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

NCT01935713 | Completed

• 1 other identifier: EZ Study
• Study Type: interventional
• Target: 89
• Locations: 1 country
• Sites: 1

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.

Conditions

Secondhand Smoke

Outcome Measures

Primary Outcomes (1)

• Change in child salivary cotinine

  Child salivary cotinine will be measured to assess the level of secondhand smoke exposure. We will measure the change throughout the study.

  2, 4, 8, and 12 weeks

Secondary Outcomes (1)

• Change in Parent and Child Lung Function

  2, 4, 8, and 12 weeks

Study Arms (3)

Electronic Cigarette

EXPERIMENTAL

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

Dissolvable Tobacco Lozenge

EXPERIMENTAL

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

Dissolvable Nicotine Lozenge (Nicorette)

EXPERIMENTAL

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

Interventions

Nicotine polacrilex DRUG

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

Also known as: Nicorette

Dissolvable Nicotine Lozenge (Nicorette)

Electronic Cigarette 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.

Also known as: Smoke Tip

Electronic Cigarette

Dissolvable Tobacco Lozenge DRUG

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

Also known as: Ariva, Stonewall

Dissolvable Tobacco Lozenge

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)
• have no prior use of any potential reduced exposure product
• have no major psychiatric impairment, including psychosis, suicidality, and/or any current alcohol/drug abuse or dependence

Sponsors & Collaborators

• University of Oklahoma: lead

Study Sites (1)

The Children's Hospital at OU Medical Center

Oklahoma City, Oklahoma, 73104, United States

Location

MeSH Terms

Interventions

Tobacco Use Cessation Devices; Nicotine Chewing Gum; Electronic Nicotine Delivery Systems

Intervention Hierarchy (Ancestors)

Therapeutics; Chewing Gum; Plant Gums; Biopolymers; Polymers; Macromolecular Substances; Polysaccharides; Carbohydrates; Candy; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Smoking Devices; Manufactured Materials; Technology, Industry, and Agriculture

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 30, 2013
• First Posted: September 5, 2013
• Study Start: April 1, 2012
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: February 28, 2024

Record last verified: 2024-02

Locations

US (1)