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

Meharry Medical College

Status: Unknown

Conditions: Smoking Cessation

Treatments: Other: NRT + QuitBuddy; Other: Treatment as Usual; Other: NRT + QuitBuddy-Recall

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03690596

00061239

K23DA041616 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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).

Enrollment: 94 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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94 participants in 3 patient groups

NRT + QuitBuddy

Experimental group

Description:

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.

Treatment:

Other: NRT + QuitBuddy

NRT + QuitBuddy-Recall

Experimental group

Description:

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.

Treatment:

Other: NRT + QuitBuddy-Recall

NRT Control (treatment as usual)

Active Comparator group

Description:

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.

Treatment:

Other: Treatment as Usual