Nicotine Patch as an Adjunctive Intervention to Reduce Secondhand Smoke Among NICU Families
NCT ID: NCT04045964
Last Updated: 2024-12-11
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
PHASE4
32 participants
INTERVENTIONAL
2017-10-29
2018-06-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Motivational advice and free NRT
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
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
Quitline referral
Quitline referral
Quitline participants received information about tobacco-smoke exposure reduction and a referral to a tobacco Quitline.
Interventions
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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
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
Quitline referral
Quitline participants received information about tobacco-smoke exposure reduction and a referral to a tobacco Quitline.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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)
ALL
Yes
Sponsors
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The University of Texas Health Science Center, Houston
OTHER
Responsible Party
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Angela L Stotts
Professor and Vice Chair for Research (Department of Family & Community Medicine)
Principal Investigators
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Angela L Stotts, PhD
Role: PRINCIPAL_INVESTIGATOR
The University of Texas Health Science Center, Houston
Locations
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University of Texas Health Science Center at Houston
Houston, Texas, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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HSC-MS-11-0641(Substudy)
Identifier Type: -
Identifier Source: org_study_id