Stage Ib Trial of mSMART With Varenicline

NCT03069768 | Withdrawn Phase 1 FDA Drug

• 2 other identifiers: Pro00080336271201400069C-0-0-1
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Nicotine Dependence

Keywords

Nicotine addiction; Cigarette smoking; Smoking cessation; Quit smoking

Outcome Measures

Primary Outcomes (3)

• Adherence to smoking cessation medication as assessed via Medication Event Monitoring System (MEMS)

  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

  Week 12

• Acceptability of mSMART based on responses to an exit interview

  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?

  Week 12

• Feasibility of mSMART based on frequency of participant use of the app

  Feasibility of mSMART will be based on frequency of participant use of the app, totalled at the end of the study.

  Week 12

Secondary Outcomes (2)

• Adherence to smoking cessation medication indicated by smoking abstinence

  Week 12

• Adherence to smoking cessation medication indicated by mSMART medication event data

  Week 12

Study Arms (2)

mSMART

EXPERIMENTAL

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.

Device: mSMART; Drug: Chantix

Control

ACTIVE COMPARATOR

Smokers in this group will not be given the mSMART application.

Drug: Chantix

Interventions

mSMART DEVICE

A smartphone application that targets medication adherence in substance users, providing information and reminders and tracking medication usage and factors interfering with adherence.

Also known as: mSMART app, mSMART Smartphone Application

mSMART

Chantix DRUG

For the first 3 days smokers in this group will receive treatment with Chantix at a dose of 0.5 mg once per day followed by 0.5 mg twice a day for the remaining 4 days of that week. Subsequently, the dose will be 1 mg twice per day, and will remain at that dose for the remainder of the 12-week active treatment duration.

Also known as: Varenicline

Control; mSMART

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)
• years of age

You may not qualify if:

• 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)

Sponsors & Collaborators

• Duke University: lead
• Intelligent Automation, Inc.: collaborator
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

Duke Health Behavior Neuroscience Research Lab

Durham, North Carolina, 27705, United States

Location

MeSH Terms

Conditions

Tobacco Use Disorder; Cigarette Smoking; Smoking Cessation

Interventions

Varenicline

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Tobacco Smoking; Smoking; Behavior; Tobacco Use; Health Behavior

Intervention Hierarchy (Ancestors)

Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Quinoxalines

Study Officials

• F. Joseph McClernon, Ph.D.

  Duke University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 28, 2017
• First Posted: March 3, 2017
• Study Start: April 1, 2018
• Primary Completion: January 1, 2019
• Study Completion: June 1, 2019
• Last Updated: April 17, 2018

Record last verified: 2018-04

Locations

US (1)