Overview

This trial is active, not recruiting.

Condition cocaine dependence
Treatments ondansetron, placebo
Phase phase 2
Sponsor University of Virginia
Collaborator National Institute on Drug Abuse (NIDA)
Start date July 2008
End date November 2014
Trial size 200 participants
Trial identifier NCT00689572, 13419, 1R01DA021776-01A1

Summary

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
Ondansetron + Cognitive Behavioral Therapy + Brief Behavioral Enhancement Therapy
ondansetron Zofran
4 mg twice a day + Cognitive Behavioral Therapy + Brief Behavioral Enhancement Therapy
(Placebo Comparator)
Placebo + Cognitive Behavioral Therapy + Brief Behavioral Enhancement Therapy
placebo Sugar Pill
twice a day + Cognitive Behavioral Therapy + Brief Behavioral Enhancement Therapy

Primary Outcomes

Measure
increase in cocaine free days (abstinent)assessed by self-reported use and urine analysis for benzoylecgonine
time frame: Throughout the study

Secondary Outcomes

Measure
Decrease cocaine craving,and improvement in general well-being, social function, quality of life.
time frame: Throughout the study

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title New Medication Treatment for Stimulant Dependence
Principal investigator Nassima Ait-Daoud Tiouririne, M.D.
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.
Trial information was received from ClinicalTrials.gov and was last updated in June 2014.
Information provided to ClinicalTrials.gov by University of Virginia.