Clinical trial NCT02973425: Take a Break (TAB): mHealth-assisted Skills Building Challenge for Unmotivated Smokers
Official title: Take a Break (TAB): mHealth-assisted Skills Building Challenge for Unmotivated Smokers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Smoking Cessation
Keywords: mHealth, Smoking cessation,
Lead sponsor: University of Massachusetts, Worcester
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2016-11-25
Enrollment: 433
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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..

Detailed description: The Take a Break intervention is designed to increase self-efficacy and support new skills for Motivation Phase smokers. We 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.

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.

Primary outcomes:
measure: Time to First Quit Attempt
timeFrame: 6 months
Secondary outcomes:
measure: Change in Self-Efficacy at the End of the 6 Months
timeFrame: 6 months
measure: Point Prevalent Cessation as Measured by Carbon Monoxide Levels
timeFrame: 6 months
measure: Mean Number of Days Abstinent During the First 3 Weeks
timeFrame: 3 Weeks
measure: Number of Participants Abstinent During the First 3 Weeks
timeFrame: 3 Weeks
Other outcomes:
measure: Number of Participants Completing Daily Challenge Quiz
timeFrame: 3 weeks
measure: Number of Participants Completing a Call With Study Team to Establish a Smoking Abstinence Goal.
timeFrame: 1 week
measure: Number of Participants Use of Mobile Health Application (mHealth App) to Manage Nicotine Cravings.
timeFrame: 3 week
measure: Number of TAB Participants Setting a Brief Abstinence Goal With the TTS (Tobacco Treatment Specialist)
timeFrame: 2 week
Locations:
city: Worcester
country: United States
facility: Reliant Medical Group
state: Massachusetts
city: Worcester
country: United States
facility: VA Central Western Massachusetts Healthcare System
state: Massachusetts
city: Worcester
country: United States
facility: University of Massachusetts Medical School
state: Massachusetts
city: Great Neck
country: United States
facility: Northwell Health
state: New York
Study officials:
affiliation: UMMS
name: Rajani S Sadasivam, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Houston TK, Chen J, Amante DJ, Blok AC, Nagawa CS, Wijesundara JG, Kamberi A, Allison JJ, Person SD, Flahive J, Morley J, Conigliaro J, Mattocks KM, Garber L, Sadasivam RS. Effect of Technology-Assisted Brief Abstinence Game on Long-term Smoking Cessation in Individuals Not Yet Ready to Quit: A Randomized Clinical Trial. JAMA Intern Med. 2022 Mar 1;182(3):303-312. doi: 10.1001/jamainternmed.2021.7866.