Novel Pharmacotherapy for Dual Dependence

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2013 by University of Virginia
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Bankole Johnson, University of Virginia
ClinicalTrials.gov Identifier:
NCT00448825
First received: March 15, 2007
Last updated: March 14, 2013
Last verified: March 2013
  Purpose

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


Condition Intervention Phase
Alcohol Dependence
Cocaine Dependence
Drug: Topiramate + Cognitive Behavioral Therapy
Drug: Placebo + Cognitive Behavioral Therapy
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Novel Pharmacotherapy for Dual Dependence

Resource links provided by NLM:


Further study details as provided by University of Virginia:

Primary Outcome 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, decreasing self-reported drinking, and decreasing craving for cocaine and alcohol. [ Time Frame: According to Preston Rules from weeks 6 to 12. ] [ Designated as safety issue: No ]

    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



Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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


Estimated Enrollment: 180
Study Start Date: March 2007
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Topiramate
Topiramate + Cognitive Behavioral Therapy
Drug: Topiramate + Cognitive Behavioral Therapy
Topiramate up to 300 mg per day
Other Name: Topamax
Placebo Comparator: Placebo
Placebo + Cognitive Behavioral Therapy
Drug: Placebo + Cognitive Behavioral Therapy
Placebo twice a day
Other Name: Sugar Pill

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00448825

Contacts
Contact: Mindy Borszich 1-888-882-2345 mcb3x@virginia.edu
Contact: Eva Jenkins-Mendoza (434)243-0562 emj9c@virginia.edu

Locations
United States, Virginia
University of Virginia Center for Addiction Research and Education Recruiting
Charlottesville, Virginia, United States, 22911
Contact: Mindy Borszich    888-882-2345    mcb3x@virginia.edu   
Contact: Eva Jenkins-Mendoza    (434)243-0562    emj9c@virginia.edu   
Principal Investigator: Bankole Johnson, DSc,MD,PhD         
Sub-Investigator: Nassima Ait-Daoud, MD         
University of Virginia Center for Addiction Research and Education Recruiting
Richmond, Virginia, United States, 23294
Contact: Mindy Borszich    888-882-2345    mcb3x@virginia.edu   
Contact: Eva Jenkins-Mendoza    (434)243-0562    emj9c@virginia.edu   
Principal Investigator: Bankole Johnson, DSc,MD,PhD         
Sub-Investigator: Nassima Ait-Daoud, MD         
Sponsors and Collaborators
Bankole Johnson
Investigators
Principal Investigator: Bankole Johnson, DSc, MD, PhD University of Virginia
  More Information

Additional Information:
No publications provided

Responsible Party: Bankole Johnson, Chair of Psychiatry and Neurobehavioral Sciences, University of Virginia
ClinicalTrials.gov Identifier: NCT00448825     History of Changes
Other Study ID Numbers: 11620, R01DA019804, DPMCDA
Study First Received: March 15, 2007
Last Updated: March 14, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Virginia:
alcohol dependence
alcoholism
cocaine addiction
cocaine dependence

Additional relevant MeSH terms:
Cocaine-Related Disorders
Alcoholism
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Topiramate
Anticonvulsants
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Neuroprotective Agents
Protective Agents
Physiological Effects of Drugs
Anti-Obesity Agents

ClinicalTrials.gov processed this record on August 28, 2014