New Medication Treatment for Stimulant 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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