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Sponsored by: |
National Institute on Drug Abuse (NIDA) |
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Information provided by: | National Institute on Drug Abuse (NIDA) |
ClinicalTrials.gov Identifier: | NCT00015106 |
The purpose of this CREST (Clinical Rapid Evaluation Screening Trial) study is the treatment of cocaine dependence using reserpine, gabapentin, or lamotrigine vs. an unmatched placebo control.
Condition | Intervention | Phase |
---|---|---|
Cocaine-Related Disorders |
Drug: Lamotrigine |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Placebo Control, Parallel Assignment |
Official Title: | CREST-I: Resperine, Gabapentin, or Lamotrigine Vs. Placebo |
Estimated Enrollment: | 0 |
Study Start Date: | November 1997 |
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.
Ages Eligible for Study: | 18 Years to 59 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study ID Numbers: | NIDA-5-0012-7, Y01-5-0012-7 |
Study First Received: | April 18, 2001 |
Last Updated: | November 3, 2005 |
ClinicalTrials.gov Identifier: | NCT00015106 |
Health Authority: | United States: Federal Government |
Cocaine-Related Disorders Calcium, Dietary Gabapentin Mental Disorders |
Lamotrigine Substance-Related Disorders Disorders of Environmental Origin Cocaine |
Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Therapeutic Uses Calcium Channel Blockers |
Cardiovascular Agents Central Nervous System Agents Anticonvulsants Pharmacologic Actions |