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Behavioural Intervention

mSMART for Nicotine Addiction (mSMART-Ib Trial)

N/A
Waitlist Available
Led By F. Joseph McClernon, Ph.D.
Research Sponsored by Duke University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 12
Awards & highlights

mSMART-Ib Trial 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.

Eligible Conditions
  • Nicotine Addiction

mSMART-Ib Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 12
This trial's timeline: 3 weeks for screening, Varies for treatment, and week 12 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Acceptability of mSMART based on responses to an exit interview
Adherence to smoking cessation medication as assessed via Medication Event Monitoring System (MEMS)
Feasibility of mSMART based on frequency of participant use of the app
Secondary outcome measures
Pharmaceutical Preparations
Adherence to smoking cessation medication indicated by smoking abstinence

mSMART-Ib Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: mSMARTExperimental Treatment1 Intervention
Smokers in this group will have the mSMART application installed on their smartphones. The mSMART application will provide information about varenicline (Chantix) and reminders when it's time to take the medication.
Group II: ControlActive Control1 Intervention
Smokers in this group will not be given the mSMART application.

Find a Location

Who is running the clinical trial?

Duke UniversityLead Sponsor
2,365 Previous Clinical Trials
3,420,580 Total Patients Enrolled
3 Trials studying Nicotine Addiction
164 Patients Enrolled for Nicotine Addiction
Intelligent Automation, Inc.Industry Sponsor
6 Previous Clinical Trials
150 Total Patients Enrolled
National Institute on Drug Abuse (NIDA)NIH
2,470 Previous Clinical Trials
2,619,579 Total Patients Enrolled
15 Trials studying Nicotine Addiction
2,130 Patients Enrolled for Nicotine Addiction

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Stage Ib Trial of mSMART for Smoking Cessation Medication Adherence
2016. "Stage Ib Trial of mSMART for Smoking Cessation Medication Adherence". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02635919.
All > Smoking > Smoking Cessation
~7 spots leftby May 2025
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