The END Perioperative Smoking Pilot Study

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.

Conditions

• Smoking
• Nicotine Addiction
• Surgery

Interventions

BEHAVIORAL

ENDD (NJOY)

As described above.

DRUG

NRT (NicoDerm CQ)

As described above.

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

Sponsors & Collaborators

• University of California, San Francisco

  lead OTHER

Principal Investigators

• Susan M Lee, MD, MAS · UCSF / SFVAMC

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2015-08-31

Primary Completion

2016-05-31

Completion

2016-09-30

Countries

• United States

Study Locations