Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04045964
Other study ID # HSC-MS-11-0641(Substudy)
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date October 29, 2017
Est. completion date June 28, 2018

Study information

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

Clinical 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.


Recruitment information / eligibility

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)

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
nicotine replacement therapy (NRT)
Participants were provided with either 2 weeks of 14-mg or 21-mg transdermal nicotine patches for every smoker in the home
Behavioral:
motivational advice
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 referral
Quitline participants received information about tobacco-smoke exposure reduction and a referral to a tobacco Quitline.

Locations

Country Name City State
United States University of Texas Health Science Center at Houston Houston Texas

Sponsors (1)

Lead Sponsor Collaborator
The University of Texas Health Science Center, Houston

Country where clinical trial is conducted

United States, 

Outcome

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)
See also
  Status Clinical Trial Phase
Completed NCT03999411 - Smartphone Intervention for Smoking Cessation and Improving Adherence to Treatment Among HIV Patients Phase 4
Completed NCT04043728 - Addressing Psychological Risk Factors Underlying Smoking Persistence in COPD Patients: The Fresh Start Study N/A
Completed NCT04617444 - The ESTxENDS Trial- Substudy on Effects of Using Electronic Nicotine Delivery Systems (ENDS) on Olfactory Function N/A
Completed NCT02796391 - Facilitating Smoking Cessation With Reduced Nicotine Cigarettes Phase 2
Completed NCT03397511 - Incorporating Financial Incentives to Increase Smoking Cessation Among Asian Americans Residing in New York City N/A
Not yet recruiting NCT05188287 - A Culturally Tailored Smartphone Application for African American Smokers N/A
Recruiting NCT05264428 - The Effect of Honey on Lessening the Withdrawal Symptoms N/A
Recruiting NCT05846841 - Personalized Tobacco Treatment in Primary Care (MOTIVATE) N/A
Completed NCT04133064 - Assessment of the Pivot Breath Sensor: Single-Arm Cohort Study N/A
Completed NCT03187730 - Integrating Financial Management Counseling and Smoking Cessation Counseling to Reduce Health and Economic Disparities in Low-Income Immigrants Phase 4
Completed NCT03474783 - To Explore the Factors Affecting the Effectiveness of Smoking Cessation N/A
Completed NCT04635358 - Feasibility Study of Smoking Cessation for the Staff of a Hospital Center N/A
Terminated NCT03670264 - BE Smokefree: Behavioral Economics Incentives to Engage Adolescents in Smoking Cessation N/A
Not yet recruiting NCT06307496 - VIDeOS for Smoking Cessation N/A
Completed NCT03206619 - A Health Recommeder System to Tailor Message Preferences in a Smoking Cessation Programme
Completed NCT02905656 - Strategies to Promote Cessation in Smokers Who Are Not Ready To Quit N/A
Completed NCT02997657 - Positive Psychotherapy for Smoking Cessation Enhanced With Text Messaging: A Randomized Controlled Trial N/A
Completed NCT02239770 - Pharmacokinetics of Nicotine Film in Smokers N/A
Completed NCT02562521 - A Smoking Cessation Intervention for Yale Dining Employees Phase 4
Recruiting NCT02422914 - Benefits of Tobacco Free Cigarette N/A