The END Perioperative Smoking Pilot Study

• Status: Completed
• Trial end date: 2016-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of California, San Francisco
• Treatments: Nicotine

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)