clinical Trials Network affiliated community based treatment programs. Up to 600 eligible participants will be randomized to treatment with XR-NTX or BUP-NX for 24 weeks (sufficient to include 350 participants who are randomized more than 72 hours after their last opioid).

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Division
HEAL Study
Investigator(s)
Title
Phase I, Double-Blind, Placebo-Controlled Assessment Of Potential Interactions Between Intravenous Cocaine And Ethanol And Oral Disulfiram
Short Description
The primary outcome measures to address the safety of disulfiram treatment are adverse events, changes in cardiac (ECG) and cardiovascular responses (HR, BP) and observations of significant negative psychiatric effects (mPSRS, as well as POMS and self-rated DER) from disulfiram, ethanol and cocaine.
Release Date
Dec 21, 2017
Description

The primary study objective is to assess the safety of disulfiram as a putative cocaine treatment agent by increasing our understanding of how disulfiram alters the cocaine response and how the addition of small doses of ethanol may alter this cocaine response. Satisfaction of this objective is required before the FDA will consider approval of further clinical trials with disulfiram treatment for cocaine dependence.

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Division
HEAL Study
Investigator(s)
Title
Double-Blind, Placebo-Controlled Assessment of Interactions Between Intravenous Methamphetamine and Modafinil
Short Description
Study to assess the potential interactions between intravenous methamphetamine and oral Modafinil
Release Date
Dec 21, 2017
Description

The primary aims of this study are to determine if there are significant safety interactions between oral modafinil and intravenous methamphetamine. Safety will be assessed by measuring adverse events and cardiovascular responses of heart rate (HR), blood pressure (BP), and electrocardiogram (ECG) and stroke distance (ICG).

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