Secondhand SmokeEZIINCT01896518
Novel Methods to Reduce Children's Secondhand Smoke Exposure II
A study testing Nicotine polacrilex and Tobacco lozenge in people with Secondhand Smoke, run by University of Oklahoma at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Secondhand Smoke
- What is being tested?
- Nicotine polacrilex and Tobacco lozenge
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2012to Dec 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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,
Show all 12Show fewer
- 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
Who cannot join
- Does not meet all of the requirements of inclusion criteria
Trial locations and contacts
1 site in 1 country.
United States1 site
The Children's Hospital at OU Medical Center
Oklahoma City, Oklahoma, 73104
About this study
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
- Being tested
- Nicotine polacrilex, Tobacco lozenge
- Keywords
- second hand smoke exposure; children
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nicotine polacrilexDrug
Tobacco lozengeDrug
| Study group | Role | What they receive |
|---|---|---|
| Counseling | No intervention | Not described |
| Nicotine lozenge | Experimental | Participants will receive nicotine lozenge to use as needed for 12 weeks. Receives: Drug: Nicotine polacrilex |
| Tobacco lozenge | Experimental | Participants will receive tobacco lozenge to use as needed for 12 weeks. Receives: Drug: Tobacco lozenge |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3, 6, and 12 weeks
Secondary outcomes (1)
Change in Parent and Child Lung Function
We will collect both parent and child spirometry data and compare changes.
Measured: 3, 6, 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2013 (estimated)
- Study startNov 2012
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Secondhand SmokeStudies of the same condition, open and under way.
- More trials run by University of OklahomaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oklahoma
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Theodore Wagener, Ph.D., Principal investigator, OTRC, OU Children's Hospital Dept. of Pediatrics, OU Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01896518
- Sponsor's protocol ID
- 0642P
- Other IDs
- 1R21CA164521-01A1
- Acronym
- EZII
- Status last verified
- Apr 2026
- First submitted
- 20 Jun 2013
- Last updated
- 7 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Novel Methods to Reduce Children's Secondhand Smoke Exposure II
- ClinicalTrials.gov ID
- NCT01896518
- Acronym / sponsor ID
- EZII / 0642P
- Conditions
- Secondhand Smoke
- Keywords
- second hand smoke exposure; children
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- University of OklahomaUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Nov 2012 (actual)
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 11 Jul 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Counseling | No intervention | – |
| Nicotine lozenge | Experimental | Drug: Nicotine polacrilexParticipants will receive nicotine lozenge to use as needed for 12 weeks. |
| Tobacco lozenge | Experimental | Drug: Tobacco lozengeParticipants will receive tobacco lozenge to use as needed for 12 weeks. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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,
Key exclusion criteria (1 listed)
- Does not meet all of the requirements of inclusion criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nicotine polacrilex | Drug | Nicotine lozenge |
| Tobacco lozenge | Drug | Tobacco lozenge |
Primary outcome
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.
1 secondary outcome
Change in Parent and Child Lung Function
Time frame: 3, 6, 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2026.
Related trials for Secondhand Smoke
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Smoking Cessation Intervention Including Health Navigators to Address Unmet Social Needs of Parents Who Smoke
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Theodore Wagener, Ph.D. principal investigator
OTRC, OU Children's Hospital Dept. of Pediatrics, OU Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nicotine polacrilex and Tobacco lozenge in people with Secondhand Smoke, run by University of Oklahoma at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Child Salivary Cotinine (time frame: 3, 6, and 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2026.