An interventional study of Genetic Test Results Return and Alcohol Flushing Education in Healthy Adult and Flushing, sponsored by Northwestern University. Not yet recruiting at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-28.
Sponsored by Northwestern University · Not applicable, Interventional, and Prevention
The goal of this clinical trial is to learn whether education plus genetic testing for ALDH2*2 and ADH1B*2 is feasible and acceptable and whether it influences modifiable health behaviors in East Asian American adults who experience alcohol flushing when they drink alcohol or have a family history of flushing. The main questions it aims to answer are:
Participants will:
Alcohol flushing syndrome affects an estimated >500 million individuals worldwide and is strongly associated with functional variants in alcohol metabolism genes, particularly ALDH2 (e.g., ALDH2*2) and ADH1B (e.g., ADH1B*2). ALDH2*2 reduces aldehyde dehydrogenase activity, contributing to acetaldehyde accumulation and is associated with increased risk for alcohol-related morbidity, including certain cancers and cardiometabolic outcomes. Despite the public health relevance, ALDH2/ADH1B implementation in clinical care remains limited, and evidence-based strategies are needed to support equitable and ethical adoption, especially for populations underrepresented in genomics research. This study will engage the East Asian American community to evaluate implementation strategies for ALDH2*2 and ADH1B*2 genetic testing and education in clinical settings and to examine the behavioral impact of returning genetic risk information. Using a pragmatic, randomized comparative effectiveness pilot design, East Asian American adults who self-report alcohol flushing and/or a family history of flushing will be randomized to either: (1) education plus ALDH2*2/ADH1B*2 genetic testing with genotype-informed result disclosure, or (2) education alone. Primary outcomes are feasibility and acceptability of the testing-and-education approach; secondary outcomes include changes in modifiable health behaviors (e.g., alcohol-related decision-making) following education with or without genetic result return. Findings will inform scalable implementation pathways and contribute to equitable integration of genomic testing into routine care for populations experiencing healthcare disparities.
22 studies on the registry are indexed under Flushing; 5 are open to participants now.
This study's planned enrollment of 100 is above the median of 90 across 19 interventional studies indexed under Flushing.
Browse Flushing studies →Northwestern University is the lead sponsor of 1,423 studies on the registry; 198 are open to participants now.
Of its 105 completed or terminated interventional studies of FDA-regulated products, 78 (74%) have results posted.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria:
Behavioral: Alcohol Flushing Education
Behavioral: Genetic Test Results Return · Behavioral: Alcohol Flushing Education
Returning genetic test results for alcohol flushing genes (i.e., ALDH2, ADH1B)
Administering alcohol flushing educational module.
Feasibility of Alcohol Flushing Genetic Testing in Primary Care
Feasibility of Intervention Measure (FIM) will be administered to primary care clinicians to measure the extent to which alcohol flushing genetic testing can be successfully used or carried out within a primary care setting. Post-intervention, we will quantitatively assess feasibility of ALDH2 education and genetic testing via 1 questionnaire (4 items total): Feasibility of Intervention Measure (FIM). This 4-item psychometrically-validated measure captures the extent to which individuals believe an implementation strategy is feasible.
Time frame: From enrollment to the end of data collection at 8 weeks.
Acceptability of Alcohol Flushing Genetic Testing in Primary Care
Acceptability of Intervention Measure (AIM) assess how agreeable, palatable, or satisfactory alcohol flushing genetic testing is to primary care clinicians. Post-intervention, we will quantitatively assess acceptability of ALDH2 education and genetic testing via 1 questionnaire (4 items total): Acceptability of Intervention Measure (AIM). This 4-item psychometrically-validated measure captures the extent to which individuals believe an implementation strategy is acceptable.
Time frame: From enrollment to the end of data collection at 8 weeks.
Change(s) in Alcohol Consumption
Alcohol consumption outcome measurements at baseline and one month after educational modules are shared AND after genetic testing results are received. This results in 3 alcohol outcome measurements total for both arms of the study.
Time frame: Alcohol consumption outcome measurements at baseline and one month after educational modules are shared AND after genetic testing results are received.
Plan to share: No — Consent language approved by IRB board did not include broad data sharing AND IDP may be identifiable.
Start is estimated for Feb 2027; primary completion for Jun 2029, 28 months later.
Start moved once since we started tracking on Sep 25, 2026: Nov 2026 → Feb 2027, on Oct 28, 2026.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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