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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
108
4 mg twice a day + Cognitive Behavioral Therapy + Brief Behavioral Enhancement Therapy
twice a day + Cognitive Behavioral Therapy + Brief Behavioral Enhancement Therapy
University of Virginia Center for Addiction Research and Education
Charlottesville, Virginia, United States
University of Virginia Center for Addiction Research and Education
Richmond, Virginia, United States
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
Time frame: 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
Time frame: up to 9 weeks
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