Novel Pharmacotherapy for Dual Dependence

March 14, 2013 updated by: Bankole Johnson
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 Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Anticipated)

180

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Virginia
      • Charlottesville, Virginia, United States, 22911
        • Recruiting
        • University of Virginia Center for Addiction Research and Education
        • Contact:
        • Contact:
        • Principal Investigator:
          • Bankole Johnson, DSc,MD,PhD
        • Sub-Investigator:
          • Nassima Ait-Daoud, MD
      • Richmond, Virginia, United States, 23294
        • Recruiting
        • University of Virginia Center for Addiction Research and Education
        • Contact:
        • Contact:
        • Principal Investigator:
          • Bankole Johnson, DSc,MD,PhD
        • Sub-Investigator:
          • Nassima Ait-Daoud, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Placebo + Cognitive Behavioral Therapy
Drug: Placebo + Cognitive Behavioral Therapy
Placebo twice a day
Other Names:
  • Sugar Pill
Experimental: Topiramate
Topiramate + Cognitive Behavioral Therapy
Drug: Topiramate + Cognitive Behavioral Therapy
Topiramate up to 300 mg per day
Other Names:
  • Topamax

What is the study measuring?

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

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.
Time Frame: According to Preston Rules from weeks 1 to 12
  1. Cocaine free weeks is assessed by a combination of self-report of use and urine assays;
  2. 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bankole Johnson

Collaborators

National Institute on Drug Abuse (NIDA)

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2007

Primary Completion (Anticipated)

June 1, 2013

Study Completion (Anticipated)

June 1, 2013

Study Registration Dates

First Submitted

March 15, 2007

First Submitted That Met QC Criteria

March 15, 2007

First Posted (Estimate)

March 19, 2007

Study Record Updates

Last Update Posted (Estimate)

March 15, 2013

Last Update Submitted That Met QC Criteria

March 14, 2013

Last Verified

March 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 11620
  • DPMCDA (Other Identifier: NIDA)
  • R01DA019804 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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