Clinical trial NCT02482233: The END Perioperative Smoking Pilot Study
Official title: A Pilot Randomized Controlled Clinical Trial - "Electronic Nicotine Delivery Device (E-cigarette) for Perioperative Smoking Cessation in Veterans"
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Smoking
Nicotine Addiction
Surgery
Keywords: electronic cigarette
nicotine replacement therapy
smoking cessation
perioperative
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
First posted: 2015-06-26
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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)

Primary outcomes:
measure: Smoking Status on the Day of Surgery (48-hour Point-prevalence Abstinence), by Self-report and Confirmed With Exhaled Carbon Monoxide (CO)
timeFrame: day of surgery (expected average around 1-2 weeks after enrollment/randomization)
Secondary outcomes:
measure: Frequency of Use of Product - Number Reporting Use Daily or Most Days
timeFrame: 8-weeks
measure: Report of How Helpful the Product Was for Quitting
timeFrame: 8-weeks
measure: How Satisfied the Patient Was With the Product (E-cigarette or Patch)
timeFrame: 8-weeks
measure: How Likely the Patient Would be to Recommend the Product (E-cigarette or Patch) to Others
timeFrame: 8-weeks
measure: Smoking Status 8-weeks After Randomization (Confirmed by Exhaled CO)
timeFrame: 8-weeks
measure: Smoking Reduction
timeFrame: on day of surgery and 8-weeks after randomization
measure: Number of Participants With Dual Use
timeFrame: on day of surgery and 8-weeks after randomization
measure: Spirometry - FEV1/FVC Change
timeFrame: day of surgery and 8-weeks
measure: Spirometry - FEV1
timeFrame: day of surgery and 8-weeks
measure: Cotinine Level (Change in)
timeFrame: day of surgery and 8-weeks
measure: Number of Participants With Postoperative Complications (Composite)
timeFrame: 30-days postop
measure: Long-term Smoking Status - Use of Conventional Cigarettes
timeFrame: 6 months
measure: Number of Participants With Adverse Events as a Measure of Safety and Tolerability
timeFrame: 8 weeks
measure: Number of Participants Postoperative Complications (Composite)
timeFrame: 30-days postop
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: San Francisco VA Medical Center
state: California
Study officials:
affiliation: UCSF / SFVAMC
name: Susan M Lee, MD, MAS
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.