Carbamazepine is an anticonvulsant that has been studied for treatment of cocaine dependence in open-label trials. This is a double-blind, placebo-controlled, random assignment, parallel group design protocol to determine the effectiveness of carbamazepine (Tegretol) in reducing cocaine use and craving among cocaine-dependent outpatients. In this study, one-hundred forty (140) volunteer cocaine dependent subjects are expected to enter into the study. We expect to obtain a sample of 70 subjects who complete the 8-week medication treatment. The primary outcome measures are urine toxicology samples collected under direct staff observation, and self-reported cocaine craving. Secondary outcome measures include a cocaine craving 100 nun visual-analog scale, self-reported drug use, changes in psychological state as measured by the Profile of Mood States questionnaire, Addiction Severity Index, Beck Depression Inventory, and Symptom Checklist 90-Revised (SCL-90R). All subjects will receive individual counseling at two of their weekly visits. Every 2 weeks blood will be drawn to measure medication blood levels, to verify medication compliance, and assess CBC and liver function. Forty-one subjects have started treatment, with 11 having completed.

Agency
National Institute of Health (NIH)
Institute
National Institute on Drug Abuse (NIDA)
Type
Intramural Research (Z01)
Project #
1Z01DA000068-02
Application #
3838578
Study Section
Project Start
Project End
Budget Start
Budget End
Support Year
2
Fiscal Year
1992
Total Cost
Indirect Cost
Name
National Institute on Drug Abuse
Department
Type
DUNS #
City
State
Country
United States
Zip Code