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.

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Factorial Assignment, Safety/Efficacy Study

Study Primary Completion Date: March 2012

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.

Intervention(s) in this Clinical Trial

• Drug: Topiramate
  • Topiramate up to 300 mg per day

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: Topiramate
• Placebo Comparator: Placebo

Primary Measures

• The topiramate group will be superior to the placebo group on the following outcome measures:increasing the weekly mean proportion of cocaine-free days and decreasing self-reported drinking.
  • Time Frame: Throughout the study (Visit 0 to Visit 12, and at 2 weeks, 1, 2, and 3 months following completion of treatment)
    Safety Issue?: No

Secondary Measures

• 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.
  • Time Frame: Measured throughout the study, and at 2 weeks and 1,2, and 3 months following completion of treatment
    Safety Issue?: No

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 week 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 within the two-week baseline prior to randomization with a minimum of four samples tested.

Exclusion Criteria:

• Individuals likely to require hospitalization for severe medical complications or surgery, or those whose severity of illness precludes utilization of the behavioral treatments.
• Women who are pregnant, breastfeeding, or unwilling to use effective birth control to prevent becoming pregnant during the study
• Certain physical or psychiatric conditions that would compromise participation
• Current dependence, defined by DSM-IV criteria, on any psychoactive substance other than cocaine, alcohol, nicotine, caffeine, or marijuana or physiological dependence on alcohol requiring medical detoxification.
• Mandated by court to obtain treatment for alcohol and/or cocaine dependence.
• Elevation of liver enzymes (SGOT), serum glutamic pyruvic transaminase (SGPT), blood urea nitrogen (BUN), or lactate dehydrogenase (LDH).
• Anyone who, in the opinion of the investigator, would not be expected to complete the study protocol because of probable incarceration or relocation from the clinic area.
• Severe or life-threatening adverse reactions to topiramate in the past or during this clinical trial.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: National Institute on Drug Abuse (NIDA)

Overall Clinical Trial Officials and Contacts

Bankole Johnson, DSc, MD, PhD Principal Investigator University of Virginia  

Overall Contact: Mindy Borszich, BA 1-888-882-2345 uvacare@virginia.edu

Information obtained from ClinicalTrials.gov on September 05, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00448825

Study ID Number: 1 R01 DA019804-01A1

ClinicalTrials.gov Identifier: NCT00448825

Health Authority: United States: Food and Drug Administration

(UVA CARE website)