SmokingPhase 4NCT06051474
Treating Caregivers Who Smoke at AFCH
A Phase 4 study testing Nicotine Replacement Product in people with Smoking and Smoking Cessation, run by University of Wisconsin, Madison at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Smoking, Smoking Cessation
- What is being tested?
- Nicotine Replacement Product
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Mar 2024to 18 Apr 2025
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
American Family Children's Hospital
Madison, Wisconsin, 53792
About this study
Official title: Treating Nicotine Addiction in Caregivers of Children at American Family Children's Hospital
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
Read the detailed description
All participants will receive a one-time visit with the study physician. This visit will consist of a brief counseling session. Counseling sessions will last approximately 20 minutes and cover the 3 objectives of 1) review participants' motivation for smoking and for quitting; 2) use the information on participants' motives to provide tailored education regarding a) benefits of quitting smoking to the caregiver and the child, b) strategies to reduce nicotine withdrawal symptoms/urges to smoke during the hospitalization, and c) benefits of smoke-free home and car rules; and, 3) review smoking cessation resources.
After the counseling session, participants will be provided a 2-week supply of nicotine patches and nicotine mini-lozenges, along with instructions for their use. The study physician will review how to use the medication, dosing, benefits of use, and potential side effects of use.
Within 24 hours of discharge, participants will be contacted to complete a post-intervention survey, which will assess nicotine replacement therapy (NRT) use during the hospitalization and likelihood that the participant would recommend program implementation in the hospital. Smoking behavior during the child's hospitalization will be examined, including assessments of 1) number of cigarettes smoked per day and 2) number of times participant left the child's bedside to smoke per day. Participant's self-efficacy and interest in quitting smoking will be assessed, using the same questions from the pre-intervention survey, to assess for changes after the intervention.
Participants will be contacted 2 weeks after discharge with a link to complete the follow-up survey to again assess current smoking status, use of NRT post-hospitalization, self-efficacy and interest in quitting smoking, establishment of smoke-free home and car rules, and interest in ongoing smoking cessation treatment.
- Conditions
- Smoking, Smoking Cessation
- Being tested
- Nicotine Replacement Product
- Medical subject headings
- Smoking, Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nicotine Replacement ProductDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Caregivers of hospitalized children | Experimental | Not described Receives: Drug: Nicotine Replacement Product |
What is being measured
The primary outcome is the main question the study is designed to answer.
Enrollment in Study
Enrollment will be measured as a relation between the number of people invited to enroll versus the number who enroll
Measured: Study recruitment, approximately 6 months
NRT Use
Number of participants who use the NRT provided
Measured: 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.
Measured: 2 weeks post-discharge, up to 4 weeks
Secondary outcomes (4)
Change in Number of Cigarettes Smoked Per Day
Self-report by participants via survey
Measured: Baseline to 2 weeks post-discharge, up to 4 weeks
Change in Trips Outside
Self-report by participant via survey
Measured: From admission to discharge, up to 4 weeks
Change in Self-confidence in Quitting Smoking
Self-report by participant via survey. Score ranges from 1-7, with 1 indicating no confidence in ability to quit smoking and 7 indicating extreme confidence.
Measured: Baseline to 2 weeks post-discharge, up to 4 weeks
Change in Motivation to Quit Smoking
Self-report by participant via survey. Score ranges from 1-7, with 1 indicating no motivation to quit smoking and 7 indicating extreme motivation.
Measured: Baseline to 2 weeks post-discharge, up to 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2023
- Study start5 Mar 2024
- Primary completion18 Apr 2025
- Study completion18 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for SmokingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Brian Williams, MD, Principal investigator, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06051474
- Sponsor's protocol ID
- 2023-0727
- Other IDs
- SMPH\PEDIATRICS\PED HOSP, Protocol Version 5/23/23
- Status last verified
- Mar 2026
- First submitted
- 12 Sep 2023
- Last updated
- 16 Apr 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treating Nicotine Addiction in Caregivers of Children at American Family Children's Hospital
- ClinicalTrials.gov ID
- NCT06051474
- Acronym / sponsor ID
- 2023-0727
- Conditions
- Smoking, Smoking Cessation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Study start
- 5 Mar 2024 (actual)
- Primary completion
- 18 Apr 2025 (actual)
- Study completion
- 18 Apr 2025 (actual)
- First posted
- 25 Sep 2023 (actual)
- Results
- Posted 16 Apr 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
All participants will receive a one-time visit with the study physician. This visit will consist of a brief counseling session. Counseling sessions will last approximately 20 minutes and cover the 3 objectives of 1) review participants' motivation for smoking and for quitting; 2) use the information on participants' motives to provide tailored education regarding a) benefits of quitting smoking to the caregiver and the child, b) strategies to reduce nicotine withdrawal symptoms/urges to smoke during the hospitalization, and c) benefits of smoke-free home and car rules; and, 3) review smoking cessation resources.
After the counseling session, participants will be provided a 2-week supply of nicotine patches and nicotine mini-lozenges, along with instructions for their use. The study physician will review how to use the medication, dosing, benefits of use, and potential side effects of use.
Within 24 hours of discharge, participants will be contacted to complete a post-intervention survey, which will assess nicotine replacement therapy (NRT) use during the hospitalization and likelihood that the participant would recommend program implementation in the hospital. Smoking behavior during the child's hospitalization will be examined, including assessments of 1) number of cigarettes smoked per day and 2) number of times participant left the child's bedside to smoke per day. Participant's self-efficacy and interest in quitting smoking will be assessed, using the same questions from the pre-intervention survey, to assess for changes after the intervention.
Participants will be contacted 2 weeks after discharge with a link to complete the follow-up survey to again assess current smoking status, use of NRT post-hospitalization, self-efficacy and interest in quitting smoking, establishment of smoke-free home and car rules, and interest in ongoing smoking cessation treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Caregivers of hospitalized children | Experimental | Drug: Nicotine Replacement Product |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nicotine Replacement ProductAdults 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. | Drug | Caregivers of hospitalized children |
Primary outcome
Enrollment in Study
Time frame: Study recruitment, approximately 6 months
Enrollment will be measured as a relation between the number of people invited to enroll versus the number who enroll
NRT Use
Time frame: 2 weeks post-discharge, up to 4 weeks
Number of participants who use the NRT provided
Acceptability of Smoking Intervention
Time frame: 2 weeks post-discharge, up to 4 weeks
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.
4 secondary outcomes
Change in Number of Cigarettes Smoked Per Day
Time frame: Baseline to 2 weeks post-discharge, up to 4 weeks
Change in Trips Outside
Time frame: From admission to discharge, up to 4 weeks
Change in Self-confidence in Quitting Smoking
Time frame: Baseline to 2 weeks post-discharge, up to 4 weeks
Change in Motivation to Quit Smoking
Time frame: Baseline to 2 weeks post-discharge, up to 4 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Smoking
Not yet recruiting
The Effects of Manual Acupuncture on Superoxide Dismutase Enzyme Activity and Questionnaire of Smoking Urges-Brief Scores in Active Smokers: A Randomized Controlled Trial
Superoxide Dismutase, Acupuncture
Recruiting
Smoking Cessation in Patients With Cancer
Cancer, Tobacco Use
RecruitingPhase 1
Nicotinic Receptor Genetic Variation and Alcohol Reward
Alcohol Drinking
Enrolling by invitationObservational study
Using Smartwatches to Monitor Smoking in Real-life Situations
Smoking
Not yet recruiting
Effectiveness Of Project EX: A Classroom-Based Smoking Prevention And Cessation Intervention Program
Focus of the Study is Smoking Cessation and Prevention, Smoking Prevention
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Brian Williams, MD principal investigator
University of Wisconsin, Madison
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Nicotine Replacement Product in people with Smoking and Smoking Cessation, run by University of Wisconsin, Madison at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 Apr 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Enrollment in Study (time frame: Study recruitment, approximately 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2026.