Pharmacogenetic Treatments for Alcoholism
Primary Purpose
Alcoholism
Status
Withdrawn
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Ondansetron + Brief Behavioral Enhancement Treatment
Placebo + Brief Behavioral Enhancement Treatment
Sponsored by
About this trial
This is an interventional treatment trial for Alcoholism focused on measuring alcohol dependence, alcohol addiction
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
Sites / Locations
- University of Virginia Center for Addiction Research and Education
- University of Virginia Center for Addiction Research and Education
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Ondansetron
Placebo
Arm Description
Outcomes
Primary Outcome Measures
Percent heavy drinking days
The timeline follow-back (TLFB) method of measuring alcohol consumption will be used to get the percent heavy drinking days.
Secondary Outcome Measures
Drinks per drinking day
From the TLFB data, other measures of drinking such as drinking intensity (drinks per drinking day; DDD) will be derived.
Percentage of days abstinent
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
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
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
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.
Full Information
NCT ID
NCT01591291
First Posted
April 17, 2012
Last Updated
April 18, 2023
Sponsor
University of Virginia
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
1. Study Identification
Unique Protocol Identification Number
NCT01591291
Brief Title
Pharmacogenetic Treatments for Alcoholism
Official Title
1/2 - Pharmacogenetic Treatments for Alcoholism
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Withdrawn
Why Stopped
Grant was transferred to University of Maryland and results were reported under NCT02354703.
Study Start Date
June 2012 (undefined)
Primary Completion Date
December 2017 (Anticipated)
Study Completion Date
February 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Virginia
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcoholism
Keywords
alcohol dependence, alcohol addiction
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Factorial Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Ondansetron
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Ondansetron + Brief Behavioral Enhancement Treatment
Other Intervention Name(s)
Zofran
Intervention Description
Ondansetron 4ug/kg twice daily
Intervention Type
Drug
Intervention Name(s)
Placebo + Brief Behavioral Enhancement Treatment
Other Intervention Name(s)
Sugar Pill
Intervention Description
Placebo twice daily
Primary Outcome Measure Information:
Title
Percent heavy drinking days
Description
The timeline follow-back (TLFB) method of measuring alcohol consumption will be used to get the percent heavy drinking days.
Time Frame
up to 24 weeks
Secondary Outcome Measure Information:
Title
Drinks per drinking day
Description
From the TLFB data, other measures of drinking such as drinking intensity (drinks per drinking day; DDD) will be derived.
Time Frame
up to 24 weeks
Title
Percentage of days abstinent
Description
From the TLFB data, other measures of drinking such as the percentage of days abstinent (PDA) will be derived.
Time Frame
up to 24 weeks
Title
Percentage of subjects with no heavy drinking days
Description
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.
Time Frame
up to 24 weeks
Title
Measures of quality of life
Description
Quality of life will be assessed using the Quality of Life Enjoyment and Satisfaction Questionnaire and Short Index of Problems.
Time Frame
Various time points in the study (screen, weeks 1, 4, 8, 12, 16, 20, 24)
Title
Objective measure of treatment measure and adverse event using RNA
Description
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.
Time Frame
We will collect RNA on screen, weeks 4, 8, 12, 16, 20, 24
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bankole Johnson, DSc, MD, PhD
Organizational Affiliation
University of Virginia
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Virginia Center for Addiction Research and Education
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22911
Country
United States
Facility Name
University of Virginia Center for Addiction Research and Education
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23294
Country
United States
12. IPD Sharing Statement
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Pharmacogenetic Treatments for Alcoholism
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