Recruiting

mSMART

Sponsor:

Duke University

Code:

NCT02635919

Conditions

Nicotine Dependence

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

mSMART

Study Details

Brief summary:

The primary aim of this study is to conduct a 60-patient feasibility, acceptability, and preliminary efficacy study of mSMART (Mobile App based Personalized Solutions and Tools for Medication Adherence of Rx Pill), a smartphone application ("app") for improving medication adherence among substance users. The investigators will compare 2 groups of cigarette smokers undergoing a quit attempt with varenicline (Chantix): a) an experimental group using the mSMART app on their smartphone and a MEMS Cap (Medication Event Monitoring System, a smart pillbox that will a record a date and time-stamped medication event whenever pill box is opened and closed, and thus allow for primary measurement of medication adherence) and b) a control group using the MEMS Cap and mobile web-based surveys on their smartphone.

Conditions

Nicotine Dependence

Study ID

NCT02635919

Start date

Apr, 2016

Status verified date

Apr, 2018

Completion date

Nov, 2018

Anticipated

Primary completion date

Nov, 2018

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Recently prescribed varenicline (Chantix) with the intention to quit smoking in the next 3 months
  • Has an Android smartphone (using v5.x.x or lollipop) or Apple smartphone (iPhone) Operating System (iOS) (using v6.0)

Exclusion Criteria:

  • Unwillingness to be randomized to either treatment condition
  • Use of only non-cigarette forms of tobacco (i.e., participant is not a cigarette smoker but instead uses other tobacco products)

Study Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Other

Interventions and Outcome Measures

Arms

experimental: mSMART

Smokers in this group will have the mSMART application installed on their smartphones. The mSMART application will provide information about varenicline (Chantix) and reminders when it's time to take the medication.

no intervention: Control

Smokers in this group will not be given the mSMART application.

Interventions

mSMART

A smartphone application that targets medication adherence in substance users, providing information and reminders and tracking medication usage and factors interfering with adherence.

Primary outcome measure

  • Adherence to smoking cessation medication as assessed via Medication Event Monitoring System (MEMS) [ Time Frame: Week 12 ]
  • Acceptability of mSMART based on responses to an exit interview [ Time Frame: Week 12 ]
  • Feasibility of mSMART based on frequency of participant use of the app [ Time Frame: Week 12 ]

Central Contacts and Locations

Central contacts

John Mitchell, Ph.D.

919-681-0012john.mitchell@duke.edu

Al Salley, M.A.

919-668-5153al.salley@duke.edu

Locations

Duke Health Behavior Neuroscience Research Lab

Recruiting

Durham, North Carolina, United States, 27705

More Information

Sponsor

Duke University

Last update posted

Apr 3, 2018

Last verified

Apr, 2018

Keywords

  • Nicotine addiction
  • Cigarette smoking
  • Smoking cessation
  • Quit smoking

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Duke University on 2018-04-03.