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Completed

NCT Number: NCT01896518

Novel Methods to Reduce Children's Secondhand Smoke Exposure II

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.

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Key information

Conditions

Secondhand Smoke

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Children's Hospital at OU Medical Center

Oklahoma City, Oklahoma, 73104, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Nicotine polacrilex

Drug

Tobacco lozenge

Drug

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

University of Oklahoma

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Acronym: EZII

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Jul 11, 2013
Registry last updated
Apr 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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