Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06544772
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-05
Brief Title:
Study of a Smartphone-Based Switch Program
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Pilot Study of a Smartphone-Based Program in Adults to Measure Switch Rates From Cigarettes to Smoke-free Nicotine Products C-520
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
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:
Prospective open label single center clinical study enrolling up to 120 participants to evaluate the Pivot cigarette smoking cessation program in adult smokers previously unable to quit who also use other smoke-free nicotine products poly-use and wish to stop cigarette smoking by switching to these smoke-free nicotine products
Detailed Description:
This is a prospective open label single center clinical study conducted with Institutional Review Board approval enrolling up to 120 adult participants who report cigarette smoking and concurrent use of smoke-free nicotine products and wish to switch completely off cigarettes The study will be performed remotely on an ambulatory basis
Participants will be asked to set up and use the Pivot cigarette smoking cessation program which comprises a mobile personal breath carbon monoxide sensor Pivot Breath Sensor and a smartphone app Pivot app with in-app asynchronous text-based coaching with a certified human tobacco cessation coach The study duration is 26 weeks with main outcomes assessed at 12 weeks primary endpoint and 26 weeks Participants will receive online questionnaires at intervals throughout the study Participants who indicate abstinence from cigarette smoking at 12 weeks will be invited to do a video call biovalidation visit in which they perform an observed breath sample using their Pivot breath sensor
Potential participants will complete an online screening form Eligible participants will be called to confirm eligibility discuss the study and have their questions about the study answered Interested eligible participants will complete the electronic informed consent form and baseline questionnaire prior to downloading the app on their smartphone
The investigators aim to assess the performance of the Pivot program among adult smokers who also use other smoke-free nicotine products with a focus on assessing trial feasibility program acceptability use and engagement changes in attitudes towards switching from cigarettes to smoke-free nicotine products and changes in cigarette nicotine product use and carbon monoxide CO values over the course of the 26-week study as well as participant feedback on the set-up design use experience and impact of the program
Participants will be asked to set up and use the Pivot cigarette smoking cessation program which comprises a mobile personal breath carbon monoxide sensor Pivot Breath Sensor and a smartphone app Pivot app with in-app asynchronous text-based coaching with a certified human tobacco cessation coach The study duration is 26 weeks with main outcomes assessed at 12 weeks primary endpoint and 26 weeks Participants will receive online questionnaires at intervals throughout the study Participants who indicate abstinence from cigarette smoking at 12 weeks will be invited to do a video call biovalidation visit in which they perform an observed breath sample using their Pivot breath sensor
Potential participants will complete an online screening form Eligible participants will be called to confirm eligibility discuss the study and have their questions about the study answered Interested eligible participants will complete the electronic informed consent form and baseline questionnaire prior to downloading the app on their smartphone
The investigators aim to assess the performance of the Pivot program among adult smokers who also use other smoke-free nicotine products with a focus on assessing trial feasibility program acceptability use and engagement changes in attitudes towards switching from cigarettes to smoke-free nicotine products and changes in cigarette nicotine product use and carbon monoxide CO values over the course of the 26-week study as well as participant feedback on the set-up design use experience and impact of the program
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