- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07657221
Impact of Risk Feedback on Behavioral Trajectories
June 12, 2026 updated by: Susan Luczak, University of Southern California
Alcohol Metabolism and Disease Risk in Asians: Examining the Impact of Personalized Phenotypic/Genotypic Feedback on Early Drinking Trajectories
The goal of this study is to examine the effects of providing personalized information about behavioral, physical, and genetic factors that are associated with elevations in risk for some health problems.
The main research question is: can we affect young adult behaviors through communication about these health-related risks?
Participants will be asked to complete an in-person baseline session where they provide a DNA sample, complete online surveys, and do a brief interview.
They will then receive one of several brief online information sessions and be followed in online surveys approximately every 3 months over the next 2 years.
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
450
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Susan Luczak, PhD
- Phone Number: 2137402203
- Email: luczak@usc.edu
Study Locations
-
-
California
-
Los Angeles, California, United States, 90089
- University of Southern California
-
Contact:
- Susan Luczak, PhD
- Phone Number: 2137402203
- Email: luczak@usc.edu
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- USC student of Chinese, Japanese, Korean, or Vietnamese heritage
Exclusion Criteria:
- not a USC student, not 17-25 years old, not of Chinese, Japanese, Korean, or Vietnamese heritage
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: PHEN
provided phenotypic feedback
|
Feedback on alcohol response (phenotype)
|
|
Experimental: GENE
provides genotypic feedback
|
Feedback on alcohol response (phenotype)
Feedback on both phenotype and genotype (PHEN+GENE)
|
|
Placebo Comparator: CONTROL
provided a control feedback
|
Feedback that serves as control
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Drinking frequency
Time Frame: up to 2 years post-intervention
|
Number of days consumed alcohol
|
up to 2 years post-intervention
|
|
Average alcohol quantity
Time Frame: up to 2 years post-intervention
|
Average amount of alcohol consumed on drinking days
|
up to 2 years post-intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Amount of alcohol consumed
Time Frame: up to 2 years post-intervention
|
Total number of drinks consumed
|
up to 2 years post-intervention
|
|
Maximum daily alcohol
Time Frame: up to 2 years post-intervention
|
Highest number of drinks consumed on one day
|
up to 2 years post-intervention
|
|
Use of flush cures
Time Frame: up to 2 years post-intervention
|
Proportion of drinking days used flush cures
|
up to 2 years post-intervention
|
|
Use of drinking behavioral strategies
Time Frame: up to 2 years post-intervention
|
Proportion of drinking days used behavioral strategies
|
up to 2 years post-intervention
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Susan Luczak, PhD, University of Southern California
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
August 18, 2026
Primary Completion (Estimated)
February 28, 2029
Study Completion (Estimated)
August 31, 2030
Study Registration Dates
First Submitted
June 9, 2026
First Submitted That Met QC Criteria
June 12, 2026
First Posted (Actual)
June 18, 2026
Study Record Updates
Last Update Posted (Actual)
June 18, 2026
Last Update Submitted That Met QC Criteria
June 12, 2026
Last Verified
June 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- UP-24-00754
- R01AA032036 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
For participants who agree to have their data included, de-identified participant data will be uploaded to the National Institute of Mental Health Data Archive (NDA).
IPD Sharing Time Frame
Data will be available no later than 2 years post-study completion and will be available indefinitely.
IPD Sharing Access Criteria
Access will be made in accordance with NDA regulations.
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.