Clinical trial NCT04045964: Nicotine Patch as an Adjunctive Intervention to Reduce Secondhand Smoke Among NICU Families
Official title: Nicotine Patch as an Adjunctive Intervention to Reduce Secondhand Smoke Among NICU Families
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Environmental Tobacco Smoke
Smoking Cessation
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
First posted: 2019-08-06
Enrollment: 32
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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)

Primary outcomes:
measure: Feasibility as Assessed by Number of Participants Who Accepted NRT Patches From Research Staff.
timeFrame: From time of randomization to intervention session number 2 (generally completed within 2-3 weeks of randomization)
measure: Efficacy as Assessed by the Number of Participants Who Reported That Anyone in Their Household Used NRT.
timeFrame: From time of randomization to follow-up visit #2 (generally completed within 2-3 months)
Secondary outcomes:
measure: Cigarette Use (Point Prevalence), as Measured by Number of Cigarettes Smoked Per Day by the Participant
timeFrame: Baseline
measure: Cigarette Use (Point Prevalence), as Measured by Number of Cigarettes Smoked Per Day by the Participant's Partner
timeFrame: baseline
measure: 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)
timeFrame: baseline
measure: Smoking Quit Attempts, as Measured by Number of Participants Who Reported One or Greater Quit Attempts
timeFrame: at the time of follow-up visit #1 (about 2 weeks post-intervention)
measure: Smoking Quit Attempts, as Measured by Number of Participants Who Reported One or Greater Quit Attempts
timeFrame: at the time of follow-up visit #2 (about 1 month post-intervention)
measure: Smoking Quit Attempts, as Measured by Number of Participant's Partners Who Reported One or Greater Quit Attempts
timeFrame: at the time of follow-up visit #1 (about 2 weeks post-intervention)
measure: Smoking Quit Attempts, as Measured by Number of Participant's Partners Who Reported One or Greater Quit Attempts
timeFrame: at the time of follow-up visit #2 (about 1 month post-intervention)
measure: 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
timeFrame: at the time of follow-up visit #1 (about 2 weeks post-intervention)
measure: 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
timeFrame: at the time of follow-up visit #2 (about 1 month post-intervention)
measure: Home Smoking Ban Status, as Measured by Number of Participants Who Report a Home-smoking Ban.
timeFrame: From time of randomization to follow-up visit #2 (generally completed within 2-3 months)
measure: Car Smoking Ban Status, as Measured by Number of Participants Who Report a Car-smoking Ban.
timeFrame: From time of randomization to follow-up visit #2 (generally completed within 2-3 months)
Other outcomes:
Locations:
city: Houston
country: United States
facility: University of Texas Health Science Center at Houston
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center, Houston
name: Angela L Stotts, PhD
role: PRINCIPAL_INVESTIGATOR
References: