Overview

Appeal of Nicotine Pouches Versus Cigarettes in the Ohio Appalachia Population

Status:
Not yet recruiting
Trial end date:
2025-12-31
Target enrollment:
0
Participant gender:
All
Summary
This clinical trial estimates the abuse liability of nicotine pouches with varying nicotine concentrations relative to cigarette smoking in Ohio Appalachian smokers. Nicotine pouches are a novel tobacco product with potential to reduce or increase the harm of tobacco use. Evaluating nicotine pouches abuse liability among Appalachian smokers may clarify the public health effect of NPs in Appalachian Ohio. Results may inform public health efforts, policy, and clinical care aimed at reducing tobacco-related disparities in Appalachia.
Phase:
Early Phase 1
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Ohio State University Comprehensive Cancer Center
Treatments:
Nicotine
Criteria
Inclusion Criteria:

- Age 21 years or older.

- Reside in an Ohio Appalachian county.

- Willing to complete study procedures, including abstaining from all tobacco, nicotine,
and marijuana for 12 hours before clinic visits.

- Ability to read and speak English.

- Smoke at least 5 cigarettes per day for the past 30 days.

Exclusion Criteria:

- Use tobacco products other than cigarettes >10 days per month.

- Use NP in the past 3 months.

- Unstable or significant psychiatric conditions (past and stable conditions will be
allowed).

- Pregnant, planning to become pregnant, or breastfeeding.

- History of cardiac event or distress within the past 3 months.

- Currently attempting to quit all tobacco use.

- Self-reported diagnosis of lung disease including asthma (if uncontrolled or worse
than usual), cystic fibrosis, or chronic obstructive pulmonary disease.