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

NCT04045964 | Completed Phase 4 Results FDA Drug

• 1 other identifier: HSC-MS-11-0641(Substudy)
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Environmental Tobacco Smoke; Smoking Cessation

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (11)

• 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)

Study Arms (2)

Motivational advice and free NRT

EXPERIMENTAL

Drug: nicotine replacement therapy (NRT); Behavioral: motivational advice

Quitline referral

ACTIVE COMPARATOR

Behavioral: Quitline referral

Interventions

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

Also known as: nicotine patch

Motivational advice and free NRT

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

Motivational advice and free NRT

Quitline referral BEHAVIORAL

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

Quitline referral

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• The University of Texas Health Science Center, Houston: lead

Study Sites (1)

University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Smoking Cessation

Interventions

Nicotine Replacement Therapy; Tobacco Use Cessation Devices

Condition Hierarchy (Ancestors)

Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Drug Therapy; Therapeutics

Results Point of Contact

• Title: Angela Stotts, PhD
• Organization: The University of Texas Health Science Center at Houston

Angela.L.Stotts@uth.tmc.edu

(713) 500-7590

Study Officials

• Angela L Stotts, PhD

  The University of Texas Health Science Center, Houston

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Vice Chair for Research (Department of Family & Community Medicine)

Study Record Dates

• First Submitted: August 2, 2019
• First Posted: August 6, 2019
• Study Start: October 29, 2017
• Primary Completion: June 28, 2018
• Study Completion: June 28, 2018
• Last Updated: December 11, 2024
• Results First Posted: September 17, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)