Cocaine-Related Disorders Clinical Trial
Official title:
CREST-II: Tiagabine, Sertraline, or Donepezil vs. Unmatched Placebo
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.
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.
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Intervention Model: Parallel Assignment, Primary Purpose: Treatment
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