Novel Methods to Reduce Children's Secondhand Smoke Expos... | NCT01896518

Studies
Novel Methods to Reduce Children's Secondhand Smoke Exposure II

NCT01896518

Sponsor

University of Oklahoma

Status

Completed

Last Update Posted

Apr 7, 2026Actual

Enrollment

74Actual

Phase

Not Applicable

Conditions

Secondhand Smoke

Interventions

Nicotine polacrilex
Tobacco lozenge

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
1R21CA164521-01A1	U.S. NIH Grant/Contract		View source

Status Module

Record Verification Date

Apr 2026

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2012Actual

Primary Completion Date

Dec 2014Actual

Completion Date

Dec 2014Actual

First Submitted Date

Jun 20, 2013

First Submission Date that Met QC Criteria

Jul 10, 2013

First Posted Date

Jul 11, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 1, 2026

Last Update Posted Date

Apr 7, 2026Actual

Name	Class
National Cancer Institute (NCI)	NIH

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

74Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Nicotine polacrilex	Drug		Nicotine lozenge
Tobacco lozenge

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Change in Parent and Child Lung Function	We will collect both parent and child spirometry data and compare changes.	3, 6, 12 weeks

Other Outcomes

Not provided

Eligibility Module

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)
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

Exclusion Criteria:

Does not meet all of the requirements of inclusion criteria

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Theodore Wagener, Ph.D.	OTRC, OU Children's Hospital Dept. of Pediatrics, OU Cancer Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
The Children's Hospital at OU Medical Center		Oklahoma City	Oklahoma	73104	United States