Appeal of Nicotine Pouches Versus Cigarettes in the Ohio Appalachia Population

Cigarette Smoking-Related Carcinoma Clinical Trial

Official title:

Examining the Appeal of Nicotine Pouches in Ohio Appalachia

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05236894
• Other study ID #: OSU-21257
• Secondary ID: NCI-2021-14062
• Status: Active, not recruiting
• Phase: Early Phase 1
• Start date: March 1, 2022
• Est. completion date: December 31, 2025

Study information

• Verified date: July 2023
• Source: Ohio State University Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 55
• Est. completion date: December 31, 2025
• Est. primary completion date: April 18, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cigarette Smoking-Related Carcinoma

Intervention

Behavioral:
• Cigarette Smoking
Smoke preferred brand of cigarette

Drug:
• Nicotine Oral Pouch
Given lower dose nicotine pouch
• Nicotine Oral Pouch
Given higher dose nicotine pouch

Other:
• Questionnaire Administration
Ancillary studies

Drug:
• Nicotine Oral Pouch
Given 3mg nicotine pouch (Aim 2)
• Nicotine Oral Pouch
Given 3mg nicotine pouch (Aim 2)
• Nicotine Oral Pouch
Given 3mg nicotine pouch (Aim 2)

Locations

Country	Name	City	State
United States	Ohio State University Comprehensive Cancer Center	Columbus	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Ohio State University Comprehensive Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Aim 1 and 2: Nicotine pharmacokinetics	Will use linear or logistic mixed effects regression models (with a random subject effect) to assess the main effects of product on plasma nicotine delivery.	Up to 6 months
Other	Subjective effects - likability and substitutability of product compared to cigarette smoking will be assessed	Will use linear or logistic mixed effects regression models (with a random subject effect) to assess the main effects of product on subjective effects.	Up to 6 months
Other	Aim 1: Intentions to use and switch to NPs - quit intentions will be assessed using a 10 question survey	Will use linear or logistic mixed effects regression models (with a random subject effect) to assess the main effects of product behavioral intentions.	Up to 6 months
Other	Aim 2: Public health effect of NPs in adult smokers - if NPs can be used as a substitute for cigarette smoking.	Public health impact of NPs in adult smokers as an alternative for cigarette smoking.	Up to 6 months
Primary	Evaluate plasma nicotine concentration at t=30 minutes for each product.		Up to 6 months
Secondary	Aim 1: Public health effect of NPs in Appalachian Ohio - if NPs can be used as a substitute for cigarette smoking	Data collected will show if NPs are a viable substitute for cigarette smoking.	Up to 6 months
Secondary	Evaluate plasma nicotine concentrations at t=5 through t=90 minutes		Up to 6 months
Secondary	Evaluate withdrawal relief at t=5 through t=90 minutes	We measure withdrawal relief using the Minnesota Withdrawal Scale (MNWS). We administer this questionnaire at each timepoint along the standardized scale of t=0, t=5, t=15, t=30, t=60 and t=90. The MNWS includes a minimum value of "none" and a maximum value or "severe." The higher scores indicate increased withdrawal symptoms and lower scores indicate lessened or no withdrawal symptoms.	Up to 6 months
Secondary	Evaluate product appeal across all 3 products	Product appeal will be assessed using several scales, including the Modified E-Cigarette Smoking Questionnaire (mCEQ), the Product Evaluation Scale (PES), the Adapted Drug Effects Liking Scale, and the Study Product Effects Liking Scale which are administered after the final timepoint of each study visit. For both the mCEQ and PES, the minimum scale value is "not at all" and the maximum scale value is "extremely." Higher scores can mean both better or worse depending on the question. Ex: "Was using your smokeless tobacco satisfying?" and "Did using your smokeless tobacco make you nauseous?" are both questions on each scale, so a higher score would vary in meaning based on the question. For the Adapted Drug Effects Liking and Study Product Effects Liking scales, minimum values include "not at all" and maximum value includes "very pleasant." With the exception of one question on the Study Product Effects Liking Scale, a higher score indicates increased enjoyment of the product.	Up to 6 months

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