Conditions: Cocaine Dependence
Keywords: cocaine dependence cocaine abuse cocaine crack
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 108
Healthy volunteers: no

Brief summary:
This study will evaluate the efficacy of ondansetron compared with placebo in the treatment of cocaine dependence.

Detailed description:
We propose to conduct a 9 week randomized, controlled clinical trial to evaluate the efficacy of ondansetron 4 mg twice daily compared with placebo (total N = 100/group × 2 groups = 200 individuals randomized, 400 total subjects will be consented), provided as an adjunct to manual-driven, structured CBT + BBCET in the treatment of cocaine dependence.

Arms:
arm 1: Ondansetron + Cognitive Behavioral Therapy + Brief Behavioral Enhancement Therapy arm 2: Placebo + Cognitive Behavioral Therapy + Brief Behavioral Enhancement Therapy

Interventions: intervention 1: Ondansetron intervention 2: Placebo
Intervention descriptions: intervention 1: 4 mg twice a day + Cognitive Behavioral Therapy + Brief Behavioral Enhancement Therapy intervention 2: twice a day + Cognitive Behavioral Therapy + Brief Behavioral Enhancement Therapy

Protocol document: