Novel Methods to Reduce Children's Secondhand Smoke Exposure II (EZII)

April 1, 2026 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

  • United States
    • 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

Description

Inclusion Criteria:

In order to be included in the study, participants must:

  1. 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),
  2. smoke at least 10 cigarettes per day for the past year,
  3. indicate that they smoke around their child or in the car or home at least one time per week],
  4. have no intention of quitting smoking in the next 12-weeks,
  5. aged 18-65 years,
  6. be fluent in English,
  7. have no recent history of cardiovascular distress that may contraindicate medicinal nicotine lozenge use (heart attack in the past year, arrhythmia, uncontrolled hypertension),
  8. not currently pregnant, planning to become pregnant, or breastfeeding,
  9. do not use non-cigarette tobacco (cigars, chewing tobacco)
  10. have no prior use of any potential reduced exposure product,
  11. 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.
Drug: Nicotine polacrilex
Experimental: Tobacco lozenge
Participants will receive tobacco lozenge to use as needed for 12 weeks.
Drug: Tobacco lozenge

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

University of Oklahoma

Collaborators

National Cancer Institute (NCI)

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 (Estimated)

July 11, 2013

Study Record Updates

Last Update Posted (Actual)

April 7, 2026

Last Update Submitted That Met QC Criteria

April 1, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0642P
  • 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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