Cocaine-Related Disorders
Conditions
Keywords
cocaine dependence
Brief summary
The purpose of this study is to assess tiagabine for the treatment of cocaine dependence.
Detailed description
To assess the efficacy and safety of tiagabine in reducing cocaine use in subjects with cocaine dependence. It is hypothesized that tiagabine treatment, compared to placebo, will be associated with fewer days of cocaine use as assessed by self-report confirmed with urine assays for benzoylecgonine (BE). This is a double-blind, placebo-controlled, parallel-group design study, in which, after screening and a 2-week baseline assessment period, subjects will be equally randomly assigned to 1 of 2 treatment groups, tiagabine or matched placebo.
Interventions
DRUGTiagabine
Sponsors
University of Cincinnati
National Institute on Drug Abuse (NIDA)
Study design
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
Inclusion criteria
Must be at least 18 years of age and be seeking treatment for cocaine dependence. Have the ability to understand, and having understood, provide written informed consent. If female, agree to use a method of birth control as indicated by the clinician. Please contact the participating site in your area for more information.
Exclusion criteria
Please contact the participating site in your area for more information.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Drug use | — |
| Cocaine use | — |
| Addiction severity | — |
| Clinical improvement | — |
Countries
United States
Outcome results
None listed