Novel Methods to Reduce Children's Secondhand Smoke Exposure II

NCT01896518 | Completed

• 2 other identifiers: 06421R21CA164521-01A1
• Study Type: interventional
• Target: 74
• 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

Keywords

second hand smoke exposure; children

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.

  3, 6, and 12 weeks

Secondary Outcomes (1)

• Change in Parent and Child Lung Function

  3, 6, 12 weeks

Study Arms (3)

Counseling

NO INTERVENTION

Nicotine lozenge

EXPERIMENTAL

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

Drug: Nicotine polacrilex

Tobacco lozenge

EXPERIMENTAL

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

Drug: Tobacco lozenge

Interventions

Nicotine polacrilex DRUG

Nicotine lozenge

Tobacco lozenge DRUG

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:

• 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)
• 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
• National Cancer Institute (NCI): collaborator

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

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Theodore Wagener, Ph.D.

  OTRC, OU Children's Hospital Dept. of Pediatrics, OU Cancer Center

  PRINCIPAL INVESTIGATOR

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: June 20, 2013
• First Posted: July 11, 2013
• Study Start: November 1, 2012
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: March 15, 2018

Record last verified: 2018-03

Locations

US (1)