New Medication Treatment for Stimulant Dependence

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

Detailed Description
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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.

Official Title
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New Medication Treatment for Stimulant Dependence

Conditions
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Cocaine Dependence

Intervention / Treatment
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* Drug: Ondansetron
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ondansetron<br>Ondansetron + Cognitive Behavioral Therapy + Brief Behavioral Enhancement Therapy | Drug: Ondansetron<br>* 4 mg twice a day + Cognitive Behavioral Therapy + Brief Behavioral Enhancement Therapy<br>* Other names: Zofran;|
| Placebo Comparator: Placebo<br>Placebo + Cognitive Behavioral Therapy + Brief Behavioral Enhancement Therapy | Drug: Placebo<br>* twice a day + Cognitive Behavioral Therapy + Brief Behavioral Enhancement Therapy<br>* Other names: Sugar Pill;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cocaine dependence, cocaine abuse, cocaine, crack