Mobile Sensing of Smoking Behavior

Smoking Clinical Trial

— Mobi-Smoke  

Official title:

Mobile Sensing of Smoking Behavior

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02116283
• Other study ID #: Pro00044941
• Status: Completed
• Phase: N/A
• First received: January 16, 2014
• Last updated: November 4, 2014
• Start date: March 2014
• Est. completion date: May 2014

Study information

• Verified date: November 2014
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2
• Est. completion date: May 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Health
• Smoking

Intervention

Behavioral:
• 48 hour smoking abstinence
Participants will maintain smoking abstinence for 48 hours

Other:
• Smartphone
Participants will use an Android-based smartphone as their own for one month

Locations

Country	Name	City	State
United States	Duke University Medical Center	Durham	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Duke University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in smoking behaviors as measured by an algorithm of social variables	phone calls (time, duration, coded identity of contact, including smoking status); SMS texting (time sent, coded identity of contact)	up to 4 weeks	No
Secondary	Change in smoking behaviors as measured by an algorithm of motion variables	acceleration; direction and magnitude of gravity; device orientation	up to 4 weeks	No
Secondary	Change in smoking behaviors as measured by an algorithm of environmental variables	light; proximity; magnetic field; pressure; temperature	up to 4 weeks	No
Secondary	Change in smoking behaviors as measured by an algorithm of device interaction variables	running applications; applications installed; screen status	up to 4 weeks	No
Secondary	Change in smoking behaviors as measured by an algorithm of positioning variables	location; Bluetooth devices within range; available WiFi access points; ID for the current cell tower the device is connected to	up to 4 weeks	No