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

December 9, 2024 updated by: Angela L Stotts, The University of Texas Health Science Center, Houston
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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
32

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
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)
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)
From time of randomization to follow-up visit #2 (generally completed within 2-3 months)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Cigarette Use (Point Prevalence), as Measured by Number of Cigarettes Smoked Per Day by the Participant
Time Frame: Baseline
Baseline
Cigarette Use (Point Prevalence), as Measured by Number of Cigarettes Smoked Per Day by the Participant's Partner
Time Frame: baseline
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)
Time Frame: baseline
baseline
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)
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
Time Frame: at the time of follow-up visit #2 (about 1 month post-intervention)
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
Time Frame: at the time of follow-up visit #1 (about 2 weeks post-intervention)
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
Time Frame: at the time of follow-up visit #2 (about 1 month post-intervention)
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
Time Frame: at the time of follow-up visit #1 (about 2 weeks post-intervention)
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
Time Frame: at the time of follow-up visit #2 (about 1 month post-intervention)
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.
Time Frame: From time of randomization to follow-up visit #2 (generally completed within 2-3 months)
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.
Time Frame: From time of randomization to follow-up visit #2 (generally completed within 2-3 months)
From time of randomization to follow-up visit #2 (generally completed within 2-3 months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
The University of Texas Health Science Center, Houston

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Angela L Stotts, PhD, The University of Texas Health Science Center, Houston

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 29, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 28, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 28, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 2, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 2, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 6, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 11, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 9, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

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Locations

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