Nicotine Patch as an Adjunctive Intervention to Reduce Secondhand Smoke Among NICU Families
Condition: Environmental Tobacco Smoke; Smoking Cessation
Intervention: nicotine replacement therapy (NRT); motivational advice; Quitline referral
Intervention description: Participants were provided with either 2 weeks of 14-mg or 21-mg transdermal nicotine patches for every smoker in the home; Received two in-hospital motivational advice sessions by a research associate (RA). The RA adapted session content from a previous tobacco-smoke exposure protocol; Quitline participants received information about tobacco-smoke exposure reduction and a referral to a tobacco Quitline.
Intervention MeSH terms: Nicotine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 32.0
Sex: All
Healthy volunteers: Accepts Healthy Volunteers

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.
    

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)