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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

Page last updated: August 23, 2015

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