Stage Ib Trial of mSMART With Varenicline

NCT ID: NCT03069768

Last Updated: 2018-04-17

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE1
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-04-30
• Study Completion Date: 2019-06-30

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.

Conditions

Nicotine Dependence

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

mSMART

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 Type: EXPERIMENTAL

mSMART

Intervention Type: DEVICE

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

Chantix

Intervention Type: 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.

Control

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

Group Type: ACTIVE_COMPARATOR

Chantix

Intervention Type: 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.

Interventions

mSMART

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

Intervention Type: DEVICE

Chantix

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.

Intervention Type: DRUG

Other Intervention Names

mSMART app; mSMART Smartphone Application; Varenicline

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Intelligent Automation, Inc.

INDUSTRY

Sponsor Role: collaborator

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role: collaborator

Duke University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

F. Joseph McClernon, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Duke University

Locations

Duke Health Behavior Neuroscience Research Lab

Durham, North Carolina, United States

Countries

United States

Other Identifiers

271201400069C-0-0-1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

Pro00080336

Identifier Type: -

Identifier Source: org_study_id