Pharmacogenetic Treatments for Alcoholism

April 18, 2023 updated by: University of Virginia

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Virginia
      • Charlottesville, Virginia, United States, 22911
        • University of Virginia Center for Addiction Research and Education
        • Contact:
        • Contact:
        • Principal Investigator:
          • Bankole Johnson, DSc, MD, PhD
        • Sub-Investigator:
          • Nassima Ait-Daoud Tiouririne, MD
      • Richmond, Virginia, United States, 23294
        • University of Virginia Center for Addiction Research and Education
        • Contact:
        • Contact:
        • Principal Investigator:
          • Bankole Johnson, DSc, MD, PhD
        • Sub-Investigator:
          • Nassima Ait-Daoud Tiouririne, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: Placebo + Brief Behavioral Enhancement Treatment
Placebo twice daily
Other Names:
  • Sugar Pill
Experimental: Ondansetron
Drug: Ondansetron + Brief Behavioral Enhancement Treatment
Ondansetron 4ug/kg twice daily
Other Names:
  • Zofran

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
up to 24 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
up to 24 weeks
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.
up to 24 weeks
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.
up to 24 weeks
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.
Various time points in the study (screen, weeks 1, 4, 8, 12, 16, 20, 24)
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.
We will collect RNA on screen, weeks 4, 8, 12, 16, 20, 24

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Virginia

Collaborators

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Investigators

  • Principal Investigator: Bankole Johnson, DSc, MD, PhD, University of Virginia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2012

Primary Completion (Anticipated)

December 1, 2017

Study Completion (Anticipated)

February 1, 2018

Study Registration Dates

First Submitted

April 17, 2012

First Submitted That Met QC Criteria

May 2, 2012

First Posted (Estimate)

May 3, 2012

Study Record Updates

Last Update Posted (Actual)

April 20, 2023

Last Update Submitted That Met QC Criteria

April 18, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • G15991

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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