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

NCT03690596 | Unknown

• 2 other identifiers: 00061239K23DA041616
• Study Type: interventional
• Target: 94
• Locations: 1 country
• Sites: 1

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).

Conditions

Smoking Cessation

Outcome Measures

Primary Outcomes (1)

• Abstinence from cigarettes

  Biochemically-verified smoking status (CO\<6) obtained at 3-month follow-up

  12 Weeks

Secondary Outcomes (2)

• Abstinence from cigarettes

  4 weeks

• Abstinence from cigarettes

  1 week

Study Arms (3)

NRT + QuitBuddy

EXPERIMENTAL

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

NRT + QuitBuddy-Recall

EXPERIMENTAL

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

NRT Control (treatment as usual)

ACTIVE COMPARATOR

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

Interventions

NRT + QuitBuddy OTHER

QuitBuddy treatment app and 1 month supply of 4 mg nicotine lozenge

NRT + QuitBuddy

NRT + QuitBuddy-Recall OTHER

QuitBuddy-Recall treatment app and 1 month supply of 4 mg nicotine lozenge

NRT + QuitBuddy-Recall

Treatment as Usual OTHER

1 month supply of 4 mg nicotine lozenge

NRT Control (treatment as usual)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• FDA contraindications for use of NRT:
• Pregnant
• Breastfeeding or planning to become pregnant
• Recent (past 3 months) cardiovascular trauma: MI, stroke
• current use (past 30 days) of alternative tobacco products or smoking cessation medications

Sponsors & Collaborators

• Meharry Medical College: lead
• National Institute on Drug Abuse (NIDA): collaborator
• Medical University of South Carolina: collaborator

Study Sites (1)

Meharry Medical College

Nashville, Tennessee, 37208, United States

Location

MeSH Terms

Conditions

Smoking Cessation

Interventions

Nicotine Replacement Therapy; Therapeutics

Condition Hierarchy (Ancestors)

Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Drug Therapy

Study Officials

• Bryan W Heckman, PhD

  Meharry Medical College

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 24, 2018
• First Posted: October 1, 2018
• Study Start: April 16, 2019
• Primary Completion: January 31, 2022
• Study Completion: January 31, 2022
• Last Updated: December 13, 2021

Record last verified: 2021-12

Locations

US (1)