New Medication Treatment for Stimulant Dependence

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.

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:

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