VIVITROL as a Treatment for Cocaine & Alcohol Dependence

Status Completed

Clinical Trial Summary

To evaluate the efficacy of VIVITROL (naltrexone for extended-release injectable suspension) for the treatment of co-occurring cocaine and alcohol dependence

Clinical Trial Description

This is a Phase II double-blind randomized controlled clinical pilot study. The exploratory objectives in the proposed study will be examined with a 2-group design to assess the efficacy of naltrexone extended-release injectable suspension (VIVITROL™) as compared to placebo. Safety measures will be collected weekly through medical management (MM) by medical practitioners, including adverse events and concomitant meds. The psychosocial treatment will be Cognitive Behavioral Coping Skills Therapy (CBT). Subjects will be 80 men and women with current DSM-IV diagnoses of alcohol dependence and cocaine dependence that will be randomized to receive either VIVITROL or placebo (40 subjects per group). All subjects will receive weekly sessions of CBT and MM. The study length for each subject is comprised of 1-3 weeks of screening, an 8-week double-blind, placebo-controlled trial with MM and CBT (medication phase), and an end of medication visit.

Primary Exploratory Objectives:

- To compare medication groups' rates of cocaine abstinence, as determined by urine assay for benzoylecgonine (BE), the primary metabolite of cocaine. This will be cross-checked against participants' self-reports of cocaine use through Time-Line Follow Back (TLFB)(Sobell & Sobell, 1992).

- To compare medication groups' rates of abstinence from drinking, and of clinically significant drinking, as measured by the TLFB.

Secondary Exploratory Objectives:

- To evaluate medication groups' reports of craving for cocaine and alcohol, as measured by scores on the Penn Alcohol Craving Scale and the Minnesota Cocaine Craving Scale during the medication treatment phase.

- To compare women's reports of medication tolerance of naltrexone extended-release injectable suspension versus high dose oral naltrexone that was reported in our recently published pilot trial of high dose naltrexone for dual cocaine and alcohol dependence (Pettinati et al., 2008). ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT00777062
Study type	Interventional
Source	University of Pennsylvania
Contact
Status	Completed
Phase	Phase 2
Start date	July 2009
Completion date	September 2013

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

VIVITROL as a Treatment for Cocaine and Alcohol Dependence

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms