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Completed

NCT Number: NCT02212041

Electronic Cigarettes in Smokers With Mental Illness

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.

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Key information

Conditions

Schizophrenia Behavior Bipolar Disorder Bipolar and Related Disorders Mental Disorders Mood Disorders Psychotic Disorders Schizophrenia Spectrum and Other Psychotic Disorders Schizophreniform Disorder Smoking Vaping

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

South London and Maudsley Foundation Trust (SLaM)

London, SE5 8AF, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

disposable electronic cigarettes

Other

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 names: NJOY

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

King's College London

Other

Registry information

Official study title

Acceptability, Patterns of Use and Safety of Electronic Cigarette in People With Mental Illness: a Pilot Study

Acronym: APUS e-Cigs

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Aug 8, 2014
Registry last updated
May 16, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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