Combining Medications Treatment for Alcoholism
Trial Snapshot
- Phase
- Phase 2
- Sponsor
- Bankole Johnson
- Enrollment
- 320
- Locations
- 1
- Primary Endpoint
- Self-report measures of alcohol-related problems and consumption, Objective measures of alcohol consumption
Study Overview
Brief 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.
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Factorial
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Ondansetron
Ondansetron + cognitive behavioral therapy
Intervention: ondansetron + cognitive behavioral therapy (Drug)
Topiramate
Topiramate + cognitive behavioral therapy
Intervention: topiramate + cognitive behavioral therapy (Drug)
Placebo
Placebo + cognitive behavioral therapy
Intervention: Placebo + cognitive behavioral therapy (Drug)
Ondansetron + Topiramate
Ondansetron + Topiramate + cognitive behavioral therapy
Intervention: ondansetron + topiramate + cognitive behavioral therapy (Drug)
Outcomes
Primary Outcomes
Self-report measures of alcohol-related problems and consumption, Objective measures of alcohol consumption
Time Frame: Throughout the study
Drinks per drinking day, Drinks per day, Percent Days Abstinent, BAC, CDT, GGT
Secondary Outcomes
- Medication compliance, alcohol craving, social functioning, quality of life, alcohol withdrawal, attendance at psychosocial services, pre-morbid risk factors(Throughout the study)
Investigators
Bankole Johnson
Chair of Psychiatry and Neurobehavioral Sciences
University of Virginia