Preliminary Investigation of Novel Methods to Reduce Children's Secondhand Smoke Exposure (EZI)

Novel Methods to Reduce Children's Secondhand Smoke Exposure I

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: Secondhand Smoke
• Intervention / Treatment: Drug: Electronic Cigarette; Drug: Dissolvable Tobacco Lozenge; Drug: Nicotine polacrilex

• Study Type: Interventional
• Enrollment (Actual): 89
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73104
      • The Children's Hospital at OU Medical Center

Participation Criteria

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

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Electronic Cigarette; Participants received the electronic cigarette for use instead of cigarettes when in the presence of their child(ren) for up to 8 weeks.	Drug: Electronic Cigarette; Participants were given an e-cigarette starter kit, charging case, and cartridges in either 12mg or 16 mg nicotine, depending on their current amount of cigarettes smoked per day.; Other Names: Smoke Tip
Experimental: Dissolvable Tobacco Lozenge; Participants received the dissolvable tobacco lozenge for use instead of cigarettes when in the presence of their child(ren) for up to 8 weeks.	Drug: Dissolvable Tobacco Lozenge; Participants were given Ariva (light to moderate smokers) or Stonewall (heavier smokers, >2 packs per day).; Other Names: Ariva, Stonewall
Experimental: Dissolvable Nicotine Lozenge (Nicorette); Participants received the dissolvable nicotine lozenge (Nicorette) for use instead of cigarettes when in the presence of their child(ren) for up to 8 weeks.	Drug: Nicotine polacrilex; Participants were given the choice of 2mg or 4mg lozenges depending on how many cigarettes per day they reported to smoke.; Other Names: Nicorette

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in child salivary cotinine	Child salivary cotinine will be measured to assess the level of secondhand smoke exposure. We will measure the change throughout the study.	2, 4, 8, and 12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Parent and Child Lung Function	We will collect both parent and child spirometry data and compare changes.	2, 4, 8, and 12 weeks

Collaborators and Investigators

• Sponsor: University of Oklahoma
• Investigators: Principal Investigator: Theodore Wagener, Ph.D., OTRC, OU Children's Hospital Dept. of Pediatrics, OU Cancer Center

Study record dates

Study Major Dates

• Study Start: April 1, 2012
• Primary Completion (Actual): December 1, 2012
• Study Completion (Actual): December 1, 2012

Study Registration Dates

• First Submitted: August 30, 2013
• First Submitted That Met QC Criteria: August 30, 2013
• First Posted (Estimated): September 5, 2013

Study Record Updates

• Last Update Posted (Actual): February 28, 2024
• Last Update Submitted That Met QC Criteria: February 26, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Cholinergic Agents; Ganglionic Stimulants; Nicotinic Agonists; Cholinergic Agonists; Nicotine
• Other Study ID Numbers: EZ Study