Mobile Sensing of Smoking Behavior (Mobi-Smoke)

November 4, 2014 updated by: Duke University
Smokers will use a smartphone app on a smartphone provided for the study that will passively sense and record information about their activities. Information collected from the smartphone app will be used to develop future smartphone apps that will predict when an individual is at risk of smoking.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Smokers will carry an Android-based smartphone, which they are to use as their own for one month. After using the smartphone for two weeks, they will abstain from smoking for 48 hours. The phone will passively sense and record information from onboard sensors and send that information to a central server. When server based algorithms detect a pattern of signals likely associated with smoking behavior, the smoker will be queried regarding their current state (smoking?, not smoking but likely to in the next 10 minutes?, etc.). Likewise, when smokers are about to smoke but were not queried, they can indicate they are about to smoke. This information will be used to update algorithms using machine learning techniques. As such, in this study investigators will gain knowledge that will increase understanding of antecedents of smoking behavior and improve the accuracy with which smoking risk can be detected.

Study Type

Interventional

Enrollment (Actual)

2

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Durham, North Carolina, United States, 27705
        • Duke University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • generally healthy
  • between the ages of 18 and 65
  • smoking of at least 10 cig/day of a brand delivering ≥ 0.5 mg nicotine (FTC method) for > 1 year AND an afternoon expired CO concentration >5 ppm (to confirm inhalation) or morning urinary cotinine > 100 ng/mL
  • willingness to carry and use a study smartphone as their own for one month

Exclusion Criteria:

  • inability to attend all required sessions
  • use of smokeless tobacco products
  • current use of nicotine replacement therapy or other smoking cessation treatment

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in smoking behaviors as measured by an algorithm of social variables
Time Frame: up to 4 weeks
phone calls (time, duration, coded identity of contact, including smoking status); SMS texting (time sent, coded identity of contact)
up to 4 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in smoking behaviors as measured by an algorithm of motion variables
Time Frame: up to 4 weeks
acceleration; direction and magnitude of gravity; device orientation
up to 4 weeks
Change in smoking behaviors as measured by an algorithm of environmental variables
Time Frame: up to 4 weeks
light; proximity; magnetic field; pressure; temperature
up to 4 weeks
Change in smoking behaviors as measured by an algorithm of device interaction variables
Time Frame: up to 4 weeks
running applications; applications installed; screen status
up to 4 weeks
Change in smoking behaviors as measured by an algorithm of positioning variables
Time Frame: up to 4 weeks
location; Bluetooth devices within range; available WiFi access points; ID for the current cell tower the device is connected to
up to 4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Duke University

Investigators

  • Principal Investigator: Joseph McClernon, Ph.D, Duke University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2014

Primary Completion (Actual)

May 1, 2014

Study Completion (Actual)

May 1, 2014

Study Registration Dates

First Submitted

January 16, 2014

First Submitted That Met QC Criteria

April 15, 2014

First Posted (Estimate)

April 16, 2014

Study Record Updates

Last Update Posted (Estimate)

November 5, 2014

Last Update Submitted That Met QC Criteria

November 4, 2014

Last Verified

November 1, 2014

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Pro00044941

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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