- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05625685
Equitable Smoking Relapse Prevention
Accelerating Health Equity Via Just-In-Time Adaptive Interventions (JITAIs): Scalable and High Impact mHealth Precision Smoking Relapse Prevention.
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.
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Tennessee
-
Nashville, Tennessee, United States, 37208
- Meharry Medical College
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Sequential Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Quitbuddy
Participants will be assigned to use a smartphone app (QuitBuddy) that will automatically guide NRT treatment delivery through the integration of ecological momentary assessments (EMA) and GPS into personalized relapse prevention algorithms.
|
Participants will be mailed a one week supply of nicotine lozenges as nicotine replacement therapy (NRT) for their upcoming quit attempt, with the ability to order more as needed.
Participants will have a set "Target Quit Date" (TQD) set on Day 8 after enrollment, following one week of ad-lib smoking that comprises the pre-TQD EMA/GPS smoking data collection.
GPS guided NRT usage prompts, via hotspot algorithms, will be provided to participants in the Quitbuddy Arm.
Participants will contribute four weeks of post-TQD EMA/GPS data to capture lapses and NRT use in real-time.
Carbon Monoxide (CO) levels will be tested at each of the six post-TQD remote assessments to provide objective verification of smoking status (i.e., 1 day, 1 week, 1 month, 2 month, 3 month, and 6 month abstinence rates).
Computerized data collection methods (RedCap) will be used throughout the study to optimize quality assurance.
The SDoH intervention is based on the findhelp.org
online platform, with customization to meet the specific needs of the study and communities being served: includes validated SDoH assessments, personalized social needs searching based on priorities, access to the most comprehensive social service database, and a streamlined closed loop referral system that integrates with workflows.
No SDoH intervention
|
Active Comparator: Control
Control is intended to approximate the real-world experience where Participants will use The National Cancer Institute's smartphone app (QuitGuide) and will self-manage NRT treatment delivery based on written instructions.
|
The SDoH intervention is based on the findhelp.org
online platform, with customization to meet the specific needs of the study and communities being served: includes validated SDoH assessments, personalized social needs searching based on priorities, access to the most comprehensive social service database, and a streamlined closed loop referral system that integrates with workflows.
No SDoH intervention
Participants will be mailed a one week supply of nicotine lozenges as nicotine replacement therapy (NRT) for their upcoming quit attempt, with the ability to order more as needed.
Participants will have a set "Target Quit Date" (TQD) set on Day 8 after enrollment, following one week of ad-lib smoking that comprises the pre-TQD smoking data collection.
Participants will contribute four weeks of post-TQD data to capture lapses and NRT use.
CO levels will be tested at each of the six post-TQD remote assessments to provide objective verification of smoking status (i.e., 1 day, 1 week, 1 month, 2 month, 3 month, and 6 month abstinence rates).
Computerized data collection methods (RedCap) will be used throughout the study to optimize quality assurance.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Abstinence Rate
Time Frame: 24 hours
|
Self-report.
Participant enters number of cigarettes smoked.
|
24 hours
|
NRT Compliance
Time Frame: 24 hours
|
Self report.
Participant enters number of nicotine lozenges used.
|
24 hours
|
Cravings
Time Frame: 24 hours
|
Self reported number of cravings experienced.
|
24 hours
|
Withdrawal 1-day
Time Frame: Measured one day after a participant's target quit-date.
|
Minnesota Nicotine Withdrawal Scale - A nine-item self-report scale for examining the severity of nicotine withdrawal symptoms in a subject.
Participants select 0 (none) - 4 (severe) for each of the items.
Higher scores correspond to higher perceived severity of withdrawal.
|
Measured one day after a participant's target quit-date.
|
Withdrawal 1-week
Time Frame: Measured one week after a participant's target quit-date.
|
Minnesota Nicotine Withdrawal Scale - A nine-item self-report scale for examining the severity of nicotine withdrawal symptoms in a subject.
Participants select 0 (none) - 4 (severe) for each of the items.
Higher scores correspond to higher perceived severity of withdrawal.
|
Measured one week after a participant's target quit-date.
|
Withdrawal 1-month
Time Frame: Measured one month after a participant's target quit-date.
|
Minnesota Nicotine Withdrawal Scale - A nine-item self-report scale for examining the severity of nicotine withdrawal symptoms in a subject.
Participants select 0 (none) - 4 (severe) for each of the items.
Higher scores correspond to higher perceived severity of withdrawal.
|
Measured one month after a participant's target quit-date.
|
Withdrawal 2-month
Time Frame: Measured two months after a participant's target quit-date.
|
Minnesota Nicotine Withdrawal Scale - A nine-item self-report scale for examining the severity of nicotine withdrawal symptoms in a subject.
Participants select 0 (none) - 4 (severe) for each of the items.
Higher scores correspond to higher perceived severity of withdrawal.
|
Measured two months after a participant's target quit-date.
|
Withdrawal 3-month
Time Frame: Measured three months after a participant's target quit-date.
|
Minnesota Nicotine Withdrawal Scale - A nine-item self-report scale for examining the severity of nicotine withdrawal symptoms in a subject.
Participants select 0 (none) - 4 (severe) for each of the items.
Higher scores correspond to higher perceived severity of withdrawal.
|
Measured three months after a participant's target quit-date.
|
Withdrawal 6-month
Time Frame: Measured six months after a participant's target quit-date.
|
Minnesota Nicotine Withdrawal Scale - A nine-item self-report scale for examining the severity of nicotine withdrawal symptoms in a subject.
Participants select 0 (none) - 4 (severe) for each of the items.
Higher scores correspond to higher perceived severity of withdrawal.
|
Measured six months after a participant's target quit-date.
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Bryan W Heckman, Ph.D., Meharry Medical College
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1P50MD017347-01 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Tobacco Use Disorder
-
Washington University School of MedicineNational Cancer Institute (NCI); National Institutes of Health (NIH)CompletedSmoking | Smoking Cessation | Tobacco Use | Tobacco Smoking | Tobacco Use Cessation | Nicotine Dependence | Tobacco Dependence | Smoking, Tobacco | Nicotine Use Disorder | Nicotine Dependence, Cigarettes | Smoking, Cigarette | Nicotine Dependence Tobacco Product | Tobacco; Use, Rehabilitation | Smoking (Tobacco) Addiction and other conditionsUnited States
-
Johns Hopkins UniversityNational Institute on Drug Abuse (NIDA)RecruitingTobacco Use | Tobacco Smoking | Tobacco Use Disorder | Tobacco Use Cessation | Tobacco DependenceUnited States
-
Harvard School of Public Health (HSPH)Beacon Communities; The Community BuildersEnrolling by invitationTobacco Use | Tobacco Smoking | Tobacco Use Disorder | Tobacco Use Cessation | Second Hand Tobacco SmokeUnited States
-
University of California, San FranciscoNational Institute on Minority Health and Health Disparities (NIMHD)CompletedSmoking | Smoking Cessation | Tobacco Use | Tobacco Smoking | Tobacco Use Disorder | Tobacco Use Cessation | Tobacco Dependence | Smoking, Tobacco | Smoking, CigaretteUnited States
-
University of California, San FranciscoTobacco Related Disease Research ProgramCompletedSmoking | Smoking Cessation | Tobacco Use | Tobacco Smoking | Tobacco Use Disorder | Tobacco Use Cessation | Tobacco Dependence | Smoking, Tobacco | Smoking, CigaretteUnited States
-
New York State Psychiatric InstituteTerminatedSmoking | Smoking Cessation | Tobacco Use | Tobacco Smoking | Tobacco Use Disorder | Nicotine Dependence | Cigarette Smoking | Tobacco Dependence | Nicotine Use Disorder | Smoking, CigaretteUnited States
-
Rutgers, The State University of New JerseyNational Institute on Drug Abuse (NIDA)CompletedSchizophrenia | Schizoaffective Disorder | Tobacco Use | Tobacco Smoking | Tobacco Use Disorder | Tobacco Use CessationUnited States
-
University of PennsylvaniaFood and Drug Administration (FDA)Completed
-
University of Kansas Medical CenterCompletedTobacco Use Disorder/Cigarette SmokingUnited States
-
Ottawa Hospital Research InstituteCompletedTobacco Use Disorder | Tobacco Use Cessation | Tobacco Dependence
Clinical Trials on Quitbuddy
-
Meharry Medical CollegeNational Institute on Drug Abuse (NIDA); Medical University of South CarolinaActive, not recruiting