Clinical trial NCT05236894: Appeal of Nicotine Pouches Versus Cigarettes in the Ohio Appalachia Population
Official title: Examining the Appeal of Nicotine Pouches in Ohio Appalachia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Cigarette Smoking-Related Carcinoma
Lead sponsor: Ohio State University Comprehensive Cancer Center
Sponsor class: OTHER
First posted: 2022-02-11
Enrollment: 55
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Detailed description: Aim 1:

PRIMARY OBJECTIVE:

I. To estimate the abuse liability of nicotine pouches (NPs) with varying nicotine concentrations relative to cigarette smoking.

SECONDARY OBJECTIVE:

I. To clarify the public health effect of NPs in Appalachian Ohio.

EXPLORATORY OBJECTIVES:

I. To estimate the abuse liability of NPs with varying nicotine concentrations relative to cigarette smoking by measuring nicotine pharmacokinetics.

II. To estimate the abuse liability of NPs with varying nicotine concentrations relative to cigarette smoking by measuring subjective effects.

III. To estimate the abuse liability of NPs with varying nicotine concentrations relative to cigarette smoking by measuring intentions to use and switch to NPs.

OUTLINE: Patients are randomized to 1 of 3 arms.

ARM I: Patients receive lower dose nicotine pouch orally (PO) over 30 minutes at visits 1, 2, and 3.

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

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

Aim 2:

PRIMARY OBJECTIVE:

I. To understand the pharmacokinetic difference between tobacco-derived and synthetic NPs.

SECONDARY OBJECTIVE:

I. To clarify the public health effect of NPs on adult smokers

EXPLORATORY OBJECTIVES:

I. To understand the differences in abuse liability between tobacco-derived and synthetic NPs by measuring nicotine pharmacokinetics.

II. To understand the differences in abuse liability between tobacco-derived and synthetic NPs by measuring subjective effects.

III. To estimate the abuse liability of tobacco-derived vs. synthetic NPs by measuring intentions to use and switch to NPs.

OUTLINE: Patients are randomized to 1 of 3 arms.

ARM I: Patients receive a 3mg dose nicotine pouch orally (PO) over 30 minutes at visits 1, 2, and 3.

ARM II: Patients receive a 3mg dose nicotine pouch PO over 30 minutes at visits 1, 2, and 3.

ARM III: Patients receive a 3mg dose nicotine pouch PO over 30 minutes at visits 1, 2, and 3.

Eligibility criteria: Aim 1 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.

Aim 2 Inclusion Criteria:

* 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.

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.

Primary outcomes:
measure: Evaluate plasma nicotine concentration at t=30 minutes for each product.
timeFrame: Up to 6 months
Secondary outcomes:
measure: Aim 1: Public health effect of NPs in Appalachian Ohio - if NPs can be used as a substitute for cigarette smoking
timeFrame: Up to 6 months
measure: Evaluate plasma nicotine concentrations at t=5 through t=90 minutes
timeFrame: Up to 6 months
measure: Evaluate withdrawal relief at t=5 through t=90 minutes
timeFrame: Up to 6 months
measure: Evaluate product appeal across all 3 products
timeFrame: Up to 6 months
Other outcomes:
measure: Aim 1 and 2: Nicotine pharmacokinetics
timeFrame: Up to 6 months
measure: Subjective effects - likability and substitutability of product compared to cigarette smoking will be assessed
timeFrame: Up to 6 months
measure: Aim 1: Intentions to use and switch to NPs - quit intentions will be assessed using a 10 question survey
timeFrame: Up to 6 months
measure: Aim 2: Public health effect of NPs in adult smokers - if NPs can be used as a substitute for cigarette smoking.
timeFrame: Up to 6 months
Locations:
city: Columbus
country: United States
facility: Ohio State University Comprehensive Cancer Center
state: Ohio
Study officials:
affiliation: Ohio State University Comprehensive Cancer Center
name: Brittney L Keller-Hamilton, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.