Resperine, Gabapentin, or Lamotrigine for the Treatment of Cocaine Dependence: 2 - 7
|Study Design:||Intervention Model: Parallel Assignment
Primary Purpose: Treatment
|Official Title:||CREST-I: Resperine, Gabapentin, or Lamotrigine vs. Placebo|
- Urine toxicology for cocaine
- Adverse events
- Clinical improvement
|Study Start Date:||November 1997|
|Study Completion Date:||February 1999|
|Primary Completion Date:||January 1999 (Final data collection date for primary outcome measure)|
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, 60-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 reserpine, gabapentin and lamotrigine. Reserpine is being screened because of its well-known preclinical ability to functionally antagonize cocaine (by depleting neurochemicals elevated by cocaine). Gabapentin and lamotrigine are hypothesized to interfere with glutamatergic cocaine sensitization/kindling mechanisms relevant to addiction.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00015106
|United States, Ohio|
|Cincinnati, Ohio, United States, 45220|
|Principal Investigator:||Eugene Somoza, M.D., Ph.D.||Cincinnati MDRU|