Alcohol Dependence Clinical Trial
Official title:
Novel Pharmacotherapy for Dual Dependence
The purpose of this study is to evaluate the effects of Topiramate and Cognitive Behavioral Therapy for the treatment of alcohol and cocaine dependence.
Status | Recruiting |
Enrollment | 180 |
Est. completion date | June 2013 |
Est. primary completion date | June 2013 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Subjects will be men and women between the ages of 18 years and older. - Must meet at least three of the seven DSM IV diagnostic criteria for alcohol and cocaine dependence. - Express a desire for treatment. - Literacy in English and ability to read, understand, and complete the ratings scales and questionnaires accurately, follow instructions, and make use of the behavioral treatments are required. - Prospective subjects must report cocaine use of at least once per month and alcohol consumption of =21 drinks/week and =14 drinks/week for men and women respectively, during the past 30 days - At least one positive urine drug screen for cocaine at screen or baseline prior to randomization. Exclusion Criteria: Please contact site for additional information |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | University of Virginia Center for Addiction Research and Education | Charlottesville | Virginia |
United States | University of Virginia Center for Addiction Research and Education | Richmond | Virginia |
Lead Sponsor | Collaborator |
---|---|
Bankole Johnson | National Institute on Drug Abuse (NIDA) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The topiramate group will be superior to the placebo group on the following outcome measures:increasing the weekly mean proportion of cocaine-free days, decreasing self-reported drinking, and decreasing craving for cocaine and alcohol. | Alcohol - assessed by self-report of use (TLFB,DD,DDD,PDA, PHDD), biochemical markers (GGT, CDT), OCDS Cocaine - assessed by self-report of use (CTFB, substance use inventory, QFI),urine assay for benzoylecgonine, and CCQ-NOW |
According to Preston Rules from weeks 6 to 12. | No |
Secondary | a. Cocaine free weeks; b. Topiramate, compared with placebo, will be associated with an improvement in psychosocial functioning as exemplified by improved general well-being, social functioning, and quality of life. | Cocaine free weeks is assessed by a combination of self-report of use and urine assays; Assessed by increased scores in the following assessments: CGI, BSI, Q-LES-Q, DrInC, SFQ, medication compliance, CIWA-Ar, POMS, BIS |
According to Preston Rules from weeks 1 to 12 | No |
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