Secondhand Smoke
Conditions
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
Participants were given the choice of 2mg or 4mg lozenges depending on how many cigarettes per day they reported to smoke.
DRUGElectronic 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.
DRUGDissolvable Tobacco Lozenge
Participants were given Ariva (light to moderate smokers) or Stonewall (heavier smokers, \>2 packs per day).
Sponsors
University of Oklahoma
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 | 2, 4, 8, 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 | 2, 4, 8, and 12 weeks | We will collect both parent and child spirometry data and compare changes. |
Countries
United States
Outcome results
None listed