Pharmacogenetic Treatments for Alcoholism

NCT01591291 | Withdrawn Phase 2 DMC

• 1 other identifier: G15991
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 2

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.

Conditions

Alcoholism

Keywords

alcohol dependence; alcohol addiction

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Drinks per drinking day

  up to 24 weeks

• Percentage of days abstinent

  up to 24 weeks

• Percentage of subjects with no heavy drinking days

  up to 24 weeks

• Measures of quality of life

  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

  We will collect RNA on screen, weeks 4, 8, 12, 16, 20, 24

Study Arms (2)

Ondansetron

EXPERIMENTAL

Drug: Ondansetron + Brief Behavioral Enhancement Treatment

Placebo

PLACEBO COMPARATOR

Drug: Placebo + Brief Behavioral Enhancement Treatment

Interventions

Ondansetron + Brief Behavioral Enhancement Treatment DRUG

Ondansetron 4ug/kg twice daily

Also known as: Zofran

Ondansetron

Placebo + Brief Behavioral Enhancement Treatment DRUG

Placebo twice daily

Also known as: Sugar Pill

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Please contact site for additional information

Sponsors & Collaborators

• University of Virginia: lead
• National Institute on Alcohol Abuse and Alcoholism (NIAAA): collaborator

Study Sites (2)

University of Virginia Center for Addiction Research and Education

Charlottesville, Virginia, 22911, United States

Location

University of Virginia Center for Addiction Research and Education

Richmond, Virginia, 23294, United States

Location

MeSH Terms

Conditions

Alcoholism

Interventions

Ondansetron; Sugars

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Carbazoles; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds, 3-Ring; Carbohydrates

Study Officials

• Bankole Johnson, DSc, MD, PhD

  University of Virginia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 17, 2012
• First Posted: May 3, 2012
• Study Start: June 1, 2012
• Primary Completion: December 1, 2017
• Study Completion: February 1, 2018
• Last Updated: April 20, 2023

Record last verified: 2023-04

Locations

US (2)