THRIVE Study: Understanding How Oral Nicotine Pouches Affect Public Health

Purpose

Although nicotine pouches have been gaining popularity over the last few years, little known about how nicotine pouch users actually use these products. This study will be comprised of adults who use nicotine pouches. If eligible, participants will be asked to complete three study visits and participate in two switching periods where participants use study-provided nicotine pouches.

Condition

  • Tobacco-Related Carcinoma

Eligibility

Eligible Ages
Over 21 Years
Eligible Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • Age 21 or older - Able to read and speak English - Willing to abstain from tobacco, nicotine, and marijuana for at least 12 hours prior to study visits - Exclusive use of ONPs (other product use <10x/mo). - Exhaled CO reading <10 ppm - Owns a smartphone and can receive SMS text messages with embedded survey links - Negative pregnancy test at V1 and V2 (if applicable) - Uses ≥1.5 cans of ONPs/week - Daily use of ONPs for the past 3 months - At least half of ONPs used are 6mg nicotine concentration.

Exclusion Criteria

  • Non-English speaker - Individuals currently pregnant, planning to become pregnant, or breastfeeding are excluded due to potential risks associated with nicotine exposure and study procedures (e.g., blood draws). - Individuals with unstable or significant psychiatric conditions are excluded to minimize risk and ensure reliable participation. - Individuals actively attempting to quit nicotine use are excluded to avoid ethical concerns and ensure that study participation does not interfere with cessation efforts - Non-nicotine users and regular tobacco users are excluded from the clinical trial component to ensure that participants have established use patterns appropriate for assessing ONP use behaviors.

Study Design

Phase
Phase 4
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Prevention
Masking
Double (Participant, Investigator)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Small particle size oral nicotine pouches 		CLINIC VISIT: Participants sample a small particle size ONP product. Patients also undergo blood sample collection throughout study. SWITCHING PERIOD: Participants complete a 1-week ad libitum switching period using assigned ONPs. Daily diary surveys are completed remotely to track product use and switching behavior.
  • Procedure: Biospecimen Collection
    Undergo blood sample collection
    Other names:
    • Biological Sample Collection
  • Drug: Nicotine Oral Pouch
    Insert small particle size ONP
  • Other: Survey Administration
    Ancillary studies
  • Other: Text Message-Based Navigation Intervention
    Receive text with a link to daily diary surveys
    Other names:
    • Automated Text Message-Based Navigation
Experimental
Variable particle size oral nicotine pouches 		CLINIC VISIT: Participants sample a variable particle size ONP product. Patients also undergo blood sample collection throughout study. SWITCHING PERIOD: Participants complete a 1-week ad libitum switching period using assigned ONPs. Daily diary surveys are completed remotely to track product use and switching behavior.
  • Procedure: Biospecimen Collection
    Undergo blood sample collection
    Other names:
    • Biological Sample Collection
  • Drug: Nicotine Oral Pouch
    Insert variable particle size ONP
  • Other: Survey Administration
    Ancillary studies
  • Other: Text Message-Based Navigation Intervention
    Receive text with a link to daily diary surveys
    Other names:
    • Automated Text Message-Based Navigation

Recruiting Locations

Ohio State University Comprehensive Cancer Center
Columbus, Ohio 43210

More Details

Status
Recruiting
Sponsor
Ohio State University Comprehensive Cancer Center

Study Contact

The Ohio State University Comprehensive Cancer Center
800-293-5066
OSUCCCClinicaltrials@osumc.edu

Detailed Description

This investigation expands on the parent study's Aims 1 and 2 by examining the effects of a feature that the investigators have identified varies across nicotine pouches (ONP): particle size. The investigators expect that particle size differences may translate to differences in user experience. The investigators wish to further explore this hypothesis among current ONP users. Data will be captured over the course of 3 clinic visits and across two week-long switching periods with daily diary surveys. This will inform interpretation of results from Aims 1 and 2, including how to translate those findings to commercially-available nicotine pouches. Aim 1: Assess the effects of nicotine concentration, form, and isomer on the satisfaction and appeal of ONPs relative to cigarettes and ST. ONPs with high FBN and >99% S-nicotine will have (H1a) increased satisfaction and appeal (e.g., faster nicotine delivery, greater liking). H1b: Associations of form and isomer with addiction potential and appeal will be strongest in the high nicotine concentration arm. Aim 2: Evaluate the effects of nicotine concentration, form, and isomer on switching from cigarettes or ST to ONPs. Over 4 weeks, participants randomized to use ONPs with high FBN and >99% S-nicotine (vs. other ONPs) will report higher prevalence of (H2a) partially switching to ONPs (use ONPs >14 days but continued usual product use) and (H2b) complete switching to ONPs by week 4. H2c: Associations of form and isomer with switching outcomes will be strongest in the high nicotine concentration arm. Study Procedures: Participants will complete three in-person visits. Visits involve randomized, double-blinded use of either small-particle ONPs or a distribution of particle-size ONPs (one assigned product per visit). Visit 1 - 12-hour abstinence requirement prior to visit. - Informed consent procedures. - Baseline questionnaires. - Exhaled carbon monoxide (CO) testing and pregnancy screening (if applicable). - IV-line placement followed by four timed blood draws to assess plasma nicotine levels. - 120-minute controlled ONP use session. Post-use surveys assessing: - Product appeal - Withdrawal symptoms and relief - Sensory scales - Behavioral intentions One-Week Switching Period (at-home) Following Visit 1, participants enter a 7-day ad libitum use period using their assigned ONPs. During this phase, participants complete online daily diary surveys (1 per day) to capture product use and switching behavior. Visit 2 - 12-hour abstinence prior to visit. - Exhaled CO testing and pregnancy screening (if applicable). - IV-line placement and four timed blood draws (plasma nicotine levels). - 120-minute controlled ONP use session. - Post-use surveys (same as Visit 1). One-Week Switching Period (at-home) Following Visit 2, participants enter a 7-day ad libitum use period using their assigned ONPs. During this phase, participants complete online daily diary surveys (1 per day) to capture product use and switching behavior. Visit 3 - Completion of survey measures only (no product administration or IV-lines). - Return of unused ONPs from the at-home switching period.