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

University of Oklahoma (OU)

Status: Completed

Conditions: Secondhand Smoke

Treatments: Drug: Electronic Cigarette; Drug: Dissolvable Tobacco Lozenge; Drug: Nicotine polacrilex

Study type: Interventional

Funder types: Other

Identifiers

NCT01935713

EZ Study

Details and patient eligibility

About

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.

Enrollment: 89 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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89 participants in 3 patient groups

Electronic Cigarette

Experimental group

Description:

Participants received the electronic cigarette for use instead of cigarettes when in the presence of their child(ren) for up to 8 weeks.

Treatment:

Drug: Electronic Cigarette

Dissolvable Tobacco Lozenge

Experimental group

Description:

Participants received the dissolvable tobacco lozenge for use instead of cigarettes when in the presence of their child(ren) for up to 8 weeks.

Treatment:

Drug: Dissolvable Tobacco Lozenge

Dissolvable Nicotine Lozenge (Nicorette)

Experimental group

Description:

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.

Treatment:

Drug: Nicotine polacrilex