Alcohol Dependency Study: Combining Medication Treatment for Alcoholism
Information source: University of Virginia
ClinicalTrials.gov processed this data on August 23, 2015
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
(UVA CARE Website)
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: March 14, 2013
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