Smoking Cessation
Conditions
Brief summary
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).
Interventions
QuitBuddy treatment app and 1 month supply of 4 mg nicotine lozenge
QuitBuddy-Recall treatment app and 1 month supply of 4 mg nicotine lozenge
1 month supply of 4 mg nicotine lozenge
Sponsors
Study design
Eligibility
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: 1. Pregnant 2. Breastfeeding or planning to become pregnant 3. Recent (past 3 months) cardiovascular trauma: MI, stroke * current use (past 30 days) of alternative tobacco products or smoking cessation medications
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Abstinence from cigarettes | 12 Weeks | Biochemically-verified smoking status (CO\<6) obtained at 3-month follow-up |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Abstinence from cigarettes | 4 weeks | Biochemically-verified smoking status (CO\<6) obtained at 1-month follow-up |
Countries
United States