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

Sponsor

Meharry Medical College (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT03690596

Collaborator

National Institute on Drug Abuse (NIDA) (NIH), Medical University of South Carolina (Other)

Enrollment

Location

Arms

33.5

Anticipated Duration (Months)

2.8

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Smoking Cessation	Other: NRT + QuitBuddy Other: NRT + QuitBuddy-Recall Other: Treatment as Usual	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

94 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Apr 16, 2019

Anticipated Primary Completion Date :

Jan 31, 2022

Anticipated Study Completion Date :

Jan 31, 2022

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Abstinence from cigarettes [12 Weeks]
Biochemically-verified smoking status (CO<6) obtained at 3-month follow-up

Secondary Outcome Measures

Abstinence from cigarettes [4 weeks]
Biochemically-verified smoking status (CO<6) obtained at 1-month follow-up
Abstinence from cigarettes [1 week]
Biochemically-verified smoking status (CO<6) obtained at 1-week follow-up

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Meharry Medical College	Nashville	Tennessee	United States	37208

Sponsors and Collaborators

Meharry Medical College
National Institute on Drug Abuse (NIDA)
Medical University of South Carolina

Investigators

Principal Investigator: Bryan W Heckman, PhD, Meharry Medical College

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Meharry Medical College

ClinicalTrials.gov Identifier:

NCT03690596

Other Study ID Numbers:

00061239
K23DA041616

First Posted:

Oct 1, 2018

Last Update Posted:

Dec 13, 2021

Last Verified:

Dec 1, 2021

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Recurrence

Study Results

No Results Posted as of Dec 13, 2021