NCT00777062

VIVITROL as a Treatment for Cocaine and Alcohol Dependence

A Phase II, Randomized, Double-Blind Pilot Trial of VIVITROL® (Naltrexone for Extended-Release Injectable Suspension) for the Treatment of Cocaine and Alcohol Dependence

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 80 (actual)
• Sponsor: University of Pennsylvania · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed 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).

Conditions

• Cocaine Dependence
• Alcohol Dependence

Interventions

Type	Name	Description
DRUG	VIVITROL (Naltrexone extended-release injectable suspension)	VIVITROL (Naltrexone extended-release injectable suspension), 380 mg injection at the start of weeks 2 and 6.
DRUG	Placebo	Placebo injection at the start of weeks 2 and 6.

Timeline

• Start date: 2009-07-01
• Primary completion: 2012-07-01
• Completion: 2013-09-01
• First posted: 2008-10-22
• Last updated: 2018-01-26
• Results posted: 2014-01-29

Locations

1 site across 1 country: United States