Pharmacogenetic Treatments for Alcoholism
| Status: | Not yet recruiting |
|---|---|
| Conditions: | Psychiatric |
| Therapuetic Areas: | Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 18 - 65 |
| Updated: | 4/2/2016 |
| Start Date: | June 2012 |
| End Date: | February 2018 |
| Contact: | Mindy Borszich |
| Email: | mcb3x@virginia.edu |
| Phone: | 1-888-882-2345 |
1/2 - Pharmacogenetic Treatments for Alcoholism
Heavy drinking can cause serious health, family, and economic problems. Finding treatments
that are effective in decreasing heavy drinking among alcohol-dependent individuals is,
therefore, an important scientific and health goal. A novel and important strategy to
enhance alcoholism treatment efforts uses a personalized medicine approach to optimize
treatment effects by selecting the "right" patient therapeutically and potentially with a
minimum of adverse events, for a specific medication.
This study will extend findings from a randomized double-blind clinical trial of
ondansetron, in which the medication was found to reduce drinking among individuals with
certain genotypes (i.e., forms of DNA, the material that controls the inheritance of
characteristics). The proposed study will address a number of limitations in the prior work,
including testing the medication in both European-American and African-American samples.
that are effective in decreasing heavy drinking among alcohol-dependent individuals is,
therefore, an important scientific and health goal. A novel and important strategy to
enhance alcoholism treatment efforts uses a personalized medicine approach to optimize
treatment effects by selecting the "right" patient therapeutically and potentially with a
minimum of adverse events, for a specific medication.
This study will extend findings from a randomized double-blind clinical trial of
ondansetron, in which the medication was found to reduce drinking among individuals with
certain genotypes (i.e., forms of DNA, the material that controls the inheritance of
characteristics). The proposed study will address a number of limitations in the prior work,
including testing the medication in both European-American and African-American samples.
This study is a 24 week clinical trial. During the 24 weeks participants will receive either
ondansetron or placebo. Participants will also receive Brief Behavioral Compliance
enhancement Treatment (BBCET) as their psychosocial adjuct weekly in weeks 1 to 12, and then
every 2 weeks in weeks 12 to 24. We will enroll two separate population groups (i.e.,
African-Americans and European-Americans), each with 128 treatment-seeking,
alcohol-dependent individuals in a 24-week clinical trial. Subjects in each of these two
population groups (N=128/group) will be randomized into 4 cells (N=32/cell) in a 2 (TT vs.
TG or GG) × 2 (ondansetron 4 μg/kg twice daily vs. placebo) factorial design. Group
assignment will be achieved using a block randomization procedure that balances the
treatment groups on PHDD, age, and gender.
ondansetron or placebo. Participants will also receive Brief Behavioral Compliance
enhancement Treatment (BBCET) as their psychosocial adjuct weekly in weeks 1 to 12, and then
every 2 weeks in weeks 12 to 24. We will enroll two separate population groups (i.e.,
African-Americans and European-Americans), each with 128 treatment-seeking,
alcohol-dependent individuals in a 24-week clinical trial. Subjects in each of these two
population groups (N=128/group) will be randomized into 4 cells (N=32/cell) in a 2 (TT vs.
TG or GG) × 2 (ondansetron 4 μg/kg twice daily vs. placebo) factorial design. Group
assignment will be achieved using a block randomization procedure that balances the
treatment groups on PHDD, age, and gender.
Inclusion Criteria:
- Males and females who have given written informed consent
- Between the ages of 18 and 65 years and weighing within 30% of ideal body weight.
Also, patients must weigh at least 40 kg and no more than 155 kg.
- Good physical health as determined by a complete physical examination, an
electrocardiogram (EKG) within normal limits, and laboratory screening tests within
acceptable parameters.
- Current DSM-IV diagnosis of alcohol dependence
- AUDIT score of ≥8
- Currently drinking ≥14 alcohol units/week for women and ≥21 alcohol units/week for
men in the last 30 days, and have met this criteria prior to randomization
- Provide evidence of stable residence in the last month prior to enrollment in the
study, and have no plans to move in the next 9 months.
- Literate in English and able to read, understand, and complete the rating scales and
questionnaires accurately, follow instructions, and make use of the behavioral
treatments
- Expressed a wish to reduce or stop drinking
- Willingness to participate in behavioral treatments for alcoholism
Exclusion Criteria:
- Please contact site for additional information
We found this trial at
2
sites
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