Pilot Study of a Smartphone-Based Program in Adults to Measure Switch Rates From Cigarettes to Smoke-free Nicotine Products (C-520)
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Smoking Cessation
- Sponsor
- Pivot Health Technologies Inc.
- Enrollment
- 105
- Locations
- 1
- Primary Endpoint
- Proportion of participants who completely switch from cigarettes to a smoke-free nicotine product by 12 weeks
- Status
- Completed
- Last Updated
- 7 months ago
Overview
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 product(s) (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 product(s), 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.
Investigators
MacKenzie Utley
Senior Clinical Research Associate
Pivot Health Technologies Inc.
Eligibility Criteria
Inclusion Criteria
- •21-65 years of age
- •Smoke ≥ 5 CPD on ≥ 5 days per week
- •Have smoked cigarettes for ≥ the last 6 months
- •Current use of ≥1 reduced risk smoke-free nicotine product which includes e-cigarettes/vaping, oral nicotine pouch (ONP; ex. Zyn, On, Velo), or heat-not-burn (ex. IQOS, Glo, Ploom, Pulze)
- •Planning to quit cigarette smoking by switching to a reduced risk smoke-free nicotine product
- •Self-report of ≥ 1 past failed cigarette smoking quit attempt
- •Resident of the United States
- •Able to read and comprehend English
- •Owns and uses a smartphone compatible with the study app (iPhone 6 and above with operating system iOS 15 and above, or, Android 7.0 and above with operating system Android 7.0 and above)
- •Has daily internet access on smartphone
Exclusion Criteria
- •Pregnant or breast-feeding (self-report)
- •Use of other smoking cessation apps, coaching, classes, or quit programs at entry or within previous 30 days
- •Current use of nicotine replacement therapy (NRT), chewing tobacco or cigars
- •Smokes marijuana ≥ 4 days per week
- •Current enrollment in another clinical trial
- •Failure to provide contact or collateral information, and/or failure to verify email address
- •Participation in a previous study sponsored by Pivot Health Technologies Inc. (formerly Carrot Inc.)
Outcomes
Primary Outcomes
Proportion of participants who completely switch from cigarettes to a smoke-free nicotine product by 12 weeks
Time Frame: 12 weeks
The proportion of participants who self-report 7-day point prevalence abstinence (PPA) from cigarettes at 12 weeks and self-report the use of 1 or more smoke-free nicotine products at 12 weeks.
Secondary Outcomes
- Engagement with program - number of weeks with app openings/sessions(12 weeks)
- Engagement with program - average duration of app sessions(12 weeks)
- Engagement with program - use of app features(12 weeks)
- Engagement with coaching(12 weeks)
- Average number of weeks with coaching engagement(12 weeks)
- User satisfaction - Net Promoter Score(4, 12 and 26 weeks)
- User feedback - setting up and getting started with the program(1 week)
- Participant need for the program(4 weeks)
- User satisfaction - helpful for switching(8 weeks)
- Change in Self-Efficacy(6, 12 and 26 weeks)
- Change in Expected Difficulty in Staying Switched(4, 8 and 12 weeks)
- Change in Confidence Levels Towards Switching(4, 8 and 12 weeks)
- Desire to Switch (Yes/No)(4 weeks)
- Interest in Switching(Baseline)
- Self-Reported Switch(12 and 26 weeks)
- Biochemically Confirmed Abstinence(12 weeks)
- Self-Reported Continuous Maintenance of Switch(26 weeks)
- Duration of Self-Reported Switch(12 and 26 weeks)
- Duration of Abstinence from Cigarettes(12 and 26 weeks)
- Self-Reported Use/Abstinence of Other Nicotine-Containing Products(12 and 26 weeks)
- Duration of Self-Reported Abstinence from All Nicotine Products(12 and 26 weeks)
- Proportion with ≥ 50% CPD Reduction(12 and 26 weeks)
- Average % CPD Reduction(12 and 26 weeks)
- Change in CPD(12 and 26 weeks)
- Change in Nicotine Product Use(12 and 26 weeks)
- Attempts to Switch(4, 8, 12 and 26 weeks)
- Attempts to Quit Nicotine Products(8, 12 and 26 weeks)
- Change in breath CO values for frequent breath sensor users(1, 4, 8 and 12 weeks)
- Change in breath CO values on Saturdays(1-12 weeks)
- Change in participant self-reported health(26 weeks)
- Use of other smoking cessation tools(12 and 26 weeks)
- Change in Alcohol Use Behavior(12 and 26 weeks)
- Change in presence of depressive symptoms(12 and 26 weeks)
- Living environment relating to nicotine product use and cigarette smoking(12 and 26 weeks)
- Living/relationship environment relating to nicotine product use and cigarette smoking(12 and 26 weeks)
- Social environment relating to nicotine product use and cigarette smoking(12 and 26 weeks)
- Trial feasibility: online screening form completers(Enrollment)
- Trial feasibility: eligible online screening form completers(Enrollment)
- Trial feasibility: study enrollment(Enrollment)
- Trial feasibility: Study completion(12 and 26 weeks)
- Engagement with program - app openings/sessions(12 weeks)
- Engagement with program - number of days with app openings/sessions(12 weeks)