Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
170 participants
INTERVENTIONAL
2022-07-08
2027-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
BASIC_SCIENCE
NONE
Study Groups
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Group I (alcohol consumption)
Participants who consume alcohol receive a standard drink or an alcohol dose that will result in a 0.03% BAC PO on study. Participants also undergo collection of saliva and breathalyzer testing throughout the trial.
Alcohol
Alcohol dose given orally that will result in a 0.03% blood alcohol concentration (BAC).
Biospecimen Collection
Undergo saliva, mouthwash, and cheek brush collection
Breath Test
Undergo breathalyzer testing
Group II (biospecimen collection)
Participants who do not drink alcohol undergo collection of saliva, mouthwash, and cheek brush samples throughout the trial.
Biospecimen Collection
Undergo saliva, mouthwash, and cheek brush collection
Breath Test
Undergo breathalyzer testing
Interventions
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Alcohol
Alcohol dose given orally that will result in a 0.03% blood alcohol concentration (BAC).
Biospecimen Collection
Undergo saliva, mouthwash, and cheek brush collection
Breath Test
Undergo breathalyzer testing
Eligibility Criteria
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Inclusion Criteria
* Occasionally consume alcohol
* At least 1 drink per month for healthy volunteers
* At least 1 drink in the last 3 months for Fanconi anemia patients
* Meets one of the three criteria
* Healthy volunteer - ALDH2\*1/1\* homozygotes-not of Eastern Asian decent;
* Healthy volunteer - ALDH2\*1/2\* heterozygotes-of Eastern Asian decent and experience flushing when drinking
* Individual's with Fanconi anemia (FA).
* 18-45 years of age for non-drinkers
* Never consume alcohol/not had alcohol in the last 6 months
* Healthy volunteers.
* Non-smoker (smoked \< 100 cigarettes in a lifetime)
Exclusion Criteria
* Taking any medication or drug that might affect alcohol use and absorption or that might be affected by alcohol consumption
* Healthy volunteers who have taken any antibiotics in the last 3 months
* Currently consuming more than 21 drinks per week
* Have any history of alcohol or drug related problems
* Current or former tobacco/nicotine product(s) user
* Any regular use of tobacco/nicotine products or marijuana in the last year (cigarettes, e-cigarettes, cigars, pipes, smokeless tobacco)
* "Trying" or limited use of any nicotine products or marijuana in the last 1 month
* Active infection (influenza, cold, COVID, respiratory / sinus infection) - admission in the study will be delayed pending improved health
* Non-FA volunteers who have an unstable medical condition or condition that could be affected by alcohol consumption (insulin-dependent diabetes, ulcers, heart issues)
* Experience severe adverse events (nausea, blacking out) when consuming even low doses of alcohol
18 Years
45 Years
ALL
Yes
Sponsors
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National Institutes of Health (NIH)
NIH
Masonic Cancer Center, University of Minnesota
OTHER
Responsible Party
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Locations
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Masonic Cancer Center, University of Minnesota
Minneapolis, Minnesota, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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NCI-2022-09710
Identifier Type: REGISTRY
Identifier Source: secondary_id
SPH-2021-29712
Identifier Type: -
Identifier Source: org_study_id
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