At a glance
ClinicalIndex Comparison Record- ✓DSM-IV diagnosis of opioid dependence documented by prior addiction treatment, withdrawal signs, ≥1 year self-reported history, and positive urine opioid test
- ✓DSM-IV diagnosis of cocaine dependence with ≥1 weekly use for ≥1 month prior to entry, positive cocaine urine test, and Severity Dependence Scale score >3
- ✕Dependence on any drugs other than opiates, cocaine, or tobacco
- ✕Current major psychiatric illness including schizophrenia, bipolar disorder, or psychotic disorder
- ✕Current suicidal or homicidal ideation
- ✕Current prescribed psychotropic medication that cannot be discontinued
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Effectiveness of Disulfiram for Treating Cocaine Dependence in Individuals With Different Dopamine Beta Hydroxylase (DBH) Genes
In Brief
A Phase 2 clinical trial evaluating Disulfiram, Methadone, and 2 other interventions for Cocaine Dependence and Opioid Dependence. Completed, enrolled 93 participants across 1 site.
Detailed Summary
Previous research has shown that disulfiram, a medication sometimes used for treating alcoholism, discourages cocaine use among cocaine addicts who are undergoing methadone treatment. By blocking the enzyme dopamine beta hydroxylase (DBH), disulfiram increases levels of dopamine and produces an unpleasant sense of hyperstimulation and discomfort in cocaine users. This study will evaluate the effectiveness of disulfiram in preventing drug relapse among cocaine and opiate addicts with varying inherited levels of DBH.
Study Details
Timeline
Interventions
Disulfiram 250 mg/day by mouth daily during study weeks 2-13. Disulfiram discontinued during study weeks 14-15.
Initial dose 25 mg; increased by 5 mg at each subsequent daily dosing until 60 mg maintenace dose reached.
1-hour weekly, individual, manual-guided Cognitive Behaviorial Therapy.
Lactose was added to both the active disulfiram and placebo doses so they tasted identical.