Promoting Home Smoking Restrictions: Biomarker Feedback to Smoking and Non-Smoking Adults

Smoking Cessation Clinical Trial

Official title:

Promoting Home Smoking Restrictions: Biomarker Feedback to Cohabitating Smoking and Non-Smoking Adults

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01497158
• Other study ID #: 2007NT053
• Status: Completed
• Phase: N/A
• First received: December 20, 2011
• Last updated: August 21, 2014
• Start date: June 2007
• Est. completion date: February 2012

Study information

• Verified date: August 2014
• Source: University of Minnesota - Clinical and Translational Science Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

This study is directed at decreasing home environmental tobacco smoking (ETS) exposure with a novel approach of adoption of home smoking restrictions. This will be done by providing the cohabitating smoker and non-smoker with biomarker feedback documenting exposure to ETS. The intent is to identify an intervention strategy(ies) to reduce ETS exposure.

Description:

This is a two-group interventional trial targeting cohabitating smokers and non-smokers. Participants will be randomized to the control condition or biomarker feedback group.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 122
• Est. completion date: February 2012
• Est. primary completion date: February 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Must be at least 18 years of age

• Cohabitating Non-Smoker (control) and smoker (active)

• Smoker must test > 6ppm on carbon dioxide (CO) test and non-smoker < 6ppm

• General good health

• Written informed consent

• Live within Twin Cities 7 county metropolitan area (Minnesota)

• Plan to live in same home for 6 months and be willing for researchers to come to their home

Exclusion Criteria:

• Individuals that live in a treatment facility or shelter

• Individuals endorsing current domestic violence

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Smoking Cessation
• Tobacco Use Disorder

Intervention

Other:
• Self-help brochure
Self help brochure given at baseline visit.
• Biomarker feedback
Biomarker feedback from urine of adult non-smoker in the home.

Locations

Country	Name	City	State
United States	University of Minnesota	Minneapolis	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
University of Minnesota - Clinical and Translational Science Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comparison of Self-Reported Home Smoking Restrictions - Active Counseling	Received self-help brochure and biomarker feedback from urine collected from non-smoking adult in home. Outcome criteria categorized into 3 areas: establishment of a complete ban (defined as no one allowed to smoke anywhere, ever), some restrictions (smoking allowed in some places or some time), and no restrictions (smoking permitted anywhere, no rules).	From baseline to week 12	No
Primary	Comparison of Self-Reported Home Smoking Restrictions - Control Group	Received only self-help brochure on home ETS exposure. Outcome criteria categorized into 3 areas: establishment of a complete ban (defined as no one allowed to smoke anywhere, ever), some restrictions (smoking allowed in some places or some time), and no restrictions (smoking permitted anywhere, no rules).	From baseline to week 12	No