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

Secondhand Smoke Clinical Trial

— EZI  

Official title:

Novel Methods to Reduce Children's Secondhand Smoke Exposure I

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01935713
• Other study ID #: EZ Study
• Status: Completed
• Phase: N/A
• Start date: April 2012
• Est. completion date: December 2012

Study information

• Verified date: February 2024
• Source: University of Oklahoma
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 89
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Secondhand Smoke

Intervention

Drug:
• Nicotine polacrilex
Participants were given the choice of 2mg or 4mg lozenges depending on how many cigarettes per day they reported to smoke.
• 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.
• Dissolvable Tobacco Lozenge
Participants were given Ariva (light to moderate smokers) or Stonewall (heavier smokers, >2 packs per day).

Locations

Country	Name	City	State
United States	The Children's Hospital at OU Medical Center	Oklahoma City	Oklahoma

Sponsors (1)

Lead Sponsor	Collaborator
University of Oklahoma

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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