Overview

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

Status:
Completed
Trial end date:
2018-06-28
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 4
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
The University of Texas Health Science Center, Houston
Treatments:
Nicotine
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)