Novel Pharmacotherapy for Dual Dependence

Alcohol Dependence Clinical Trial

Official title:

Novel Pharmacotherapy for Dual Dependence

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00448825
• Other study ID #: 11620
• Secondary ID: R01DA019804DPMCD
• Status: Recruiting
• Phase: Phase 3
• First received: March 15, 2007
• Last updated: March 14, 2013
• Start date: March 2007
• Est. completion date: June 2013

Study information

• Verified date: March 2013
• Source: University of Virginia
• Contact: Mindy Borszich
• Phone: 1-888-882-2345
• Email: mcb3x[@]virginia.edu
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 180
• Est. completion date: June 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Alcohol Dependence
• Alcoholism
• Cocaine Dependence
• Cocaine-Related Disorders

Intervention

Drug:
• Topiramate + Cognitive Behavioral Therapy
Topiramate up to 300 mg per day
• Placebo + Cognitive Behavioral Therapy
Placebo twice a day

Locations

Country	Name	City	State
United States	University of Virginia Center for Addiction Research and Education	Charlottesville	Virginia
United States	University of Virginia Center for Addiction Research and Education	Richmond	Virginia

Sponsors (2)

Lead Sponsor	Collaborator
Bankole Johnson	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	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.	No
Secondary	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.	Cocaine free weeks is assessed by a combination of self-report of use and urine assays; 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	No

External Links

•   (UVA CARE website)