Phase 2
N=74
Pharmacogenetics of Disulfiram for Cocaine
Cocaine Dependence · Opioid Dependence
Bottom Line
View on ClinicalTrials.gov: NCT00149630 ↗Enrolled (actual)
74
Serious AEs
0.0%
Results posted
Dec 2012
Primary outcome: Primary: Urine Toxicology for Cocaine. — 84; 68; 56; 67 % cocaine + urines over 2 week blocks
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Disulfiram (Drug); Methadone (Drug); CBT (Behavioral); Lactose (Other)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Baylor College of Medicine
- Primary completion
- Dec 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Urine Toxicology for Cocaine. |
84; 68; 56; 67 | — |
| SECONDARY Retention by Treatment Condition. |
77; 87 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Meets DSM-IV diagnosis criteria for opioid dependence, as determined by documentation of prior treatment for addiction; signs of withdrawal; self-reported history of dependence for at least 1 year; and a positive urine test for opioids
- Meets DSM-IV diagnosis criteria for cocaine dependence, as determined by self-reported use of cocaine at least once weekly for at least 1 month prior to study entry; a positive urine test for cocaine; and a score greater than 3 on the Severity Dependence Scale
- If female, willing to use contraception throughout the study
Exclusion criteria
- Meets DSM-IV diagnosis criteria for dependence on any drugs other than opiates, cocaine, or tobacco
- Current major psychiatric illness, including schizophrenia, bipolar disorder, or other psychotic disorder
- Current suicidal or homicidal ideation
- Current use of a prescribed psychotropic medication that cannot be discontinued
- History of or current major medical illness, including major heart, kidney, endocrine, or liver disorder; abnormal liver function (SGOT or SGPT levels three times greater than normal);
- High risk factor for heart disease, seizure disorders, or any illness for which disulfiram or methadone treatment would be inadvisable
- Currently taking metronidazole or clotrimazole
- Pregnant or breastfeeding
Data sourced from ClinicalTrials.gov (NCT00149630). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.