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Alcohol Dependency Study: Combining Medication Treatment for Alcoholism

Information source: University of Virginia
Information obtained from ClinicalTrials.gov on February 07, 2013
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Alcoholism

Intervention: ondansetron + cognitive behavioral therapy (Drug); topiramate + cognitive behavioral therapy (Drug); Placebo + cognitive behavioral therapy (Drug); ondansetron + topiramate + cognitive behavioral therapy (Drug)

Phase: Phase 2

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 learn whether ondansetron and topiramate either alone or in combination is safe and effective in the treatment of alcohol dependence. This 13 week out-patient clinical trial is randomized, double-blind, and placebo-controlled. There are post-study follow up visits 1, 2 and 3 months after the end of the study. Participants will receive ondansetron and topiramate either alone or in combination or a placebo coupled with psychotherapy.

Clinical Details

Official title: Combining Medications Treatment for Alcoholism

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

Primary outcome: Self-report measures of alcohol-related problems and consumption, Objective measures of alcohol consumption

Secondary outcome: Medication compliance, alcohol craving, social functioning, quality of life, alcohol withdrawal, attendance at psychosocial services, pre-morbid risk factors

Detailed description: This study is a 13 week clinical trial. During the 13 weeks participants receive placebo, ondansetron and topiramate alone or in combination. During the 13 weeks participants come to an outpatient clinic to receive the study medication, physical checks, and cognitive behavioral therapy. The duration of the weekly visit is 3 hours. There is a 1, 2, and 3 month post-study follow up visit. Screening for this study is initially done over the telephone and takes 15-20 minutes. If there is nothing found to make someone ineligible to participate, they come to the out-patient clinic for a more thorough in-clinic screening.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Current diagnosis of alcohol dependence and drinking greater than or equal to 14

alcohol drinks/week for women and greater than or equal to 21 alcohol drinks/week for men in the last 30 days.

- Provide a written, informed consent.

- Good physical health and must weigh within at least 40 kg and no more than 140 kg.

- Literate in English and able to read, understand, follow instructions, and complete

questionnaires accurately.

- Willingness to participate in behavioral treatments for alcoholism.

- Provide evidence of stable residence in the last month prior to enrollment in the

study and have no plans to move during the next three months.

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 Tiouririne, 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 Tiouririne, MD, Sub-Investigator

Additional Information

Related publications:

Johnson BA. An overview of the development of medications including novel anticonvulsants for the treatment of alcohol dependence. Expert Opin Pharmacother. 2004 Sep;5(9):1943-55. Review.

Starting date: March 2005
Last updated: February 2, 2012

Page last updated: February 07, 2013

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