Trials / Unknown
UnknownNCT03690596
Smoking Relapse Prevention Via Just-in-Time-Adaptive Interventions
Personalized Smoking Relapse Prevention Delivered in Real-Time Via Just-in-Time-Adaptive Interventions
- Status
- Unknown
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 94 (estimated)
- Sponsor
- Meharry Medical College · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Accepted
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).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | NRT + QuitBuddy | QuitBuddy treatment app and 1 month supply of 4 mg nicotine lozenge |
| OTHER | NRT + QuitBuddy-Recall | QuitBuddy-Recall treatment app and 1 month supply of 4 mg nicotine lozenge |
| OTHER | Treatment as Usual | 1 month supply of 4 mg nicotine lozenge |
Timeline
- Start date
- 2019-04-16
- Primary completion
- 2022-01-31
- Completion
- 2022-01-31
- First posted
- 2018-10-01
- Last updated
- 2021-12-13
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT03690596. Inclusion in this directory is not an endorsement.