Novel Pharmacotherapy for Dual Dependence

Bankole Johnson

Status and phase: Unknown; Phase 3

Conditions: Cocaine Dependence; Alcohol Dependence

Treatments: Drug: Placebo + Cognitive Behavioral Therapy; Drug: Topiramate + Cognitive Behavioral Therapy

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00448825

DPMCDA

R01DA019804 (U.S. NIH Grant/Contract)

11620

Details and patient eligibility

About

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

Full 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.

Enrollment: 180 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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180 participants in 2 patient groups, including a placebo group

Topiramate

Experimental group

Description:

Topiramate + Cognitive Behavioral Therapy

Treatment:

Drug: Topiramate + Cognitive Behavioral Therapy

Placebo

Placebo Comparator group

Description:

Placebo + Cognitive Behavioral Therapy

Treatment:

Drug: Placebo + Cognitive Behavioral Therapy