MedTrace Logo

Appeal of Nicotine Pouches Versus Cigarettes in the Ohio Appalachia Population

NCT05236894 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 55

Last updated 2024-05-21

No results posted yet for this study

Summary

This clinical trial estimates the abuse liability of nicotine pouches with varying nicotine concentrations relative to cigarette smoking in Appalachian, Ohio and Ohio 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 smokers in Ohio including the unique demographic of Appalachia may clarify the public health effect of NPs in Appalachian Ohio and across Ohio. Results may inform public health efforts, policy, and clinical care aimed at reducing tobacco-related disparities.

Conditions

  • Cigarette Smoking-Related Carcinoma

Interventions

BEHAVIORAL

Cigarette Smoking

Smoke preferred brand of cigarette

DRUG

Nicotine Oral Pouch

Given lower dose nicotine pouch

DRUG

Nicotine Oral Pouch

Given higher dose nicotine pouch

OTHER

Questionnaire Administration

Ancillary studies

DRUG

Nicotine Oral Pouch

Given 3mg nicotine pouch (Aim 2)

DRUG

Nicotine Oral Pouch

Given 3mg nicotine pouch (Aim 2)

DRUG

Nicotine Oral Pouch

Given 3mg nicotine pouch (Aim 2)

Sponsors & Collaborators

  • Ohio State University Comprehensive Cancer Center

    lead OTHER

Principal Investigators

  • Brittney L Keller-Hamilton, PhD, MPH · Ohio State University Comprehensive Cancer Center

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-03-01
Primary Completion
2023-04-18
Completion
2023-04-18
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05236894 on ClinicalTrials.gov