Clinical trial NCT01591291: Pharmacogenetic Treatments for Alcoholism
Official title: 1/2 - Pharmacogenetic Treatments for Alcoholism
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
PHASE3
Conditions: Alcoholism
Keywords: alcohol dependence
alcohol addiction
Lead sponsor: University of Virginia
Sponsor class: OTHER
Collaborators: name: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
First posted: 2012-05-03
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

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 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.

Eligibility 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

Primary outcomes:
measure: Percent heavy drinking days
timeFrame: up to 24 weeks
Secondary outcomes:
measure: Drinks per drinking day
timeFrame: up to 24 weeks
measure: Percentage of days abstinent
timeFrame: up to 24 weeks
measure: Percentage of subjects with no heavy drinking days
timeFrame: up to 24 weeks
measure: Measures of quality of life
timeFrame: Various time points in the study (screen, weeks 1, 4, 8, 12, 16, 20, 24)
measure: Objective measure of treatment measure and adverse event using RNA
timeFrame: We will collect RNA on screen, weeks 4, 8, 12, 16, 20, 24
Other outcomes:
Locations:
city: Charlottesville
country: United States
facility: University of Virginia Center for Addiction Research and Education
state: Virginia
city: Richmond
country: United States
facility: University of Virginia Center for Addiction Research and Education
state: Virginia
Study officials:
affiliation: University of Virginia
name: Bankole Johnson, DSc, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: