Phase 1
N=99
CBT With Disulfiram and Contingency Management
Cocaine Abuse
Bottom Line
View on ClinicalTrials.gov: NCT00350870 ↗Enrolled (actual)
99
Serious AEs
34.3%
Results posted
Dec 2014
Primary outcome: Primary: Change in Cocaine Use by Self Report — 72.2; 79.2; 91.1; 69.6 percentage of days abstinent
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- disulfiram (Drug); Placebo (Drug); Placebo plus Contingency Management (Behavioral); Disulfiram plus Contingency Management (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Yale University
- Primary completion
- Dec 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Cocaine Use by Self Report |
72.2; 79.2; 91.1; 69.6 | — |
| PRIMARY Change in Cocaine Use by Urine Toxicology Results |
17.9; 30.1; 53; 42.6 | — |
Summary
This is a study of four treatments for chronic cocaine use and may help study participants to control their drug use. All participants will receive weekly individual cognitive behavioral therapy (CBT).
Eligibility Criteria
Inclusion Criteria
- 18-50 year old
- cocaine dependent
- willing to sign consent
- willing to accept randomization to intervention
Exclusion Criteria
- significant medical conditions
- psychiatric disorder with current use of prescribed psychotropic medication
- lifetime schizophrenia or bipolar disorder
- suicidality or homicidality
- unlikely to be able to complete 1 year follow up
- unable to speak or read English at a third grade level
Data sourced from ClinicalTrials.gov (NCT00350870). 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.