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| Sponsor: | National Institute on Drug Abuse (NIDA) |
|---|---|
| Information provided by: | National Institute on Drug Abuse (NIDA) |
| ClinicalTrials.gov Identifier: | NCT00015106 |
Purpose
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: | Intervention Model: Parallel Assignment Primary Purpose: Treatment |
| 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.
Eligibility| Ages Eligible for Study: | 18 Years to 59 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations
More Information
| ClinicalTrials.gov Identifier: | NCT00015106 History of Changes |
| Other Study ID Numbers: | NIDA-5-0012-7, Y01-5-0012-7 |
| Study First Received: | April 18, 2001 |
| Last Updated: | November 3, 2005 |
| Health Authority: | United States: Federal Government |
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Cocaine-Related Disorders Substance-Related Disorders Mental Disorders Gabapentin Lamotrigine Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses Anticonvulsants Antiparkinson Agents |
Anti-Dyskinesia Agents Calcium Channel Blockers Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Cardiovascular Agents Anti-Anxiety Agents Tranquilizing Agents Central Nervous System Depressants Psychotropic Drugs Excitatory Amino Acid Antagonists Excitatory Amino Acid Agents Neurotransmitter Agents Antimanic Agents |