Clinical Trial: Pharmacogenetic Treatments for Alcoholism

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

Official Title: 1/2 - Pharmacogenetic Treatments for Alcoholism

Brief 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.


Detailed Summary: 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.
Sponsor: Bankole Johnson

Current Primary Outcome: Percent heavy drinking days [ Time Frame: up to 24 weeks ]

The timeline follow-back (TLFB) method of measuring alcohol consumption will be used to get the percent heavy drinking days.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Drinks per drinking day [ Time Frame: up to 24 weeks ]
    From the TLFB data, other measures of drinking such as drinking intensity (drinks per drinking day; DDD) will be derived.
  • Percentage of days abstinent [ Time Frame: up to 24 weeks ]
    From the TLFB data, other measures of drinking such as the percentage of days abstinent (PDA) will be derived.
  • Percentage of subjects with no heavy drinking days [ Time Frame: up to 24 weeks ]
    The TLFB will also be used for other experimental measures that we have validated in previous studies, such as the percentage of subjects with no heavy drinking.
  • Measures of quality of life [ Time Frame: Various time points in the study (screen, weeks 1, 4, 8, 12, 16, 20, 24) ]
    Quality of life will be assessed using the Quality of Life Enjoyment and Satisfaction Questionnaire and Short Index of Problems.
  • Objective measure of treatment measure and adverse event using RNA [ Time Frame: We will collect RNA on screen, weeks 4, 8, 12, 16, 20, 24 ]
    We will collect RNA samples and using genome-wide expression studies of total RNA, we will compare 15 of the most responsive and 15 of the most least responsive on percent heavy drinking days and 15 with the most and 15 with the fewest adverse events, we will identify changes that mediate ondansetron's efficacy and adverse event profile, respestively.


Original Secondary Outcome: Same as current

Information By: University of Virginia

Dates:
Date Received: April 17, 2012
Date Started: June 2012
Date Completion: February 2018
Last Updated: May 2, 2012
Last Verified: May 2012