Tiagabine, Sertraline, or Donepezil for the Treatment of Cocaine Dependence - 9
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|ClinicalTrials.gov Identifier: NCT00015132|
Recruitment Status : Completed
First Posted : April 18, 2001
Last Update Posted : January 12, 2017
|Condition or disease||Intervention/treatment||Phase|
|Cocaine-Related Disorders||Drug: Sertraline||Phase 2|
Considerable progress in preclinical research has provided a basis for hypothesis driven clinical trials in cocaine dependence. A greater mechanistic understanding of both cocaine and many clinically approved medications has led to the identification of many promising medications for the treatment of cocaine dependence.
For this reason NIDA has developed a CREST (Clinical Rapid Evaluation Screening Trial) protocol to provide a needed incremental medication screening step between preclinical research and full blown expensive Phase III pivotal trials. While patients receive manual based psychotherapy, three medications are screened compared to unmatched placebo in an eight-week, 80-subject, four cell design trial. Other important features of the CREST protocol include collecting baseline measurements over a two week period and analyzing primary outcome measures (quantitative urine toxicology and clinical global improvement scales) in terms of a composite score of overall individual patient improvement.
The three medications being evaluated in this trial include tiagabine, sertraline, and donepzil. Tiagabine is hypothesized to interfere with glutamatergic cocaine mechanisms relevant to addiction. Sertraline is a potent and selective inhibitor of neuronal 5-HT reuptake, which may modulate the reinforcing and cueing effects of cocaine. Donepezil is hypothesized to interfere with cholinergic cocaine mechanisms relevant to addiction.
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||0 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||CREST-II: Tiagabine, Sertraline, or Donepezil vs. Unmatched Placebo|
|Study Start Date :||March 1999|
|Actual Primary Completion Date :||September 2000|
|Actual Study Completion Date :||November 2000|
- Cocaine use
- Adverse events
- Clinical improvement
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00015132
|United States, Ohio|
|Cincinnati, Ohio, United States, 45220|
|Principal Investigator:||Eugene Somoza, M.D., Ph.D.||Cincinnati MDRU|