Status:
COMPLETED
Nicotine Patch as an Adjunctive Intervention to Reduce Secondhand Smoke Among NICU Families
Lead Sponsor:
The University of Texas Health Science Center, Houston
Conditions:
Environmental Tobacco Smoke
Smoking Cessation
Eligibility:
All Genders
Phase:
PHASE4
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 ...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
October 29 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 28 2018
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT04045964
Start Date
October 29 2017
End Date
June 28 2018
Last Update
December 11 2024
Active Locations (1)
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1
University of Texas Health Science Center at Houston
Houston, Texas, United States, 77030