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

NCT ID: NCT03690596

Last Updated: 2021-12-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

94 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-04-16

Study Completion Date

2022-01-31

Brief Summary

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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

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Conditions

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Smoking Cessation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

NRT + QuitBuddy

Intervention Type OTHER

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

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.

Group Type EXPERIMENTAL

NRT + QuitBuddy-Recall

Intervention Type OTHER

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

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.

Group Type ACTIVE_COMPARATOR

Treatment as Usual

Intervention Type OTHER

1 month supply of 4 mg nicotine lozenge

Interventions

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NRT + QuitBuddy

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

Intervention Type OTHER

NRT + QuitBuddy-Recall

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

Intervention Type OTHER

Treatment as Usual

1 month supply of 4 mg nicotine lozenge

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role collaborator

Medical University of South Carolina

OTHER

Sponsor Role collaborator

Meharry Medical College

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bryan W Heckman, PhD

Role: PRINCIPAL_INVESTIGATOR

Meharry Medical College

Locations

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Meharry Medical College

Nashville, Tennessee, United States

Site Status

Countries

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United States

Other Identifiers

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K23DA041616

Identifier Type: NIH

Identifier Source: secondary_id

View Link

00061239

Identifier Type: -

Identifier Source: org_study_id