NCT00015132

Tiagabine, Sertraline, or Donepezil for the Treatment of Cocaine Dependence - 9

CREST-II: Tiagabine, Sertraline, or Donepezil vs. Unmatched Placebo

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (planned)
• Sponsor: National Institute on Drug Abuse (NIDA) · NIH
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Cocaine-Related Disorders

Interventions

Type	Name	Description
DRUG	Sertraline

Timeline

• Start date: 1999-03-01
• Primary completion: 2000-09-01
• Completion: 2000-11-01
• First posted: 2001-04-18
• Last updated: 2017-01-12

Locations

1 site across 1 country: United States