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

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

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).

Study Overview

• Status: Active, not recruiting
• Conditions: Smoking Cessation
• Intervention / Treatment: Other: NRT + QuitBuddy; Other: NRT + QuitBuddy-Recall; Other: Treatment as Usual

• Study Type: Interventional
• Enrollment (Anticipated): 94
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Tennessee
    • Nashville, Tennessee, United States, 37208
      • Meharry Medical College

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Other: NRT + QuitBuddy; QuitBuddy treatment app and 1 month supply of 4 mg nicotine lozenge
Experimental: 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.	Other: NRT + QuitBuddy-Recall; QuitBuddy-Recall treatment app and 1 month supply of 4 mg nicotine lozenge
Active Comparator: NRT Control (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.	Other: Treatment as Usual; 1 month supply of 4 mg nicotine lozenge

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Meharry Medical College
• Collaborators: National Institute on Drug Abuse (NIDA); Medical University of South Carolina
• Investigators: Principal Investigator: Bryan W Heckman, PhD, Meharry Medical College

Study record dates

Study Major Dates

• Study Start (Actual): April 16, 2019
• Primary Completion (Anticipated): January 31, 2022
• Study Completion (Anticipated): January 31, 2022

Study Registration Dates

• First Submitted: September 24, 2018
• First Submitted That Met QC Criteria: September 27, 2018
• First Posted (Actual): October 1, 2018

Study Record Updates

• Last Update Posted (Actual): December 13, 2021
• Last Update Submitted That Met QC Criteria: December 9, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Recurrence
• Other Study ID Numbers: 00061239; K23DA041616 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No