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Electronic Cigarettes in Smokers With Mental Illness (APUS e-Cigs)

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ClinicalTrials.gov Identifier: NCT02212041
Recruitment Status : Completed
First Posted : August 8, 2014
Last Update Posted : May 16, 2017
Sponsor:
Information provided by (Responsible Party):
King's College London

Brief Summary:

People with mental illness are more likely to smoke and are more severely addicted to nicotine than the general population. As a result, the number of deaths related to tobacco is higher.

Smoking is highly addictive because it delivers nicotine very quickly. Research studies show that people who use nicotine replacement therapies (such us patches, gums, etc) are more likely to quit smoking than those who try to quit without using these nicotine products. Recently a new electronic nicotine delivery system (ENDS), also known as electronic cigarette (e-cigarette) is rapidly gaining popularity. Electronic cigarettes are devices that mimic traditional cigarettes and deliver nicotine but do not carry the dangerous chemicals contained in tobacco cigarettes.

Given the increasing popularity of e-cigs, there is an urgent need to improve our understanding of both the potential benefits and risks of e-cigs use in people with serious mental illness. In this pilot we propose inviting 50 people with schizophrenia (or schizophrenia-related disorder) who are not intending to quit smoking in the near future to take part in a study in which we will provide 6-weeks of free e-cigs, followed by a 4-week period in which they will not receive free e-cigs and we monitor which products participants choose, and a final 24-week follow-up visit. During the 24-week study period we will assess the use of e-cigs and tobacco cigarettes, the exposure to nicotine and tobacco toxicants, nicotine withdrawal symptoms, the changes in respiratory symptoms and psychiatric symptoms as well as the e-cigs perceived benefits and risks.


Condition or disease Intervention/treatment Phase
Schizophrenia Schizophreniform Disorder Bipolar Disorder Other: disposable electronic cigarettes Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Acceptability, Patterns of Use and Safety of Electronic Cigarette in People With Mental Illness: a Pilot Study
Actual Study Start Date : September 24, 2014
Actual Primary Completion Date : May 2, 2017
Actual Study Completion Date : May 2, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Electronic cigarettes
Free disposable electronic cigarettes will be provided during 6 weeks to smokers with serious mental illness.
Other: disposable electronic cigarettes

Participants will receive e-cigs free of charge during 6-week. Each week for 6 weeks, participants will receive enough e-cigs to cover 150% of their usual weekly cigarette smoking rate. We will encourage participants to use the e-cigs whenever they would usually smoke a cigarette.

During a 4-week post-distribution period, we will assess e-cig and cigarette use and other measures when e-cigs are not being freely provided and participants must purchase them on their own. The Week 10 session at the end of this period includes assessment of total nicotine intake, nicotine dependence, subjective and reinforcing effects of e-cigs and cigarettes, attitudes toward e-cigs, motivation to quit and self-efficacy for smoking cessation. At the Week 24 follow-up session we will again collect these measures to determine if any changes observed during the intervention phases have been maintained.

Other Name: NJOY




Primary Outcome Measures :
  1. Electronic cigarette use [ Time Frame: weekly measurements from baseline to 10 weeks and a final assessment at 24 weeks ]
    Time Line Follow Back (TLFB) questionnaire

  2. electronic cigarette acceptability [ Time Frame: Baseline, week 2, week6, week 10 and week 24 ]
    electronic cigarette evaluation scale (it measures product liking, satisfaction, sensory and physical effects)

  3. Respiratory symptoms [ Time Frame: weekly measures from baseline to 10 weeks and at 24 weeks ]
    An abbreviated and adapted version of the American Thoracic Society Questionnaire (ATS) will be used to assess respiratory symptoms.

  4. Cotinine [ Time Frame: Baseline, week 2, 6, 10 and 24 ]
    Cotinine levels in urine

  5. Nitrosamines [ Time Frame: Baseline and at 6 week ]
    NNAL and 3-HPMA levels in urine

  6. Side effects of antipsychotics [ Time Frame: weekly the first 10 weeks and at 24 weeks ]
    The Udvalg for Kliniske Undersøgelser (UKU) scale

  7. Withdrawal symptoms [ Time Frame: weekly the first 10 weeks and at 24 weeks ]
    Mood and Physical Symptoms Scale, MPSS

  8. Respiratory symptoms [ Time Frame: weekly the first 10 weeks and at 24 weeks ]
    Peak Expiratory Flow Rate (PEFR) to monitor airway obstruction, assess its severity and variation.


Secondary Outcome Measures :
  1. Predictors of e-Cigs use [ Time Frame: Baseline, week 2, 6, 10 and 24. ]
    Motivation To Stop Scale -MTSS-

  2. Predictors of e-Cigs use [ Time Frame: Baseline, week 2, 6, 10 and 24 ]
    Smoking Consequences Questionnaire

  3. Psychiatric symptoms [ Time Frame: weekly during the first 10 weeks and at 24 weeks ]
    Positive and Negative Syndrome Scale

  4. Psychiatric symptoms [ Time Frame: weekly the first 10 weeks and at 24 weeks ]
    Calgary Depression Scale for Schizophrenia

  5. Physical symptoms [ Time Frame: weekly the first 10 weeks and at 24 weeks ]
    Blood pressure and heart rate



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • smokers (≥ 5 cigarettes/day for > 1 yr and breath CO > 5 ppm)
  • ages 18-65 years
  • ICD-10 diagnosis of schizophreniform, schizophrenia, schizoaffective or bipolar disorder

Exclusion Criteria:

  • used e-cigs on > 2 occasions in the past 30 days;
  • intend to quit smoking within the next 30 days;
  • currently use medications that may reduce smoking (bupropion, varenicline, NRT, naltrexone, buprenorphine, acamprosate, baclofen, clonidine, nortriptyline, anti-seizure medications, disulfiram);
  • have unstable psychiatric conditions (hospitalization or change in dose of chronic medication in the past 30 days);
  • People with a serious medical condition including uncontrolled high blood pressure, something wrong with their heart or blood vessels that occurred or got worse in the past 3 months (including fast or irregular heart rhythm, angina, chest pain, had a heart attack or stroke).
  • People who have ever had a serious stomach ulcer, and/or phaeochromocytoma (tumor of the adrenal gland).
  • People who in the last 3 months have had severe heartburn; or a stroke, or unstable kidney disease, unstable liver disease, uncontrolled over-active thyroid gland
  • met DSM-IV criteria for drug dependence
  • have medical contraindications to nicotine, since nicotine intake may increase in this study;
  • have past-month suicidal ideation or past-year suicide attempt.
  • are pregnant, as determined through a pregnancy test

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): NCT02212041


Locations
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United Kingdom
South London and Maudsley Foundation Trust (SLaM)
London, United Kingdom, SE5 8AF
Sponsors and Collaborators
King's College London
Investigators
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Principal Investigator: Rocio Perez-Iglesias, MD, PhD King's College London
Principal Investigator: Ann McNeill, BSc, PhD, Prof King's College London
Principal Investigator: Lynne Dawkins, BSc, PhD University of East London
Principal Investigator: John Moxham, MD, PhD, Prof King's College London
Principal Investigator: Philip McGuire, MD, PhD, Prof King's College London

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: King's College London
ClinicalTrials.gov Identifier: NCT02212041     History of Changes
Other Study ID Numbers: 149240
First Posted: August 8, 2014    Key Record Dates
Last Update Posted: May 16, 2017
Last Verified: August 2015
Keywords provided by King's College London:
electronic cigarettes
smoking
schizophrenia
serious mental illness
Additional relevant MeSH terms:
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Disease
Schizophrenia
Bipolar Disorder
Mental Disorders
Psychotic Disorders
Pathologic Processes
Schizophrenia Spectrum and Other Psychotic Disorders
Bipolar and Related Disorders