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

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.

Study Overview

• Status: Completed
• Conditions: Smoking Cessation; Environmental Tobacco Smoke
• Intervention / Treatment: Drug: nicotine replacement therapy (NRT); Behavioral: motivational advice; Behavioral: Quitline referral

• Study Type: Interventional
• Enrollment (Actual): 32
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • University of Texas Health Science Center at Houston

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Motivational advice and free NRT	Drug: nicotine replacement therapy (NRT); Participants were provided with either 2 weeks of 14-mg or 21-mg transdermal nicotine patches for every smoker in the home; Other Names: nicotine patch; Behavioral: motivational advice; Received two in-hospital motivational advice sessions by a research associate (RA). The RA adapted session content from a previous tobacco-smoke exposure protocol
Active Comparator: Quitline referral	Behavioral: Quitline referral; Quitline participants received information about tobacco-smoke exposure reduction and a referral to a tobacco Quitline.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
Cigarette Use (Point Prevalence), as Measured by Number of Cigarettes Smoked Per Day by the Participant	Baseline
Cigarette Use (Point Prevalence), as Measured by Number of Cigarettes Smoked Per Day by the Participant's Partner	baseline
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
Smoking Quit Attempts, as Measured by Number of Participants Who Reported One or Greater Quit Attempts	at the time of follow-up visit #1 (about 2 weeks post-intervention)
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)
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 #1 (about 2 weeks post-intervention)
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 #1 (about 2 weeks 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)
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)
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)

Collaborators and Investigators

• Sponsor: The University of Texas Health Science Center, Houston
• Investigators: Principal Investigator: Angela L Stotts, PhD, The University of Texas Health Science Center, Houston

Study record dates

Study Major Dates

• Study Start (Actual): October 29, 2017
• Primary Completion (Actual): June 28, 2018
• Study Completion (Actual): June 28, 2018

Study Registration Dates

• First Submitted: August 2, 2019
• First Submitted That Met QC Criteria: August 2, 2019
• First Posted (Actual): August 6, 2019

Study Record Updates

• Last Update Posted (Actual): December 11, 2024
• Last Update Submitted That Met QC Criteria: December 9, 2024
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Neurotransmitter Agents; Cholinergic Agents; Ganglionic Stimulants; Nicotinic Agonists; Cholinergic Agonists; Nicotine
• Other Study ID Numbers: HSC-MS-11-0641(Substudy)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No