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

Primary Purpose

Smoking Cessation

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
NRT + QuitBuddy
NRT + QuitBuddy-Recall
Treatment as Usual
Sponsored by
Meharry Medical College
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Smoking Cessation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts 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

Sites / Locations

  • Meharry Medical College

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

NRT + QuitBuddy

NRT + QuitBuddy-Recall

NRT Control (treatment as usual)

Arm 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.

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
September 24, 2018
Last Updated
December 9, 2021
Sponsor
Meharry Medical College
Collaborators
National Institute on Drug Abuse (NIDA), Medical University of South Carolina
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1. Study Identification

Unique Protocol Identification Number
NCT03690596
Brief Title
Smoking Relapse Prevention Via Just-in-Time-Adaptive Interventions
Official Title
Personalized Smoking Relapse Prevention Delivered in Real-Time Via Just-in-Time-Adaptive Interventions
Study Type
Interventional

2. Study Status

Record Verification Date
December 2021
Overall Recruitment Status
Active, not recruiting
Study Start Date
April 16, 2019 (Actual)
Primary Completion Date
January 31, 2022 (Anticipated)
Study Completion Date
January 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Meharry Medical College
Collaborators
National Institute on Drug Abuse (NIDA), Medical University of South Carolina

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Smoking Cessation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
94 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
NRT + QuitBuddy
Arm Type
Experimental
Arm 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.
Arm Title
NRT + QuitBuddy-Recall
Arm Type
Experimental
Arm 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.
Arm Title
NRT Control (treatment as usual)
Arm Type
Active Comparator
Arm 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.
Intervention Type
Other
Intervention Name(s)
NRT + QuitBuddy
Intervention Description
QuitBuddy treatment app and 1 month supply of 4 mg nicotine lozenge
Intervention Type
Other
Intervention Name(s)
NRT + QuitBuddy-Recall
Intervention Description
QuitBuddy-Recall treatment app and 1 month supply of 4 mg nicotine lozenge
Intervention Type
Other
Intervention Name(s)
Treatment as Usual
Intervention Description
1 month supply of 4 mg nicotine lozenge
Primary Outcome Measure Information:
Title
Abstinence from cigarettes
Description
Biochemically-verified smoking status (CO<6) obtained at 3-month follow-up
Time Frame
12 Weeks
Secondary Outcome Measure Information:
Title
Abstinence from cigarettes
Description
Biochemically-verified smoking status (CO<6) obtained at 1-month follow-up
Time Frame
4 weeks
Title
Abstinence from cigarettes
Description
Biochemically-verified smoking status (CO<6) obtained at 1-week follow-up
Time Frame
1 week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bryan W Heckman, PhD
Organizational Affiliation
Meharry Medical College
Official's Role
Principal Investigator
Facility Information:
Facility Name
Meharry Medical College
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37208
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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