Novel Methods to Reduce Children's Secondhand Smoke Exposure II (EZII)

University of Oklahoma (OU)

Status: Completed

Conditions: Secondhand Smoke

Treatments: Drug: Nicotine polacrilex; Drug: Tobacco lozenge

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01896518

1R21CA164521-01A1 (U.S. NIH Grant/Contract)

0642

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: 74 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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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74 participants in 3 patient groups

Counseling

No Intervention group

Nicotine lozenge

Experimental group

Description:

Participants will receive nicotine lozenge to use as needed for 12 weeks.

Treatment:

Drug: Nicotine polacrilex

Tobacco lozenge

Experimental group

Description:

Participants will receive tobacco lozenge to use as needed for 12 weeks.

Treatment:

Drug: Tobacco lozenge