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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2013 by University of Oklahoma.
Recruitment status was  Recruiting
National Cancer Institute (NCI)
Information provided by (Responsible Party):
University of Oklahoma Identifier:
First received: June 20, 2013
Last updated: July 10, 2013
Last verified: July 2013
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 Intervention
Secondhand Smoke
Drug: Nicotine polacrilex
Drug: Tobacco lozenge

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Prevention
Official Title: Novel Methods to Reduce Children's Secondhand Smoke Exposure II

Resource links provided by NLM:

Further study details as provided by University of Oklahoma:

Primary Outcome Measures:
  • Change in Child Salivary Cotinine [ Time Frame: 3, 6, and 12 weeks ] [ Designated as safety issue: No ]
    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:
  • Change in Parent and Child Lung Function [ Time Frame: 3, 6, 12 weeks ] [ Designated as safety issue: No ]
    We will collect both parent and child spirometry data and compare changes.

Estimated Enrollment: 90
Study Start Date: June 2013
Estimated Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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


Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01896518

Contact: Leslie Driskill, MS (405)271-4749
Contact: Noor Tahirkheli, BS (405)271-8001 ext 42180

United States, Oklahoma
The Children's Hospital at OU Medical Center Recruiting
Oklahoma City, Oklahoma, United States, 73104
Contact: Leslie Driskill         
Sponsors and Collaborators
University of Oklahoma
National Cancer Institute (NCI)
Principal Investigator: Theodore Wagener, Ph.D. OTRC, OU Children's Hospital Dept. of Pediatrics, OU Cancer Center
  More Information

Responsible Party: University of Oklahoma Identifier: NCT01896518     History of Changes
Other Study ID Numbers: EZII  1R21CA164521-01A1 
Study First Received: June 20, 2013
Last Updated: July 10, 2013
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by University of Oklahoma:
second hand smoke exposure; children

Additional relevant MeSH terms:
Autonomic Agents
Cholinergic Agents
Cholinergic Agonists
Ganglionic Stimulants
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Nicotinic Agonists
Peripheral Nervous System Agents
Physiological Effects of Drugs processed this record on May 23, 2016