New Medication Treatment for Stimulant Dependence

Cocaine Dependence Clinical Trial

Official title:

New Medication Treatment for Stimulant Dependence

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00689572
• Other study ID #: 13419
• Secondary ID: 1R01DA021776-01A
• Status: Completed
• Phase: Phase 2
• Start date: July 2008
• Est. completion date: December 2013

Study information

• Verified date: August 2021
• Source: University of Virginia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 108
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cocaine Dependence
• Cocaine-Related Disorders

Intervention

Drug:
• Ondansetron
4 mg twice a day + Cognitive Behavioral Therapy + Brief Behavioral Enhancement Therapy
• Placebo
twice a day + Cognitive Behavioral Therapy + Brief Behavioral Enhancement Therapy

Locations

Country	Name	City	State
United States	University of Virginia Center for Addiction Research and Education	Charlottesville	Virginia
United States	University of Virginia Center for Addiction Research and Education	Richmond	Virginia

Sponsors (2)

Lead Sponsor	Collaborator
University of Virginia	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cocaine Use by Self-report	Participants were assessed up to three times weekly for up to 9 weeks to evaluate cocaine use by self-report	up to 9 weeks
Primary	Cocaine Use by Urine Benzoylecgonine	Urine samples were collected up to three times weekly for up to 9 weeks to test for the major cocaine metabolite benzoylecgonine	up to 9 weeks

External Links

•   (UVA CARE Website)