Clinical trial NCT03069768: Stage Ib Trial of mSMART With Varenicline
Official title: Stage Ib Trial of mSMART With Varenicline
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
Conditions: Nicotine Dependence
Keywords: Nicotine addiction
Cigarette smoking
Smoking cessation
Quit smoking
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: Intelligent Automation, Inc.
name: National Institute on Drug Abuse (NIDA)
First posted: 2017-03-03
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

Detailed description: Poor medication adherence (a) results in poorer treatment outcome and (b) accounts for $100 to $290 billion in U.S. healthcare costs annually. Therefore, interventions that target medication adherence are increasingly crucial for patient care and cost-effectiveness. Mobile technologies such as smartphones are increasingly ubiquitous and affordable in the U.S., and can be integrated to augment medication adherence. mSMART is a smartphone application that targets medication adherence in substance users. The study team has developed and assessed mSMART in a Stage Ia trial among 9 non-treatment seeking cigarette smokers. mSMART provides psychoeducation about medication (e.g., dosage, benefits, side-effects), assessment of medication compliance and characteristics associated with substance use, provides reminders to take medications, and conducts real-time medication event feedback intervention. The aim of the current study is to extend findings from the Stage Ia trial assessing preliminary feasibility and acceptability of mSMART for cigarette smokers. In the proposed study, the investigators will conduct a Stage Ib for the continued development of mSMART in an occupational wellness setting. This will also include a study of the feasibility, acceptability, and preliminary efficacy of mSMART for treatment seeking cigarette smokers undergoing a quit attempt. A sample of 60 cigarette smokers will be given varenicline (Chantix) and randomized to either a control condition (i.e., use of MEMS Cap, a smart pillbox that records instances that the pill bottle is opened) or treatment condition (i.e., use of MEMS Cap and mSMART) over a 12 week treatment period. The primary hypothesis is that the treatment group will achieve higher levels of medication adherence assessed via MEMS Cap. The secondary hypothesis is that the treatment group will also yield lower levels of salivary cotinine at week 12 assessment, indicating higher rates of smoking abstinence relative to the control group. Findings from the current study will inform the continued development of mSMART as an intervention to enhance substance use treatment outcome, including other forms of substance use besides cigarette smoking.

Eligibility 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)

Primary outcomes:
measure: Adherence to smoking cessation medication as assessed via Medication Event Monitoring System (MEMS)
timeFrame: Week 12
measure: Acceptability of mSMART based on responses to an exit interview
timeFrame: Week 12
measure: Feasibility of mSMART based on frequency of participant use of the app
timeFrame: Week 12
Secondary outcomes:
measure: Adherence to smoking cessation medication indicated by smoking abstinence
timeFrame: Week 12
measure: Adherence to smoking cessation medication indicated by mSMART medication event data
timeFrame: Week 12
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke Health Behavior Neuroscience Research Lab
state: North Carolina
Study officials:
affiliation: Duke University
name: F. Joseph McClernon, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: