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

The University of Texas System (UT)

Status and phase

Completed

Phase 4

Conditions

Smoking Cessation

Environmental Tobacco Smoke

Treatments

Behavioral: Quitline referral

Behavioral: motivational advice

Drug: nicotine replacement therapy (NRT)

Study type

Interventional

Funder types

Other

Identifiers

NCT04045964

HSC-MS-11-0641(Substudy)

Details and patient eligibility

About

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.

Enrollment

32 patients

Sex

All

Volunteers

Accepts Healthy Volunteers

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)