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Clinical Trials/NCT01896518
NCT01896518
Completed
Not Applicable

Novel Methods to Reduce Children's Secondhand Smoke Exposure II

University of Oklahoma1 site in 1 country74 target enrollmentNovember 2012
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ConditionsSecondhand Smoke
InterventionsNicotine polacrilexTobacco lozenge
DrugsNicotine polacrilexTobacco lozenge

Overview

Phase
Not Applicable
Intervention
Nicotine polacrilex
Conditions
Secondhand Smoke
Sponsor
University of Oklahoma
Enrollment
74
Locations
1
Primary Endpoint
Change in Child Salivary Cotinine
Status
Completed
Last Updated
8 years ago
OverviewInvestigatorsEligibility CriteriaArms & InterventionsOutcomesSitesSimilar Trials

Overview

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.

Registry
clinicaltrials.gov
Start Date
November 2012
End Date
December 2014
Last Updated
8 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • •In order to be included in the study, participants must:
  • •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),
  • •smoke at least 10 cigarettes per day for the past year,
  • •indicate that they smoke around their child or in the car or home at least one time per week\],
  • •have no intention of quitting smoking in the next 12-weeks,
  • •aged 18-65 years,
  • •be fluent in English,
  • •have no recent history of cardiovascular distress that may contraindicate medicinal nicotine lozenge use (heart attack in the past year, arrhythmia, uncontrolled hypertension),
  • •not currently pregnant, planning to become pregnant, or breastfeeding,
  • •do not use non-cigarette tobacco (cigars, chewing tobacco)

Exclusion Criteria

  • •Does not meet all of the requirements of inclusion criteria

Arms & Interventions

Nicotine lozenge

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

Intervention: Nicotine polacrilex

Tobacco lozenge

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

Intervention: Tobacco lozenge

Outcomes

Primary Outcomes

Change in Child Salivary Cotinine

Time Frame: 3, 6, 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 Outcomes

  • Change in Parent and Child Lung Function(3, 6, 12 weeks)

Study Sites (1)

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