SmokingPhase 4NCT02482233
The END Perioperative Smoking Pilot Study
A Phase 4 study testing ENDD (NJOY), NRT (NicoDerm CQ) and telephone counseling in people with Smoking and Nicotine Addiction, run by University of California, San Francisco at 1 site in United States.
Trial summary
The purpose of this pilot randomized trial is to determine the feasibility of e-cigarettes and telephone counselling (compared to transdermal nicotine replacement and telephone counselling) as a harm-reduction tool that may lead to increased smoking cessation in the perioperative setting in smokers presenting for… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Smoking, Nicotine Addiction, Surgery
- What is being tested?
- ENDD (NJOY), NRT (NicoDerm CQ) and telephone counseling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2015to Sep 2016
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- adults (age >18)
- any gender
- scheduled to undergo elective surgery at the San Francisco Veterans Affairs Medical Center (SFVAMC)
- daily smoker, based on self-report of at least 2 cigarettes/day and having smoked in the last 7 days
- presenting to the anesthesia preoperative (APO) clinic at least 3 days preoperatively
Who cannot join
- emergency surgery (booked <24 hours preoperatively)
- consumers of non-cigarette forms of tobacco only (pipe, smokeless tobacco) or marijuana only
- already enrolled in a smoking cessation trial
- current smoking cessation pharmacotherapy
- daily user of e-cigarettes
- previous adverse reaction to e-cigarette or transdermal nicotine
Show all 10Show fewer
- poor proficiency of English language¸as indicated by need for an interpreter (including family members) at the preadmission visit
- lacking capacity for consent (e.g. due to mental illness or dementia), as indicated by consent for surgery and other medical procedures being obtained from a substitute decision maker
- pregnant or breastfeeding
- unstable cardiac condition (unstable angina, unstable arrhythmia)
Trial locations and contacts
1 site in 1 country.
United States1 site
San Francisco VA Medical Center
San Francisco, California, 94121
About this study
Official title: A Pilot Randomized Controlled Clinical Trial - "Electronic Nicotine Delivery Device (E-cigarette) for Perioperative Smoking Cessation in Veterans"
The purpose of this pilot randomized trial is to determine the feasibility of e-cigarettes and telephone counselling (compared to transdermal nicotine replacement and telephone counselling) as a harm-reduction tool that may lead to increased smoking cessation in the perioperative setting in smokers presenting for elective surgery at the San Francisco Veterans Affairs Medical Center. Secondary outcomes include acceptability of e-cigarettes over transdermal nicotine replacement, length-of-stay in the post-anesthesia care unit, hospital length-of-stay, postoperative complications within the first 30-days, and smoking status 8-weeks after randomization. This pilot study is designed to provide the preliminary data necessary to plan and fund a larger-scale randomized clinical trial that will assess the utility of e-cigarettes in achieving smoking cessation perioperatively. Our ultimate goal is to add to the limited existing data on the safety and efficacy of e-cigarette use in smoking cessation, specifically in the perioperative setting where the risks of continued smoking are great and the motivation to stop is high.
Read the detailed description
It is well-known that smokers suffer more complications and higher risk of mortality after surgery than non-smokers. Despite this knowledge, it is unclear what clinicians can do to minimize this risk. Surgery represents a 'teachable moment' that might encourage smokers to engage in permanent cessation. Several small trials have shown that smoking cessation interventions can increase smoking cessation and reduce postoperative complications, particularly wound-healing complications, which can have an absolute risk reduction of up to 25%. Smoking cessation initiated in the perioperative period can also promote long-term smoking cessation. Despite the benefits of comprehensive smoking cessation interventions including nicotine replacement therapy, current standard of care at the SFVAMC does not routinely include specific preoperative smoking cessation pharmacotherapy or counselling. Although there is an urgent need for more data, e-cigarettes have been proposed as an alternative to nicotine replacement therapy that are at least as effective for smoking cessation, and may be more acceptable to some patients.
The main hypothesis of this pilot study is that the use of e-cigarettes and telephone counselling, compared to telephone counselling and transdermal nicotine replacement, in the perioperative period results in increased smoking cessation on the day of surgery and at 8-weeks after randomization in smokers presenting for elective surgery. As secondary hypotheses, the study will also assess the acceptability of e-cigarettes versus nicotine patches, postoperative complications within the first 30-days, length-of-stay in the PACU and hospital length-of-stay. The investigators will examine the above hypotheses through the following aims:
" Aim 1) To determine how e-cigarettes plus counselling compare to transdermal nicotine replacement plus counselling for the achievement of smoking cessation, when introduced prior to elective surgery in veterans.
The investigators plan to carry-out a pilot randomized controlled trial with parallel design comparing e-cigarettes and telephone counselling with transdermal nicotine replacement and telephone counselling. Our primary outcome is smoking cessation on the day of surgery, as confirmed biochemically by exhaled carbon monoxide. Smoking reduction (self-reported cigarettes per day) of 50% or more and bedside spirometry readings will be assessed as secondary outcomes.
" Aim 2) To determine the acceptability of e-cigarettes amongst veterans as an aid for smoking cessation and to determine the feasibility of recruitment, randomization, and follow-up procedures in preparation for large-scale trial.
Through implementation of this pilot trial, the investigators will determine the feasibility and acceptability of e-cigarettes for smoking cessation perioperatively in the veteran population and obtain the preliminary data necessary to run a larger trial on the effectiveness of e-cigarettes as a perioperative smoking cessation aid.
" Aim 3) To determine the safety of e-cigarettes as a harm reduction strategy to achieve short-term perioperative smoking cessation.
The investigators plan to improve the overall knowledge of the safety of short-term e-cigarettes use through careful surveillance for adverse events and side effects.
" Aim 4) To determine if e-cigarette use preoperatively is associated with a lower risk of complications postoperatively.
The investigators plan to measure the following secondary outcomes: postoperative complications and mortality within the first 30 days, post-anesthesia care unit (PACU) length-of-stay, and hospital length-of-stay. This will help us understand if e-cigarettes have the potential to be used for harm-reduction perioperatively.
- Conditions
- Smoking, Nicotine Addiction, Surgery
- Being tested
- ENDD (NJOY), NRT (NicoDerm CQ), telephone counseling, brief advice, brochure
- Keywords
- electronic cigarette, nicotine replacement therapy, smoking cessation, perioperative
- Medical subject headings
- Smoking, Tobacco Use Disorder, Vaping, Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ENDD (NJOY)Behavioural
Also called electronic nicotine delivery device, NJOY e-cigarettes
As described above.
NRT (NicoDerm CQ)Drug
Also called nicotine patch
As described above.
telephone counselingBehavioural
Referral to the California Smokers' Helpline. California Smokers' Helpline will call the patient 4 times, or as agreed upon by the patient.
brief adviceBehavioural
Brief advice lasting less than 2 minutes will be delivered by the research assistant, investigator, or healthcare provider. The advice will be similar to the following statement (customized as needed to the patient): "The most important advice I can give you is that quitting smoking is the number one thing you can do for your health and to prepare yourself for surgery. Quitting smoking before surgery may improve your chances of healing quickly. There's evidence that the longer you quit before your surgery, the fewer complications you'll have. I encourage you to make use of the resources that have been provided to you to help you quit and set your quit date for as soon as possible."
brochureBehavioural
A brochure from the ASA (American Society of Anesthesiologists) about quitting smoking before surgery.
Available free from the ASA: http://ecommerce.asahq.org/publicationsAndServices/PatientBrochure_%20For%20Posting.pdf
| Study group | Role | What they receive |
|---|---|---|
| ENDD | Experimental | 6-week supply of disposable "NJOY" ENDDs (e-cigarettes)
* the number of e-cigarettes will be determined by equating the number of e-cigarettes to the number of cigarettes smoked per day (1 pack per day = 2 e-cigarettes per day = 14 e-cigarettes/week)
* veterans will be given detailed instructions for use and also instructed to start with the high nicotine content (4.5%) strength for three weeks, then decrease to the low nicotine content (2.4%) for two weeks, then switch to nicotine-free for the final week
Both groups will receive:
i) referral to the California Smokers' Helpline, ii) brief advice lasting less than 2 minutes, iii) a brochure from the ASA about quitting smoking before surgery Receives: Behavioral: ENDD (NJOY); Behavioral: telephone counseling; Behavioral: brief advice; Behavioral: brochure |
| NRT (NicoDerm CQ) | Active comparator | A prescription for 6 weeks of transdermal nicotine replacement (on-formulary at the VA) in the following doses: For smokers of 10 cigarettes per day or more, a 3-week supply of 21 mg/d, 1-week supply of 14 mg/d, 1-week supply of 7 mg/d, and 1-week of 0mg/d. Smokers of <10 cigarettes per day, 3 weeks of 14 mg/d patches 2 weeks of 7 mg/d patches, and 1-week of 0mg/d.
Both groups will receive:
i) referral to the California Smokers' Helpline, ii) brief advice lasting less than 2 minutes, iii) a brochure from the ASA about quitting smoking before surgery Receives: Drug: NRT (NicoDerm CQ); Behavioral: telephone counseling; Behavioral: brief advice; Behavioral: brochure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Smoking Status on the Day of Surgery (48-hour Point-prevalence Abstinence), by Self-report and Confirmed With Exhaled Carbon Monoxide (CO)
Confirmed abstinent. Abstinence confirmed with exhaled carbon monoxoide <10ppm.
Time Frame depends on date of preadmission clinic visit
Measured: day of surgery (expected average around 1-2 weeks after enrollment/randomization)
Secondary outcomes (14)
Frequency of Use of Product - Number Reporting Use Daily or Most Days
how often product (e-cigarette or patch) was used (everyday except while hospitalized, most days, a few times a week, once a week, less than once a week, not at all)
Result reported is those that used the product daily or most days
Measured: 8-weeks
Report of How Helpful the Product Was for Quitting
7-point likert scale (strongly disagree to strongly agree)
- strongly disagree
- disagree
- disagree somewhat
- neither agree nor disagree
- agree somewhat
- agree
- strongly agree
Measured: 8-weeks
How Satisfied the Patient Was With the Product (E-cigarette or Patch)
7-point likert scale (strongly disagree to strongly agree)
- strongly disagree
- disagree
- disagree somewhat
- neither agree nor disagree
- agree somewhat
- agree
- strongly agree
Measured: 8-weeks
How Likely the Patient Would be to Recommend the Product (E-cigarette or Patch) to Others
7-point likert scale (strongly disagree to strongly agree)
- strongly disagree
- disagree
- disagree somewhat
- neither agree nor disagree
- agree somewhat
- agree
- strongly agree
Measured: 8-weeks
Smoking Status 8-weeks After Randomization (Confirmed by Exhaled CO)
by self-report and confirmed by exhaled CO<10ppm - confirmed abstinent
Measured: 8-weeks
Smoking Reduction
50% or less regular cigarette use compared to baseline as determined by asking participants to self-report daily cigarette use in cigarettes per day at each time point.
Measured: on day of surgery and 8-weeks after randomization
Number of Participants With Dual Use
use of both regular and e-cigarettes concurrently
Measured: on day of surgery and 8-weeks after randomization
Spirometry - FEV1/FVC Change
Change in FEV1/FVC from baseline to day of surgery / 8-weeks. FEV1/FVC is expressed in percent. For example, if FEV1/FVC was 75%, 80%, and 85% at baseline, day of surgery and 8-weeks, result is reported as change in FEV1/FVC being +5% and +10% for day of surgery and 8-weeks respectively.
Measured: day of surgery and 8-weeks
Spirometry - FEV1
change in FEV1 (mL) compared to baseline
Measured: day of surgery and 8-weeks
Cotinine Level (Change in)
salivary
Measured: day of surgery and 8-weeks
Number of Participants With Postoperative Complications (Composite)
by chart review - research assistant or investigator examined notes and investigations postoperatively for complications by telephone self-report - patients were asked open-ended question about whether they experienced any postoperative complications
Measured: 30-days postop
Long-term Smoking Status - Use of Conventional Cigarettes
by self-report (7-day point prevalence)
Measured: 6 months
Number of Participants With Adverse Events as a Measure of Safety and Tolerability
all patients will be asked about adverse events each time they are contacted (day of surgery, 30-days postoperatively, and 8-weeks after randomization), and they will also be able to call to report adverse events to the study team any time during the study.
Measured: 8 weeks
Number of Participants Postoperative Complications (Composite)
by telephone self-report
Measured: 30-days postop
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2015 (estimated)
- Study startAug 2015
- Primary completionMay 2016
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SmokingStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Susan M Lee, MD, MAS, Principal investigator, UCSF / SFVAMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02482233
- Sponsor's protocol ID
- 14-15274
- Status last verified
- Mar 2022
- First submitted
- 17 Jun 2015
- Last updated
- 9 Mar 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Lee SM, Tenney R, Wallace AW, Arjomandi M. E-cigarettes versus nicotine patches for perioperative smoking cessation: a pilot randomized trial. PeerJ. 2018 Sep 28;6:e5609. doi: 10.7717/peerj.5609. eCollection 2018.
PubMed 30280019
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Randomized Controlled Clinical Trial - "Electronic Nicotine Delivery Device (E-cigarette) for Perioperative Smoking Cessation in Veterans"
- ClinicalTrials.gov ID
- NCT02482233
- Acronym / sponsor ID
- 14-15274
- Conditions
- Smoking, Nicotine Addiction, Surgery
- Keywords
- electronic cigarette, nicotine replacement therapy, smoking cessation, perioperative
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Study start
- Aug 2015
- Primary completion
- May 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 26 Jun 2015 (estimated)
- Results
- Posted 25 Jan 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this pilot randomized trial is to determine the feasibility of e-cigarettes and telephone counselling (compared to transdermal nicotine replacement and telephone counselling) as a harm-reduction tool that may lead to increased smoking cessation in the perioperative setting in smokers presenting for elective surgery at the San Francisco Veterans Affairs Medical Center. Secondary outcomes include acceptability of e-cigarettes over transdermal nicotine replacement, length-of-stay in the post-anesthesia care unit, hospital length-of-stay, postoperative complications within the first 30-days, and smoking status 8-weeks after randomization. This pilot study is designed to provide the preliminary data necessary to plan and fund a larger-scale randomized clinical trial that will assess the utility of e-cigarettes in achieving smoking cessation perioperatively. Our ultimate goal is to add to the limited existing data on the safety and efficacy of e-cigarette use in smoking cessation, specifically in the perioperative setting where the risks of continued smoking are great and the motivation to stop is high.
Detailed description
It is well-known that smokers suffer more complications and higher risk of mortality after surgery than non-smokers. Despite this knowledge, it is unclear what clinicians can do to minimize this risk. Surgery represents a 'teachable moment' that might encourage smokers to engage in permanent cessation. Several small trials have shown that smoking cessation interventions can increase smoking cessation and reduce postoperative complications, particularly wound-healing complications, which can have an absolute risk reduction of up to 25%. Smoking cessation initiated in the perioperative period can also promote long-term smoking cessation. Despite the benefits of comprehensive smoking cessation interventions including nicotine replacement therapy, current standard of care at the SFVAMC does not routinely include specific preoperative smoking cessation pharmacotherapy or counselling. Although there is an urgent need for more data, e-cigarettes have been proposed as an alternative to nicotine replacement therapy that are at least as effective for smoking cessation, and may be more acceptable to some patients.
The main hypothesis of this pilot study is that the use of e-cigarettes and telephone counselling, compared to telephone counselling and transdermal nicotine replacement, in the perioperative period results in increased smoking cessation on the day of surgery and at 8-weeks after randomization in smokers presenting for elective surgery. As secondary hypotheses, the study will also assess the acceptability of e-cigarettes versus nicotine patches, postoperative complications within the first 30-days, length-of-stay in the PACU and hospital length-of-stay. The investigators will examine the above hypotheses through the following aims:
" Aim 1) To determine how e-cigarettes plus counselling compare to transdermal nicotine replacement plus counselling for the achievement of smoking cessation, when introduced prior to elective surgery in veterans.
The investigators plan to carry-out a pilot randomized controlled trial with parallel design comparing e-cigarettes and telephone counselling with transdermal nicotine replacement and telephone counselling. Our primary outcome is smoking cessation on the day of surgery, as confirmed biochemically by exhaled carbon monoxide. Smoking reduction (self-reported cigarettes per day) of 50% or more and bedside spirometry readings will be assessed as secondary outcomes.
" Aim 2) To determine the acceptability of e-cigarettes amongst veterans as an aid for smoking cessation and to determine the feasibility of recruitment, randomization, and follow-up procedures in preparation for large-scale trial.
Through implementation of this pilot trial, the investigators will determine the feasibility and acceptability of e-cigarettes for smoking cessation perioperatively in the veteran population and obtain the preliminary data necessary to run a larger trial on the effectiveness of e-cigarettes as a perioperative smoking cessation aid.
" Aim 3) To determine the safety of e-cigarettes as a harm reduction strategy to achieve short-term perioperative smoking cessation.
The investigators plan to improve the overall knowledge of the safety of short-term e-cigarettes use through careful surveillance for adverse events and side effects.
" Aim 4) To determine if e-cigarette use preoperatively is associated with a lower risk of complications postoperatively.
The investigators plan to measure the following secondary outcomes: postoperative complications and mortality within the first 30 days, post-anesthesia care unit (PACU) length-of-stay, and hospital length-of-stay. This will help us understand if e-cigarettes have the potential to be used for harm-reduction perioperatively.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ENDD | Experimental | Behavioral: ENDD (NJOY), Behavioral: telephone counseling, Behavioral: brief advice, Behavioral: brochure6-week supply of disposable "NJOY" ENDDs (e-cigarettes) * the number of e-cigarettes will be determined by equating the number of e-cigarettes to the number of cigarettes smoked per day (1 pack per day = 2 e-cigarettes per day = 14 e-cigarettes/week) * veterans will be given detailed instructions for use and also instructed to start with the high nicotine content (4.5%) strength for three weeks, then decrease to the low nicotine content (2.4%) for two weeks, then switch to nicotine-free for the final week Both groups will receive: i) referral to the California Smokers' Helpline, ii) brief advice lasting less than 2 minutes, iii) a brochure from the ASA about quitting smoking before surgery |
| NRT (NicoDerm CQ) | Active comparator | Drug: NRT (NicoDerm CQ), Behavioral: telephone counseling, Behavioral: brief advice, Behavioral: brochureA prescription for 6 weeks of transdermal nicotine replacement (on-formulary at the VA) in the following doses: For smokers of 10 cigarettes per day or more, a 3-week supply of 21 mg/d, 1-week supply of 14 mg/d, 1-week supply of 7 mg/d, and 1-week of 0mg/d. Smokers of <10 cigarettes per day, 3 weeks of 14 mg/d patches 2 weeks of 7 mg/d patches, and 1-week of 0mg/d. Both groups will receive: i) referral to the California Smokers' Helpline, ii) brief advice lasting less than 2 minutes, iii) a brochure from the ASA about quitting smoking before surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- adults (age >18)
- any gender
- scheduled to undergo elective surgery at the San Francisco Veterans Affairs Medical Center (SFVAMC)
- daily smoker, based on self-report of at least 2 cigarettes/day and having smoked in the last 7 days
- presenting to the anesthesia preoperative (APO) clinic at least 3 days preoperatively
Key exclusion criteria (10 listed)
- emergency surgery (booked <24 hours preoperatively)
- consumers of non-cigarette forms of tobacco only (pipe, smokeless tobacco) or marijuana only
- already enrolled in a smoking cessation trial
- current smoking cessation pharmacotherapy
- daily user of e-cigarettes
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 |
|---|---|---|
| ENDD (NJOY)Also: electronic nicotine delivery device, NJOY e-cigarettesAs described above. | Behavioural | ENDD |
| NRT (NicoDerm CQ)Also: nicotine patchAs described above. | Drug | NRT (NicoDerm CQ) |
| telephone counselingReferral to the California Smokers' Helpline. California Smokers' Helpline will call the patient 4 times, or as agreed upon by the patient. | Behavioural | ENDD, NRT (NicoDerm CQ) |
| brief adviceBrief advice lasting less than 2 minutes will be delivered by the research assistant, investigator, or healthcare provider. The advice will be similar to the following statement (customized as needed to the patient): "The most important advice I can give you is that quitting smoking is the number one thing you can do for your health and to prepare yourself for surgery. Quitting smoking before surgery may improve your chances of healing quickly. There's evidence that the longer you quit before your surgery, the fewer complications you'll have. I encourage you to make use of the resources that have been provided to you to help you quit and set your quit date for as soon as possible." | Behavioural | ENDD, NRT (NicoDerm CQ) |
| brochureA brochure from the ASA (American Society of Anesthesiologists) about quitting smoking before surgery. Available free from the ASA: http://ecommerce.asahq.org/publicationsAndServices/PatientBrochure_%20For%20Posting.pdf | Behavioural | ENDD, NRT (NicoDerm CQ) |
Primary outcome
Smoking Status on the Day of Surgery (48-hour Point-prevalence Abstinence), by Self-report and Confirmed With Exhaled Carbon Monoxide (CO)
Time frame: day of surgery (expected average around 1-2 weeks after enrollment/randomization)
Confirmed abstinent. Abstinence confirmed with exhaled carbon monoxoide <10ppm. Time Frame depends on date of preadmission clinic visit
14 secondary outcomes
Frequency of Use of Product - Number Reporting Use Daily or Most Days
Time frame: 8-weeks
Report of How Helpful the Product Was for Quitting
Time frame: 8-weeks
How Satisfied the Patient Was With the Product (E-cigarette or Patch)
Time frame: 8-weeks
How Likely the Patient Would be to Recommend the Product (E-cigarette or Patch) to Others
Time frame: 8-weeks
Smoking Status 8-weeks After Randomization (Confirmed by Exhaled CO)
Time frame: 8-weeks
Smoking Reduction
Time frame: on day of surgery and 8-weeks after randomization
Number of Participants With Dual Use
Time frame: on day of surgery and 8-weeks after randomization
Spirometry - FEV1/FVC Change
Time frame: day of surgery and 8-weeks
Spirometry - FEV1
Time frame: day of surgery and 8-weeks
Cotinine Level (Change in)
Time frame: day of surgery and 8-weeks
Number of Participants With Postoperative Complications (Composite)
Time frame: 30-days postop
Long-term Smoking Status - Use of Conventional Cigarettes
Time frame: 6 months
Number of Participants With Adverse Events as a Measure of Safety and Tolerability
Time frame: 8 weeks
Number of Participants Postoperative Complications (Composite)
Time frame: 30-days postop
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 30280019Lee SM, Tenney R, Wallace AW, Arjomandi M. E-cigarettes versus nicotine patches for perioperative smoking cessation: a pilot randomized trial. PeerJ. 2018 Sep 28;6:e5609. doi: 10.7717/peerj.5609. eCollection 2018.
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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.
Susan M Lee, MD, MAS principal investigator
UCSF / SFVAMC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing ENDD (NJOY), NRT (NicoDerm CQ) and telephone counseling in people with Smoking and Nicotine Addiction, run by University of California, San Francisco 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 5 inclusion and 10 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 9 Mar 2022. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 25 Jan 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Smoking Status on the Day of Surgery (48-hour Point-prevalence Abstinence), by Self-report and Confirmed With Exhaled Carbon Monoxide (CO) (time frame: day of surgery (expected average around 1-2 weeks after enrollment/randomization)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02482233, which also lists 1 linked publication.
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 9 Mar 2022.