Equitable Smoking Relapse Prevention

NCT05625685 | Withdrawn DMC

• 1 other identifier: 1P50MD017347-01
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Tobacco Use Disorder; Tobacco Dependence

Keywords

Smoking Cessation; Nicotine Replacement Therapy; Ecological Momentary Assessment; GPS; mHealth; Digital Intervention; Social Determinants of Health

Outcome Measures

Primary Outcomes (9)

• Abstinence Rate

  Self-report. Participant enters number of cigarettes smoked.

  24 hours

• NRT Compliance

  Self report. Participant enters number of nicotine lozenges used.

  24 hours

• Cravings

  Self reported number of cravings experienced.

  24 hours

• Withdrawal 1-day

  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

  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

  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

  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

  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

  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.

Study Arms (2)

Quitbuddy

EXPERIMENTAL

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.

Other: Quitbuddy; Other: SDoH Augmentation; Other: SDoH Control

Control

ACTIVE COMPARATOR

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.

Other: Control; Other: SDoH Augmentation; Other: SDoH Control

Interventions

Quitbuddy OTHER

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.

Quitbuddy

Control OTHER

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.

Control

SDoH Augmentation OTHER

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.

Control; Quitbuddy

SDoH Control OTHER

No SDoH intervention

Control; Quitbuddy

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Bryan W. Heckman: lead
• City of Hope Medical Center: collaborator
• Virginia Tech Carilion School of Medicine and Research Institute: collaborator

Study Sites (1)

Meharry Medical College

Nashville, Tennessee, 37208, United States

Location

MeSH Terms

Conditions

Tobacco Use Disorder; Smoking Cessation

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Health Behavior; Behavior

Study Officials

• Bryan W Heckman, Ph.D.

  Meharry Medical College

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Model Details: 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).

Study Record Dates

• First Submitted: November 1, 2022
• First Posted: November 23, 2022
• Study Start: October 2, 2023
• Primary Completion: November 30, 2023
• Study Completion: November 30, 2023
• Last Updated: May 8, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)