Smoking Cessation Clinical Trial
Official title:
Nicotine Patch as an Adjunctive Intervention to Reduce Secondhand Smoke Among NICU Families
Verified date | October 2019 |
Source | The University of Texas Health Science Center, Houston |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 32 |
Est. completion date | June 28, 2018 |
Est. primary completion date | June 28, 2018 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | N/A and older |
Eligibility |
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) |
Country | Name | City | State |
---|---|---|---|
United States | University of Texas Health Science Center at Houston | Houston | Texas |
Lead Sponsor | Collaborator |
---|---|
The University of Texas Health Science Center, Houston |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Feasibility as Assessed by Number of Participants Who Accepted NRT Patches From Research Staff. | From time of randomization to intervention session number 2 (generally completed within 2-3 weeks of randomization) | ||
Primary | Efficacy as Assessed by the Number of Participants Who Reported That Anyone in Their Household Used NRT. | From time of randomization to follow-up visit #2 (generally completed within 2-3 months) | ||
Secondary | Cigarette Use (Point Prevalence), as Measured by Number of Cigarettes Smoked Per Day by the Participant | Baseline | ||
Secondary | Cigarette Use (Point Prevalence), as Measured by Number of Cigarettes Smoked Per Day by the Participant's Partner | baseline | ||
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) | baseline | ||
Secondary | Smoking Quit Attempts, as Measured by Number of Participants Who Reported One or Greater Quit Attempts | at the time of follow-up visit #1 (about 2 weeks post-intervention) | ||
Secondary | Smoking Quit Attempts, as Measured by Number of Participants Who Reported One or Greater Quit Attempts | at the time of follow-up visit #2 (about 1 month post-intervention) | ||
Secondary | Smoking Quit Attempts, as Measured by Number of Participant's Partners Who Reported One or Greater Quit Attempts | at the time of follow-up visit #1 (about 2 weeks post-intervention) | ||
Secondary | Smoking Quit Attempts, as Measured by Number of Participant's Partners Who Reported One or Greater Quit Attempts | at the time of follow-up visit #2 (about 1 month post-intervention) | ||
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 | at the time of follow-up visit #1 (about 2 weeks post-intervention) | ||
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 | at the time of follow-up visit #2 (about 1 month post-intervention) | ||
Secondary | Home Smoking Ban Status, as Measured by Number of Participants Who Report a Home-smoking Ban. | From time of randomization to follow-up visit #2 (generally completed within 2-3 months) | ||
Secondary | Car Smoking Ban Status, as Measured by Number of Participants Who Report a Car-smoking Ban. | From time of randomization to follow-up visit #2 (generally completed within 2-3 months) |
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