Alcohol Dependency Study: Combining Medication Treatment for Alcoholism
| Status: | Completed |
|---|---|
| Conditions: | Psychiatric |
| Therapuetic Areas: | Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/2/2016 |
| Start Date: | March 2005 |
| End Date: | December 2013 |
| Contact: | Mindy Borszich |
| Email: | mcb3x@virginia.edu |
| Phone: | 1-888-882-2345 |
Combining Medications Treatment for Alcoholism
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.
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.
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.
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.
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:
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