Ignite Creation Date:
2024-05-06 @ 8:15 PM
Last Modification Date:
2024-10-26 @ 3:24 PM
Study NCT ID:
NCT06315881
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-03-18
First Post:
2024-02-14
Brief Title:
Informing Oral Nicotine Pouch Regulations to Promote Public Health
Sponsor:
Ohio State University Comprehensive Cancer Center
Organization:
Ohio State University Comprehensive Cancer Center
Study Overview
Official Title:
Informing Oral Nicotine Pouch Regulations to Promote Public Health
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-03
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 evaluates the characteristics of oral nicotine pouches ONPs to determine if they are a comparable substitute to cigarette or smokeless tobacco ST products ONPs contain nicotine but no tobacco and are used primarily by adult tobacco uses in the United States US ONPs are recognized by the Food and Drug Administration as having lower risk than combustible cigarettes and are approved as a modified risk tobacco product While ONPs have lower toxic risk than other tobacco products acute and longer term harm related to their use has not been studied Information gathered from this study may identify product characteristics of ONPs that improve successful switching from high-risk cigarettes or ST to lower risk ONPs
Detailed Description:
PRIMARY OBJECTIVES
I Assess the effects of nicotine concentration form and isomer on the satisfaction and appeal of ONPs relative to cigarettes and ST
II Evaluate the effects of nicotine concentration form and isomer on switching from cigarettes or ST to ONPs
EXPLORATORY OBJECTIVE
I Examine changes in oral microbiome-host interactions associated with degree of switching from cigarettesST to ONPs
OUTLINE
PHASE I Participants are randomized to use one of the 4 study ONP products or their usual product brand of ST or cigarette in either the low or high nicotine concentration arm
ARM I Participants insert low free-base nicotine FBN RS ONP product over 30 minutes Patients also undergo blood sample collection at 0 5 15 30 60 and 90 minutes
ARM II Participants insert low FBN 99 S ONP product over 30 minutes Patients also undergo blood sample collection at 0 5 15 30 60 and 90 minutes
ARM III Participants insert high RS ONP product over 30 minutes Patients also undergo blood sample collection at 0 5 15 30 60 and 90 minutes
ARM IV Participants insert high FBN 99 S ONP product over 30 minutes Patients also undergo blood sample collection at 0 5 15 30 60 and 90 minutes
ARM V Participants insert usual brand of ST over 30 minutes or smoke usual brand of cigarette over 5 minutes Patients also undergo blood sample collection at 0 5 15 30 60 and 90 minutes
PHASE II
WASHOUT PERIOD Participants use usual brand of ST or cigarettes for 1 week
CONTROL WEEK Participants continue regular use of ST or cigarettes for 1 week and receive a text with a link to daily diary surveys to record tobacco use
PHASE II SWITCH Participants are randomized to switch to 1 of 4 study ONP
ARM I Participants insert low FBN RS ONP for 4 weeks Participants also attend 2 study visits and undergo oral mucosa sample collection
ARM II Participants insert to low FBN 99 S ONP product for 4 weeks Participants also attend 2 study visits and undergo oral mucosa sample collection
ARM III Participants insert to high RS ONP product for 4 weeks Participants also attend 2 study visits and undergo oral mucosa sample collection
ARM IV Participants insert high FBN 99 S ONP product for 4 weeks Participants also attend 2 study visits and undergo oral mucosa sample collection
I Assess the effects of nicotine concentration form and isomer on the satisfaction and appeal of ONPs relative to cigarettes and ST
II Evaluate the effects of nicotine concentration form and isomer on switching from cigarettes or ST to ONPs
EXPLORATORY OBJECTIVE
I Examine changes in oral microbiome-host interactions associated with degree of switching from cigarettesST to ONPs
OUTLINE
PHASE I Participants are randomized to use one of the 4 study ONP products or their usual product brand of ST or cigarette in either the low or high nicotine concentration arm
ARM I Participants insert low free-base nicotine FBN RS ONP product over 30 minutes Patients also undergo blood sample collection at 0 5 15 30 60 and 90 minutes
ARM II Participants insert low FBN 99 S ONP product over 30 minutes Patients also undergo blood sample collection at 0 5 15 30 60 and 90 minutes
ARM III Participants insert high RS ONP product over 30 minutes Patients also undergo blood sample collection at 0 5 15 30 60 and 90 minutes
ARM IV Participants insert high FBN 99 S ONP product over 30 minutes Patients also undergo blood sample collection at 0 5 15 30 60 and 90 minutes
ARM V Participants insert usual brand of ST over 30 minutes or smoke usual brand of cigarette over 5 minutes Patients also undergo blood sample collection at 0 5 15 30 60 and 90 minutes
PHASE II
WASHOUT PERIOD Participants use usual brand of ST or cigarettes for 1 week
CONTROL WEEK Participants continue regular use of ST or cigarettes for 1 week and receive a text with a link to daily diary surveys to record tobacco use
PHASE II SWITCH Participants are randomized to switch to 1 of 4 study ONP
ARM I Participants insert low FBN RS ONP for 4 weeks Participants also attend 2 study visits and undergo oral mucosa sample collection
ARM II Participants insert to low FBN 99 S ONP product for 4 weeks Participants also attend 2 study visits and undergo oral mucosa sample collection
ARM III Participants insert to high RS ONP product for 4 weeks Participants also attend 2 study visits and undergo oral mucosa sample collection
ARM IV Participants insert high FBN 99 S ONP product for 4 weeks Participants also attend 2 study visits and undergo oral mucosa sample collection
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 |
|---|---|---|---|
| U54CA287392 | NIH | CTRP Clinical Trial Reporting Program | httpsreporternihgovquickSearchU54CA287392 |
| NCI-2024-00666 | REGISTRY | None | None |