Appeal of Nicotine Pouches Versus Cigarettes in the Ohio Appalachia Population

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

55 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-03-01

Study Completion Date

2023-04-18

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Cigarette Smoking-Related Carcinoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Intervention Type DRUG

Given 3mg nicotine pouch (Aim 2)

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Eligibility Criteria

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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.

* 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.

* 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.

Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes