Stage Ib Trial of mSMART With Varenicline

• Status: Withdrawn
• Trial end date: 2019-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Duke University
• Collaborators: Intelligent Automation, Inc.; National Institute on Drug Abuse (NIDA)
• Treatments: Varenicline

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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)