Novel Pharmacotherapy for Dual Dependence

Study Overview
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Brief Summary
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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
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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.

Official Title
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Novel Pharmacotherapy for Dual Dependence

Conditions
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Alcohol Dependence, Cocaine Dependence

Intervention / Treatment
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* Drug: Topiramate + Cognitive Behavioral Therapy
* Drug: Placebo + Cognitive Behavioral Therapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Topiramate<br>Topiramate + Cognitive Behavioral Therapy | Drug: Topiramate + Cognitive Behavioral Therapy<br>* Topiramate up to 300 mg per day<br>* Other names: Topamax;|
| Placebo Comparator: Placebo<br>Placebo + Cognitive Behavioral Therapy | Drug: Placebo + Cognitive Behavioral Therapy<br>* Placebo twice a day<br>* Other names: Sugar Pill;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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alcohol dependence, alcoholism, cocaine addiction, cocaine dependence