NCT00689572

New Medication Treatment for Stimulant Dependence

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 108 (actual)
• Sponsor: University of Virginia · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Cocaine Dependence

Interventions

Type	Name	Description
DRUG	Ondansetron	4 mg twice a day + Cognitive Behavioral Therapy + Brief Behavioral Enhancement Therapy
DRUG	Placebo	twice a day + Cognitive Behavioral Therapy + Brief Behavioral Enhancement Therapy

Timeline

• Start date: 2008-07-01
• Primary completion: 2013-12-01
• Completion: 2013-12-01
• First posted: 2008-06-03
• Last updated: 2021-11-11
• Results posted: 2021-11-11

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study