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

Conditions:Smoking Cessation
Therapuetic Areas:Pulmonary / Respiratory Diseases
Age Range:18 - Any
Start Date:November 2016
End Date:July 2021
Contact:Thomas K Houston, MD, MHP

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Take a Break (TAB) is a randomized trial designed to evaluate 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.

The Take a Break intervention is designed to increase self-efficacy and support new skills
for Motivation Phase smokers. The investigators hypothesize that, compared with the NRT-only
group, the Take a Break group will have a greater number of days abstinent during the 'break'
period, a greater increase in self-efficacy at the end of the 'break' period, a lower time to
first quit attempt, and a higher rate of quit at 6 months. This research study will also
provide valuable insight into this population of smokers and increase our understanding of
which tools may be effective in helping them quit smoking.

Our Specific Aims are

- AIM 1: Refine the Take a Break mHealth tool and implementation program.

- AIM 2: Conduct a randomized trial of the effectiveness of Take a Break.

- AIM 3: Follow participants in the AIM 2 randomized clinical trial for 6 months to
evaluate time to quit attempts, number of quit attempts, and 6-month biochemically
verified point prevalent cessation

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 or at the Boston VAMC. 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

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.
We found this trial at
55 N Lake Ave
Worcester, Massachusetts 01655
(508) 856-8989
Univ of Massachusetts Med School As the commonwealth's only public medical school, we take seriously...
Worcester, MA
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