The END Perioperative Smoking Pilot Study
A Pilot Randomized Controlled Clinical Trial - "Electronic Nicotine Delivery Device (E-cigarette) for Perioperative Smoking Cessation in Veterans"
1 other identifier
interventional
30
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4
Started Aug 2015
Shorter than P25 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 17, 2015
CompletedFirst Posted
Study publicly available on registry
June 26, 2015
CompletedStudy Start
First participant enrolled
August 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2016
CompletedResults Posted
Study results publicly available
January 25, 2019
CompletedMarch 9, 2022
March 1, 2022
9 months
June 17, 2015
November 9, 2018
March 7, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
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
8-weeks
Report of How Helpful the Product Was for Quitting
8-weeks
How Satisfied the Patient Was With the Product (E-cigarette or Patch)
8-weeks
How Likely the Patient Would be to Recommend the Product (E-cigarette or Patch) to Others
8-weeks
Smoking Status 8-weeks After Randomization (Confirmed by Exhaled CO)
8-weeks
- +9 more secondary outcomes
Study Arms (2)
ENDD
EXPERIMENTAL6-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 COMPARATORA 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
Interventions
As described above.
Referral to the California Smokers' Helpline. California Smokers' Helpline will call the patient 4 times, or as agreed upon by the patient.
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."
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
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
San Francisco VA Medical Center
San Francisco, California, 94121, United States
Related Publications (1)
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.
PMID: 30280019RESULT
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Susan Ming Lee
- Organization
- Royal Columbian Hospital / University of British Columbia
Study Officials
- PRINCIPAL INVESTIGATOR
Susan M Lee, MD, MAS
UCSF / SFVAMC
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 17, 2015
First Posted
June 26, 2015
Study Start
August 1, 2015
Primary Completion
May 1, 2016
Study Completion
September 1, 2016
Last Updated
March 9, 2022
Results First Posted
January 25, 2019
Record last verified: 2022-03