Effects of an Oral Nicotine Product in Smokeless Tobacco Users

Not Applicable

Completed

• Conditions: Tobacco Use
• Interventions: Other: oral nicotine pouch - 2 mg; Other: oral nicotine pouch - 4 mg; Other: oral nicotine pouch - 8 mg; Other: Smokeless tobacco

• Registration Number: NCT05280769
• Lead Sponsor: Virginia Commonwealth University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-03-04
• Study First Submitted QC: 2022-03-04
• Study First Posted: 2022-03-15
• Study Start: 2022-08-23
• Primary Completion: 2023-11-28
• Study Completion: 2023-11-28
• Status Verified: 2024-09
• Last Update Submitted: 2024-09-30
• Last Update Posted: 2024-10-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 31

Inclusion Criteria

• 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 Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Single arm design	oral nicotine pouch - 2 mg	On four separate occasions, participants will come to the research center and be asked to use a nicotine pouch or smokeless tobacco provided by the study team two separate times. The nicotine pouches or smokeless tobacco contain different amounts of nicotine. Participants will not know the concentration of nicotine in the nicotine pouch, but they will know the concentration and brand of the smokeless tobacco (it will be their usual brand). All participants will complete all four study conditions.
Single arm design	oral nicotine pouch - 4 mg	On four separate occasions, participants will come to the research center and be asked to use a nicotine pouch or smokeless tobacco provided by the study team two separate times. The nicotine pouches or smokeless tobacco contain different amounts of nicotine. Participants will not know the concentration of nicotine in the nicotine pouch, but they will know the concentration and brand of the smokeless tobacco (it will be their usual brand). All participants will complete all four study conditions.
Single arm design	oral nicotine pouch - 8 mg	On four separate occasions, participants will come to the research center and be asked to use a nicotine pouch or smokeless tobacco provided by the study team two separate times. The nicotine pouches or smokeless tobacco contain different amounts of nicotine. Participants will not know the concentration of nicotine in the nicotine pouch, but they will know the concentration and brand of the smokeless tobacco (it will be their usual brand). All participants will complete all four study conditions.
Single arm design	Smokeless tobacco	On four separate occasions, participants will come to the research center and be asked to use a nicotine pouch or smokeless tobacco provided by the study team two separate times. The nicotine pouches or smokeless tobacco contain different amounts of nicotine. Participants will not know the concentration of nicotine in the nicotine pouch, but they will know the concentration and brand of the smokeless tobacco (it will be their usual brand). All participants will complete all four study conditions.

Primary Outcome Measures

Name	Time	Method
Change in Plasma nicotine concentration	Baseline to the end of the session, approximately 4 hours	Blood will be taken multiple times in each session to assess the extent to which product use changes plasma nicotine levels compared to baseline

Trial Locations

Locations (1)

Virginia Commonwealth University; 🇺🇸 Richmond, Virginia, United States