Phase 4
Completed N=32
Nicotine Patch as an Adjunctive Intervention to Reduce Secondhand Smoke Among NICU Families
Environmental Tobacco Smoke · Smoking Cessation
Source: ClinicalTrials.gov NCT04045964 ↗
Enrolled (actual)
32
Serious AEs
0.0%
Results posted
Sep 2019
Primary outcomePrimary: Feasibility as Assessed by Number of Participants Who Accepted NRT Patches From Research Staff. — 13 Participants
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Feasibility as Assessed by Number of Participants Who Accepted NRT Patches From Research Staff. |
13 | — |
| PRIMARY Efficacy as Assessed by the Number of Participants Who Reported That Anyone in Their Household Used NRT. |
6; 2 | — |
| SECONDARY Cigarette Use (Point Prevalence), as Measured by Number of Cigarettes Smoked Per Day by the Participant |
2; 2; 0; 1 | — |
| SECONDARY Cigarette Use (Point Prevalence), as Measured by Number of Cigarettes Smoked Per Day by the Participant's Partner |
6; 7; 6; 5 | — |
| SECONDARY 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) |
5; 3; 2; 3 | — |
| SECONDARY Smoking Quit Attempts, as Measured by Number of Participants Who Reported One or Greater Quit Attempts |
1; 4 | — |
| SECONDARY Smoking Quit Attempts, as Measured by Number of Participant's Partners Who Reported One or Greater Quit Attempts |
2; 1 | — |
| SECONDARY 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 |
0; 0 | — |
| SECONDARY Home Smoking Ban Status, as Measured by Number of Participants Who Report a Home-smoking Ban. |
14; 14 | — |
| SECONDARY Car Smoking Ban Status, as Measured by Number of Participants Who Report a Car-smoking Ban. |
14; 14 | — |
Eligibility 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)
Data sourced from ClinicalTrials.gov (NCT04045964). 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. Informational only — not medical advice.