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R21AA28365: Alcohol Metabolism and Disease Risk in Asians

Sponsor
University of Southern California (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT04967599
Collaborator
(none)
360
Enrollment
1
Location
3
Arms
17.4
Anticipated Duration (Months)
20.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The primary pathway of alcohol metabolism involves two main enzymes, alcohol and aldehyde dehydrogenase. Several genes that encode these enzymes have variants that alter the rate of alcohol metabolism and increase levels of acetaldehyde. The variant ALDH2*2 allele is associated with the flushing response (i.e., Asian glow) and is found almost exclusively in individuals of east Asian descent. Although having variant ALDH2 alleles is protective against heavy drinking and alcohol use disorders, for those who do drink, these variants also are associated with elevations in risk for several health problems. The premise of this study is that we can affect early drinking behavior through personalized communication about these health-related risks.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Phenotype Feedback Intervention
  • Behavioral: Genotype Feedback Intervention
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
360 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
Alcohol Metabolism and Disease Risk in Asians: Examining the Impact of Personalized Phenotypic/Genotypic Feedback and Motivational Processes on Early Drinking Trajectories
Actual Study Start Date :
Aug 18, 2021
Anticipated Primary Completion Date :
Jan 31, 2023
Anticipated Study Completion Date :
Jan 31, 2023

Arms and Interventions

Arm Intervention/Treatment
No Intervention: Control (CONTROL)

Participants do not receive PHEN or GENE.
Experimental: Phenotype Feedback (PHEN)

Participants receive the PHEN intervention.

Behavioral: Phenotype Feedback Intervention
Online session providing information on health-related risk associated with alcohol consumption and alcohol metabolism gene variations plus personalized feedback on flushing phenotype and associated risks.
Other Names:
  • PHEN

    		•
    Experimental: Phenotype and Genotype Feedback (PHEN+GENE)

    Participants receive the PHEN and GENE interventions.

    Behavioral: Phenotype Feedback Intervention
    Online session providing information on health-related risk associated with alcohol consumption and alcohol metabolism gene variations plus personalized feedback on flushing phenotype and associated risks.
    Other Names:
  • PHEN

    • Behavioral: Genotype Feedback Intervention
    Online session providing personalized feedback on alcohol metabolism genotypes and associated health-related risks.
    Other Names:
  • GENE

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Alcohol peak consumption [Baseline through 10-months post-intervention]

      Drinking quantity on heaviest drinking day

    Secondary Outcome Measures

    1. Alcohol frequency of consumption [Baseline through 10-months post-intervention]

      Number of drinking days

    2. Alcohol weekend consumption [Baseline through 10-months post-intervention]

      Weekend quantity of alcohol consumed

    3. Alcohol consumption [Baseline through 10-months post-intervention]

      Total quantity of alcohol consumed

    4. Non-drinker [Baseline through 10-months post-intervention]

      Non-drinker will be assessed at baseline with RESPONSE: N/A, I have never had more than sips or tastes of alcohol to the QUESTION: How old were you when you first started drinking, not counting small sips or tastes of alcohol?, and 2) in all follow-up surveys with RESPONSE: never to the QUESTION: How old were you when you had your first drink of alcohol, not counting small sips or tastes of alcohol?

    5. Flush cure use [Baseline through 10-months post-intervention]

      Proportion of time use products to reduce flushing when drinking

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    17 Years to 25 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    • All participants will be of Asian heritage (i.e. Chinese/Taiwanese, Japanese, Korean, Vietnamese).

    • Half of the sample will be incoming first-year undergraduates

    • Half of the sample will be current undergraduates who self-report having flushed when they first started drinking alcohol

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Southern California Los Angeles California United States 90089

    Sponsors and Collaborators

    • University of Southern California

    Investigators

    • Principal Investigator: Susan E. Luczak, Ph.D., University of Southern California

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Susan Luczak, Professor (Research), University of Southern California
    ClinicalTrials.gov Identifier:
    NCT04967599
    Other Study ID Numbers:
    • HS-20-00814
    First Posted:
    Jul 19, 2021
    Last Update Posted:
    Apr 18, 2022
    Last Verified:
    Apr 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No

    Study Results

    No Results Posted as of Apr 18, 2022