Ignite Creation Date:
2025-12-25 @ 2:00 AM
Ignite Modification Date:
2025-12-26 @ 12:24 AM
Study NCT ID:
NCT05236894
Status:
COMPLETED
Last Update Posted:
2024-05-21
First Post:
2022-01-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Appeal of Nicotine Pouches Versus Cigarettes in the Ohio Appalachia Population
Sponsor:
Ohio State University Comprehensive Cancer Center
Organization:
Study Overview
Official Title:
Examining the Appeal of Nicotine Pouches in Ohio Appalachia
Status:
COMPLETED
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| NCI-2021-14062 | REGISTRY | CTRP (Clinical Trial Reporting Program) | View |