Novel Pharmacotherapy for Dual Dependence
Information source: University of Virginia
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Alcohol Dependence; Cocaine Dependence
Intervention: Topiramate + Cognitive Behavioral Therapy (Drug); Placebo + Cognitive Behavioral Therapy (Drug)
Phase: Phase 3
Status: Recruiting
Sponsored by: Bankole Johnson Official(s) and/or principal investigator(s): Bankole Johnson, DSc, MD, PhD, Principal Investigator, Affiliation: University of Virginia
Overall contact: Mindy Borszich, Phone: 1-888-882-2345, Email: mcb3x@virginia.edu
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.
Clinical Details
Official title: Novel Pharmacotherapy for Dual Dependence
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: 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.
Secondary outcome: 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.
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
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Mindy Borszich, Phone: 1-888-882-2345, Email: mcb3x@virginia.edu
University of Virginia Center for Addiction Research and Education, Charlottesville, Virginia 22911, United States; Recruiting Mindy Borszich, Phone: 888-882-2345, Email: mcb3x@virginia.edu Eva Jenkins-Mendoza, Phone: (434)243-0562, Email: emj9c@virginia.edu Bankole Johnson, DSc,MD,PhD, Principal Investigator Nassima Ait-Daoud, MD, Sub-Investigator
University of Virginia Center for Addiction Research and Education, Richmond, Virginia 23294, United States; Recruiting Mindy Borszich, Phone: 888-882-2345, Email: mcb3x@virginia.edu Eva Jenkins-Mendoza, Phone: (434)243-0562, Email: emj9c@virginia.edu Bankole Johnson, DSc,MD,PhD, Principal Investigator Nassima Ait-Daoud, MD, Sub-Investigator
Additional Information
(UVA CARE website)
Starting date: March 2007
Last updated: March 14, 2013
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