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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control (CONTROL) | No Intervention | Participants do not receive PHEN or GENE. | |
| Phenotype Feedback (PHEN) | Experimental | Participants receive the PHEN intervention. |
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| Phenotype and Genotype Feedback (PHEN+GENE) | Experimental | Participants receive the PHEN and GENE interventions. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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) |
| 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 |
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Inclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Susan E. Luczak, Ph.D. | University of Southern California | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Southern California | Los Angeles | California | 90089 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42310974 | Derived | Saldich EB, Beam CR, Lai MHC, Monterosso JR, Walden KR, Hendershot CS, Witkiewitz K, Culver JO, Luczak SE. The Effects of Personalized Feedback About ALDH2*2, Alcohol Use, and Associated Health Risks on Drinking Intention and Consumption: The Role of Self-Efficacy and Perceived Threat. Alcohol Clin Exp Res (Hoboken). 2026 Jun;50(6):e70291. doi: 10.1111/acer.70291. |
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De-identified participant data will be uploaded to the National Institute of Mental Health Data Archive.
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Data will be shared no later than 2 years after the project end date.
De-identified data will be available to eligible researchers, and summary information will be available to the public.
All 360 participants were assigned to a group.
Participants were recruited July to October 2021 as a college student sample in Los Angeles
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| ID | Title | Description |
|---|---|---|
| FG000 | Control (CONTROL) | Participants do not receive PHEN or GENE. |
| FG001 | Phenotype Feedback (PHEN) | Participants receive the PHEN intervention. 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. |
| FG002 | Phenotype and Genotype Feedback (PHEN+GENE) | Participants receive the PHEN and GENE interventions. 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. Genotype Feedback Intervention: Online session providing personalized feedback on alcohol metabolism genotypes and associated health-related risks. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Control (CONTROL) | Participants do not receive PHEN or GENE. |
| BG001 | Phenotype Feedback (PHEN) | Participants receive the PHEN intervention. 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Peak Number of Alcohol Drinks Consumed in a Day | Drinking quantity (i.e. total number of alcoholic drinks) consumed on heaviest drinking day | 360 participants were in the baseline assessment, 280 had this outcome in the 10-month follow-up assessment | Posted | Mean | Standard Deviation | drinks | Baseline through 10-months post-intervention (which occurred on 1 day) |
|
This study provided a brief informational online intervention session to participants so no information on adverse medical event data were obtained.
This study provided a brief informational online intervention session to participants so no information on adverse medical event data were obtained.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Control (CONTROL) | Participants do not receive PHEN or GENE. | 0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Susan Luczak, PI of study | University of Southern California | 2137402203 | luczak@usc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan: Study Protocol and Statistical Analysis Plan | Aug 8, 2024 | Aug 8, 2024 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Oct 8, 2021 | Nov 9, 2024 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D005796 | Genes |
| ID | Term |
|---|---|
| D040481 | Genome Components |
| D016678 | Genome |
| D040342 | Genetic Structures |
| D055614 | Genetic Phenomena |
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| Genotype Feedback Intervention | Behavioral | Online session providing personalized feedback on alcohol metabolism genotypes and associated health-related risks. |
|
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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) |
| BG002 | Phenotype and Genotype Feedback (PHEN+GENE) | Participants receive the PHEN and GENE interventions. 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. Genotype Feedback Intervention: Online session providing personalized feedback on alcohol metabolism genotypes and associated health-related risks. |
| BG003 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
| OG002 | Phenotype and Genotype Feedback (PHEN+GENE) | Participants receive the PHEN and GENE interventions. 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. Genotype Feedback Intervention: Online session providing personalized feedback on alcohol metabolism genotypes and associated health-related risks. |
|
|
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| Secondary | Number of Drinking Days | Number of days consumed alcohol in the past month | 360 participants were in the baseline assessment, 279 of whom reported this variable in the 10-month follow-up assessment | Posted | Mean | Standard Deviation | days | Baseline through 10-months post-intervention (which occurred on 1 day) |
|
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| Secondary | Number of Alcoholic Drinks Consumed on Weekend | Alcohol quantity (total number of drinks) consumed on a typical drinking weekend | 360 participants were in the baseline assessment, 269 of whom reported on this variable in the 10-month follow-up assessment | Posted | Mean | Standard Deviation | drinks | Baseline through 10-months post-intervention (which occurred on 1 day) |
|
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|
|
| Secondary | Number of Alcoholic Drinks Consumed Weekly | Total quantity (i.e. number of drinks) of alcohol consumed in a typical drinking week | 360 participants were in the baseline assessment, 269 of whom reported this variable in the 10-month follow-up | Posted | Mean | Standard Deviation | drinks | Baseline through 10-months post-intervention (which occurred on 1 day) |
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| Secondary | 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) | 360 participants were in the baseline assessment, 280 of whom reported on this variable in the 10-month follow-up | Posted | Count of Participants | Participants | Baseline through 10-months post-intervention (which occurred on 1 day) |
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| Secondary | Alcohol Flush Cure Use Rate | Proportion of time used a product to reduce flushing when drinking alcohol | 311 participants in the baseline assessment and 220 in the 10-month follow-up assessment were current drinkers and could have used a flush cure (i.e. taken a substance to reduce flushing when drinking alcohol) | Posted | Count of Participants | Participants | Baseline through 10-months post-intervention (which occurred on 1 day) |
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| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | Phenotype Feedback (PHEN) | Participants receive the PHEN intervention. 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. | 0 | 0 | 0 | 0 | 0 | 0 |
| EG002 | Phenotype and Genotype Feedback (PHEN+GENE) | Participants receive the PHEN and GENE interventions. 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. Genotype Feedback Intervention: Online session providing personalized feedback on alcohol metabolism genotypes and associated health-related risks. | 0 | 0 | 0 | 0 | 0 | 0 |
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| 10-month follow-up |
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| 10-month follow-up |
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| 10-month follow-up |
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| 10-month follow-up |
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| Almost never/never used a flush cure |
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| Half of the time or more used a flush cure |
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| 10-month follow-up |
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