Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
PHASE2
108 participants
INTERVENTIONAL
2008-07-31
2013-12-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Ondansetron
Ondansetron + Cognitive Behavioral Therapy + Brief Behavioral Enhancement Therapy
Ondansetron
4 mg twice a day + Cognitive Behavioral Therapy + Brief Behavioral Enhancement Therapy
Placebo
Placebo + Cognitive Behavioral Therapy + Brief Behavioral Enhancement Therapy
Placebo
twice a day + Cognitive Behavioral Therapy + Brief Behavioral Enhancement Therapy
Interventions
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Ondansetron
4 mg twice a day + Cognitive Behavioral Therapy + Brief Behavioral Enhancement Therapy
Placebo
twice a day + Cognitive Behavioral Therapy + Brief Behavioral Enhancement Therapy
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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National Institute on Drug Abuse (NIDA)
NIH
University of Virginia
OTHER
Responsible Party
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Nassima Ait-Daoud Tiouririne
Associate Professor, Director of UVA Center for Addiction Research and Education
Principal Investigators
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Nassima Ait-Daoud Tiouririne, M.D.
Role: PRINCIPAL_INVESTIGATOR
University of Virginia
Locations
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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
Countries
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References
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Blevins D, Seneviratne C, Wang XQ, Johnson BA, Ait-Daoud N. A randomized, double-blind, placebo-controlled trial of ondansetron for the treatment of cocaine use disorder with post hoc pharmacogenetic analysis. Drug Alcohol Depend. 2021 Nov 1;228:109074. doi: 10.1016/j.drugalcdep.2021.109074. Epub 2021 Sep 24.
Related Links
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(UVA CARE Website)
Other Identifiers
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13419
Identifier Type: -
Identifier Source: org_study_id