Alcohol Metabolism and Disease Risk in Asians (R21AA28365)

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

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Behavioral: Phenotype Feedback Intervention; Behavioral: Genotype Feedback Intervention

• Study Type: Interventional
• Enrollment (Actual): 360
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90089
      • University of Southern California

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 17 years to 25 years (Child, Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Peak Number of Alcohol Drinks Consumed in a Day	Drinking quantity (i.e. total number of alcoholic drinks) consumed on heaviest drinking day	Baseline through 10-months post-intervention (which occurred on 1 day)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Drinking Days	Number of days consumed alcohol in the past month	Baseline through 10-months post-intervention (which occurred on 1 day)
Number of Alcoholic Drinks Consumed on Weekend	Alcohol quantity (total number of drinks) consumed on a typical drinking weekend	Baseline through 10-months post-intervention (which occurred on 1 day)
Number of Alcoholic Drinks Consumed Weekly	Total quantity (i.e. number of drinks) of alcohol consumed in a typical drinking week	Baseline through 10-months post-intervention (which occurred on 1 day)
Number of Participants Identified as Non-drinkers	Number of Participants Identified as Non-drinkers (i.e. have not had alcohol beyond small sips or tastes)	Baseline through 10-months post-intervention (which occurred on 1 day)
Alcohol Flush Cure Use Rate	Proportion of time used a product to reduce flushing when drinking alcohol	Baseline through 10-months post-intervention (which occurred on 1 day)

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): August 18, 2021
• Primary Completion (Actual): January 18, 2023
• Study Completion (Actual): January 18, 2023

Study Registration Dates

• First Submitted: June 29, 2021
• First Submitted That Met QC Criteria: July 14, 2021
• First Posted (Actual): July 19, 2021

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: November 13, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: HS-20-00814

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified participant data will be uploaded to the National Institute of Mental Health Data Archive.
• IPD Sharing Time Frame: Data will be shared no later than 2 years after the project end date.
• IPD Sharing Access Criteria: De-identified data will be available to eligible researchers, and summary information will be available to the public.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No