Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06595459
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-10
Brief Title:
The Options 2 Study
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Randomized Comparative Effectiveness Trial of Nicotine Pouches for Cigarette Substitution a Question of Public Health
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this clinical trial is to investigate how well nicotine pouches and nicotine mini lozenges serve as substitutes for cigarettes when people try to switch from smoking to using these alternate nicotine products
Participants will
Use nicotine pouches nicotine mini lozenges or no study product for a week and then try not to smoke for 3 weeks
Have 6 in-person research visits and 1 follow-up call
Complete questionnaires at each study contact and use a smartphone app to record smoking and study product use
Participants will
Use nicotine pouches nicotine mini lozenges or no study product for a week and then try not to smoke for 3 weeks
Have 6 in-person research visits and 1 follow-up call
Complete questionnaires at each study contact and use a smartphone app to record smoking and study product use
Detailed Description:
Researchers currently lack critical data needed to appraise the potential for nicotine pouches to benefit public health Specifically they do not know how readily smokers will adopt pouches how effectively they can substitute for cigarettes when smokers are trying to avoid smoking the role of nicotine dose in the ability of pouches to serve as a substitute or the mechanisms that facilitate or hinder successful product transition This study will address these questions using a 4-arm randomized controlled trial of adults who smoke 5 cigarettes daily and are not planning to quit smoking in the next 30 days This study will provide a rigorous evaluation of the potential efficacy of a relatively modified risk new nicotine product as a substitute for combusted cigarettes The head-to-head comparison with FDA-approved mini lozenges can inform tobacco regulatory policy decisions
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None