New Medication Treatment for Stimulant Dependence

Phase 2

Completed

• Conditions: Cocaine Dependence
• Interventions: Drug: Placebo; Drug: Ondansetron

• Registration Number: NCT00689572
• Lead Sponsor: University of Virginia

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.

Study Timeline

• Study First Submitted: 2008-05-29
• Study First Submitted QC: 2008-05-29
• Study First Posted: 2008-06-03
• Study Start: 2008-07
• Primary Completion: 2013-12
• Study Completion: 2013-12
• Results First Submitted: 2021-03-26
• Status Verified: 2021-08
• Results First Submitted QC: 2021-10-15
• Last Update Submitted: 2021-10-15
• Results First Posted: 2021-11-11
• Last Update Posted: 2021-11-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 108

Inclusion Criteria

• Males and females who have given written informed consent.
• Ages 18 years and above and, must weigh at least 40 Kg and no more than 140 Kg.
• Good physical health as determined by a complete physical examination, an EKG within normal limits, and laboratory screening tests within acceptable parameters.
• Current DSM-IV diagnosis of cocaine dependence.
• At least one positive urine drug screen for cocaine at screen or baseline prior to randomization.
• The pregnancy test for females at intake must be negative.
• Literacy in English and ability to read, understand, and complete the ratings scales and questionnaires accurately, follow instructions, and make use of the behavioral treatments.
• Answered an advertisement in the newspaper/radio/television, and expressing a wish to stop using cocaine.
• Willing to participate in behavioral treatments for cocaine dependence.

Exclusion Criteria

Please contact site for additional information

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Placebo + Cognitive Behavioral Therapy + Brief Behavioral Enhancement Therapy
Ondansetron	Ondansetron	Ondansetron + Cognitive Behavioral Therapy + Brief Behavioral Enhancement Therapy

Primary Outcome Measures

Name	Time	Method
Cocaine Use by Self-report	up to 9 weeks	Participants were assessed up to three times weekly for up to 9 weeks to evaluate cocaine use by self-report
Cocaine Use by Urine Benzoylecgonine	up to 9 weeks	Urine samples were collected up to three times weekly for up to 9 weeks to test for the major cocaine metabolite benzoylecgonine

Trial Locations

Locations (1)

University of Virginia Center for Addiction Research and Education; 🇺🇸 Richmond, Virginia, United States