Treating Caregivers Who Smoke at AFCH

NCT06051474 | Completed Phase 4 Results DMC FDA Drug

• 3 other identifiers: 2023-0727SMPH\PEDIATRICS\PED HOSPProtocol Version 5/23/23
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this research study is to 1) see if a smoking cessation program is something that caregivers will use while their child is hospitalized, 2) see if caregivers think this program is something we should institute across the hospital, and 3) see if this program can help caregivers reduce their smoking. Participants will:

• Complete a survey regarding smoking behavior and thoughts about quitting;
• Undergo a 20-minute counseling session; and,
• Use nicotine patches and mini-lozenges for 2 weeks

Conditions

Smoking; Smoking Cessation

Outcome Measures

Primary Outcomes (3)

• Enrollment in Study

  Enrollment will be measured as a relation between the number of people invited to enroll versus the number who enroll

  Study recruitment, approximately 6 months

• NRT Use

  Number of participants who use the NRT provided

  2 weeks post-discharge, up to 4 weeks

• Acceptability of Smoking Intervention

  Self-report by participant via survey. Score ranges from 1-7, with 1 indicating would not recommend implementing cessation program and 7 indicating definitely recommend implementing program.

  2 weeks post-discharge, up to 4 weeks

Secondary Outcomes (4)

• Change in Number of Cigarettes Smoked Per Day

  Baseline to 2 weeks post-discharge, up to 4 weeks

• Change in Trips Outside

  From admission to discharge, up to 4 weeks

• Change in Self-confidence in Quitting Smoking

  Baseline to 2 weeks post-discharge, up to 4 weeks

• Change in Motivation to Quit Smoking

  Baseline to 2 weeks post-discharge, up to 4 weeks

Study Arms (1)

Caregivers of hospitalized children

EXPERIMENTAL

Drug: Nicotine Replacement Product

Interventions

Nicotine Replacement Product DRUG

Adults will receive a 2-week supply of nicotine patches to place on skin (14mg or 21mg; dosing depending on tobacco use per package insert) and oral nicotine mini-lozenges (2mg, 4mg, dosing depending on tobacco use per package insert). All participants will also receive a single smoking cessation counseling session with a physician. Surveys will be completed pre-intervention, within 24 hours of hospital discharge, and 2-weeks after hospital discharge.

Caregivers of hospitalized children

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Hospitalized child will have a 'yes' response to the screening question, "Does anyone in your household smoke"
• Hospitalized child is expected to be admitted for \>24 hours
• Caregiver is at least 18 years of age
• Participant self-identifies as the primary caregiver of the hospitalized child during the hospitalization
• Participant smokes ≥5 cigarettes per day
• Participant is willing and able to use NRT
• Participant is not currently pregnant, trying to get pregnant, or breastfeeding and willing to use acceptable birth control for duration of medication use
• Participant is willing to comply with all study procedures and be available for the duration of the study

You may not qualify if:

• Contraindication to NRT use (pregnancy, myocardial infarction in past 2 weeks)
• Previous reaction to the nicotine patch or mini-lozenge that prevented them from continuing to use it
• Current use of smoking cessation medications (any NRT, bupropion, varenicline)
• Caregiver's child is being cared for by study physician (Dr. Brian Williams)
• Need for an interpreter

Sponsors & Collaborators

• University of Wisconsin, Madison: lead

Study Sites (1)

American Family Children's Hospital

Madison, Wisconsin, 53792, United States

Location

MeSH Terms

Conditions

Smoking; Smoking Cessation

Interventions

Tobacco Use Cessation Devices

Condition Hierarchy (Ancestors)

Behavior; Health Behavior

Intervention Hierarchy (Ancestors)

Therapeutics

Results Point of Contact

• Title: Brian Williams
• Organization: University of Wisconsin - Madison

bswillia@medicine.wisc.edu

608-262-9364

Study Officials

• Brian Williams, MD

  University of Wisconsin, Madison

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 12, 2023
• First Posted: September 25, 2023
• Study Start: March 5, 2024
• Primary Completion: April 18, 2025
• Study Completion: April 18, 2025
• Last Updated: April 16, 2026
• Results First Posted: April 16, 2026

Record last verified: 2026-03

Locations

US (1)