N/A
Completed N=433
Take a Break (TAB): mHealth-assisted Skills Building Challenge for Unmotivated Smokers
Source: ClinicalTrials.gov NCT02973425 ↗Enrolled (actual)
433
Serious AEs
0.0%
Results posted
Aug 2022
Primary outcomePrimary: Time to First Quit Attempt — 0.89; 1.48 days — p=0.02
Summary
Take a Break (TAB) is a randomized trial designed to evaluate Nicotine Replacement Therapy (NRT)-sampling and a mHealth suite of apps. TAB is a time-limited self-efficacy and skills building experience for Motivation Phase smokers. TAB is designed to create a timeline within which motivation smokers will be encouraged to try a brief period of abstinence. Smokers in this Motivation Phase are relatively untapped in research available information. This project offers these smokers point-of-need technology support in the many components of the intervention..
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time to First Quit Attempt |
0.89; 1.48 | 0.02 sig |
| SECONDARY Change in Self-Efficacy at the End of the 6 Months |
2.7; 2.9 | 0.03 sig |
| SECONDARY Point Prevalent Cessation as Measured by Carbon Monoxide Levels |
17; 28 | 0.048 sig |
| SECONDARY Mean Number of Days Abstinent During the First 3 Weeks |
0.60; 1.20 | 0.01 sig |
| SECONDARY Number of Participants Abstinent During the First 3 Weeks |
29; 49 | — |
Eligibility Criteria
Inclusion Criteria
- For all Aims, investigators will include individuals 18 years and older who are identified as current smokers who are not preparing to quit, and are active in care within the UMMHC system, Northwell Health in Long Island, NY, Reliant Medical Group (RMG) in Worcester, MA and Central Western Massachusetts VA (VACWM) in Worcester, MA. Active in care is defined as having at least two clinical visits in the past year. If an eligible participant does not already have a smart phone, one will be provided to them, free of charge, for the duration of their participation in the study.
Exclusion Criteria
- Exclusion Criteria: Those unwilling to sample nicotine lozenges or participate in the game will be excluded. All patients already on NRT will be excluded. All participants who have a FDA contraindication or cautions for nicotine lozenge use (pregnancy, breastfeeding, recent cardiovascular distress, or phenylketonuria) will be excluded. We have chosen to exclude patients with a diagnosis of depression, due to confounding factors.
Adults unable to consent, individuals who are not yet adults (infants, children, teenagers), and prisoners will be excluded from this study. The Food and Drug Administration (FDA) advises caution for nicotine lozenge use among women who are pregnant. Thus, women who are pregnant at the time of baseline will be excluded from the study.
Data sourced from ClinicalTrials.gov (NCT02973425). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.