NCT02116283

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2014

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 16, 2014

Completed
1 month until next milestone

Study Start

First participant enrolled

March 1, 2014

Completed
2 months until next milestone

First Posted

Study publicly available on registry

April 16, 2014

Completed
15 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2014

Completed
Last Updated

November 5, 2014

Status Verified

November 1, 2014

Enrollment Period

2 months

First QC Date

January 16, 2014

Last Update Submit

November 4, 2014

Conditions

SmokingHealth

Keywords

smokinghealthysmartphone

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (4)

  • Change in smoking behaviors as measured by an algorithm of motion variables

    up to 4 weeks

  • Change in smoking behaviors as measured by an algorithm of environmental variables

    up to 4 weeks

  • Change in smoking behaviors as measured by an algorithm of device interaction variables

    up to 4 weeks

  • Change in smoking behaviors as measured by an algorithm of positioning variables

    up to 4 weeks

Interventions

48 hour smoking abstinenceBEHAVIORAL

Participants will maintain smoking abstinence for 48 hours

SmartphoneOTHER

Participants will use an Android-based smartphone as their own for one month

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27705, United States

Location

MeSH Terms

Conditions

Smoking

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Joseph McClernon, Ph.D

    Duke University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 16, 2014

First Posted

April 16, 2014

Study Start

March 1, 2014

Primary Completion

May 1, 2014

Study Completion

May 1, 2014

Last Updated

November 5, 2014

Record last verified: 2014-11

Locations

US(1)