Stage Ib Trial of mSMART With Varenicline
| Status: | Recruiting |
|---|---|
| Conditions: | Smoking Cessation, Tobacco Consumers |
| Therapuetic Areas: | Pulmonary / Respiratory Diseases |
| Healthy: | No |
| Age Range: | 18 - 65 |
| Updated: | 2/23/2018 |
| Start Date: | April 27, 2017 |
| End Date: | June 30, 2019 |
| Contact: | John Mitchell, Ph.D. |
| Email: | john.mitchell@duke.edu |
| Phone: | 919-681-0012 |
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.
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.
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.
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.
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)
We found this trial at
1
site
Click here to add this to my saved trials
