Status:
COMPLETED
New Medication Treatment for Stimulant Dependence
Lead Sponsor:
University of Virginia
Collaborating Sponsors:
National Institute on Drug Abuse (NIDA)
Conditions:
Cocaine Dependence
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This study will evaluate the efficacy of ondansetron compared with placebo in the treatment of cocaine dependence.
Detailed Description
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 ra...
Eligibility Criteria
Inclusion
- 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
- Please contact site for additional information
Key Trial Info
Start Date :
July 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2013
Estimated Enrollment :
108 Patients enrolled
Trial Details
Trial ID
NCT00689572
Start Date
July 1 2008
End Date
December 1 2013
Last Update
November 11 2021
Active Locations (2)
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1
University of Virginia Center for Addiction Research and Education
Charlottesville, Virginia, United States, 22911
2
University of Virginia Center for Addiction Research and Education
Richmond, Virginia, United States, 23294