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

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

89 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-04-30

Study Completion Date

2012-12-31

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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Electronic Cigarette

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

Group Type EXPERIMENTAL

Electronic Cigarette

Intervention Type DRUG

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.

Dissolvable Tobacco Lozenge

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

Group Type EXPERIMENTAL

Dissolvable Tobacco Lozenge

Intervention Type DRUG

Participants were given Ariva (light to moderate smokers) or Stonewall (heavier smokers, \>2 packs per day).

Dissolvable Nicotine Lozenge (Nicorette)

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.

Group Type EXPERIMENTAL

Nicotine polacrilex

Intervention Type DRUG

Participants were given the choice of 2mg or 4mg lozenges depending on how many cigarettes per day they reported to smoke.

Interventions

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Nicotine polacrilex

Participants were given the choice of 2mg or 4mg lozenges depending on how many cigarettes per day they reported to smoke.

Intervention Type DRUG

Electronic 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.

Intervention Type DRUG

Dissolvable Tobacco Lozenge

Participants were given Ariva (light to moderate smokers) or Stonewall (heavier smokers, \>2 packs per day).

Intervention Type DRUG

Other Intervention Names

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Nicorette Smoke Tip Ariva, Stonewall

Eligibility Criteria

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Inclusion Criteria

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