Clinical trial NCT02116283: Mobile Sensing of Smoking Behavior
Official title: Mobile Sensing of Smoking Behavior
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Smoking
Health
Keywords: smoking
healthy
smartphone
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2014-04-16
Enrollment: 2
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in smoking behaviors as measured by an algorithm of social variables
timeFrame: up to 4 weeks
Secondary outcomes:
measure: Change in smoking behaviors as measured by an algorithm of motion variables
timeFrame: up to 4 weeks
measure: Change in smoking behaviors as measured by an algorithm of environmental variables
timeFrame: up to 4 weeks
measure: Change in smoking behaviors as measured by an algorithm of device interaction variables
timeFrame: up to 4 weeks
measure: Change in smoking behaviors as measured by an algorithm of positioning variables
timeFrame: up to 4 weeks
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
Study officials:
affiliation: Duke University
name: Joseph McClernon, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: