HealthyR21AA28365NCT04967599
Alcohol Metabolism and Disease Risk in Asians
A study testing Phenotype Feedback Intervention and Genotype Feedback Intervention in people with Healthy, run by University of Southern California at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 17 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Phenotype Feedback Intervention and Genotype Feedback Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 360 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Aug 2021to 18 Jan 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 17 to 25 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Southern California
Los Angeles, California, 90089
About this study
Official title: 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.
- Conditions
- Healthy
- Being tested
- Phenotype Feedback Intervention, Genotype Feedback Intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Phenotype Feedback InterventionBehavioural
Also called PHEN
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 InterventionBehavioural
Also called GENE
Online session providing personalized feedback on alcohol metabolism genotypes and associated health-related risks.
| Study group | Role | What they receive |
|---|---|---|
| Control (CONTROL) | No intervention | Participants do not receive PHEN or GENE. |
| Phenotype Feedback (PHEN) | Experimental | Participants receive the PHEN intervention. Receives: Behavioral: Phenotype Feedback Intervention |
| Phenotype and Genotype Feedback (PHEN+GENE) | Experimental | Participants receive the PHEN and GENE interventions. Receives: Behavioral: Phenotype Feedback Intervention; Behavioral: Genotype Feedback Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak Number of Alcohol Drinks Consumed in a Day
Drinking quantity (i.e. total number of alcoholic drinks) consumed on heaviest drinking day
Measured: Baseline through 10-months post-intervention (which occurred on 1 day)
Secondary outcomes (5)
Number of Drinking Days
Number of days consumed alcohol in the past month
Measured: 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
Measured: 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
Measured: 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)
Measured: 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
Measured: Baseline through 10-months post-intervention (which occurred on 1 day)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2021
- Study start18 Aug 2021
- Primary completion18 Jan 2023
- Study completion18 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by University of Southern CaliforniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 360 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southern California
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Susan Luczak, University of Southern California
- Investigators
- Susan E. Luczak, Ph.D., Principal investigator, University of Southern California
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04967599
- Sponsor's protocol ID
- HS-20-00814
- Acronym
- R21AA28365
- Status last verified
- Nov 2024
- First submitted
- 29 Jun 2021
- Last updated
- 24 Dec 2024
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified participant data will be uploaded to the National Institute of Mental Health Data Archive.
Publications
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.
PubMed 42310974
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Alcohol Metabolism and Disease Risk in Asians: Examining the Impact of Personalized Phenotypic/Genotypic Feedback and Motivational Processes on Early Drinking Trajectories
- ClinicalTrials.gov ID
- NCT04967599
- Acronym / sponsor ID
- R21AA28365 / HS-20-00814
- Conditions
- Healthy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 360 participants (actual)
- Lead sponsor
- University of Southern CaliforniaUniversity, hospital or other
- Study start
- 18 Aug 2021 (actual)
- Primary completion
- 18 Jan 2023 (actual)
- Study completion
- 18 Jan 2023 (actual)
- First posted
- 19 Jul 2021 (actual)
- Results
- Posted 24 Dec 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control (CONTROL) | No intervention | –Participants do not receive PHEN or GENE. |
| Phenotype Feedback (PHEN) | Experimental | Behavioral: Phenotype Feedback InterventionParticipants receive the PHEN intervention. |
| Phenotype and Genotype Feedback (PHEN+GENE) | Experimental | Behavioral: Phenotype Feedback Intervention, Behavioral: Genotype Feedback InterventionParticipants receive the PHEN and GENE interventions. |
Who may qualify
- Ages
- 17 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Phenotype Feedback InterventionAlso: PHENOnline 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. | Behavioural | Phenotype Feedback (PHEN), Phenotype and Genotype Feedback (PHEN+GENE) |
| Genotype Feedback InterventionAlso: GENEOnline session providing personalized feedback on alcohol metabolism genotypes and associated health-related risks. | Behavioural | Phenotype and Genotype Feedback (PHEN+GENE) |
Primary outcome
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
5 secondary outcomes
Number of Drinking Days
Time frame: Baseline through 10-months post-intervention (which occurred on 1 day)
Number of Alcoholic Drinks Consumed on Weekend
Time frame: Baseline through 10-months post-intervention (which occurred on 1 day)
Number of Alcoholic Drinks Consumed Weekly
Time frame: Baseline through 10-months post-intervention (which occurred on 1 day)
Number of Participants Identified as Non-drinkers
Time frame: Baseline through 10-months post-intervention (which occurred on 1 day)
Alcohol Flush Cure Use Rate
Time frame: Baseline through 10-months post-intervention (which occurred on 1 day)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 42310974Saldich 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.
- Individual participant dataSharing planned: Yes. De-identified participant data will be uploaded to the National Institute of Mental Health Data Archive.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Susan E. Luczak, Ph.D. principal investigator
University of Southern California
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Phenotype Feedback Intervention and Genotype Feedback Intervention in people with Healthy, run by University of Southern California at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 Dec 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Peak Number of Alcohol Drinks Consumed in a Day (time frame: Baseline through 10-months post-intervention (which occurred on 1 day)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04967599, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Dec 2024.