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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: | NCT00015132 |
The purpose of this CREST (Clinical Rapid Evaluation Screening Trial) study is the use of tiagabine, sertraline, or donepezil for the treatment of cocaine dependence using a modified placebo-controlled experimental design.
Condition | Intervention | Phase |
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Cocaine-Related Disorders |
Drug: Sertraline |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Placebo Control, Parallel Assignment |
Official Title: | CREST-II: Tiagabine, Sertraline, or Donepezil Vs. Unmatched Placebo |
Estimated Enrollment: | 0 |
Study Start Date: | March 1999 |
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.
Ages Eligible for Study: | 18 Years to 60 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
oral contraceptives, b. barrier (diaphragm or condom) with spermicide, c. intrauterine progesterone contraceptive system, d. levonorgestrel implant, e. medroxyprogesterone acetate contraceptive injection, f.complete abstinence
Exclusion Criteria:
For individuals who may be suspect for asthma but carry no diagnosis (exclude if on beta agonists).
Patients with FEV1 <70 should be excluded.
Study ID Numbers: | NIDA-5-0012-9, Y01-5-0012-9 |
Study First Received: | April 18, 2001 |
Last Updated: | November 3, 2005 |
ClinicalTrials.gov Identifier: | NCT00015132 History of Changes |
Health Authority: | United States: Federal Government |
Cocaine-Related Disorders Neurotransmitter Agents Psychotropic Drugs Disorders of Environmental Origin Serotonin Uptake Inhibitors Serotonin Mental Disorders |
Tiagabine Donepezil Substance-Related Disorders Sertraline Cocaine Antidepressive Agents |
Cocaine-Related Disorders Neurotransmitter Uptake Inhibitors Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Psychotropic Drugs Disorders of Environmental Origin Serotonin Uptake Inhibitors |
Pharmacologic Actions Serotonin Agents Mental Disorders Therapeutic Uses Substance-Related Disorders Sertraline Central Nervous System Agents Antidepressive Agents |