NCT02206971

Brief Summary

The purpose of this study is to examine the impact of providing light smokers with feedback about their health, including exposure to tobacco-related chemicals.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
109

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2012

Typical duration 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

Study Start

First participant enrolled

May 1, 2012

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

July 30, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 1, 2014

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

January 10, 2020

Status Verified

January 1, 2020

Enrollment Period

2.6 years

First QC Date

July 30, 2014

Last Update Submit

January 7, 2020

Conditions

Cigarette Smoking

Outcome Measures

Primary Outcomes (1)

  • urinary cotinine level

    changes to biomarker levels with smoking reduction or cessation

    week 0, week 8, week 26

Study Arms (2)

Feedback Group

ACTIVE COMPARATOR

receive a Smoking Cessation Manual, the opportunity for smoking cessation counseling on the phone, and urine analyses feedback via the mail plus a phone call to discuss the information

Other: urine analyses feedback

Standard Care

NO INTERVENTION

receive a Smoking Cessation Manual and the opportunity for smoking cessation counseling on the phone

Interventions

urine analyses feedbackOTHER

biomarker feedback report regarding the urine sample analyzed for the tobacco chemicals, cotinine, nicotine and NNAL

Feedback Group

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male or female cigarette smokers, 18-75 years
  • Smoked an average of less than 10 cigarettes per day during past month
  • A personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study.

You may not qualify if:

  • Only one subject per household may participate
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Minnesota

Minneapolis, Minnesota, 55414, United States

Location

MeSH Terms

Conditions

Cigarette Smoking

Condition Hierarchy (Ancestors)

Tobacco SmokingSmokingBehaviorTobacco Use

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 30, 2014

First Posted

August 1, 2014

Study Start

May 1, 2012

Primary Completion

December 1, 2014

Study Completion

December 1, 2014

Last Updated

January 10, 2020

Record last verified: 2020-01

Locations

US(1)