Novel Methods to Reduce Children's Secondhand Smoke Exposure II

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

74 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-11-30

Study Completion Date

2014-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Secondhand Smoke

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Investigators

Study Groups

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Counseling

Group Type NO_INTERVENTION

No interventions assigned to this group

Nicotine lozenge

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

Group Type EXPERIMENTAL

Nicotine polacrilex

Intervention Type DRUG

Tobacco lozenge

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

Group Type EXPERIMENTAL

Tobacco lozenge

Intervention Type DRUG

Interventions

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Nicotine polacrilex

Intervention Type DRUG

Tobacco lozenge

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes