Clinical trial NCT05625685: Equitable Smoking Relapse Prevention
Official title: Accelerating Health Equity Via Just-In-Time Adaptive Interventions (JITAIs): Scalable and High Impact mHealth Precision Smoking Relapse Prevention.
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Tobacco Use Disorder
Tobacco Dependence
Keywords: Smoking Cessation
Nicotine Replacement Therapy
Ecological Momentary Assessment
GPS
mHealth
Digital Intervention
Social Determinants of Health
Lead sponsor: Meharry Medical College
Sponsor class: OTHER
Collaborators: name: City of Hope Medical Center
name: Virginia Tech Carilion School of Medicine and Research Institute
First posted: 2022-11-23
Enrollment: 0
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: Will employ two interventions as part of a sequential multiple-assignment randomized trial (SMART).

First-stage intervention - Participants are randomized to one of two arms, QuitBuddy (a novel smoking cessation app) or Control.

Participants will be randomized again after reaching a predefined tailoring variable, operationalized as biochemically verified 24h smoking abstinence within 1-week from target quit date (TQD).

Second-stage intervention - Social determinants of health (SDoH) intervention.

Participants are randomized to receive either a digital SDoH intervention (powered by findhelp.org and integrated into QuitBuddy) or will receive an emailed list of social service providers in their Zip Code (standard care control).
Primary purpose: OTHER

Brief summary: The goal of this clinical trial is to test a GPS (Global Positioning System)-enabled smartphone app (QuitBuddy) in current smokers. The main questions it aims to answer are:

* Is Quitbuddy a good treatment for quitting smoking and "staying quit"?
* Will a second treatment that connects people to help for their social and financial needs improve Quitbuddy?

Participants will:

* get nicotine lozenges in the mail
* check in with the study team to report on their quitting progress after 1 day, 1 week, 1 month, 2 months, 3 months, and 6 months

Researchers will compare Quitbuddy to an app made by the National Cancer Institute to see if Quitbuddy is better for helping people stay quit.

Detailed description: Tobacco smoking is a primary preventable trans-diagnostic risk factor that if targeted more effectively, could reduce a wide range of health disparities in prevalence, severity, treatment efficacy, and mortality across many chronic health conditions (e.g., diabetes, obstructive sleep apnea), reduce treatment complexity/multi-morbidity, and reduce healthcare costs up to 80%. The Southeast, in particular, has an urgent need to disrupt the status quo of tobacco control (\<2% The Centers for Disease Control and Prevention (CDC) recommended tobacco control appropriations; highest smoking and mortality) driven in large part through neglected patterns of social determinants of health (SDoH; poverty, access to care) that disproportionately impact racial and ethnic minorities in the form of greater smoking and chronic disease rates, and ultimately nearly a decade of life lost. Unfortunately, only 5% of smoking cessation attempts last at least one year, with lower success among Black smokers even though they smoke at similar rates and intensity, and make more quit attempts. Accordingly, mobile health (mHealth) may have particular utility in addressing racial disparities.

Black smokers show high engagement rates with smartphones to access healthcare and greater adherence to digital interventions, which may facilitate tailoring to meet distinct needs. There is an urgent need to overcome equity gaps, which will require diversity and inclusion of individuals from underrepresented races/ethnicities to identify effective treatments. There is a need for just-in-time adaptive interventions (JITAIs) that 1) can be deployed rapidly (ideally before craving occurs), 2) effectively prevent or attenuate cravings quickly, and 3) are amenable to personalized treatment. Quitbuddy, the automated, yet personalized, JITAI app developed by the investigators, allows patients to prepare for high-risk situations before they arise, effectively promoting abstinence and preventing relapse. The overall goals are to optimize smart algorithms, identify personalized relapse risk, and automatically prompt NRT delivery in a real-time, preemptive manner, upon approaching personalized high-risk locations. Results from a National Institute on Drug abuse (NIDA)-funded (K23) pilot randomized controlled trial demonstrated outstanding usability (top 10% of over 500 apps), acceptability (\>80% compliance), and technical feasibility (\<10% GPS data loss). The investigators will build upon these promising data by testing effectiveness in a fully powered and rigorous SMART design with diverse representation of underserved populations and meeting community needs for SDoH interventions.

Specific Aims

Aims 1 \& 2: Evaluate QuitBuddy and SDoH augmentation intervention effectiveness for smoking cessation and relapse prevention via pragmatic remote SMART design (N=2,090).

Expected Outcome: Superior 6-month biochemically verified abstinence rates for the QuitBuddy and SDoH augmentation interventions, relative to controls.

Exploratory Aims: Test potential moderators/mediators of the effectiveness of the interventions.

This approach integrates for the first time established theories of relapse risk, evidence-based treatment, smartphone/GPS technology, and SDoH. This project offers high-impact solutions to address health disparities across a wide range of chronic diseases that disproportionately affect under-served populations.

Eligibility criteria: Inclusion Criteria:

* At least 21 years of age
* Smoking at least 10 cigarettes per day for the past year
* Literate in English/Spanish
* Willing to make a NRT-aided quit attempt within the next week

Exclusion Criteria:

* Pregnancy (according to urine pregnancy test)
* Breastfeeding or planning to become pregnant (self-report)
* Recent (past 3 months) cardiovascular trauma: myocardial infarction, stroke (self-report)
* Current use (past 30 days) of alternative tobacco products (e.g., electronic cigarettes, smokeless tobacco) or smoking cessation medications (self-report)

Primary outcomes:
measure: Abstinence Rate
timeFrame: 24 hours
measure: NRT Compliance
timeFrame: 24 hours
measure: Cravings
timeFrame: 24 hours
measure: Withdrawal 1-day
timeFrame: Measured one day after a participant's target quit-date.
measure: Withdrawal 1-week
timeFrame: Measured one week after a participant's target quit-date.
measure: Withdrawal 1-month
timeFrame: Measured one month after a participant's target quit-date.
measure: Withdrawal 2-month
timeFrame: Measured two months after a participant's target quit-date.
measure: Withdrawal 3-month
timeFrame: Measured three months after a participant's target quit-date.
measure: Withdrawal 6-month
timeFrame: Measured six months after a participant's target quit-date.
Secondary outcomes:
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Meharry Medical College
state: Tennessee
Study officials:
affiliation: Meharry Medical College
name: Bryan W Heckman, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: