NCT00913484

Disulfiram for Cocaine Abuse in Buprenorphine Treatment

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 177 (actual)
• Sponsor: Yale University · Academic / Other
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Not accepted

Summary

The investigators are proposing a placebo-controlled clinical trial to evaluate the efficacy and potential mechanisms of action of disulfiram (versus placebo) for treating cocaine abuse in subjects with concurrent opiate dependence and cocaine abuse or dependence maintained on buprenorphine/naloxone combination.

Detailed description

The Specific Aims and hypotheses for the proposed study are as follows: 1. To compare the efficacy of disulfiram versus placebo for the treatment of buprenorphine maintained patients with concurrent opioid and cocaine dependence. Study hypothesis 1 is that disulfiram is superior to placebo. 2. To evaluate whether dopamine-B-hydroxylase (DBH) genotypes associated with high, intermediate or low enzyme activity predict responses to disulfiram treatment of cocaine use in buprenorphine treated subjects. Study hypothesis 2 is that disulfiram efficacy is higher in subjects with low DBH compared to subjects with high DBH. 3. To explore whether baseline measures of alcohol use predict response to disulfiram. Study Hypothesis 3 is that the effects of disulfiram on cocaine use are independent of the severity of baseline alcohol use.

Conditions

• Cocaine Dependence
• Opioid Dependency

Interventions

Type	Name	Description
DRUG	Disulfiram	Disulfiram 250 mg per day
DRUG	Placebo	Placebo daily

Timeline

• Start date: 2000-10-01
• Primary completion: 2004-02-01
• Completion: 2004-02-01
• First posted: 2009-06-04
• Last updated: 2020-11-19

Locations

2 sites across 1 country: United States