Take a Break (TAB): mHealth-assisted Skills Building Challenge for Unmotivated Smokers

Completed · Not applicable

Conditions studied: Smoking Cessation

In brief

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..

Key facts

Study ID

NCT02973425

Run by

University of Massachusetts, Worcester

People needed

433

Starts

2016-11-07

Expected to finish

2020-07-31

Last updated by the study team

2022-08-11

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Reliant Medical Group — Worcester, Massachusetts, United States
• VA Central Western Massachusetts Healthcare System — Worcester, Massachusetts, United States
• University of Massachusetts Medical School — Worcester, Massachusetts, United States
• Northwell Health — Great Neck, New York, United States

Full record on ClinicalTrials.gov

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