Novel Pharmacotherapy for Dual Dependence

Phase 3

• Conditions: Alcohol Dependence; Cocaine Dependence
• Interventions: Drug: Placebo + Cognitive Behavioral Therapy; Drug: Topiramate + Cognitive Behavioral Therapy

• Registration Number: NCT00448825
• Lead Sponsor: Bankole Johnson

Brief Summary

The purpose of this study is to evaluate the effects of Topiramate and Cognitive Behavioral Therapy for the treatment of alcohol and cocaine dependence.

Detailed Description

Our objective is to understand the basic mechanisms that underpin substance dependence, and to develop efficacious treatments for individuals with comorbid cocaine and alcohol dependence.

Participants in this study will be randomly assigned to receive either 300 mg per day of topiramate or placebo. In addition, participants will receive weekly cognitive behavioral therapy for 12 weeks.Follow-up visits will occur at 2 weeks and 1,2,, and 3 months following completion of treatment.

Study Timeline

• Study Start: 2007-03
• Study First Submitted: 2007-03-15
• Study First Submitted QC: 2007-03-15
• Study First Posted: 2007-03-19
• Status Verified: 2013-03
• Last Update Submitted: 2013-03-14
• Last Update Posted: 2013-03-15
• Primary Completion: 2013-06
• Study Completion: 2013-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 180

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo + Cognitive Behavioral Therapy	Placebo + Cognitive Behavioral Therapy
Topiramate	Topiramate + Cognitive Behavioral Therapy	Topiramate + Cognitive Behavioral Therapy

Primary Outcome Measures

Name	Time	Method
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.	According to Preston Rules from weeks 6 to 12.	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

Secondary Outcome Measures

Name	Time	Method
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.	According to Preston Rules from weeks 1 to 12	1. Cocaine free weeks is assessed by a combination of self-report of use and urine assays; 2. Assessed by increased scores in the following assessments: CGI, BSI, Q-LES-Q, DrInC, SFQ, medication compliance, CIWA-Ar, POMS, BIS

Trial Locations

Locations (1)

University of Virginia Center for Addiction Research and Education; 🇺🇸 Richmond, Virginia, United States