Novel Pharmacotherapy for Dual Dependence

Bankole Johnson180 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

180

Conditions

Alcohol Dependence Cocaine Dependence

Interventions

Topiramate + Cognitive Behavioral TherapyDRUG

Topiramate up to 300 mg per day

Placebo + Cognitive Behavioral TherapyDRUG

Placebo twice a day

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (2)

University of Virginia Center for Addiction Research and Education

Charlottesville, Virginia, United States

RECRUITING

University of Virginia Center for Addiction Research and Education

Richmond, Virginia, United States

RECRUITING

Outcomes

Primary Outcomes

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

Time frame: According to Preston Rules from weeks 6 to 12.

Secondary Outcomes

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.

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

Time frame: According to Preston Rules from weeks 1 to 12

Central Contacts

Mindy Borszich

CONTACT

1-888-882-2345 mcb3x@virginia.edu

Eva Jenkins-Mendoza

CONTACT

(434)243-0562 emj9c@virginia.edu

Data from ClinicalTrials.gov

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