Environmental Tobacco SmokePhase 4NCT04045964

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

A Phase 4 study testing nicotine replacement therapy (NRT), motivational advice and Quitline referral in people with Environmental Tobacco Smoke and Smoking Cessation, run by The University of Texas Health Science Center, Houston at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Any ageHealthy volunteers can take part
Conditions the study is for: Environmental Tobacco Smoke, Smoking Cessation
What is being tested?: nicotine replacement therapy (NRT), motivational advice and Quitline referral
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 32 participants
Where: 1 siteUnited States
Study dates: 29 Oct 2017to 28 Jun 2018
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 Any age
All sexes
Healthy volunteers accepted
Child, Adult, Older adult

Who may be able to join

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

Who cannot join

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

Show all 9Show fewer

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)

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Texas Health Science Center at Houston
Houston, Texas, 77030

Other trials in United States

About this study

Conditions: Environmental Tobacco Smoke, Smoking Cessation
Being tested: nicotine replacement therapy (NRT), motivational advice, Quitline referral
Medical subject headings: Smoking Cessation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

nicotine replacement therapy (NRT)Drug
Also called nicotine patch
Participants were provided with either 2 weeks of 14-mg or 21-mg transdermal nicotine patches for every smoker in the home
motivational adviceBehavioural
Received two in-hospital motivational advice sessions by a research associate (RA). The RA adapted session content from a previous tobacco-smoke exposure protocol
Quitline referralBehavioural
Quitline participants received information about tobacco-smoke exposure reduction and a referral to a tobacco Quitline.

Study groups in NCT04045964
Study group	Role	What they receive
Motivational advice and free NRT	Experimental	Not described Receives: Drug: nicotine replacement therapy (NRT); Behavioral: motivational advice
Quitline referral	Active comparator	Not described Receives: Behavioral: Quitline referral

What is being measured

The primary outcome is the main question the study is designed to answer.

Feasibility as Assessed by Number of Participants Who Accepted NRT Patches From Research Staff.
Measured: From time of randomization to intervention session number 2 (generally completed within 2-3 weeks of randomization)
Efficacy as Assessed by the Number of Participants Who Reported That Anyone in Their Household Used NRT.
Measured: From time of randomization to follow-up visit #2 (generally completed within 2-3 months)

Secondary outcomes (11)

Cigarette Use (Point Prevalence), as Measured by Number of Cigarettes Smoked Per Day by the Participant
Measured: Baseline
Cigarette Use (Point Prevalence), as Measured by Number of Cigarettes Smoked Per Day by the Participant's Partner
Measured: baseline
Cigarette Use (Point Prevalence), as Measured by Number of Cigarettes Smoked Per Day by Other Household Members (Other Than the Participant or Participant's Partner)
Measured: baseline
Smoking Quit Attempts, as Measured by Number of Participants Who Reported One or Greater Quit Attempts
Measured: at the time of follow-up visit #1 (about 2 weeks post-intervention)
Smoking Quit Attempts, as Measured by Number of Participants Who Reported One or Greater Quit Attempts
Measured: at the time of follow-up visit #2 (about 1 month post-intervention)
Smoking Quit Attempts, as Measured by Number of Participant's Partners Who Reported One or Greater Quit Attempts
Measured: at the time of follow-up visit #1 (about 2 weeks post-intervention)
Smoking Quit Attempts, as Measured by Number of Participant's Partners Who Reported One or Greater Quit Attempts
Measured: at the time of follow-up visit #2 (about 1 month post-intervention)
Smoking Quit Attempts, as Measured by Number of Other Household Members (Other Than the Participant or the Participant's Partner) Who Reported One or Greater Quit Attempts
Measured: at the time of follow-up visit #1 (about 2 weeks post-intervention)
Smoking Quit Attempts, as Measured by Number of Other Household Members (Other Than the Participant or the Participant's Partner) Who Reported One or Greater Quit Attempts
Measured: at the time of follow-up visit #2 (about 1 month post-intervention)
Home Smoking Ban Status, as Measured by Number of Participants Who Report a Home-smoking Ban.
Measured: From time of randomization to follow-up visit #2 (generally completed within 2-3 months)
Car Smoking Ban Status, as Measured by Number of Participants Who Report a Car-smoking Ban.
Measured: From time of randomization to follow-up visit #2 (generally completed within 2-3 months)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

29 Oct 201728 Jun 2018

First posted6 Aug 2019
Study start29 Oct 2017
Primary completion28 Jun 2018
Study completion28 Jun 2018

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 Environmental Tobacco SmokeStudies 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: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 32 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04045964
Sponsor's protocol ID: HSC-MS-11-0641(Substudy)
Status last verified: Oct 2019
First submitted: 2 Aug 2019
Last updated: 11 Dec 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Lungs on Fire: Wildfire Smoke, Incident Diseases, Susceptible Populations, and Community Values in Canada
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Not yet recruitingObservational study
Postoperative Residual Neuromuscular Block and Passive Smoke Exposure in Pediatric Dental Patients
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Recruiting
A Study Evaluating the Use of an Indoor Air Quality Monitor to Promote a Smoke-free Home
Smoking, Smoking Cessation
Recruiting
Smoking Cessation Intervention Including Health Navigators to Address Unmet Social Needs of Parents Who Smoke
Smoking Cessation, Tobacco Dependence
RecruitingPhase 4
Modifying Progesterone and Estradiol Levels to Prevent Postpartum Cigarette Smoking Relapse and Reduce Secondhand Smoke Exposure in Infants and Children
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All Environmental Tobacco Smoke trials

Study at a glance

From the registry record, last updated by the sponsor on 11 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Nicotine Patch as an Adjunctive Intervention to Reduce Secondhand Smoke Among NICU Families
ClinicalTrials.gov ID: NCT04045964
Acronym / sponsor ID: HSC-MS-11-0641(Substudy)
Conditions: Environmental Tobacco Smoke, Smoking Cessation
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 32 participants (actual)
Lead sponsor: The University of Texas Health Science Center, HoustonUniversity, hospital or other
Study start: 29 Oct 2017 (actual)
Primary completion: 28 Jun 2018 (actual)
Study completion: 28 Jun 2018 (actual)
First posted: 6 Aug 2019 (actual)
Results: Posted 17 Sep 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Motivational advice and free NRT	Experimental	Drug: nicotine replacement therapy (NRT), Behavioral: motivational advice
Quitline referral	Active comparator	Behavioral: Quitline referral

Who may qualify

Sex: All
Healthy volunteers: Accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (5 listed)

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

Key exclusion criteria (9 listed)

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

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 therapy (NRT)Also: nicotine patchParticipants were provided with either 2 weeks of 14-mg or 21-mg transdermal nicotine patches for every smoker in the home	Drug	Motivational advice and free NRT
motivational adviceReceived two in-hospital motivational advice sessions by a research associate (RA). The RA adapted session content from a previous tobacco-smoke exposure protocol	Behavioural	Motivational advice and free NRT
Quitline referralQuitline participants received information about tobacco-smoke exposure reduction and a referral to a tobacco Quitline.	Behavioural	Quitline referral

Primary outcome

Feasibility as Assessed by Number of Participants Who Accepted NRT Patches From Research Staff.
Time frame: From time of randomization to intervention session number 2 (generally completed within 2-3 weeks of randomization)
Efficacy as Assessed by the Number of Participants Who Reported That Anyone in Their Household Used NRT.
Time frame: From time of randomization to follow-up visit #2 (generally completed within 2-3 months)

11 secondary outcomes

Cigarette Use (Point Prevalence), as Measured by Number of Cigarettes Smoked Per Day by the Participant
Time frame: Baseline
Cigarette Use (Point Prevalence), as Measured by Number of Cigarettes Smoked Per Day by the Participant's Partner
Time frame: baseline
Cigarette Use (Point Prevalence), as Measured by Number of Cigarettes Smoked Per Day by Other Household Members (Other Than the Participant or Participant's Partner)
Time frame: baseline
Smoking Quit Attempts, as Measured by Number of Participants Who Reported One or Greater Quit Attempts
Time frame: at the time of follow-up visit #1 (about 2 weeks post-intervention)
Smoking Quit Attempts, as Measured by Number of Participants Who Reported One or Greater Quit Attempts
Time frame: at the time of follow-up visit #2 (about 1 month post-intervention)
Smoking Quit Attempts, as Measured by Number of Participant's Partners Who Reported One or Greater Quit Attempts
Time frame: at the time of follow-up visit #1 (about 2 weeks post-intervention)
Smoking Quit Attempts, as Measured by Number of Participant's Partners Who Reported One or Greater Quit Attempts
Time frame: at the time of follow-up visit #2 (about 1 month post-intervention)
Smoking Quit Attempts, as Measured by Number of Other Household Members (Other Than the Participant or the Participant's Partner) Who Reported One or Greater Quit Attempts
Time frame: at the time of follow-up visit #1 (about 2 weeks post-intervention)
Smoking Quit Attempts, as Measured by Number of Other Household Members (Other Than the Participant or the Participant's Partner) Who Reported One or Greater Quit Attempts
Time frame: at the time of follow-up visit #2 (about 1 month post-intervention)
Home Smoking Ban Status, as Measured by Number of Participants Who Report a Home-smoking Ban.
Time frame: From time of randomization to follow-up visit #2 (generally completed within 2-3 months)
Car Smoking Ban Status, as Measured by Number of Participants Who Report a Car-smoking Ban.
Time frame: From time of randomization to follow-up visit #2 (generally completed within 2-3 months)

Results and safety

Results posted to the registry on 17 Sep 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Motivational Advice and Free NRT	16	15
Quitline Referral	16	15

Primary outcome: Feasibility as Assessed by Number of Participants Who Accepted NRT Patches From Research Staff.

Time frame: From time of randomization to intervention session number 2 (generally completed within 2-3 weeks of randomization). Count of participants. Unit: Participants

Measure	Motivational Advice and Free NRT n = 16
Value	13

Primary outcome: Efficacy as Assessed by the Number of Participants Who Reported That Anyone in Their Household Used NRT.

Time frame: From time of randomization to follow-up visit #2 (generally completed within 2-3 months). Count of participants. Unit: Participants

Measure	Motivational Advice and Free NRT n = 16	Quitline Referral n = 16
Value	6	2

11 secondary outcomes are reported in the full results.

Adverse events

Time frame: 2-3 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Motivational Advice and Free NRT	0 of 16 (0%)	0 of 16 (0%)	0 of 16
Quitline Referral	0 of 16 (0%)	0 of 16 (0%)	0 of 16

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Environmental Tobacco Smoke

Recruiting
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Not yet recruitingObservational study
Postoperative Residual Neuromuscular Block and Passive Smoke Exposure in Pediatric Dental Patients
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Recruiting
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Recruiting
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RecruitingPhase 4
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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.

Angela L Stotts, PhD principal investigator

The University of Texas Health Science Center, Houston

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 5 inclusion and 9 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 11 Dec 2024. 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 17 Sep 2019). 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?

Feasibility as Assessed by Number of Participants Who Accepted NRT Patches From Research Staff. (time frame: From time of randomization to intervention session number 2 (generally completed within 2-3 weeks of randomization)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04045964.

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 11 Dec 2024.