NCT05973656 · Masonic Cancer Center, University of Minnesota
Role of Acetaldehyde in the Development of Oral Cancer
What this study is about
This is a minimal risk intervention study where healthy volunteers and individuals with Fanconi anemia will consume a single dose of alcohol and provide primarily non-invasive biological samples at various time points. Biospecimens to be collected include saliva, taken by mouth cells collected via mouthwash and cheek brush, and urine.
View original scientific description
This is a minimal risk intervention study where healthy volunteers and individuals with Fanconi anemia will consume a single dose of alcohol and provide primarily non-invasive biological samples at various time points. Biospecimens to be collected include saliva, oral cells collected via mouthwash and cheek brush, and urine. The collection of two blood samples (5 mL each) will be optional and banked for future use.
Interventions
DRUG
Alcohol
Alcohol dose given orally that will result in a 0.03% blood alcohol concentration (BAC).
PROCEDURE
Biospecimen Collection
Undergo saliva, mouthwash, and cheek brush collection
PROCEDURE
Breath Test
Undergo breathalyzer testing
Primary outcome measures
Determine the acetaldehyde exposure to the oral cavity by comparing saliva levels before and after alcohol dose
Time frame: Prior to alcohol dose, and 30 minutes, 1 hour, 2 hours, 4 hours, and 6 hours post alcohol dose
Identify and quantify DNA adducts in the oral cells (mouthwash and cheek brush samples).
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 21-45 years of age for alcohol drinkers
- 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
- Pregnant or nursing
- 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
Where
- Minneapolis, Minnesota
Collaborators
National Institutes of Health (NIH)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Aug 22, 2025 · Source of record for eligibility and locations