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

Not Applicable

• Conditions: Smoking Cessation
• Interventions: Other: NRT + QuitBuddy-Recall; Other: NRT + QuitBuddy; Other: Treatment as Usual

• Registration Number: NCT03690596
• Lead Sponsor: Meharry Medical College

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-09-24
• Study First Submitted QC: 2018-09-27
• Study First Posted: 2018-10-01
• Study Start: 2019-04-16
• Status Verified: 2021-12
• Last Update Submitted: 2021-12-09
• Last Update Posted: 2021-12-13
• Primary Completion: 2022-01-31
• Study Completion: 2022-01-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 94

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
NRT + QuitBuddy-Recall	NRT + QuitBuddy-Recall	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.
NRT + QuitBuddy	NRT + QuitBuddy	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.
NRT Control (treatment as usual)	Treatment as Usual	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.

Primary Outcome Measures

Name	Time	Method
Abstinence from cigarettes	12 Weeks	Biochemically-verified smoking status (CO\<6) obtained at 3-month follow-up

Secondary Outcome Measures

Name	Time	Method
Abstinence from cigarettes	1 week	Biochemically-verified smoking status (CO\<6) obtained at 1-week follow-up

Trial Locations

Locations (1)

Meharry Medical College; 🇺🇸 Nashville, Tennessee, United States