New Medication Treatment for Stimulant Dependence

Official Title: “New Medication Treatment for Stimulant Dependence”

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

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.

Intervention(s) in this Clinical Trial

• 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

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: Ondansetron
• Placebo Comparator: Placebo

Primary Measures

• increase in cocaine free days (abstinent)assessed by self-reported use and urine analysis for benzoylecgonine
  • Time Frame: Throughout the study
    Safety Issue?: No

Secondary Measures

• Decrease cocaine craving,and improvement in general well-being, social function, quality of life.
  • Time Frame: Throughout the study
    Safety Issue?: No

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: University of Virginia Other

Overall Clinical Trial Officials and Contacts

Nassima Ait-Daoud Tiouririne, M.D. Principal Investigator University of Virginia  

Overall Contact: Mindy Borszich 1-888-882-2345 mcb3x@virginia.edu

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00689572

Study ID Number: 13419

ClinicalTrials.gov Identifier: NCT00689572

Health Authority: United States: Food and Drug Administration