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The END Perioperative Smoking Pilot Study

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ClinicalTrials.gov Identifier: NCT02482233
Recruitment Status : Unknown
Verified September 2015 by Susan Ming Lee, MD, University of California, San Francisco.
Recruitment status was:  Recruiting
First Posted : June 26, 2015
Last Update Posted : September 14, 2015
Sponsor:
Information provided by (Responsible Party):
Susan Ming Lee, MD, 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.

Condition or disease Intervention/treatment Phase
Smoking Nicotine Addiction Surgery Behavioral: ENDD (NJOY) Drug: NRT (NicoDerm CQ) Behavioral: telephone counseling Behavioral: brief advice Behavioral: brochure Phase 4

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Pilot Randomized Controlled Clinical Trial - "Electronic Nicotine Delivery Device (E-cigarette) for Perioperative Smoking Cessation in Veterans"
Study Start Date : August 2015
Estimated Primary Completion Date : December 2015
Estimated Study Completion Date : February 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: ENDD

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

Behavioral: ENDD (NJOY)
As described above.
Other Names:
  • electronic nicotine delivery device
  • NJOY e-cigarettes

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


Active Comparator: 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

Drug: NRT (NicoDerm CQ)
As described above.
Other Name: nicotine patch

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





Primary Outcome Measures :
  1. Smoking status on the day of surgery (48-hour point-prevalence abstinence), by self-report and confirmed with exhaled carbon monoxide (CO) [ Time Frame: day of surgery (expected average around 1-2 weeks after enrollment/randomization) ]
    Time Frame depends on date of preadmission clinic visit


Secondary Outcome Measures :
  1. Frequency of use of product [ Time Frame: 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)

  2. Report of how helpful the product was for quitting [ Time Frame: 8-weeks ]
    7-point likert scale (strongly disagree to strongly agree)

  3. how satisfied the patient was with the product (e-cigarette or patch) [ Time Frame: 8-weeks ]
    7-point likert scale (strongly disagree to strongly agree)

  4. how likely the patient would be to recommend the product (e-cigarette or patch) to others [ Time Frame: 8-weeks ]
    7-point likert scale (strongly disagree to strongly agree)

  5. Smoking status 8-weeks after randomization [ Time Frame: 8-weeks ]
    by self-report, as confirmed by exhaled CO

  6. Smoking reduction [ Time Frame: on day of surgery and 8-weeks after randomization ]
    50% or less regular cigarette use compared to baseline

  7. number of participants with dual use [ Time Frame: on day of surgery and 8-weeks after randomization ]
    use of both regular and e-cigarettes concurrently

  8. spirometry [ Time Frame: day of surgery and 8-weeks ]
    FEV1, FVC

  9. cotinine level [ Time Frame: day of surgery and 8-weeks ]
    salivary

  10. postoperative complications (composite) [ Time Frame: 30-days postop ]
    by telephone self-report and chart review

  11. length-of-stay [ Time Frame: day of surgery and immediate postoperative period ]
    PACU and hospital

  12. long-term smoking status - use of conventional cigarettes [ Time Frame: 6 months ]
    by self-report (7-day point prevalence)

  13. long-term smoking status - use of e-cigarettes [ Time Frame: 6 months ]
    by self-report (7-day point prevalence)

  14. Number of Participants with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: 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.


Other Outcome Measures:
  1. qualitative data [ Time Frame: 8-week post-randomization ]
    detailed semi-structured audio-recorded interview to determine attitudes and experiences with e-cigarettes and nicotine replacement during the perioperative period



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02482233


Contacts
Contact: Susan M Lee, MD, MAS susan.lee5@va.gov
Contact: Arthur W Wallace, MD, PhD

Locations
United States, California
San Francisco VA Medical Center Recruiting
San Francisco, California, United States, 94121
Contact: Susan M Lee, MD, FRCPC, MAS    4154433604    lees4@anesthesia.ucsf.edu   
Contact: Arthur Wallace, MD, PhD    415-750-2069    art.wallace@va.gov   
Sponsors and Collaborators
University of California, San Francisco
Investigators
Principal Investigator: Susan M Lee, MD, MAS UCSF / SFVAMC

Responsible Party: Susan Ming Lee, MD, Health Sciences Clinical Instructor, University of California, San Francisco
ClinicalTrials.gov Identifier: NCT02482233     History of Changes
Other Study ID Numbers: 14-15274
First Posted: June 26, 2015    Key Record Dates
Last Update Posted: September 14, 2015
Last Verified: September 2015

Keywords provided by Susan Ming Lee, MD, University of California, San Francisco:
electronic cigarette
nicotine replacement therapy
smoking cessation
perioperative

Additional relevant MeSH terms:
Nicotine
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action