NCT02635919

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 17, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 21, 2015

Completed
3 months until next milestone

Study Start

First participant enrolled

April 1, 2016

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2018

Completed
Last Updated

April 3, 2018

Status Verified

April 1, 2018

Enrollment Period

2.6 years

First QC Date

December 17, 2015

Last Update Submit

April 2, 2018

Conditions

Nicotine Dependence

Keywords

Nicotine addictionCigarette smokingSmoking cessationQuit smoking

Outcome Measures

Primary Outcomes (3)

  • Adherence to smoking cessation medication as assessed via Medication Event Monitoring System (MEMS)

    The MEMS Cap, placed on the subject's medication bottle, will document the number of times the bottle is opened per day, totalled at the end of study participation.

    Week 12

  • Acceptability of mSMART based on responses to an exit interview

    Acceptability of mSMART will be based on responses to an exit interview at the end of the study (Visit 2). Questionnaire asks for agreement with statements relating to acceptability of the app. Response options will be quantified on a Likert scale (1 = not at all, 2 = somewhat, 3 = moderately, 4 = extremely). Example question: What was your overall satisfaction with mSMART?

    Week 12

  • Feasibility of mSMART based on frequency of participant use of the app

    Feasibility of mSMART will be based on frequency of participant use of the app, totalled at the end of the study.

    Week 12

Secondary Outcomes (2)

  • Adherence to smoking cessation medication indicated by smoking abstinence

    Week 12

  • Adherence to smoking cessation medication indicated by mSMART medication event data

    Week 12

Study Arms (2)

mSMART

EXPERIMENTAL

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.

Device: mSMART

Control

NO INTERVENTION

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

Interventions

mSMARTDEVICE

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

Also known as: mSMART app, mSMART Smartphone Application
mSMART

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Duke Health Behavior Neuroscience Research Lab

Durham, North Carolina, 27705, United States

RECRUITING

MeSH Terms

Conditions

Tobacco Use DisorderCigarette SmokingSmoking Cessation

Condition Hierarchy (Ancestors)

Substance-Related DisordersChemically-Induced DisordersMental DisordersTobacco SmokingSmokingBehaviorTobacco UseHealth Behavior

Study Officials

  • F. Joseph McClernon, Ph.D.

    Duke University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

John Mitchell, Ph.D.

CONTACT

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

Al Salley, M.A.

CONTACT

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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 17, 2015

First Posted

December 21, 2015

Study Start

April 1, 2016

Primary Completion

November 1, 2018

Study Completion

November 1, 2018

Last Updated

April 3, 2018

Record last verified: 2018-04

Locations

US(1)