Ignite Creation Date:
2024-05-06 @ 8:25 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06372899
Status:
RECRUITING
Last Update Posted:
2024-06-20
First Post:
2024-04-12
Brief Title:
Alternative Nicotine Delivery Systems as Potential Harm Reduction Tools for Persistent Cigarette Smokers
Sponsor:
Abramson Cancer Center at Penn Medicine
Organization:
Abramson Cancer Center at Penn Medicine
Study Overview
Official Title:
Alternative Nicotine Delivery Systems as Potential Harm Reduction Tools for Persistent Cigarette Smokers
Status:
RECRUITING
Status Verified Date:
2024-10
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 between-subjects study aims to evaluate whether e-cigarettes ECIGS versus oral nicotine pouches ONPS more readily substitute for combustible cigarettes among 200 cigarette smokers After measuring baseline cigarette smoking rate participants will be randomized to ECIGS or ONPS and be instructed to switch versus smoking cigarettes over a 6-week period Relative reductions in biomarkers of exposure will be measured ECIG- and ONP-associated subjective reward and the reinforcing value of ECIGS and ONPS relative to combustible cigarettes will be assessed as mechanisms
Detailed Description:
E-cigarettes ECIGS and oral nicotine pouches ONPs expose users to few of the chemicals found in cigarette smoke and are thus promising noncombustible harm reduction tools for smokers who would not otherwise quit smoking For their harm reduction potential to be realized fundamental questions must be answered One can persistent smokers switch from combustible cigarettes to either ECIGS or ONPS Two what factors influence switching Three does one of these noncombustible alternatives expose users to lower levels of harmful chemicals than the other The proposed research will fill these gaps in the evidence base by randomizing 200 persistent cigarette smokers to a six-week regimen of ECIGS or ONPS Baseline smoking rate will be established during days 1-5 After biochemically confirmed overnight smoking abstinence laboratory visits on days 6 and 7 will assess ECIG and ONP-associated subjective reward and the reinforcing value of either ECIGS or ONPS relative to combustible cigarettes Participants will switch from cigarette smoking to ECIGS or ONPS for the following six weeks The primary outcome measure is the longitudinal daily count of cigarettes from baseline to the end of the six-week switch period measured via a validated collection protocol with cigarettes per day cpd at a 6-month follow-up as a secondary endpoint Changes in biomarkers of potential harm assessed at baseline and the end of the six-week switch phase will be secondary outcome measures
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 |
|---|---|---|---|
| R01CA290541-01A1 | NIH | None | httpsreporternihgovquickSearchR01CA290541-01A1 |
| 855140 | OTHER | None | None |