Ignite Creation Date:
2024-05-06 @ 8:04 PM
Last Modification Date:
2024-10-26 @ 3:20 PM
Study NCT ID:
NCT06249984
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-02-08
First Post:
2024-01-22
Brief Title:
Effects of Tobacco Cut and Nicotine Form on the Abuse Liability of Moist Snuff
Sponsor:
Ohio State University Comprehensive Cancer Center
Organization:
Ohio State University Comprehensive Cancer Center
Study Overview
Official Title:
Effects of Tobacco Cut and Nicotine Form on the Abuse Liability of Moist Snuff
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-01
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 tests the effects of tobacco cut and nicotine form on the abuse liability in participants who use moist snuff smokeless tobacco SLT Two features of moist snuff that are key targets of manipulation from the tobacco industry and drivers of its addiction potential are length of tobacco cut long versus fine and nicotine form low versus high levels of nicotine in the free-base form Finer tobacco cuts and higher levels of free-base nicotine FBN result in faster greater nicotine delivery Researchers want to gain information on how certain characteristics of moist snuff affect how long people use it how it delivers nicotine or how much people like it This clinical trial may provide justifications for local state or federal regulations aimed at reducing the appeal and addictiveness of moist snuff
Detailed Description:
PRIMARY OBJECTIVES
I Estimate the association between style of moist snuff and SLT addiction among Ohio Appalachian adolescents and adults
II Characterize the carcinogen and free-base nicotine content of SLT products used by adolescents and adults with varying levels of SLT dependence in Ohio Appalachia
III Assess effects of moist snuff tobacco cut and FBN content on product use effects and appeal among Appalachian adults with high versus vs low SLT dependence
OUTLINE Participants attend 5 study visits in a randomized order
VISIT I Participants use their usual brand of moist snuff on study Participants also undergo blood sample collection and carbon monoxide testing on study
VISIT II Participants use low FBN long cut moist snuff on study Participants also undergo blood sample collection and carbon monoxide testing on study
VISIT III Participants use low FBN fine cut moist snuff on study Participants also undergo blood sample collection and carbon monoxide testing on study
VISIT IV Participants use high FBN long cut moist snuff on study Participants also undergo blood sample collection and carbon monoxide testing on study
VISIT V Participants use high FBN fine cut moist snuff on study Participants also undergo blood sample collection and carbon monoxide testing on study
I Estimate the association between style of moist snuff and SLT addiction among Ohio Appalachian adolescents and adults
II Characterize the carcinogen and free-base nicotine content of SLT products used by adolescents and adults with varying levels of SLT dependence in Ohio Appalachia
III Assess effects of moist snuff tobacco cut and FBN content on product use effects and appeal among Appalachian adults with high versus vs low SLT dependence
OUTLINE Participants attend 5 study visits in a randomized order
VISIT I Participants use their usual brand of moist snuff on study Participants also undergo blood sample collection and carbon monoxide testing on study
VISIT II Participants use low FBN long cut moist snuff on study Participants also undergo blood sample collection and carbon monoxide testing on study
VISIT III Participants use low FBN fine cut moist snuff on study Participants also undergo blood sample collection and carbon monoxide testing on study
VISIT IV Participants use high FBN long cut moist snuff on study Participants also undergo blood sample collection and carbon monoxide testing on study
VISIT V Participants use high FBN fine cut moist snuff on study Participants also undergo blood sample collection and carbon monoxide testing on study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
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 |
|---|---|---|---|
| K01DA055696 | NIH | CTRP Clinical Trial Reporting Program | httpsreporternihgovquickSearchK01DA055696 |
| NCI-2023-01289 | REGISTRY | None | None |