Status:
COMPLETED
Effects of an Oral Nicotine Product in Smokeless Tobacco Users
Lead Sponsor:
Virginia Commonwealth University
Collaborating Sponsors:
National Institute on Drug Abuse (NIDA)
Conditions:
Tobacco Use
Eligibility:
All Genders
18-55 years
Phase:
NA
Brief Summary
The purpose of this research study is to find out how three different nicotine pouches and participant's own brand of smokeless tobacco affect blood nicotine levels and how participants feel.
Eligibility Criteria
Inclusion
- Healthy (determined by self-report)
- Between the ages of 18-55
- Willing to provide informed consent, attend the lab sessions and abstain from tobacco/nicotine as required
- Agree to use designated products according to study protocol
- Smokeless tobacco users and must report using smokeless tobacco daily. Smokeless tobacco users must have a 'positive' cotinine cassette result to verify nicotine use
Exclusion
- The following self-reported current, diagnosed medical condition(s): heart-related conditions (e.g., recent heart attack/stroke, coronary heart disease), severe immune system disorders (e.g., HIV/AIDS, multiple sclerosis), respiratory disorders (e.g., COPD, asthma), kidney diseases, liver diseases (e.g., cirrhosis), or seizures
- Other self-reported current, diagnosed medical conditions (e.g., diabetes, thyroid disease, Lyme disease) may be excluded after consultation with the PI and medical monitor: any medical condition/medication that may affect participant safety, study outcomes, or biomarker data will be excluded based on these consultations
- Self-reported current, diagnosed psychiatric conditions, and who are currently under the care of a physician for psychiatric conditions, or who report current psychiatric treatment or psychotropic medication use
- Not providing answers to questions related to inclusion/exclusion criteria
- Breast-feeding or pregnant women (pregnancy tested by urinalysis at screening
- Weigh less than 110 pounds
- Intend to quit tobacco/nicotine use in the next 30 days
Key Trial Info
Start Date :
August 23 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 28 2023
Estimated Enrollment :
31 Patients enrolled
Trial Details
Trial ID
NCT05280769
Start Date
August 23 2022
End Date
November 28 2023
Last Update
October 2 2024
Active Locations (1)
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1
Virginia Commonwealth University
Richmond, Virginia, United States, 23298