<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02212041</url>
  </required_header>
  <id_info>
    <org_study_id>149240</org_study_id>
    <nct_id>NCT02212041</nct_id>
  </id_info>
  <brief_title>Electronic Cigarettes in Smokers With Mental Illness</brief_title>
  <acronym>APUS e-Cigs</acronym>
  <official_title>Acceptability, Patterns of Use and Safety of Electronic Cigarette in People With Mental Illness: a Pilot Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>King's College London</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>King's College London</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      People with mental illness are more likely to smoke and are more severely addicted to&#xD;
      nicotine than the general population. As a result, the number of deaths related to tobacco is&#xD;
      higher.&#xD;
&#xD;
      Smoking is highly addictive because it delivers nicotine very quickly. Research studies show&#xD;
      that people who use nicotine replacement therapies (such us patches, gums, etc) are more&#xD;
      likely to quit smoking than those who try to quit without using these nicotine products.&#xD;
      Recently a new electronic nicotine delivery system (ENDS), also known as electronic cigarette&#xD;
      (e-cigarette) is rapidly gaining popularity. Electronic cigarettes are devices that mimic&#xD;
      traditional cigarettes and deliver nicotine but do not carry the dangerous chemicals&#xD;
      contained in tobacco cigarettes.&#xD;
&#xD;
      Given the increasing popularity of e-cigs, there is an urgent need to improve our&#xD;
      understanding of both the potential benefits and risks of e-cigs use in people with serious&#xD;
      mental illness. In this pilot we propose inviting 50 people with schizophrenia (or&#xD;
      schizophrenia-related disorder) who are not intending to quit smoking in the near future to&#xD;
      take part in a study in which we will provide 6-weeks of free e-cigs, followed by a 4-week&#xD;
      period in which they will not receive free e-cigs and we monitor which products participants&#xD;
      choose, and a final 24-week follow-up visit. During the 24-week study period we will assess&#xD;
      the use of e-cigs and tobacco cigarettes, the exposure to nicotine and tobacco toxicants,&#xD;
      nicotine withdrawal symptoms, the changes in respiratory symptoms and psychiatric symptoms as&#xD;
      well as the e-cigs perceived benefits and risks.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 24, 2014</start_date>
  <completion_date type="Actual">May 2, 2017</completion_date>
  <primary_completion_date type="Actual">May 2, 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Electronic cigarette use</measure>
    <time_frame>weekly measurements from baseline to 10 weeks and a final assessment at 24 weeks</time_frame>
    <description>Time Line Follow Back (TLFB) questionnaire</description>
  </primary_outcome>
  <primary_outcome>
    <measure>electronic cigarette acceptability</measure>
    <time_frame>Baseline, week 2, week6, week 10 and week 24</time_frame>
    <description>electronic cigarette evaluation scale (it measures product liking, satisfaction, sensory and physical effects)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Respiratory symptoms</measure>
    <time_frame>weekly measures from baseline to 10 weeks and at 24 weeks</time_frame>
    <description>An abbreviated and adapted version of the American Thoracic Society Questionnaire (ATS) will be used to assess respiratory symptoms.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Cotinine</measure>
    <time_frame>Baseline, week 2, 6, 10 and 24</time_frame>
    <description>Cotinine levels in urine</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Nitrosamines</measure>
    <time_frame>Baseline and at 6 week</time_frame>
    <description>NNAL and 3-HPMA levels in urine</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Side effects of antipsychotics</measure>
    <time_frame>weekly the first 10 weeks and at 24 weeks</time_frame>
    <description>The Udvalg for Kliniske Undersøgelser (UKU) scale</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Withdrawal symptoms</measure>
    <time_frame>weekly the first 10 weeks and at 24 weeks</time_frame>
    <description>Mood and Physical Symptoms Scale, MPSS</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Respiratory symptoms</measure>
    <time_frame>weekly the first 10 weeks and at 24 weeks</time_frame>
    <description>Peak Expiratory Flow Rate (PEFR) to monitor airway obstruction, assess its severity and variation.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Predictors of e-Cigs use</measure>
    <time_frame>Baseline, week 2, 6, 10 and 24.</time_frame>
    <description>Motivation To Stop Scale -MTSS-</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Predictors of e-Cigs use</measure>
    <time_frame>Baseline, week 2, 6, 10 and 24</time_frame>
    <description>Smoking Consequences Questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Psychiatric symptoms</measure>
    <time_frame>weekly during the first 10 weeks and at 24 weeks</time_frame>
    <description>Positive and Negative Syndrome Scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Psychiatric symptoms</measure>
    <time_frame>weekly the first 10 weeks and at 24 weeks</time_frame>
    <description>Calgary Depression Scale for Schizophrenia</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Physical symptoms</measure>
    <time_frame>weekly the first 10 weeks and at 24 weeks</time_frame>
    <description>Blood pressure and heart rate</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">50</enrollment>
  <condition>Schizophrenia</condition>
  <condition>Schizophreniform Disorder</condition>
  <condition>Bipolar Disorder</condition>
  <arm_group>
    <arm_group_label>Electronic cigarettes</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Free disposable electronic cigarettes will be provided during 6 weeks to smokers with serious mental illness.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>disposable electronic cigarettes</intervention_name>
    <description>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.&#xD;
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.</description>
    <arm_group_label>Electronic cigarettes</arm_group_label>
    <other_name>NJOY</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  smokers (≥ 5 cigarettes/day for &gt; 1 yr and breath CO &gt; 5 ppm)&#xD;
&#xD;
          -  ages 18-65 years&#xD;
&#xD;
          -  ICD-10 diagnosis of schizophreniform, schizophrenia, schizoaffective or bipolar&#xD;
             disorder&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  used e-cigs on &gt; 2 occasions in the past 30 days;&#xD;
&#xD;
          -  intend to quit smoking within the next 30 days;&#xD;
&#xD;
          -  currently use medications that may reduce smoking (bupropion, varenicline, NRT,&#xD;
             naltrexone, buprenorphine, acamprosate, baclofen, clonidine, nortriptyline,&#xD;
             anti-seizure medications, disulfiram);&#xD;
&#xD;
          -  have unstable psychiatric conditions (hospitalization or change in dose of chronic&#xD;
             medication in the past 30 days);&#xD;
&#xD;
          -  People with a serious medical condition including uncontrolled high blood pressure,&#xD;
             something wrong with their heart or blood vessels that occurred or got worse in the&#xD;
             past 3 months (including fast or irregular heart rhythm, angina, chest pain, had a&#xD;
             heart attack or stroke).&#xD;
&#xD;
          -  People who have ever had a serious stomach ulcer, and/or phaeochromocytoma (tumor of&#xD;
             the adrenal gland).&#xD;
&#xD;
          -  People who in the last 3 months have had severe heartburn; or a stroke, or unstable&#xD;
             kidney disease, unstable liver disease, uncontrolled over-active thyroid gland&#xD;
&#xD;
          -  met DSM-IV criteria for drug dependence&#xD;
&#xD;
          -  have medical contraindications to nicotine, since nicotine intake may increase in this&#xD;
             study;&#xD;
&#xD;
          -  have past-month suicidal ideation or past-year suicide attempt.&#xD;
&#xD;
          -  are pregnant, as determined through a pregnancy test&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Rocio Perez-Iglesias, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>King's College London</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Ann McNeill, BSc, PhD, Prof</last_name>
    <role>Principal Investigator</role>
    <affiliation>King's College London</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Lynne Dawkins, BSc, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of East London</affiliation>
  </overall_official>
  <overall_official>
    <last_name>John Moxham, MD, PhD, Prof</last_name>
    <role>Principal Investigator</role>
    <affiliation>King's College London</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Philip McGuire, MD, PhD, Prof</last_name>
    <role>Principal Investigator</role>
    <affiliation>King's College London</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>South London and Maudsley Foundation Trust (SLaM)</name>
      <address>
        <city>London</city>
        <zip>SE5 8AF</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>August 2015</verification_date>
  <study_first_submitted>August 6, 2014</study_first_submitted>
  <study_first_submitted_qc>August 6, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 8, 2014</study_first_posted>
  <last_update_submitted>May 15, 2017</last_update_submitted>
  <last_update_submitted_qc>May 15, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">May 16, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>electronic cigarettes</keyword>
  <keyword>smoking</keyword>
  <keyword>schizophrenia</keyword>
  <keyword>serious mental illness</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Schizophrenia</mesh_term>
    <mesh_term>Bipolar Disorder</mesh_term>
    <mesh_term>Mental Disorders</mesh_term>
    <mesh_term>Psychotic Disorders</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02212041
org study id: 149240
nct id: NCT02212041
lead sponsor: 
has dmc: No
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.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Other
masking: None (Open Label)
measure: Electronic cigarette use
time frame: weekly measurements from baseline to 10 weeks and a final assessment at 24 weeks
description: Time Line Follow Back (TLFB) questionnaire
measure: electronic cigarette acceptability
time frame: Baseline, week 2, week6, week 10 and week 24
description: electronic cigarette evaluation scale (it measures product liking, satisfaction, sensory and physical effects)
measure: Respiratory symptoms
time frame: weekly measures from baseline to 10 weeks and at 24 weeks
description: An abbreviated and adapted version of the American Thoracic Society Questionnaire (ATS) will be used to assess respiratory symptoms.
measure: Cotinine
time frame: Baseline, week 2, 6, 10 and 24
description: Cotinine levels in urine
measure: Nitrosamines
time frame: Baseline and at 6 week
description: NNAL and 3-HPMA levels in urine
measure: Side effects of antipsychotics
time frame: weekly the first 10 weeks and at 24 weeks
description: The Udvalg for Kliniske Undersøgelser (UKU) scale
measure: Withdrawal symptoms
time frame: weekly the first 10 weeks and at 24 weeks
description: Mood and Physical Symptoms Scale, MPSS
measure: Respiratory symptoms
time frame: weekly the first 10 weeks and at 24 weeks
description: Peak Expiratory Flow Rate (PEFR) to monitor airway obstruction, assess its severity and variation.
measure: Predictors of e-Cigs use
time frame: Baseline, week 2, 6, 10 and 24.
description: Motivation To Stop Scale -MTSS-
measure: Predictors of e-Cigs use
time frame: Baseline, week 2, 6, 10 and 24
description: Smoking Consequences Questionnaire
measure: Psychiatric symptoms
time frame: weekly during the first 10 weeks and at 24 weeks
description: Positive and Negative Syndrome Scale
measure: Psychiatric symptoms
time frame: weekly the first 10 weeks and at 24 weeks
description: Calgary Depression Scale for Schizophrenia
measure: Physical symptoms
time frame: weekly the first 10 weeks and at 24 weeks
description: Blood pressure and heart rate
arm group label: Electronic cigarettes
arm group type: Experimental
description: Free disposable electronic cigarettes will be provided during 6 weeks to smokers with serious mental illness.
intervention type: Other
intervention name: disposable electronic cigarettes
description: 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.
arm group label: Electronic cigarettes
other name: NJOY
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Rocio Perez-Iglesias, MD, PhD
role: Principal Investigator
affiliation: King's College London
last name: Ann McNeill, BSc, PhD, Prof
role: Principal Investigator
affiliation: King's College London
last name: Lynne Dawkins, BSc, PhD
role: Principal Investigator
affiliation: University of East London
last name: John Moxham, MD, PhD, Prof
role: Principal Investigator
affiliation: King's College London
last name: Philip McGuire, MD, PhD, Prof
role: Principal Investigator
affiliation: King's College London
facility: 
country: United Kingdom
responsible party type: Sponsor
mesh term: Schizophrenia
mesh term: Bipolar Disorder
mesh term: Mental Disorders
mesh term: Psychotic Disorders