Secondhand SmokeEZINCT01935713
Preliminary Investigation of Novel Methods to Reduce Children's Secondhand Smoke Exposure
A study testing Nicotine polacrilex, Electronic Cigarette and Dissolvable 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, Electronic Cigarette and Dissolvable Tobacco Lozenge
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 89 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2012to Dec 2012
- 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
None listed.
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
Official title: Novel Methods to Reduce Children's Secondhand Smoke Exposure I
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, Electronic Cigarette, Dissolvable Tobacco Lozenge
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nicotine polacrilexDrug
Also called Nicorette
Participants were given the choice of 2mg or 4mg lozenges depending on how many cigarettes per day they reported to smoke.
Electronic CigaretteDrug
Also called Smoke Tip
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.
Dissolvable Tobacco LozengeDrug
Also called Ariva, Stonewall
Participants were given Ariva (light to moderate smokers) or Stonewall (heavier smokers, >2 packs per day).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Drug: Nicotine polacrilex |
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: 2, 4, 8, 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: 2, 4, 8, and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2013 (estimated)
- Study startApr 2012
- Primary completionDec 2012
- Study completionDec 2012
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
- 89 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oklahoma
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01935713
- Sponsor's protocol ID
- 1582P
- Acronym
- EZI
- Status last verified
- Mar 2026
- First submitted
- 30 Aug 2013
- Last updated
- 6 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 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 I
- ClinicalTrials.gov ID
- NCT01935713
- Acronym / sponsor ID
- EZI / 1582P
- Conditions
- Secondhand Smoke
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 89 participants (actual)
- Lead sponsor
- University of OklahomaUniversity, hospital or other
- Study start
- Apr 2012
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 5 Sep 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 |
|---|---|---|
| Electronic Cigarette | Experimental | Drug: Electronic CigaretteParticipants received the electronic cigarette for use instead of cigarettes when in the presence of their child(ren) for up to 8 weeks. |
| Dissolvable Tobacco Lozenge | Experimental | Drug: Dissolvable Tobacco LozengeParticipants received the dissolvable tobacco lozenge for use instead of cigarettes when in the presence of their child(ren) for up to 8 weeks. |
| Dissolvable Nicotine Lozenge (Nicorette) | Experimental | Drug: Nicotine polacrilexParticipants received the dissolvable nicotine lozenge (Nicorette) for use instead of cigarettes when in the presence of their child(ren) for up to 8 weeks. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
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 polacrilexAlso: NicoretteParticipants were given the choice of 2mg or 4mg lozenges depending on how many cigarettes per day they reported to smoke. | Drug | Dissolvable Nicotine Lozenge (Nicorette) |
| Electronic CigaretteAlso: Smoke TipParticipants 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. | Drug | Electronic Cigarette |
| Dissolvable Tobacco LozengeAlso: Ariva, StonewallParticipants were given Ariva (light to moderate smokers) or Stonewall (heavier smokers, >2 packs per day). | Drug | Dissolvable Tobacco Lozenge |
Primary outcome
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.
1 secondary outcome
Change in Parent and Child Lung Function
Time frame: 2, 4, 8, and 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 6 Apr 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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, Electronic Cigarette and Dissolvable 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 0 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 6 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: 2, 4, 8, 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 6 Apr 2026.