Recruiting
Phase 3

Pharmacotherapy

Sponsor:

Bankole Johnson

Code:

NCT00448825

Conditions

Alcohol Dependence

Cocaine Dependence

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Topiramate + Cognitive Behavioral Therapy

Placebo + Cognitive Behavioral Therapy

Study Details

Brief 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.

Conditions

Alcohol Dependence

Cocaine Dependence

Study ID

NCT00448825

Start date

Mar, 2007

Status verified date

Mar, 2013

Completion date

Jun, 2013

Anticipated

Primary completion date

Jun, 2013

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

180 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Topiramate

Topiramate + Cognitive Behavioral Therapy

placebo comparator: Placebo

Placebo + Cognitive Behavioral Therapy

Interventions

Topiramate + Cognitive Behavioral Therapy

Topiramate up to 300 mg per day

Placebo + Cognitive Behavioral Therapy

Placebo twice a day

Primary outcome measure

  • 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. [ Time Frame: According to Preston Rules from weeks 6 to 12. ]

Central Contacts and Locations

Central contacts

Mindy Borszich

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

Eva Jenkins-Mendoza

(434)243-0562emj9c@virginia.edu

Locations

University of Virginia Center for Addiction Research and Education

Recruiting

Charlottesville, Virginia, United States, 22911

Contacts

Mindy Borszich

888-882-2345mcb3x@virginia.edu

Eva Jenkins-Mendoza

(434)243-0562emj9c@virginia.edu

Principal Investigator:

Bankole Johnson, DSc,MD,PhD

University of Virginia Center for Addiction Research and Education

Recruiting

Richmond, Virginia, United States, 23294

Contacts

Mindy Borszich

888-882-2345mcb3x@virginia.edu

Eva Jenkins-Mendoza

(434)243-0562emj9c@virginia.edu

Principal Investigator:

Bankole Johnson, DSc,MD,PhD

More Information

Sponsor

Bankole Johnson

Last update posted

Mar 15, 2013

Last verified

Mar, 2013

Keywords

  • alcohol dependence
  • alcoholism
  • cocaine addiction
  • cocaine dependence

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Bankole Johnson on 2013-03-15.