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Completed

NCT Number: NCT04045964

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.

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Key information

Conditions

Environmental Tobacco Smoke Behavior Health Behavior Smoking Cessation

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Nicotine replacement therapy (NRT)

Drug

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

motivational advice

Behavioral

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 referral

Behavioral

Quitline participants received information about tobacco-smoke exposure reduction and a referral to a tobacco Quitline.

Primary outcomes

  1. 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)

  2. 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

  1. Cigarette Use (Point Prevalence), as Measured by Number of Cigarettes Smoked Per Day by the Participant

    Time frame: Baseline

  2. Cigarette Use (Point Prevalence), as Measured by Number of Cigarettes Smoked Per Day by the Participant's Partner

    Time frame: baseline

  3. 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)

    Time frame: baseline

  4. Smoking Quit Attempts, as Measured by Number of Participants Who Reported One or Greater Quit Attempts

    Time frame: at the time of follow-up visit #1 (about 2 weeks post-intervention)

  5. Smoking Quit Attempts, as Measured by Number of Participants Who Reported One or Greater Quit Attempts

    Time frame: at the time of follow-up visit #2 (about 1 month post-intervention)

  6. Smoking Quit Attempts, as Measured by Number of Participant's Partners Who Reported One or Greater Quit Attempts

    Time frame: at the time of follow-up visit #1 (about 2 weeks post-intervention)

  7. Smoking Quit Attempts, as Measured by Number of Participant's Partners Who Reported One or Greater Quit Attempts

    Time frame: at the time of follow-up visit #2 (about 1 month post-intervention)

  8. 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

    Time frame: at the time of follow-up visit #1 (about 2 weeks post-intervention)

  9. 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

    Time frame: at the time of follow-up visit #2 (about 1 month post-intervention)

  10. Home Smoking Ban Status, as Measured by Number of Participants Who Report a Home-smoking Ban.

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

  11. Car Smoking Ban Status, as Measured by Number of Participants Who Report a Car-smoking Ban.

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

Sponsors and collaborators

Lead sponsor

The University of Texas Health Science Center, Houston

Other

Registry information

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Aug 6, 2019
Registry last updated
Dec 11, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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