The END Perioperative Smoking Pilot Study

Phase 4

Completed

Conditions: Smoking
Surgery
Nicotine Addiction

Interventions: Behavioral: ENDD (NJOY)
Drug: NRT (NicoDerm CQ)
Behavioral: telephone counseling
Behavioral: brief advice
Behavioral: brochure

Registration Number: NCT02482233

Lead Sponsor: University of California, San Francisco

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.

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 30

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)

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
NRT (NicoDerm CQ)	brochure	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
ENDD	brochure	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
NRT (NicoDerm CQ)	telephone counseling	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
NRT (NicoDerm CQ)	brief advice	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
ENDD	ENDD (NJOY)	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
ENDD	telephone counseling	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
ENDD	brief advice	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
NRT (NicoDerm CQ)	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

Primary Outcome Measures

Name	Time	Method
Smoking Status on the Day of Surgery (48-hour Point-prevalence Abstinence), by Self-report and Confirmed With Exhaled Carbon Monoxide (CO)	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

Name	Time	Method
How Satisfied the Patient Was With the Product (E-cigarette or Patch)	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
Spirometry - FEV1/FVC Change	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.
Cotinine Level (Change in)	day of surgery and 8-weeks	salivary
Number of Participants Postoperative Complications (Composite)	30-days postop	by telephone self-report
Smoking Reduction	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.
Long-term Smoking Status - Use of Conventional Cigarettes	6 months	by self-report (7-day point prevalence)
Number of Participants With Postoperative Complications (Composite)	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
Report of How Helpful the Product Was for Quitting	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
Frequency of Use of Product - Number Reporting Use Daily or Most Days	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
How Likely the Patient Would be to Recommend the Product (E-cigarette or Patch) to Others	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
Smoking Status 8-weeks After Randomization (Confirmed by Exhaled CO)	8-weeks	by self-report and confirmed by exhaled CO\<10ppm - confirmed abstinent
Number of Participants With Dual Use	on day of surgery and 8-weeks after randomization	use of both regular and e-cigarettes concurrently
Spirometry - FEV1	day of surgery and 8-weeks	change in FEV1 (mL) compared to baseline
Number of Participants With Adverse Events as a Measure of Safety and Tolerability	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.