The END Perioperative Smoking Pilot Study

• ClinicalTrials.gov Identifier: NCT02482233
• Recruitment Status: Completed
• First Posted: June 26, 2015
• Results First Posted: January 25, 2019
• Last Update Posted: March 9, 2022
• Sponsor: University of California, San Francisco
• Information provided by (Responsible Party): University of California, San Francisco

Study Description

Brief 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 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.

Condition or disease	Intervention/treatment	Phase
Smoking; Nicotine Addiction; Surgery	Behavioral: ENDD (NJOY); Drug: NRT (NicoDerm CQ); Behavioral: telephone counseling; Behavioral: brief advice; Behavioral: brochure	Phase 4

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

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 30 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: A Pilot Randomized Controlled Clinical Trial - "Electronic Nicotine Delivery Device (E-cigarette) for Perioperative Smoking Cessation in Veterans"
• Study Start Date: August 2015
• Actual Primary Completion Date: May 2016
• Actual Study Completion Date: September 2016

Arms and Interventions

Arm	Intervention/treatment
Experimental: ENDD; 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	Behavioral: ENDD (NJOY); As described above.; Other Names: electronic nicotine delivery device; NJOY e-cigarettes; Behavioral: telephone counseling; Referral to the California Smokers' Helpline. California Smokers' Helpline will call the patient 4 times, or as agreed upon by the patient.; Behavioral: brief advice; 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."; Behavioral: brochure; 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
Active Comparator: NRT (NicoDerm CQ); 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	Drug: NRT (NicoDerm CQ); As described above.; Other Name: nicotine patch; Behavioral: telephone counseling; Referral to the California Smokers' Helpline. California Smokers' Helpline will call the patient 4 times, or as agreed upon by the patient.; Behavioral: brief advice; 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."; Behavioral: brochure; 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

Outcome Measures

Primary Outcome Measures :

1. 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

Secondary Outcome Measures :

1. Frequency of Use of Product - Number Reporting Use Daily or Most Days [ Time Frame: 8-weeks ]

   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

2. Report of How Helpful the Product Was for Quitting [ Time Frame: 8-weeks ]

   7-point likert scale (strongly disagree to strongly agree)

   1. strongly disagree
   2. disagree
   3. disagree somewhat
   4. neither agree nor disagree
   5. agree somewhat
   6. agree
   7. strongly agree
3. How Satisfied the Patient Was With the Product (E-cigarette or Patch) [ Time Frame: 8-weeks ]

   7-point likert scale (strongly disagree to strongly agree)

   1. strongly disagree
   2. disagree
   3. disagree somewhat
   4. neither agree nor disagree
   5. agree somewhat
   6. agree
   7. strongly agree
4. How Likely the Patient Would be to Recommend the Product (E-cigarette or Patch) to Others [ Time Frame: 8-weeks ]

   7-point likert scale (strongly disagree to strongly agree)

   1. strongly disagree
   2. disagree
   3. disagree somewhat
   4. neither agree nor disagree
   5. agree somewhat
   6. agree
   7. strongly agree
5. Smoking Status 8-weeks After Randomization (Confirmed by Exhaled CO) [ Time Frame: 8-weeks ]
   by self-report and confirmed by exhaled CO<10ppm - confirmed abstinent
6. Smoking Reduction [ Time Frame: on day of surgery and 8-weeks after randomization ]
   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.
7. Number of Participants With Dual Use [ Time Frame: on day of surgery and 8-weeks after randomization ]
   use of both regular and e-cigarettes concurrently
8. Spirometry - FEV1/FVC Change [ Time Frame: day of surgery and 8-weeks ]
   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.
9. Spirometry - FEV1 [ Time Frame: day of surgery and 8-weeks ]
   change in FEV1 (mL) compared to baseline
10. Cotinine Level (Change in) [ Time Frame: day of surgery and 8-weeks ]
    salivary
11. Number of Participants With Postoperative Complications (Composite) [ Time Frame: 30-days postop ]
    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
12. Long-term Smoking Status - Use of Conventional Cigarettes [ Time Frame: 6 months ]
    by self-report (7-day point prevalence)
13. Number of Participants With Adverse Events as a Measure of Safety and Tolerability [ Time Frame: 8 weeks ]
    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.
14. Number of Participants Postoperative Complications (Composite) [ Time Frame: 30-days postop ]
    by telephone self-report

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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
• 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)

Contacts and Locations

Locations

United States, California

San Francisco VA Medical Center

San Francisco, California, United States, 94121

Sponsors and Collaborators

University of California, San Francisco

Investigators

• Principal Investigator: Susan M Lee, MD, MAS; UCSF / SFVAMC

More Information

Additional Information:

Full peer-reviewed results 

Publications of Results:

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.

• Responsible Party: University of California, San Francisco
• ClinicalTrials.gov Identifier: NCT02482233
• Other Study ID Numbers: 14-15274
• First Posted: June 26, 2015
• Results First Posted: January 25, 2019
• Last Update Posted: March 9, 2022
• Last Verified: March 2022

Keywords provided by University of California, San Francisco:

electronic cigarette; nicotine replacement therapy; smoking cessation; perioperative

Additional relevant MeSH terms:

Tobacco Use Disorder; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Nicotine; Ganglionic Stimulants; Autonomic Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Nicotinic Agonists; Cholinergic Agonists; Cholinergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action