Appeal of Nicotine Pouches Versus Cigarettes in the Ohio Appalachia Population

NCT05236894 | Completed Early Phase 1 DMC FDA Drug

• 2 other identifiers: OSU-21257NCI-2021-14062
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Evaluate plasma nicotine concentration at t=30 minutes for each product.

  Up to 6 months

Secondary Outcomes (4)

• Aim 1: Public health effect of NPs in Appalachian Ohio - if NPs can be used as a substitute for cigarette smoking

  Up to 6 months

• Evaluate plasma nicotine concentrations at t=5 through t=90 minutes

  Up to 6 months

• Evaluate withdrawal relief at t=5 through t=90 minutes

  Up to 6 months

• Evaluate product appeal across all 3 products

  Up to 6 months

Other Outcomes (4)

• Aim 1 and 2: Nicotine pharmacokinetics

  Up to 6 months

• Subjective effects - likability and substitutability of product compared to cigarette smoking will be assessed

  Up to 6 months

• Aim 1: Intentions to use and switch to NPs - quit intentions will be assessed using a 10 question survey

  Up to 6 months

Study Arms (6)

Aim 1: Arm I (lower dose nicotine pouch)

EXPERIMENTAL

Patients receive lower dose nicotine pouch PO over 30 minutes at visits 1, 2, and 3.

Drug: Nicotine Oral Pouch; Other: Questionnaire Administration

Aim 1: Arm II (higher dose nicotine pouches)

EXPERIMENTAL

Patients receive higher dose nicotine pouch PO over 30 minutes at visits 1, 2, and 3.

Drug: Nicotine Oral Pouch; Other: Questionnaire Administration

Aim 1: Arm III (cigarette smoking)

ACTIVE COMPARATOR

Patients smoke usual brand of cigarettes, taking one puff every 30 seconds over 5 minutes at visits 1, 2, and 3.

Behavioral: Cigarette Smoking; Other: Questionnaire Administration

Aim 2: Arm I (3mg NP)

EXPERIMENTAL

Patients receive nicotine pouch PO over 30 minutes at visits 1, 2, and 3.

Other: Questionnaire Administration; Drug: Nicotine Oral Pouch

Aim 2: Arm II (3mg NP)

EXPERIMENTAL

Patients receive nicotine pouch PO over 30 minutes at visits 1, 2, and 3.

Other: Questionnaire Administration; Drug: Nicotine Oral Pouch

Aim 2: Arm III (3mg NP)

EXPERIMENTAL

Patients receive nicotine pouch PO over 30 minutes at visits 1, 2, and 3.

Other: Questionnaire Administration; Drug: Nicotine Oral Pouch

Interventions

Cigarette Smoking BEHAVIORAL

Smoke preferred brand of cigarette

Aim 1: Arm III (cigarette smoking)

Nicotine Oral Pouch DRUG

Given lower dose nicotine pouch

Also known as: ZYN

Aim 1: Arm I (lower dose nicotine pouch)

Questionnaire Administration OTHER

Ancillary studies

Aim 1: Arm I (lower dose nicotine pouch); Aim 1: Arm II (higher dose nicotine pouches); Aim 1: Arm III (cigarette smoking); Aim 2: Arm I (3mg NP); Aim 2: Arm II (3mg NP); Aim 2: Arm III (3mg NP)

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• Age 21 years or older.
• Reside in a Ohio.
• 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.
• 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).

Sponsors & Collaborators

• Ohio State University Comprehensive Cancer Center: lead

Study Sites (1)

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, 43210, United States

Location

Related Publications (2)

• Keller-Hamilton B, Alalwan MA, Curran H, Hinton A, Long L, Chrzan K, Wagener TL, Atkinson L, Suraapaneni S, Mays D. Evaluating the effects of nicotine concentration on the appeal and nicotine delivery of oral nicotine pouches among rural and Appalachian adults who smoke cigarettes: A randomized cross-over study. Addiction. 2024 Mar;119(3):464-475. doi: 10.1111/add.16355. Epub 2023 Nov 14.

  PMID: 37964431 BACKGROUND

• Keller-Hamilton B, Curran H, Alalwan M, Hinton A, Brinkman MC, El-Hellani A, Wagener TL, Chrzan K, Atkinson L, Suraapaneni S, Mays D. Evaluating the Role of Nicotine Stereoisomer on Nicotine Pouch Abuse Liability: A Randomized Crossover Trial. Nicotine Tob Res. 2025 Mar 24;27(4):658-665. doi: 10.1093/ntr/ntae079.

  PMID: 38713545 BACKGROUND

Related Links

• The Jamesline

MeSH Terms

Interventions

WD repeat containing planar cell polarity effector

Study Officials

• Brittney L Keller-Hamilton, PhD, MPH

  Ohio State University Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 13, 2022
• First Posted: February 11, 2022
• Study Start: March 1, 2022
• Primary Completion: April 18, 2023
• Study Completion: April 18, 2023
• Last Updated: May 21, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)