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Alcohol Exposure for Oral Cancer Risk

N/A

Recruiting

Research Sponsored by Masonic Cancer Center, University of Minnesota

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be between 18 and 65 years old

Must not have

Healthy volunteers who have taken any antibiotics in the last 3 months

Any regular use of tobacco/nicotine products or marijuana in the last year (cigarettes, e-cigarettes, cigars, pipes, smokeless tobacco)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up prior to alcohol dose, and 30 minutes, 1 hour, 2 hours, 4 hours, and 6 hours post alcohol dose

Awards & highlights

No Placebo-Only Group

Summary

This trial studies the effects of a single dose of alcohol on healthy volunteers and those with Fanconi anemia. Biological samples like saliva, cells, and urine will be taken, with optional blood samples.

Who is the study for?

This trial is for healthy volunteers and individuals with Fanconi anemia who occasionally drink alcohol. Participants should be non-smokers, aged 18-45 (21-45 for drinkers), and not have used antibiotics or experienced severe reactions to alcohol recently. Pregnant or nursing individuals, heavy drinkers, those with unstable health conditions affected by alcohol, or recent tobacco/nicotine users are excluded.

What is being tested?

The study investigates how acetaldehyde contributes to oral cancer development after consuming a single dose of alcohol. It involves collecting saliva, mouthwash cells, cheek brush cells, urine samples from participants at different times post-consumption. Blood sample collection is optional.

What are the potential side effects?

Since this is a minimal risk intervention involving the consumption of a single dose of alcohol and sample collection, side effects may include typical reactions to alcohol such as mild discomfort or intoxication symptoms depending on individual tolerance.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am healthy but have taken antibiotics in the past 3 months.

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I have used tobacco/nicotine products or marijuana in the past year.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ prior to alcohol exposure

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~prior to alcohol exposure

This trial's timeline: 3 weeks for screening, Varies for treatment, and prior to alcohol exposure for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Determine the acetaldehyde exposure to the oral cavity by comparing saliva levels before and after alcohol dose

Secondary study objectives

Urine will be analyzed to confirm non-smoking status

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Group I (alcohol consumption)Experimental Treatment3 Interventions

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.

Group II: Group II (biospecimen collection)Active Control2 Interventions

Participants who do not drink alcohol undergo collection of saliva, mouthwash, and cheek brush samples throughout the trial.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Alcohol

2008

Completed Phase 3

~1990

Biospecimen Collection

2004