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

Phase 4

Completed

Interventions: Drug: nicotine replacement therapy (NRT)
Behavioral: Quitline referral
Behavioral: motivational advice

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.

Recruitment & Eligibility

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)

Arm && Interventions

Group	Intervention	Description
Motivational advice and free NRT	nicotine replacement therapy (NRT)	-
Quitline referral	Quitline referral	-
Motivational advice and free NRT	motivational advice	-

Primary Outcome Measures

Name	Time	Method
Feasibility as Assessed by Number of Participants Who Accepted NRT Patches From Research Staff.	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.	From time of randomization to follow-up visit #2 (generally completed within 2-3 months)

Secondary Outcome Measures

Name	Time	Method
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)