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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT00448825
Other study ID # 11620
Secondary ID R01DA019804DPMCD
Status Recruiting
Phase Phase 3
First received March 15, 2007
Last updated March 14, 2013
Start date March 2007
Est. completion date June 2013

Study information

Verified date March 2013
Source University of Virginia
Contact Mindy Borszich
Phone 1-888-882-2345
Email mcb3x@virginia.edu
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 180
Est. completion date June 2013
Est. primary completion date June 2013
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment


Intervention

Drug:
Topiramate + Cognitive Behavioral Therapy
Topiramate up to 300 mg per day
Placebo + Cognitive Behavioral Therapy
Placebo twice a day

Locations

Country Name City State
United States University of Virginia Center for Addiction Research and Education Charlottesville Virginia
United States University of Virginia Center for Addiction Research and Education Richmond Virginia

Sponsors (2)

Lead Sponsor Collaborator
Bankole Johnson National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. No
Secondary 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 No
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