Novel Methods to Reduce Children's Secondhand Smoke Exposure II

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01896518

Acronym

EZII

Enrollment

Registered

2013-07-11

Start date

2012-11-30

Completion date

2014-12-31

Last updated

2018-03-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Secondhand Smoke

Keywords

second hand smoke exposure; children

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.

Interventions

DRUGNicotine polacrilex

DRUGTobacco lozenge

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

SINGLE (Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

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

Design outcomes

Primary

Measure	Time frame	Description
Change in Child Salivary Cotinine	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

Measure	Time frame	Description
Change in Parent and Child Lung Function	3, 6, 12 weeks	We will collect both parent and child spirometry data and compare changes.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026