Smoking Relapse Prevention Via Just-in-Time-Adaptive Interventions

Study Overview
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Brief Summary
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A small-scale randomized controlled trial (RCT) will pilot test a personalized JITAI designed to guide delivery of fast acting nicotine replacement therapy (NRT; lozenge) in real-time, to prevent smoking relapse. Specifically, a smartphone application (app), will integrate pre-quit smoking data with objective location data captured via global positioning system (GPS) to establish relapse risk (hotspot) algorithms. During a quit attempt, the GPS-enabled app (QuitBuddy) will detect proximity to hotspots and deliver NRT prompts, all of which will occur automatically and prior to exposure. Thus, QuitBuddy will optimize NRT use to prevent cue-provoked cravings known to undermine sustained abstinence, thereby repurposing this evidence-based cessation medication to promote relapse prevention. QuitBuddy will be tested against standard care (NRT with brief instructions). Two versions of QuitBuddy will be tested, which will differ only in how hotspot algorithms are derived: retrospectively from locations recalled at the onset of a quit attempt (QuitBuddy-Recall) or based on real-time EMA completed pre-quit (QuitBuddy).

Official Title
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Personalized Smoking Relapse Prevention Delivered in Real-Time Via Just-in-Time-Adaptive Interventions

Conditions
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Smoking Cessation

Intervention / Treatment
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* Other: NRT + QuitBuddy
* Other: NRT + QuitBuddy-Recall
* Other: Treatment as Usual


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: at least 18 years of age daily cigarette smoker of > 9 cigarettes/day for past year CO breath monitor detects > 10ppm literate in English willing to make a quit attempt in the next week with nicotine replacement therapy no plans to travel outside of a 100-mile radius of Charleston during the study Exclusion Criteria: FDA contraindications for use of NRT: Pregnant Breastfeeding or planning to become pregnant Recent (past 3 months) cardiovascular trauma: MI, stroke current use (past 30 days) of alternative tobacco products or smoking cessation medications

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: NRT + QuitBuddy<br>This smartphone app will identify high-risk situations through real-time EMA data collected before and during a quit attempt. One week of pre-quit smoking behaviors will be integrated with passively sensed GPS data to create hotspot maps. Hotspot maps will provide interactive visualizations of relapse risk. GPS triggered NRT/behavioral prompts will occur when participants come within 50m from the centroid of a hotspot. | Other: NRT + QuitBuddy<br>* QuitBuddy treatment app and 1 month supply of 4 mg nicotine lozenge<br>|
| Experimental: NRT + QuitBuddy-Recall<br>This smartphone app will identify high-risk situations through retrospective recall of locations where the patient typically smoked. Hotspot maps will provide interactive visualizations of relapse risk. GPS triggered NRT/behavioral prompts will occur when participants come within 50m from the centroid of a hotspot. | Other: NRT + QuitBuddy-Recall<br>* QuitBuddy-Recall treatment app and 1 month supply of 4 mg nicotine lozenge<br>|
| Active Comparator: NRT Control (treatment as usual)<br>Standard Care Control is intended to approximate the real-world experience where smokers obtain over-the-counter NRT and, after brief instructions at the outset ( 1 lozenge per hour, during cravings, and <20 per day), determine usage for themselves. | Other: Treatment as Usual<br>* 1 month supply of 4 mg nicotine lozenge<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Abstinence from cigarettes | Biochemically-verified smoking status (CO<6) obtained at 3-month follow-up | 12 Weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Abstinence from cigarettes | Biochemically-verified smoking status (CO<6) obtained at 1-month follow-up | 4 weeks | 
| Abstinence from cigarettes | Biochemically-verified smoking status (CO<6) obtained at 1-week follow-up | 1 week |