Nicotine Dependence
Conditions
Keywords
Nicotine addiction, Cigarette smoking, Smoking cessation, Quit smoking
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 in an occupational wellness program. A sample of 60 cigarette smokers prescribed varenicline (Chantix) will be 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.
Interventions
DEVICEmSMART
A smartphone application that targets medication adherence in substance users, providing information and reminders and tracking medication usage and factors interfering with adherence.
Sponsors
Intelligent Automation, Inc.
National Institute on Drug Abuse (NIDA)
Duke University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adherence to smoking cessation medication as assessed via Medication Event Monitoring System (MEMS) | Week 12 | 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. |
| Acceptability of mSMART based on responses to an exit interview | Week 12 | 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? |
| Feasibility of mSMART based on frequency of participant use of the app | Week 12 | Feasibility of mSMART will be based on frequency of participant use of the app, totalled at the end of the study. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adherence to smoking cessation medication indicated by smoking abstinence | Week 12 | Adherence to smoking cessation medication will be evaluated by assessing a biochemical (salivary) measure of participant's cotinine level at the end of the 12 week intervention period which will assess smoking abstinence. |
| Adherence to smoking cessation medication indicated by mSMART medication event data | Week 12 | Adherence to smoking cessation medication analyzed using mSMART's medication event data from use of Medication Aide widget (a component of mSMART involving a smartphone camera-based medication identification and identification-based medication event technology developed by Intelligent Automation, Inc.) in the experimental group. |
Countries
United States
Contacts
Primary ContactJohn Mitchell, Ph.D.
Backup ContactAl Salley, M.A.
Outcome results
None listed