SmokingNCT02498145
Short Term Effects of Electronic Cigarettes in Tobacco Dependent Adults
A study testing Nicotine e-cigarette and Non-nicotine e-cigarette in people with Smoking and Nicotine Dependence, run by Yale University at 1 site in United States.
Trial summary
This is a pilot human experimental study to evaluate whether the use of an e-cigarette affects lung function, exhaled CO levels, and quantitative tobacco cigarette consumption in active tobacco smokers. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Smoking, Nicotine Dependence
- What is being tested?
- Nicotine e-cigarette and Non-nicotine e-cigarette
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2014to Nov 2016
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Smoking 1 or more tobacco cigarettes per day.
- Residence within reasonable driving distance to New Haven..
Who cannot join
- Unstable psychiatric conditions such as suicidal ideation, acute psychosis, severe alcohol dependence, or dementia.
- Unstable medical conditions requiring hospitalization.
- Acute myocardial infarction or acute cerebrovascular accident within the past 30 days.
- Unstable angina.
- History of allergic reactions to adhesives.
- Women of childbearing potential who are pregnant, nursing, or not practicing effective contraception.
- Current use of an electronic cigarette.
- Subject unable or unwilling to complete study protocol for any reason.
Trial locations and contacts
1 site in 1 country.
United States1 site
Yale-New Haven Hospital
New Haven, Connecticut, 06519
About this study
This is a pilot human experimental study to evaluate whether the use of an e-cigarette affects lung function, exhaled CO levels, and quantitative tobacco cigarette consumption in active tobacco smokers. Subjects recruited from the Winchester Chest Clinic (WCC), Adult Primary Care Clinic (PCC) and the Smilow Cancer Hospital Smoking Cessation Service will be randomized to 1 of 2 groups: (1) nicotine patch and intensive counseling (standard care) plus nicotine e-cigarette; (2) nicotine patch and intensive counseling plus non-nicotine e-cigarette.
- Conditions
- Smoking, Nicotine Dependence
- Being tested
- Nicotine e-cigarette, Non-nicotine e-cigarette
- Medical subject headings
- Smoking, Tobacco Use Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nicotine e-cigaretteOther
Patients will receive nicotine patch and intensive counseling plus e-cigarette with nicotine.
Non-nicotine e-cigaretteOther
Patients will receive nicotine patch and intensive counseling plus e-cigarette without nicotine.
| Study group | Role | What they receive |
|---|---|---|
| Nicotine e-cigarette | Experimental | Patients will receive nicotine patch and intensive counseling plus e-cigarette with nicotine. Receives: Other: Nicotine e-cigarette |
| Non-nicotine e-cigarette | Active comparator | Patients will receive nicotine patch and intensive counseling plus e-cigarette without nicotine. Receives: Other: Non-nicotine e-cigarette |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in daily quantitative cigarette smoking
Quantitative tobacco cigarette smoking will be measured by experimenter-administered rating scale for 30 days prior to treatment through 6 month follow-up.
Measured: baseline, 8 weeks, and 6 months.
Change in exhaled carbon monoxide (CO) levels
Exhaled carbon monoxide levels will be measured with a precision instrument for detecting CO in exhaled breath.
Measured: baseline, 8 weeks, and 6 months.
Secondary outcomes (1)
Short-term impact on lung function (spirometry)
Lung function will be measured by spirometry at time of study enrollment and at 6 months.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2015 (estimated)
- Study startOct 2014
- Primary completionJun 2016
- Study completionNov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SmokingStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stephen R. Baldassarri, M.D., Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02498145
- Sponsor's protocol ID
- 1407014335
- Status last verified
- Apr 2016
- First submitted
- 13 Jul 2015
- Last updated
- 2 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Short Term Effects of Electronic Cigarettes in Tobacco Dependent Adults
- ClinicalTrials.gov ID
- NCT02498145
- Acronym / sponsor ID
- 1407014335
- Conditions
- Smoking, Nicotine Dependence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Study start
- Oct 2014
- Primary completion
- Jun 2016 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 15 Jul 2015 (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.
This is a pilot human experimental study to evaluate whether the use of an e-cigarette affects lung function, exhaled CO levels, and quantitative tobacco cigarette consumption in active tobacco smokers. Subjects recruited from the Winchester Chest Clinic (WCC), Adult Primary Care Clinic (PCC) and the Smilow Cancer Hospital Smoking Cessation Service will be randomized to 1 of 2 groups: (1) nicotine patch and intensive counseling (standard care) plus nicotine e-cigarette; (2) nicotine patch and intensive counseling plus non-nicotine e-cigarette.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nicotine e-cigarette | Experimental | Other: Nicotine e-cigarettePatients will receive nicotine patch and intensive counseling plus e-cigarette with nicotine. |
| Non-nicotine e-cigarette | Active comparator | Other: Non-nicotine e-cigarettePatients will receive nicotine patch and intensive counseling plus e-cigarette without nicotine. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Smoking 1 or more tobacco cigarettes per day.
- Residence within reasonable driving distance to New Haven..
Key exclusion criteria (8 listed)
- Unstable psychiatric conditions such as suicidal ideation, acute psychosis, severe alcohol dependence, or dementia.
- Unstable medical conditions requiring hospitalization.
- Acute myocardial infarction or acute cerebrovascular accident within the past 30 days.
- Unstable angina.
- History of allergic reactions to adhesives.
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 e-cigarettePatients will receive nicotine patch and intensive counseling plus e-cigarette with nicotine. | Other | Nicotine e-cigarette |
| Non-nicotine e-cigarettePatients will receive nicotine patch and intensive counseling plus e-cigarette without nicotine. | Other | Non-nicotine e-cigarette |
Primary outcome
Change in daily quantitative cigarette smoking
Time frame: baseline, 8 weeks, and 6 months.
Quantitative tobacco cigarette smoking will be measured by experimenter-administered rating scale for 30 days prior to treatment through 6 month follow-up.
Change in exhaled carbon monoxide (CO) levels
Time frame: baseline, 8 weeks, and 6 months.
Exhaled carbon monoxide levels will be measured with a precision instrument for detecting CO in exhaled breath.
1 secondary outcome
Short-term impact on lung function (spirometry)
Time frame: 6 months
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 2 Jul 2017.
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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.
Stephen R. Baldassarri, M.D. principal investigator
Yale University
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 e-cigarette and Non-nicotine e-cigarette in people with Smoking and Nicotine Dependence, run by Yale University 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 2 inclusion and 8 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 2 Jul 2017. 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 daily quantitative cigarette smoking (time frame: baseline, 8 weeks, and 6 months.). The study lists 2 primary outcomes in all. 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 2 Jul 2017.