NCT02026440

Brief Summary

The VioOne Oral Fluid Sample Collection Device can be used to collect human oral fluid samples for detection of cotinine using an ELISA cotinine assay.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
250

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2013

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

Study Start

First participant enrolled

December 1, 2013

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

December 12, 2013

Completed
22 days until next milestone

First Posted

Study publicly available on registry

January 3, 2014

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2014

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2014

Completed
Last Updated

January 3, 2014

Status Verified

December 1, 2013

Enrollment Period

3 months

First QC Date

December 12, 2013

Last Update Submit

December 31, 2013

Conditions

Smoking

Keywords

oral fluid collection device cotinine detection

Outcome Measures

Primary Outcomes (1)

  • Presence of Nicotine in Collected Oral Fluid Samples

    ELISA assay in comparison with the Mass-spec method will be used to detect the presence of nicotine in the oral fluid samples collected with the VioOne collection device.

    Within one week of sample collection

Study Arms (2)

Smokers

Those who smoke at least one cigarette a day.

Non smokers

Those who have not smoked for at least one week when the sample is collected.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Healthy and adult population

You may qualify if:

  • healthy adults (aged 18 or older)

You may not qualify if:

  • individuals with significant health problems.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Avioq

Research Triangle Park, North Carolina, 27709, United States

RECRUITING

MeSH Terms

Conditions

Smoking

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Krista Reddington, B.S.

    Avioq, Inc.

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 12, 2013

First Posted

January 3, 2014

Study Start

December 1, 2013

Primary Completion

March 1, 2014

Study Completion

April 1, 2014

Last Updated

January 3, 2014

Record last verified: 2013-12

Locations

US(1)