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Tylenol and Nicotinamide Riboside for Therapeutic Agent Toxicity

Phase 1
Recruiting
Led By marie migaud, PHD
Research Sponsored by University of South Alabama
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
n/a
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up pre-dose and 6 hour, 12 hour and 24 hour post dose following administration and
Awards & highlights

Study Summary

This trial is studying the effects of acetaminophen (such as Tylenol) on astronauts' health in space. Researchers want to see if acetaminophen can be harmful and if a

Who is the study for?
This trial is for people who use acetaminophen (like Tylenol) to manage pain and discomfort. It's especially relevant for those in conditions similar to space travel, where such drug use is common. Participants must not be allergic to acetaminophen or the dietary supplement nicotinamide riboside.Check my eligibility
What is being tested?
The study tests if a dietary supplement called Nicotinamide Riboside can reduce harmful chemicals produced by taking acetaminophen. Volunteers will take both substances together, and their urine and blood samples will be analyzed under space-like conditions.See study design
What are the potential side effects?
While the side effects of Acetaminophen include liver damage with high doses, adding Nicotinamide Riboside might mitigate these effects. However, potential side effects from this combination are being studied.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~pre-dose and 6 hour, 12 hour and 24 hour post dose following administration and
This trial's timeline: 3 weeks for screening, Varies for treatment, and pre-dose and 6 hour, 12 hour and 24 hour post dose following administration and for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Count the DNA damage occurring upon space-like stressors following exposure to acetaminophen, with and without NR
Count the quantity of NAD(P)(H) present with exposure to acetaminophen, with and without NR
Count the quantity of PYR-nucleotides present with exposure to acetaminophen, with and without NR
+2 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Tylenol and Nicotinamide RibosideExperimental Treatment2 Interventions
Group II: Tylenol OnlyActive Control1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Acetaminophen
2017
Completed Phase 4
~2030

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

University of Alabama at BirminghamOTHER
1,598 Previous Clinical Trials
2,286,722 Total Patients Enrolled
University of South AlabamaLead Sponsor
42 Previous Clinical Trials
15,905 Total Patients Enrolled
National Aeronautics and Space Administration (NASA)FED
24 Previous Clinical Trials
1,726 Total Patients Enrolled
~0 spots leftby Jun 2024
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