Stage Ib Trial of mSMART With Varenicline

Withdrawn before enrolling · Phase 1

Conditions studied: Nicotine Dependence

In brief

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.

Key facts

Study ID

NCT03069768

Run by

Duke University

People needed

0

Starts

2018-04-01

Expected to finish

2019-06-01

Last updated by the study team

2018-04-17

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Interested in taking 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)
• 18-65 years of age

You may not qualify if…

• Unwillingness to be randomized to either treatment condition
• Subjects who have currently been taking varenicline for more than 15 days
• Currently pregnant or plan on becoming pregnant (females only)

Where it is running

• Duke Health Behavior Neuroscience Research Lab — Durham, North Carolina, United States

Full record on ClinicalTrials.gov

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