Appeal of Nicotine Pouches Versus Cigarettes in the Ohio Appalachia Population
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Early Phase 1 |
Detailed Description
Aim 1:
PRIMARY OBJECTIVE:
- To estimate the abuse liability of nicotine pouches (NPs) with varying nicotine concentrations relative to cigarette smoking.
SECONDARY OBJECTIVE:
- To clarify the public health effect of NPs in Appalachian Ohio.
EXPLORATORY OBJECTIVES:
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To estimate the abuse liability of NPs with varying nicotine concentrations relative to cigarette smoking by measuring nicotine pharmacokinetics.
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To estimate the abuse liability of NPs with varying nicotine concentrations relative to cigarette smoking by measuring subjective effects.
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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:
- To understand the pharmacokinetic difference between tobacco-derived and synthetic NPs.
SECONDARY OBJECTIVE:
- To clarify the public health effect of NPs on adult smokers
EXPLORATORY OBJECTIVES:
-
To understand the differences in abuse liability between tobacco-derived and synthetic NPs by measuring nicotine pharmacokinetics.
-
To understand the differences in abuse liability between tobacco-derived and synthetic NPs by measuring subjective effects.
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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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Aim 1: Arm I (lower dose nicotine pouch) Patients receive lower dose nicotine pouch PO over 30 minutes at visits 1, 2, and 3. |
Drug: Nicotine Oral Pouch
Given lower dose nicotine pouch
Other Names:
Other: Questionnaire Administration
Ancillary studies
|
| Experimental: Aim 1: Arm II (higher dose nicotine pouches) Patients receive higher dose nicotine pouch PO over 30 minutes at visits 1, 2, and 3. |
Drug: Nicotine Oral Pouch
Given higher dose nicotine pouch
Other Names:
Other: Questionnaire Administration
Ancillary studies
|
| Active Comparator: Aim 1: Arm III (cigarette smoking) Patients smoke usual brand of cigarettes, taking one puff every 30 seconds over 5 minutes at visits 1, 2, and 3. |
Behavioral: Cigarette Smoking
Smoke preferred brand of cigarette
Other: Questionnaire Administration
Ancillary studies
|
| Experimental: Aim 2: Arm I (3mg NP) Patients receive nicotine pouch PO over 30 minutes at visits 1, 2, and 3. |
Other: Questionnaire Administration
Ancillary studies
Drug: Nicotine Oral Pouch
Given 3mg nicotine pouch (Aim 2)
Other Names:
|
| Experimental: Aim 2: Arm II (3mg NP) Patients receive nicotine pouch PO over 30 minutes at visits 1, 2, and 3. |
Other: Questionnaire Administration
Ancillary studies
Drug: Nicotine Oral Pouch
Given 3mg nicotine pouch (Aim 2)
Other Names:
|
| Experimental: Aim 2: Arm III (3mg NP) Patients receive nicotine pouch PO over 30 minutes at visits 1, 2, and 3. |
Other: Questionnaire Administration
Ancillary studies
Drug: Nicotine Oral Pouch
Given 3mg nicotine pouch (Aim 2)
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Abuse liability of nicotine pouches (NPs) with varying nicotine concentrations using pharmacokinetics by analyzing nicotine absorbed in bloodstream [Up to 6 months]
Secondary Outcome Measures
- 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]
Other Outcome Measures
- Aim 1 and 2: Nicotine pharmacokinetics [Up to 6 months]
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.
- Subjective effects - likability and substitutability of product compared to cigarette smoking will be assessed [Up to 6 months]
Will use linear or logistic mixed effects regression models (with a random subject effect) to assess the main effects of product on subjective effects.
- Aim 1: Intentions to use and switch to NPs - quit intentions will be assessed using a 10 question survey [Up to 6 months]
Will use linear or logistic mixed effects regression models (with a random subject effect) to assess the main effects of product behavioral intentions.
- Aim 2: Public health effect of NPs in adult smokers - if NPs can be used as a substitute for cigarette smoking. [Up to 6 months]
Public health impact of NPs in adult smokers as an alternative for cigarette smoking.
Eligibility Criteria
Criteria
Aim 1 Inclusion Criteria:
-
Age 21 years or older.
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Reside in an Ohio Appalachian county.
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Willing to complete study procedures, including abstaining from all tobacco, nicotine, and marijuana for 12 hours before clinic visits.
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Ability to read and speak English.
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Smoke at least 5 cigarettes per day for the past 30 days.
Exclusion Criteria:
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Use tobacco products other than cigarettes >10 days per month.
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Use NP in the past 3 months.
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Unstable or significant psychiatric conditions (past and stable conditions will be allowed).
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Pregnant, planning to become pregnant, or breastfeeding.
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History of cardiac event or distress within the past 3 months.
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Currently attempting to quit all tobacco use.
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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.
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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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Ohio State University Comprehensive Cancer Center | Columbus | Ohio | United States | 43210 |
Sponsors and Collaborators
- Ohio State University Comprehensive Cancer Center
Investigators
- Principal Investigator: Brittney L Keller-Hamilton, PhD, MPH, Ohio State University Comprehensive Cancer Center
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- OSU-21257
- NCI-2021-14062