Nicotine Patch as an Adjunctive Intervention to Reduce Secondhand Smoke Among NICU Families

The University of Texas Health Science Center, Houston1 site in 1 country32 target enrollmentOctober 29, 2017

ConditionsEnvironmental Tobacco Smoke Smoking Cessation

Interventionsnicotine replacement therapy (NRT)motivational advice Quitline referral

Drugsnicotine replacement therapy (NRT)

Overview

Phase: Phase 4
Intervention: nicotine replacement therapy (NRT)
Conditions: Environmental Tobacco Smoke
Sponsor: The University of Texas Health Science Center, Houston
Enrollment: 32
Locations: 1
Primary Endpoint: Feasibility as Assessed by Number of Participants Who Accepted NRT Patches From Research Staff.
Status: Completed
Last Updated: last year

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this study was to explore the potential for directly targeting smoking cessation, regardless of motivation level, in a subsample of neonatal intensive care unit (NICU) parents with the ultimate goal of reducing secondhand smoke (SHS) in their homes.

Registry

clinicaltrials.gov

Start Date

October 29, 2017

End Date

June 28, 2018

Last Updated

last year

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

The University of Texas Health Science Center, Houston

Responsible Party

Principal Investigator

Angela L Stotts

Professor and Vice Chair for Research (Department of Family & Community Medicine)

The University of Texas Health Science Center, Houston

Eligibility Criteria

Inclusion Criteria

•Eligible mothers of any age or ethnic background must have an infant that is at least 1 week prior to the estimated date of hospital discharge in the NICU (ensuring time for the intervention)
•report that a household resident smokes at least 5 cigarettes per day, on average, within the 2 months preceding the screening visit
•agree to attend intervention sessions
•live within 50 miles of our center
•and have access to a telephone

Exclusion Criteria

•Mothers were ineligible if they met criteria for severe cognitive, and/or psychiatric impairment, per judgment of NICU and research staff, that precludes cooperation with study protocol
•were unable to read, write, and speak English
•were unable or unwilling to provide signed consent for participation
•and were unable or unwilling to meet study requirements for data collection and intervention purposes.
•Within the month immediately preceding the screening visit, use of any form of tobacco or nicotine products other than cigarettes (e.g., e-cigarettes, chewing tobacco, etc.) on 3 or more days within a week if the individual refuses to refrain from such tobacco use during the course of the study
•Current use of NRT or enrollment (or plans to enroll) in another smoking cessation program in the next 3 months
•Uncontrolled hypertension (systolic blood pressure \[SBP\] greater than 180 or diastolic blood pressure \[DBP\] greater than 110)
•History of severe cardiovascular (stroke, heart attack), kidney (e.g. chronic or acute kidney failure) or liver disease, or other unstable disease in the last 3 months
•History of hypersensitivity or allergic reaction to NRT or similar chemical classes or any component of these formulations (including allergy to latex)

Arms & Interventions

Motivational advice and free NRT

Intervention: nicotine replacement therapy (NRT)

Motivational advice and free NRT

Intervention: motivational advice

Quitline referral

Intervention: Quitline referral

Outcomes

Primary Outcomes

Feasibility as Assessed by Number of Participants Who Accepted NRT Patches From Research Staff.

Time Frame: From time of randomization to intervention session number 2 (generally completed within 2-3 weeks of randomization)

Efficacy as Assessed by the Number of Participants Who Reported That Anyone in Their Household Used NRT.

Time Frame: From time of randomization to follow-up visit #2 (generally completed within 2-3 months)

Secondary Outcomes

Car Smoking Ban Status, as Measured by Number of Participants Who Report a Car-smoking Ban.(From time of randomization to follow-up visit #2 (generally completed within 2-3 months))
Cigarette Use (Point Prevalence), as Measured by Number of Cigarettes Smoked Per Day by Other Household Members (Other Than the Participant or Participant's Partner)(baseline)
Home Smoking Ban Status, as Measured by Number of Participants Who Report a Home-smoking Ban.(From time of randomization to follow-up visit #2 (generally completed within 2-3 months))
Cigarette Use (Point Prevalence), as Measured by Number of Cigarettes Smoked Per Day by the Participant's Partner(baseline)
Smoking Quit Attempts, as Measured by Number of Participants Who Reported One or Greater Quit Attempts(at the time of follow-up visit #2 (about 1 month post-intervention))
Cigarette Use (Point Prevalence), as Measured by Number of Cigarettes Smoked Per Day by the Participant(Baseline)
Smoking Quit Attempts, as Measured by Number of Participant's Partners Who Reported One or Greater Quit Attempts(at the time of follow-up visit #2 (about 1 month post-intervention))
Smoking Quit Attempts, as Measured by Number of Other Household Members (Other Than the Participant or the Participant's Partner) Who Reported One or Greater Quit Attempts(at the time of follow-up visit #2 (about 1 month post-intervention))