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OpenTrials
Completed

NCT Number: NCT04967599

Alcohol Metabolism and Disease Risk in Asians

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.

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Key information

Conditions

Healthy

Age range

17 year–25 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Southern California

Los Angeles, California, 90089, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • All participants will be of Asian heritage (i.e. Chinese/Taiwanese, Japanese, Korean, Vietnamese).
  • About half of the sample will be incoming first-year undergraduates
  • About half of the sample will be current undergraduates who self-report having flushed when they first started drinking alcohol

Treatment and study plan

Phenotype Feedback Intervention

Behavioral

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

Genotype Feedback Intervention

Behavioral

Online session providing personalized feedback on alcohol metabolism genotypes and associated health-related risks.

Other names: GENE

Primary outcomes

  1. Peak Number of Alcohol Drinks Consumed in a Day

    Time frame: Baseline through 10-months post-intervention (which occurred on 1 day)

    Drinking quantity (i.e. total number of alcoholic drinks) consumed on heaviest drinking day

Secondary outcomes

  1. Number of Drinking Days

    Time frame: Baseline through 10-months post-intervention (which occurred on 1 day)

    Number of days consumed alcohol in the past month

  2. Number of Alcoholic Drinks Consumed on Weekend

    Time frame: Baseline through 10-months post-intervention (which occurred on 1 day)

    Alcohol quantity (total number of drinks) consumed on a typical drinking weekend

  3. Number of Alcoholic Drinks Consumed Weekly

    Time frame: Baseline through 10-months post-intervention (which occurred on 1 day)

    Total quantity (i.e. number of drinks) of alcohol consumed in a typical drinking week

  4. Number of Participants Identified as Non-drinkers

    Time frame: Baseline through 10-months post-intervention (which occurred on 1 day)

    Number of Participants Identified as Non-drinkers (i.e. have not had alcohol beyond small sips or tastes)

  5. Alcohol Flush Cure Use Rate

    Time frame: Baseline through 10-months post-intervention (which occurred on 1 day)

    Proportion of time used a product to reduce flushing when drinking alcohol

Sponsors and collaborators

Lead sponsor

University of Southern California

Other

Registry information

Official study title

Alcohol Metabolism and Disease Risk in Asians: Examining the Impact of Personalized Phenotypic/Genotypic Feedback and Motivational Processes on Early Drinking Trajectories

Acronym: R21AA28365

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Jul 19, 2021
Registry last updated
Dec 24, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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