Clinical Trials Directory

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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

TypeNameDescription
OTHERNRT + QuitBuddyQuitBuddy treatment app and 1 month supply of 4 mg nicotine lozenge
OTHERNRT + QuitBuddy-RecallQuitBuddy-Recall treatment app and 1 month supply of 4 mg nicotine lozenge
OTHERTreatment as Usual1 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.