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

Smoking Cessation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03690596
• Other study ID #: 00061239
• Secondary ID: K23DA041616
• Status: Active, not recruiting
• Phase: N/A
• Start date: April 16, 2019
• Est. completion date: January 31, 2022

Study information

• Verified date: December 2021
• Source: Meharry Medical College
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 94
• Est. completion date: January 31, 2022
• Est. primary completion date: January 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Recurrence
• Smoking Cessation

Intervention

Other:
• NRT + QuitBuddy
QuitBuddy treatment app and 1 month supply of 4 mg nicotine lozenge
• NRT + QuitBuddy-Recall
QuitBuddy-Recall treatment app and 1 month supply of 4 mg nicotine lozenge
• Treatment as Usual
1 month supply of 4 mg nicotine lozenge

Locations

Country	Name	City	State
United States	Meharry Medical College	Nashville	Tennessee

Sponsors (3)

Lead Sponsor	Collaborator
Meharry Medical College	Medical University of South Carolina, National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Abstinence from cigarettes	Biochemically-verified smoking status (CO<6) obtained at 3-month follow-up	12 Weeks
Secondary	Abstinence from cigarettes	Biochemically-verified smoking status (CO<6) obtained at 1-month follow-up	4 weeks
Secondary	Abstinence from cigarettes	Biochemically-verified smoking status (CO<6) obtained at 1-week follow-up	1 week