Phase 4
N=23
Treating Caregivers Who Smoke at AFCH
Smoking · Smoking Cessation
Bottom Line
View on ClinicalTrials.gov: NCT06051474 ↗Enrolled (actual)
23
Serious AEs
0.0%
Results posted
Apr 2026
Primary outcome: Primary: Enrollment in Study — 36.5 percentage of people invited who enrolle
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Nicotine Replacement Product (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Wisconsin, Madison
- Primary completion
- Apr 2025
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Enrollment in Study |
36.5 | — |
| PRIMARY NRT Use |
11 | — |
| PRIMARY Acceptability of Smoking Intervention |
6.77 | — |
| SECONDARY Change in Number of Cigarettes Smoked Per Day |
-6.31 | — |
| SECONDARY Change in Trips Outside |
-0.5 | — |
| SECONDARY Change in Self-confidence in Quitting Smoking |
0.64 | — |
| SECONDARY Change in Motivation to Quit Smoking |
0.93 | — |
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
Eligibility Criteria
Inclusion Criteria
- 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
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT06051474). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.