Pharmacogenetic Treatments for Alcoholism

Alcoholism Clinical Trial

Official title:

1/2 - Pharmacogenetic Treatments for Alcoholism

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01591291
• Other study ID #: G15991
• Status: Withdrawn
• Phase: Phase 2/Phase 3
• Start date: June 2012
• Est. completion date: February 2018

Study information

• Verified date: April 2023
• Source: University of Virginia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: February 2018
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Alcoholism

Intervention

Drug:
• Ondansetron + Brief Behavioral Enhancement Treatment
Ondansetron 4ug/kg twice daily
• Placebo + Brief Behavioral Enhancement Treatment
Placebo twice daily

Locations

Country	Name	City	State
United States	University of Virginia Center for Addiction Research and Education	Charlottesville	Virginia
United States	University of Virginia Center for Addiction Research and Education	Richmond	Virginia

Sponsors (2)

Lead Sponsor	Collaborator
University of Virginia	National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent heavy drinking days	The timeline follow-back (TLFB) method of measuring alcohol consumption will be used to get the percent heavy drinking days.	up to 24 weeks
Secondary	Drinks per drinking day	From the TLFB data, other measures of drinking such as drinking intensity (drinks per drinking day; DDD) will be derived.	up to 24 weeks
Secondary	Percentage of days abstinent	From the TLFB data, other measures of drinking such as the percentage of days abstinent (PDA) will be derived.	up to 24 weeks
Secondary	Percentage of subjects with no heavy drinking days	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.	up to 24 weeks
Secondary	Measures of quality of life	Quality of life will be assessed using the Quality of Life Enjoyment and Satisfaction Questionnaire and Short Index of Problems.	Various time points in the study (screen, weeks 1, 4, 8, 12, 16, 20, 24)
Secondary	Objective measure of treatment measure and adverse event using RNA	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.	We will collect RNA on screen, weeks 4, 8, 12, 16, 20, 24