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Novel Pharmacotherapy for Dual Dependence

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ClinicalTrials.gov Identifier: NCT00448825
Recruitment Status : Unknown
Verified March 2013 by Bankole Johnson, University of Virginia.
Recruitment status was:  Recruiting
First Posted : March 19, 2007
Last Update Posted : March 15, 2013
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Bankole Johnson, University of Virginia

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.

Condition or disease Intervention/treatment Phase
Alcohol Dependence Cocaine Dependence Drug: Topiramate + Cognitive Behavioral Therapy Drug: Placebo + Cognitive Behavioral Therapy Phase 3

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  (Clinical Trial)
Estimated Enrollment : 180 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Novel Pharmacotherapy for Dual Dependence
Study Start Date : March 2007
Estimated Primary Completion Date : June 2013
Estimated Study Completion Date : June 2013

Resource links provided by the National Library of Medicine

Drug Information available for: Topiramate
U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. 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



Secondary Outcome Measures :
  1. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
National Institute on Drug Abuse (NIDA)
Investigators
Principal Investigator: Bankole Johnson, DSc, MD, PhD University of Virginia

Additional Information:
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 ( U.S. NIH Grant/Contract )
DPMCDA ( Other Identifier: NIDA )
First Posted: March 19, 2007    Key Record Dates
Last Update Posted: March 15, 2013
Last Verified: March 2013

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

Additional relevant MeSH terms:
Alcoholism
Cocaine-Related Disorders
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Topiramate
Anticonvulsants
Neuroprotective Agents
Protective Agents
Physiological Effects of Drugs
Anti-Obesity Agents