- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01896518
Novel Methods to Reduce Children's Secondhand Smoke Exposure II (EZII)
March 13, 2018 updated by: University of Oklahoma
The overall aim of the current study is to determine if the use of nicotine containing products by caregivers who smoke and who are not interested in quitting, is effective in reducing children's secondhand smoke exposure.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
74
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Oklahoma
-
Oklahoma City, Oklahoma, United States, 73104
- The Children's Hospital at OU Medical Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
In order to be included in the study, participants must:
- be the primary caregiver(defined as a person who spends the most time with the child and spends a minimum of 4 hours per day in the presence of the child) of a child between the ages of 3-11 (if caregiver has more > 1 child between 3-11 years, we will include the youngest),
- smoke at least 10 cigarettes per day for the past year,
- indicate that they smoke around their child or in the car or home at least one time per week],
- have no intention of quitting smoking in the next 12-weeks,
- aged 18-65 years,
- be fluent in English,
- have no recent history of cardiovascular distress that may contraindicate medicinal nicotine lozenge use (heart attack in the past year, arrhythmia, uncontrolled hypertension),
- not currently pregnant, planning to become pregnant, or breastfeeding,
- do not use non-cigarette tobacco (cigars, chewing tobacco)
- have no prior use of any potential reduced exposure product,
- have no major psychiatric impairment, including psychosis, suicidality, and/or any current alcohol/drug abuse or dependence
Exclusion Criteria:
Does not meet all of the requirements of inclusion criteria
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Counseling
|
|
Experimental: Nicotine lozenge
Participants will receive nicotine lozenge to use as needed for 12 weeks.
|
|
Experimental: Tobacco lozenge
Participants will receive tobacco lozenge to use as needed for 12 weeks.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Child Salivary Cotinine
Time Frame: 3, 6, and 12 weeks
|
Child salivary cotinine will be measured to assess the level of secondhand smoke exposure.
We will measure the change throughout the study.
|
3, 6, and 12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Parent and Child Lung Function
Time Frame: 3, 6, 12 weeks
|
We will collect both parent and child spirometry data and compare changes.
|
3, 6, 12 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Theodore Wagener, Ph.D., OTRC, OU Children's Hospital Dept. of Pediatrics, OU Cancer Center
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 1, 2012
Primary Completion (Actual)
December 1, 2014
Study Completion (Actual)
December 1, 2014
Study Registration Dates
First Submitted
June 20, 2013
First Submitted That Met QC Criteria
July 10, 2013
First Posted (Estimate)
July 11, 2013
Study Record Updates
Last Update Posted (Actual)
March 15, 2018
Last Update Submitted That Met QC Criteria
March 13, 2018
Last Verified
March 1, 2018
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 0642
- 1R21CA164521-01A1 (U.S. NIH Grant/Contract)
Drug and device information, study documents
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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