Ignite Creation Date:
2024-05-06 @ 6:38 PM
Last Modification Date:
2024-10-26 @ 2:51 PM
Study NCT ID:
NCT05730439
Status:
RECRUITING
Last Update Posted:
2023-08-30
First Post:
2023-02-06
Brief Title:
Examining the Impact of Nicotine Pouches in Rural Ohio and Ohio Appalachia
Sponsor:
Ohio State University Comprehensive Cancer Center
Organization:
Ohio State University Comprehensive Cancer Center
Study Overview
Official Title:
Examining the Impact of Nicotine Pouches in Rural Ohio and Ohio Appalachia
Status:
RECRUITING
Status Verified Date:
2023-08
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 examines the impact of nicotine patches on preventing cancer in rural and Appalachia Ohio residents Nicotine pouches are new smokeless tobacco products that are marketed as substitutes for smokeless tobacco and are gaining in popularity There is little research on how nicotine pouches will be adopted by residents of Ohio Appalachia and rural Ohio This study may help researchers better understand the appeal and potential impact of nicotine pouches on public health
Detailed Description:
PRIMARY OBJECTIVES
I Assess appeal perceived substitutability and nicotine delivery of nicotine pouches NPs with high versus vs low free-base nicotine FBN content among rural and Appalachian moist snuff users
II Evaluate whether smokeless tobacco SLT dependence modifies effects of NP FBN content on product appeal perceived substitutability and nicotine delivery
OUTLINE Participants are randomized to 1 of 6 arms
ARM I Participants receive their usual brand of smokeless tobacco at study visit 1 ZYN brand nicotine pouch at study visit 2 and Rogue brand nicotine pouch at study visit 3 Participants also undergo intravenous IV line insertion and collection of blood on study
ARM II Participants receive their usual brand of smokeless tobacco at study visit 1 Rogue brand nicotine pouch at study visit 2 and ZYN brand nicotine pouch at study visit 3 Participants also undergo IV line insertion and collection of blood on study
ARM III Participants receive ZYN brand nicotine pouch at study visit 1 their usual brand of smokeless tobacco at study visit 2 and Rogue brand nicotine pouch at study visit 3 Participants also undergo IV line insertion and collection of blood on study
ARM IV Participants receive ZYN brand nicotine pouch at study visit 1 Rogue brand nicotine pouch at study visit 2 and their usual brand of smokeless tobacco at study visit 3 Participants also undergo IV line insertion and collection of blood on study
ARM V Participants receive Rogue brand nicotine patch at study visit 1 their usual brand of smokeless tobacco at study visit 2 and ZYN brand nicotine patch at study visit 3 Participants also undergo IV line insertion and collection of blood on study
ARM VI Participants receive Rogue brand nicotine pouch at study visit 1 ZYN brand nicotine pouch at study visit 2 and their usual brand of smokeless tobacco at study visit 3 Participants also undergo IV line insertion and collection of blood on study
I Assess appeal perceived substitutability and nicotine delivery of nicotine pouches NPs with high versus vs low free-base nicotine FBN content among rural and Appalachian moist snuff users
II Evaluate whether smokeless tobacco SLT dependence modifies effects of NP FBN content on product appeal perceived substitutability and nicotine delivery
OUTLINE Participants are randomized to 1 of 6 arms
ARM I Participants receive their usual brand of smokeless tobacco at study visit 1 ZYN brand nicotine pouch at study visit 2 and Rogue brand nicotine pouch at study visit 3 Participants also undergo intravenous IV line insertion and collection of blood on study
ARM II Participants receive their usual brand of smokeless tobacco at study visit 1 Rogue brand nicotine pouch at study visit 2 and ZYN brand nicotine pouch at study visit 3 Participants also undergo IV line insertion and collection of blood on study
ARM III Participants receive ZYN brand nicotine pouch at study visit 1 their usual brand of smokeless tobacco at study visit 2 and Rogue brand nicotine pouch at study visit 3 Participants also undergo IV line insertion and collection of blood on study
ARM IV Participants receive ZYN brand nicotine pouch at study visit 1 Rogue brand nicotine pouch at study visit 2 and their usual brand of smokeless tobacco at study visit 3 Participants also undergo IV line insertion and collection of blood on study
ARM V Participants receive Rogue brand nicotine patch at study visit 1 their usual brand of smokeless tobacco at study visit 2 and ZYN brand nicotine patch at study visit 3 Participants also undergo IV line insertion and collection of blood on study
ARM VI Participants receive Rogue brand nicotine pouch at study visit 1 ZYN brand nicotine pouch at study visit 2 and their usual brand of smokeless tobacco at study visit 3 Participants also undergo IV line insertion and collection of blood on study
Study Oversight
Has Oversight DMC:
None
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?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-2023-00134 | REGISTRY | CTRP Clinical Trial Reporting Program | None |