CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 433 enrolled
Drug / intervention
Take a Break as an augmentation to NRT-sampling in Motivation Phase +1 morebehavioral
Likely dose
Nicotine lozenges (dose not specified in interventions)AI-extracted
Key inclusion· 4
  • Age 18 years or older
  • Current smokers not preparing to quit
  • Active in care within participating health systems (UMMHC, Northwell Health Long Island, RMG Worcester MA, or VACWM Worcester MA)
  • Active in care defined as at least two clinical visits in past year
Key exclusion· 6
  • Unwilling to sample nicotine lozenges or participate in the game
  • Already on nicotine replacement therapy (NRT)
  • FDA contraindication or caution for nicotine lozenge use: pregnancy, breastfeeding, recent cardiovascular distress, or phenylketonuria
  • Diagnosis of depression

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02973425
NCT02973425N/ACompleted

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

University of Massachusetts, Worcester·interventional·Posted Nov 25, 2016·Updated Aug 11, 2022

In Brief

A clinical study evaluating Take a Break as an augmentation to NRT-sampling in Motivation Phase and NRT and mHealth assessment tool without feedback for Smoking Cessation. Completed, enrolled 433 participants across 4 sites.

Detailed 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..

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

N/ACompletedFinished
2017201820192020202120222023202420252026
First PostedNov 25, 2016
Enrollment StartNov 7, 2016
Primary CompletionJul 31, 2020
TodayJul 2, 2026
Enrollment to primary: 3.7 yearsPosted 9.6 years ago

Interventions

Take a Break as an augmentation to NRT-sampling in Motivation Phasebehavioral

NRT sampling experience \& Suite of mHealth motivational tools and mini-games.

NRT and mHealth assessment tool without feedbackbehavioral

NRT and mHealth assessment tool without feedback