Novel Methods to Reduce Children's Secondhand Smoke Exposure II

Not Applicable

Completed

• Conditions: Secondhand Smoke
• Interventions: Drug: Tobacco lozenge; Drug: Nicotine polacrilex

• Registration Number: NCT01896518
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-11
• Study First Submitted: 2013-06-20
• Study First Submitted QC: 2013-07-10
• Study First Posted: 2013-07-11
• Primary Completion: 2014-12
• Study Completion: 2014-12
• Status Verified: 2018-03
• Last Update Submitted: 2018-03-13
• Last Update Posted: 2018-03-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 74

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Tobacco lozenge	Tobacco lozenge	Participants will receive tobacco lozenge to use as needed for 12 weeks.
Nicotine lozenge	Nicotine polacrilex	Participants will receive nicotine lozenge to use as needed for 12 weeks.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

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

Trial Locations

Locations (1)

The Children's Hospital at OU Medical Center; 🇺🇸 Oklahoma City, Oklahoma, United States