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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01896518
Recruitment Status : Completed
First Posted : July 11, 2013
Last Update Posted : March 15, 2018
National Cancer Institute (NCI)
Information provided by (Responsible Party):
University of Oklahoma

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Secondhand Smoke Drug: Nicotine polacrilex Drug: Tobacco lozenge Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 74 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Prevention
Official Title: Novel Methods to Reduce Children's Secondhand Smoke Exposure II
Actual Study Start Date : November 2012
Actual Primary Completion Date : December 2014
Actual Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

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

Primary Outcome Measures :
  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 Outcome Measures :
  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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01896518

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United States, Oklahoma
The Children's Hospital at OU Medical Center
Oklahoma City, Oklahoma, United States, 73104
Sponsors and Collaborators
University of Oklahoma
National Cancer Institute (NCI)
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Principal Investigator: Theodore Wagener, Ph.D. OTRC, OU Children's Hospital Dept. of Pediatrics, OU Cancer Center
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Responsible Party: University of Oklahoma
ClinicalTrials.gov Identifier: NCT01896518    
Other Study ID Numbers: 0642
1R21CA164521-01A1 ( U.S. NIH Grant/Contract )
First Posted: July 11, 2013    Key Record Dates
Last Update Posted: March 15, 2018
Last Verified: March 2018

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Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Oklahoma:
second hand smoke exposure; children
Additional relevant MeSH terms:
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Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action