Pharmacogenetic Treatments for Alcoholism

• Status: Unknown status
• Trial end date: 2018-02-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bankole Johnson
• Collaborator: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
• Treatments: Ondansetron

Criteria

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