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

• ClinicalTrials.gov Identifier: NCT01935713
• Recruitment Status: Completed
• First Posted: September 5, 2013
• Last Update Posted: May 4, 2017
• Sponsor: University of Oklahoma
• Information provided by (Responsible Party): University of Oklahoma

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Secondhand Smoke	Drug: Nicotine polacrilex; Drug: Electronic Cigarette; Drug: Dissolvable Tobacco Lozenge	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 89 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Investigator)
• Primary Purpose: Prevention
• Official Title: Novel Methods to Reduce Children's Secondhand Smoke Exposure I
• Study Start Date: April 2012
• Actual Primary Completion Date: December 2012
• Actual Study Completion Date: December 2012

Arms and Interventions

Arm	Intervention/treatment
Experimental: 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.	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.; Other Name: Smoke Tip
Experimental: 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.	Drug: Dissolvable Tobacco Lozenge; Participants were given Ariva (light to moderate smokers) or Stonewall (heavier smokers, >2 packs per day).; Other Name: Ariva, Stonewall
Experimental: 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.	Drug: Nicotine polacrilex; Participants were given the choice of 2mg or 4mg lozenges depending on how many cigarettes per day they reported to smoke.; Other Name: Nicorette

Outcome Measures

Primary Outcome Measures :

1. Change in child salivary cotinine [ Time Frame: 2, 4, 8, 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 Outcome Measures :

1. Change in Parent and Child Lung Function [ Time Frame: 2, 4, 8, and 12 weeks ]
   We will collect both parent and child spirometry data and compare changes.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 65 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

United States, Oklahoma

The Children's Hospital at OU Medical Center

Oklahoma City, Oklahoma, United States, 73104

Sponsors and Collaborators

University of Oklahoma

Investigators

• Principal Investigator: Theodore Wagener, Ph.D.; OTRC, OU Children's Hospital Dept. of Pediatrics, OU Cancer Center

More Information

• Responsible Party: University of Oklahoma
• ClinicalTrials.gov Identifier: NCT01935713
• Other Study ID Numbers: EZ Study
• First Posted: September 5, 2013
• Last Update Posted: May 4, 2017
• Last Verified: May 2017

Additional relevant MeSH terms:

Nicotine; Ganglionic Stimulants; Autonomic Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Nicotinic Agonists; Cholinergic Agonists; Cholinergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action