Phase 2
N=108
New Medication Treatment for Stimulant Dependence
Cocaine Dependence
Bottom Line
View on ClinicalTrials.gov: NCT00689572 ↗Enrolled (actual)
108
Serious AEs
1.8%
Results posted
Nov 2021
Primary outcome: Primary: Cocaine Use by Self-report — 67; 67 Percent of cocaine-free (abstinent)days — p=0.972
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Ondansetron (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Virginia
- Primary completion
- Dec 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Cocaine Use by Self-report |
67; 67 | 0.972 |
| PRIMARY Cocaine Use by Urine Benzoylecgonine |
16; 26 | 0.909 |
Summary
This study will evaluate the efficacy of ondansetron compared with placebo in the treatment of cocaine dependence.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00689572). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.