Appeal of Nicotine Pouches Versus Cigarettes in the Ohio Appalachia Population
- Conditions
- Cigarette Smoking-Related Carcinoma
- Interventions
- Registration Number
- NCT05236894
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 55
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Aim 2: Arm III (3mg NP) Nicotine Oral Pouch Patients receive nicotine pouch PO over 30 minutes at visits 1, 2, and 3. Aim 1: Arm II (higher dose nicotine pouches) Questionnaire Administration Patients receive higher dose nicotine pouch PO over 30 minutes at visits 1, 2, and 3. Aim 1: Arm I (lower dose nicotine pouch) Nicotine Oral Pouch Patients receive lower dose nicotine pouch PO over 30 minutes at visits 1, 2, and 3. Aim 1: Arm III (cigarette smoking) Questionnaire Administration Patients smoke usual brand of cigarettes, taking one puff every 30 seconds over 5 minutes at visits 1, 2, and 3. Aim 2: Arm III (3mg NP) Questionnaire Administration Patients receive nicotine pouch PO over 30 minutes at visits 1, 2, and 3. Aim 2: Arm II (3mg NP) Questionnaire Administration Patients receive nicotine pouch PO over 30 minutes at visits 1, 2, and 3. Aim 1: Arm I (lower dose nicotine pouch) Questionnaire Administration Patients receive lower dose nicotine pouch PO over 30 minutes at visits 1, 2, and 3. Aim 1: Arm II (higher dose nicotine pouches) Nicotine Oral Pouch Patients receive higher dose nicotine pouch PO over 30 minutes at visits 1, 2, and 3. Aim 2: Arm I (3mg NP) Questionnaire Administration Patients receive nicotine pouch PO over 30 minutes at visits 1, 2, and 3. Aim 2: Arm I (3mg NP) Nicotine Oral Pouch Patients receive nicotine pouch PO over 30 minutes at visits 1, 2, and 3. Aim 2: Arm II (3mg NP) Nicotine Oral Pouch Patients receive nicotine pouch PO over 30 minutes at visits 1, 2, and 3. Aim 1: Arm III (cigarette smoking) Cigarette Smoking Patients smoke usual brand of cigarettes, taking one puff every 30 seconds over 5 minutes at visits 1, 2, and 3.
- Primary Outcome Measures
Name Time Method Evaluate plasma nicotine concentration at t=30 minutes for each product. Up to 6 months
- Secondary Outcome Measures
Name Time Method 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 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.
Evaluate product appeal across all 3 products Up to 6 months 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.
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 Data collected will show if NPs are a viable substitute for cigarette smoking.
Trial Locations
- Locations (1)
Ohio State University Comprehensive Cancer Center
🇺🇸Columbus, Ohio, United States