<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/NCT03809897</url>
  </required_header>
  <id_info>
    <org_study_id>BRU-VCN-2017</org_study_id>
    <nct_id>NCT03809897</nct_id>
  </id_info>
  <brief_title>Varenicline for Smoking Cessation in Hospitalized Patients With Psychiatric Disorders</brief_title>
  <official_title>An Effectiveness and Safety Study of Varenicline for Smoking Cessation in Hospitalized Patients With Psychiatric Disorders</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hospital Universitari Vall d'Hebron Research Institute</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Clínica Galatea</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Hospital Sant Rafael</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Hospital de Sant Pau</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Hospital Universitari Vall d'Hebron Research Institute</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Varenicline increases smoking abstinence rates compared to bupropion, nicotine patch or&#xD;
      placebo in outpatients with psychiatric disorders. The American Psychiatric Association&#xD;
      identifies psychiatric hospitalizations as an ideal opportunity to treat tobacco dependence.&#xD;
      However, no previous studies have tested whether varenicline may improve smoking cessation&#xD;
      rates compared to nicotine patch in hospitalized patients with mental illness. Additionally,&#xD;
      varenicline has shown to be safe for mental health stable outpatients, but safety in&#xD;
      psychiatric inpatients is unknown.&#xD;
&#xD;
      Multisite open trial controlled study designed to assess varenicline's effectiveness on&#xD;
      smoking cessation compared to nicotine patch, in patients who are discharged from a&#xD;
      psychiatric unit. Treatment will start during hospitalization and last 12 weeks followed by a&#xD;
      non-treatment follow-up phase for 4 weeks. Safety will be assessed by comparing the incidence&#xD;
      of adverse events.&#xD;
&#xD;
      Participants will be randomized to receive varenicline or nicotine patch during 12 weeks. All&#xD;
      participants will receive smoking cessation counseling.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Varenicline has shown to increase abstinence rates compared to other pharmacological&#xD;
      interventions (including nicotine patch) or placebo in outpatients with psychiatric&#xD;
      disorders. Safety of varenicline in this population has also been stated as adverse events&#xD;
      are similar to other smoking cessation medications.&#xD;
&#xD;
      Taking into account that varenicline has shown to increase abstinence rates in outpatients&#xD;
      with psychiatric disorders compared to other smoking cessation medications, and no previous&#xD;
      studies have measured the impact of initiating varenicline during psychiatric&#xD;
      hospitalization, this study will compare varenicline to nicotine patch initiated during&#xD;
      hospitalization on smoking abstinence rates (treatment will last 12 weeks; and there will be&#xD;
      additional 4 weeks of non-treatment).&#xD;
&#xD;
      Regarding safety, inpatient wards are probably the best setting to test safety as any adverse&#xD;
      effect can be reported immediately and in case of an intervention needed, this can be&#xD;
      provided at once.&#xD;
&#xD;
      This study will have three phases: screening phase (1), treatment phase (2a and 2b), and&#xD;
      non-treatment phase (3).&#xD;
&#xD;
        1. Screening phase: Psychiatrists and psychologists will be responsible for informing to&#xD;
           potential participants about the study, and check eligibility for each patient.&#xD;
           Investigators will give informed consent and information sheet to the participant, and&#xD;
           all doubts will be resolved appropriately. If subject decides to participate the&#xD;
           informed consent will be signed. The screening period will take place during first 72&#xD;
           hours after admission and participants will be randomized before 96 hours after&#xD;
           admission.&#xD;
&#xD;
        2. Treatment phase: Treatment will take 12 weeks, therefore varenicline and nicotine patch&#xD;
           will be dispensed during hospitalization and after discharge up to complete 12 weeks.&#xD;
           All participants randomized to varenicline will be titrated to the full dose during the&#xD;
           first week and continued up to week 12 following standard dosage. This would be&#xD;
           independent of time of discharge, so patients will continue the same treatment after&#xD;
           discharge up to complete the 12 weeks. Patients randomized to nicotine patch will&#xD;
           receive 8 weeks of 21mg patch followed by 2 weeks of 14 mg patch and 2 weeks of 7 mg&#xD;
           patch.&#xD;
&#xD;
             1. During hospitalization: All participants will be assessed regarding their&#xD;
                psychiatric and drug use history (including smoking) as well as past and current&#xD;
                psychiatric disorders diagnosed by their psychiatrist. Adverse events (volunteered,&#xD;
                observed, or solicited) will be also evaluated and recorded by their psychiatrist.&#xD;
                Serious adverse events will be considered as an untoward medical occurrence at any&#xD;
                dose that results in death, or is life-threatening, or requires prolongation of the&#xD;
                hospitalization, or results in persistent or significant disability/incapacity, or&#xD;
                results in congenital anomaly birth defect (following the same criteria of other&#xD;
                studies). In case of serious adverse events (SAEs) at any point of the study,&#xD;
                Principal Investigators will report to Pfizer within 24 hours of first awareness of&#xD;
                the event. Cigarette Dependence, Tobacco withdrawal, Global Clinical Impression,&#xD;
                nicotine use, suicide ideation/behavior, anxiety and depression will be assessed&#xD;
                via scales and questionnaires by a trained smoking cessation psychologist. This&#xD;
                psychologist will be also in charge of delivering weekly a motivationally tailored&#xD;
                smoking cessation group counseling (30-45 minutes) following an adaptation of the&#xD;
                manualized curriculum. A nurse will be responsible for measuring the end-expiratory&#xD;
                exhaled CO, record body height and weight, vital signs (blood pressure and heart&#xD;
                rate) and dispense medication.&#xD;
&#xD;
             2. After discharge: There will be weekly visits until week 5, and visits at weeks 7, 9&#xD;
                and 12. Post-hospitalization visits will include tobacco use assessment, mental&#xD;
                health assessment, adverse-events assessment, smoking cessation counseling and&#xD;
                varenicline or nicotine patch delivery up to following visit. A psychiatrist will&#xD;
                be responsible for assessing adverse-events and mental health. A psychologist will&#xD;
                be responsible for delivering smoking cessation counseling tailored to each&#xD;
                participant's needs according to the manualized curriculum and assessing tobacco&#xD;
                use, withdrawal, suicide ideation/behavior, Global Clinical Impression, anxiety and&#xD;
                depression. Counseling and mental health assessment will be conducted by the same&#xD;
                professional whenever possible. A nurse will be responsible for measuring the&#xD;
                end-expiratory exhaled CO, record body weight, vital signs (blood pressure and&#xD;
                heart rate) and dispense medication. Whenever participant does not attend a study&#xD;
                visit, counseling and Nicotine Use Inventory (NUI) will be delivered by telephone.&#xD;
&#xD;
        3. Non-treatment phase: This will include a telephone visit at week 14 and a face-to-face&#xD;
           visit at week 16. Telephone visit will be made by the psychologist and it will include&#xD;
           tobacco use assessment and smoking cessation counseling. A psychiatrist will be&#xD;
           responsible for assessing adverse-events and mental health at week 16 visit and a&#xD;
           psychologist will assess tobacco use, withdrawal, suicide ideation/behavior, Global&#xD;
           Clinical Impression, anxiety and depression, and deliver smoking cessation counseling.&#xD;
           Counseling and mental health assessment will be conducted by the same professional&#xD;
           whenever possible. Also at this point,an End-of-study questionnaire will be completed. A&#xD;
           nurse will be responsible for measuring the end-expiratory exhaled CO, record body&#xD;
           weight and vital signs (blood pressure and heart rate). Whenever participant does not&#xD;
           attend a study visit, NUI will be delivered by telephone. In case of early termination&#xD;
           at any point of the study, an End-of-study questionnaire will be also completed.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    Budget not sufficient to cover the study scope proposed and recruitment rates expected to be no&#xD;
    sufficient.&#xD;
  </why_stopped>
  <start_date type="Anticipated">January 2019</start_date>
  <completion_date type="Anticipated">April 2020</completion_date>
  <primary_completion_date type="Anticipated">April 2020</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>Participants will be randomized to receive varenicline or nicotine patch during 12 weeks.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Assessment of effectiveness: smoking abstinence rates</measure>
    <time_frame>Between week 9 and week 16</time_frame>
    <description>To compare smoking abstinence rates of varenicline relative to nicotine patch measured by CO-confirmed continuous abstinence rate.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Assessment of safety: incidence of emergent &quot;severe&quot; neuropsychiatric event</measure>
    <time_frame>Randomization day</time_frame>
    <description>Differences in the incidence of emergent &quot;severe&quot; neuropsychiatric event. Solicited neuropsychiatric adverse events (AEs) will be collected by the use of Neuropsychiatric Adverse Event Interview (NAEI).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Assessment of safety: incidence of emergent &quot;severe&quot; neuropsychiatric event</measure>
    <time_frame>Week 1</time_frame>
    <description>Differences in the incidence of emergent &quot;severe&quot; neuropsychiatric event. Solicited neuropsychiatric adverse events (AEs) will be collected by the use of Neuropsychiatric Adverse Event Interview (NAEI).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Assessment of safety: incidence of emergent &quot;severe&quot; neuropsychiatric event</measure>
    <time_frame>Week 2</time_frame>
    <description>Differences in the incidence of emergent &quot;severe&quot; neuropsychiatric event. Solicited neuropsychiatric adverse events (AEs) will be collected by the use of Neuropsychiatric Adverse Event Interview (NAEI).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Assessment of safety: incidence of emergent &quot;severe&quot; neuropsychiatric event</measure>
    <time_frame>Week 3</time_frame>
    <description>Differences in the incidence of emergent &quot;severe&quot; neuropsychiatric event. Solicited neuropsychiatric adverse events (AEs) will be collected by the use of Neuropsychiatric Adverse Event Interview (NAEI).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Assessment of safety: incidence of emergent &quot;severe&quot; neuropsychiatric event</measure>
    <time_frame>Week 4</time_frame>
    <description>Differences in the incidence of emergent &quot;severe&quot; neuropsychiatric event. Solicited neuropsychiatric adverse events (AEs) will be collected by the use of Neuropsychiatric Adverse Event Interview (NAEI).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Assessment of safety: incidence of emergent &quot;severe&quot; neuropsychiatric event</measure>
    <time_frame>Week 5</time_frame>
    <description>Differences in the incidence of emergent &quot;severe&quot; neuropsychiatric event. Solicited neuropsychiatric adverse events (AEs) will be collected by the use of Neuropsychiatric Adverse Event Interview (NAEI).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Assessment of safety: incidence of emergent &quot;severe&quot; neuropsychiatric event</measure>
    <time_frame>Week 6</time_frame>
    <description>Differences in the incidence of emergent &quot;severe&quot; neuropsychiatric event. Solicited neuropsychiatric adverse events (AEs) will be collected by the use of Neuropsychiatric Adverse Event Interview (NAEI).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Assessment of safety: incidence of emergent &quot;severe&quot; neuropsychiatric event</measure>
    <time_frame>Week 7</time_frame>
    <description>Differences in the incidence of emergent &quot;severe&quot; neuropsychiatric event. Solicited neuropsychiatric adverse events (AEs) will be collected by the use of Neuropsychiatric Adverse Event Interview (NAEI).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Assessment of safety: incidence of emergent &quot;severe&quot; neuropsychiatric event</measure>
    <time_frame>Week 8</time_frame>
    <description>Differences in the incidence of emergent &quot;severe&quot; neuropsychiatric event. Solicited neuropsychiatric adverse events (AEs) will be collected by the use of Neuropsychiatric Adverse Event Interview (NAEI).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Assessment of safety: incidence of emergent &quot;severe&quot; neuropsychiatric event</measure>
    <time_frame>Week 9</time_frame>
    <description>Differences in the incidence of emergent &quot;severe&quot; neuropsychiatric event. Solicited neuropsychiatric adverse events (AEs) will be collected by the use of Neuropsychiatric Adverse Event Interview (NAEI).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Assessment of safety: incidence of emergent &quot;severe&quot; neuropsychiatric event</measure>
    <time_frame>Week 10</time_frame>
    <description>Differences in the incidence of emergent &quot;severe&quot; neuropsychiatric event. Solicited neuropsychiatric adverse events (AEs) will be collected by the use of Neuropsychiatric Adverse Event Interview (NAEI).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Assessment of safety: incidence of emergent &quot;severe&quot; neuropsychiatric event</measure>
    <time_frame>Week 11</time_frame>
    <description>Differences in the incidence of emergent &quot;severe&quot; neuropsychiatric event. Solicited neuropsychiatric adverse events (AEs) will be collected by the use of Neuropsychiatric Adverse Event Interview (NAEI).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Assessment of safety: incidence of emergent &quot;severe&quot; neuropsychiatric event</measure>
    <time_frame>Week 12</time_frame>
    <description>Differences in the incidence of emergent &quot;severe&quot; neuropsychiatric event. Solicited neuropsychiatric adverse events (AEs) will be collected by the use of Neuropsychiatric Adverse Event Interview (NAEI).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Assessment of safety: incidence of emergent &quot;severe&quot; neuropsychiatric event</measure>
    <time_frame>Week 13</time_frame>
    <description>Differences in the incidence of emergent &quot;severe&quot; neuropsychiatric event. Solicited neuropsychiatric adverse events (AEs) will be collected by the use of Neuropsychiatric Adverse Event Interview (NAEI).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Psychiatric Evaluation done by a psychiatrist</measure>
    <time_frame>From the screening day, on the randomization day, weekly during hospitalization (week 1 to week 4) and on the post-discharge weeks 5, 7, 9, 12 and 16.</time_frame>
    <description>Psychiatric Evaluation done by a psychiatrist as a measure of Mental health assessment. Although psychiatric assessment will not use a specific tool, an interview with the patient will be delivered in order to assess psychopathology not covered by the instruments of the protocol, deepen in possible adverse events that may arise with the NAEI (Neuropsychiatric Adverse Event Interview) and readjust psychiatric medication if needed.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Clinical Global Impression of Severity (baseline)</measure>
    <time_frame>It is assessed in the randomization day (day 1)</time_frame>
    <description>The CGI-S is a clinician rated instrument measuring the severity of a subject's psychiatric condition on a 7 point scale at time of assessment, relative to clinician's past experience in patients with same diagnosis.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Clinical Global Impression of Improvement</measure>
    <time_frame>During hospitalization, from week 1 to week 4, and on the post-discharge weeks 5, 7, 9, 12 and 16.</time_frame>
    <description>The CGI-I is a clinician rated instrument that measures change in subject's psychiatric condition on a 7 point scale ranging from 1 (very much improved) to 7 (very much worse).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>The Hospital Anxiety and Depression Scale (HADS)</measure>
    <time_frame>From the randomization day, weekly during hospitalization (week 1 to week 4) and on the post-discharge weeks 5, 7, 9, 12 and 16.</time_frame>
    <description>The Hospital Anxiety and Depression Scale (HADS) is a subject self-report scale and contains 14 items rated on 4-point Lickert-type scales. Seven of the items relate to anxiety and seven relate to depression. Each item on the questionnaire is scored from 0-3 and this means that a person can score between 0 and 21 for either anxiety or depression, being 0 not having anxiety or depression and 21 very anxious or depressed. The HADS uses a scale and therefore the data returned from the HADS is ordinal.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Columbia Suicide-Severity Rating Scale (C-SSRS)</measure>
    <time_frame>From the screening day, on the randomization day, weekly during hospitalization (week 1 to week 4) and on the post-discharge weeks 5, 7, 9, 12 and 16.</time_frame>
    <description>The Columbia Suicide-Severity Rating Scale (C-SSRS) rates an individual's degree of suicidal ideation which may be indicative of an individual's intent to complete suicide. It contains six &quot;yes&quot; or &quot;no&quot; questions in which respondents are asked to indicate whether they have experienced several thoughts or feelings relating to suicide over the past month and behaviors over their lifetime and past 3 months. Each question addresses a different component of the respondent's suicide ideation severity and behavior.&#xD;
wish to be dead&#xD;
non-specific suicidal thoughts 3-5: more specific suicidal thoughts and intent to act&#xD;
6: suicidal behavior over the respondent's lifetime and past 3 months&#xD;
An answer of &quot;yes&quot; to any of the six questions may indicate a need for referral to a trained mental health professional and an answer of &quot;yes&quot; to questions 4, 5 or 6 indicate high-risk.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Measurement of Nicotine Use Inventory (NUI)</measure>
    <time_frame>From the randomization day, weekly during hospitalization (week 1 to week 4) and on the post-discharge weeks 5, 7, 9, 12, 14 and 16.</time_frame>
    <description>The Measurement of Nicotine Use Inventory (NUI) is a questionnaire regarding use of cigarettes and other nicotine -containing products during the treatment period or tobacco products during the non-treatment period.&#xD;
The NUI consists of the following two questions: whether the person has smoked any cigarettes (even a puff) since the last contact and whether he has smoked any other tobacco products (eg, pipe, cigars, snuff, chew) since the last contact.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Minessota Nicotine Withdrawal Scale (MNWS)</measure>
    <time_frame>From the randomization day, weekly during hospitalization (week 1 to week 4) and on the post-discharge weeks 5, 7, 9, 12 and 16.</time_frame>
    <description>The Minessota Nicotine Withdrawal Scale (MNWS) is a subject self-report scale and contains 8 items (e.g., irritability, anxious, depressed mood, difficulty concentrating, increased appetite, insomnia, restless...) on a 5-point Lickert-type scales measuring nicotine withdrawal symptoms.&#xD;
Subjects were given a score on each item on a scale of 0 (not present) to 4 (severe). Summed (total) score excluding craving represent subject's symptoms of tobacco withdrawal, ranging from 0 to 32. We calculated a craving for tobacco score and a total score of withdrawal symptoms excluding craving. The higher score represent more sever craving and withdrawal.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Fagerström test for Cigarette Dependence (FTCD)</measure>
    <time_frame>It is assessed in the randomization day (day 1)</time_frame>
    <description>Cigarrette dependence was assessed using the Fagerström Test of Nicotine Dependence (FTND), which consists of six questions. Question 1 of the FTND read as follows: &quot;How soon after you wake up do you smoke your first cigarette?&quot; A total score was calculated as a sum of the six questions, with lower scores indicating lower dependence on nicotine: 0-2, very low dependence; 3-4, low dependence; 5, medium dependence; 6-7, high dependence; and 8-10, very high dependence.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>End-expiratory exhaled carbon monoxid (exhaled CO)</measure>
    <time_frame>From the randomization day, weekly during hospitalization (week 1 to week 4) and on the post-discharge weeks 5, 7, 9, 12 and 16.</time_frame>
    <description>Breath carbon monoxide is the level of carbon monoxide in a person's exhalation. It can be measured in a breath carbon monoxide test, generally by using a carbon monoxide breath monitor (breath CO monitor), such as for motivation and education for smoking cessation and also as a clinical aid in assessing carbon monoxide poisoning.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Tobacco Use Cessation</condition>
  <condition>Psychiatric Disorders</condition>
  <arm_group>
    <arm_group_label>Varenicline</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients randomized to the experimental arm will receive 3 days of 0.5 mg of varenicline, followed by 4 days of 1 mg of varenicline (until day 7). Finally, until week 12, they will receive 2 mg of varenicline. Varenicline is supplied in capsules and taken orally.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Nicotine patch</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients randomized to nicotine patch will receive 8 weeks of 21 mg patch followed by 2 weeks of 14 mg patch and 2 weeks of 7 mg patch.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Varenicline</intervention_name>
    <description>All participants randomized to varenicline will be titrated to the full dose during the first week and continued up to week 12 following standard dosage. This would be independent of time of discharge, so patients will continue the same treatment after discharge up to complete the 12 weeks.</description>
    <arm_group_label>Varenicline</arm_group_label>
    <other_name>Champix</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Nicotine patch</intervention_name>
    <description>Patients randomized to nicotine patch will receive 8 weeks of 21mg patch followed by 2 weeks of 14 mg patch and 2 weeks of 7 mg patch.</description>
    <arm_group_label>Nicotine patch</arm_group_label>
    <other_name>Nicotinell</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Age 18 to 65 years old, inclusive.&#xD;
&#xD;
          2. Good understanding of protocol to informed consent.&#xD;
&#xD;
          3. Hospitalized for a mental health condition at one of the three acute psychiatric&#xD;
             facilities who participate in this study.&#xD;
&#xD;
          4. Having at least a psychiatric disorder according to DSM-5.&#xD;
&#xD;
          5. Living in Barcelona city or in the metropolitan area.&#xD;
&#xD;
          6. Not being at high risk of self-injury or suicidal behavior, in the opinion of the&#xD;
             Investigator.&#xD;
&#xD;
          7. Smoking an average of at least 10 cigarettes per day during the year before hospital&#xD;
             admission.&#xD;
&#xD;
          8. Females who are not childbearing potential (surgical sterilized or at least 2 years&#xD;
             postmenopausal) and who are not nursing may be included. Females who are childbearing&#xD;
             potential may be included if they agree to avoid pregnancy during the study, and agree&#xD;
             to use a birth control method.&#xD;
&#xD;
          9. Able to comply with schedule visits, treatment plan and study procedures.&#xD;
&#xD;
         10. Signed and dated informed consent indicating that the participant has been informed of&#xD;
             all aspects of the study. In case of involuntary admission, a judge will consent the&#xD;
             participant is capable to participate.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. History of suicide attempt in the previous year.&#xD;
&#xD;
          2. Not agree to abstain from cannabis.&#xD;
&#xD;
          3. Taking bupropion.&#xD;
&#xD;
          4. Recent (less than two months) myocardial infarction.&#xD;
&#xD;
          5. Previous adverse reaction that the investigator considers due to varenicline/nicotine&#xD;
             patch and of sufficient concern that further exposure to varenicline/nicotine patch&#xD;
             would be inadvisable.&#xD;
&#xD;
          6. Severe renal insufficiency.&#xD;
&#xD;
          7. Pregnancy or lactation.&#xD;
&#xD;
          8. Other severe acute or chronic medical or psychiatric condition that would make the&#xD;
             subject inappropriate for entry into this study.&#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>Eugeni Bruguera, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Vall d'Hebron Institute of Research, Galatea Clinic</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Dolores Braquehais, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Galatea Clinic</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Naia Sáez-Francàs, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Sant Rafael Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Cristina Pinet, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hospital de Sant Pau</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Gemma Nieva, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Vall d'Hebron Institute of Research, Galatea Clinic</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Galatea Clinic</name>
      <address>
        <city>Barcelona</city>
        <zip>08017</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sant Rafael Hospital</name>
      <address>
        <city>Barcelona</city>
        <zip>08035</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Vall d'Hebron Institute of Research</name>
      <address>
        <city>Barcelona</city>
        <zip>08035</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital de Sant Pau</name>
      <address>
        <city>Barcelona</city>
        <zip>08041</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <link>
    <url>http://dx.doi.org/10.1016/S0140-6736(16)30272-0</url>
    <description>Neuropsychiatric safety and efficacy of varenicline, bupropion, and nicotine patch in smokers with and without psychiatric disorders (EAGLES): a double-blind, randomised, placebo-controlled clinical trial.</description>
  </link>
  <reference>
    <citation>Colton CW, Manderscheid RW. Congruencies in increased mortality rates, years of potential life lost, and causes of death among public mental health clients in eight states. Prev Chronic Dis. 2006 Apr;3(2):A42. Epub 2006 Mar 15.</citation>
    <PMID>16539783</PMID>
  </reference>
  <reference>
    <citation>Callaghan RC, Veldhuizen S, Jeysingh T, Orlan C, Graham C, Kakouris G, Remington G, Gatley J. Patterns of tobacco-related mortality among individuals diagnosed with schizophrenia, bipolar disorder, or depression. J Psychiatr Res. 2014 Jan;48(1):102-10. doi: 10.1016/j.jpsychires.2013.09.014. Epub 2013 Sep 27.</citation>
    <PMID>24139811</PMID>
  </reference>
  <reference>
    <citation>Prochaska JJ. Ten critical reasons for treating tobacco dependence in inpatient psychiatry. J Am Psychiatr Nurses Assoc. 2009 Dec;15(6):404-9. doi: 10.1177/1078390309355318. No abstract available.</citation>
    <PMID>20336177</PMID>
  </reference>
  <reference>
    <citation>Prochaska JJ, Fletcher L, Hall SE, Hall SM. Return to smoking following a smoke-free psychiatric hospitalization. Am J Addict. 2006 Jan-Feb;15(1):15-22. doi: 10.1080/10550490500419011.</citation>
    <PMID>16449089</PMID>
  </reference>
  <reference>
    <citation>Prochaska JJ, Hall SE, Delucchi K, Hall SM. Efficacy of initiating tobacco dependence treatment in inpatient psychiatry: a randomized controlled trial. Am J Public Health. 2014 Aug;104(8):1557-65. doi: 10.2105/AJPH.2013.301403. Epub 2013 Aug 15.</citation>
    <PMID>23948001</PMID>
  </reference>
  <reference>
    <citation>Hickman NJ, Prochaska JJ, Dunn LB. Screening for understanding of research in the inpatient psychiatry setting. J Empir Res Hum Res Ethics. 2011 Sep;6(3):65-72. doi: 10.1525/jer.2011.6.3.65.</citation>
    <PMID>21931239</PMID>
  </reference>
  <reference>
    <citation>Lasser K, Boyd JW, Woolhandler S, Himmelstein DU, McCormick D, Bor DH. Smoking and mental illness: A population-based prevalence study. JAMA. 2000 Nov 22-29;284(20):2606-10. doi: 10.1001/jama.284.20.2606.</citation>
    <PMID>11086367</PMID>
  </reference>
  <reference>
    <citation>Stockings EA, Bowman JA, Baker AL, Terry M, Clancy R, Wye PM, Knight J, Moore LH, Adams MF, Colyvas K, Wiggers JH. Impact of a postdischarge smoking cessation intervention for smokers admitted to an inpatient psychiatric facility: a randomized controlled trial. Nicotine Tob Res. 2014 Nov;16(11):1417-28. doi: 10.1093/ntr/ntu097. Epub 2014 Jun 17.</citation>
    <PMID>24939916</PMID>
  </reference>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>November 21, 2018</study_first_submitted>
  <study_first_submitted_qc>January 17, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 18, 2019</study_first_posted>
  <last_update_submitted>March 8, 2019</last_update_submitted>
  <last_update_submitted_qc>March 8, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">March 12, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Mental Disorders</mesh_term>
    <mesh_term>Problem Behavior</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Nicotine</mesh_term>
    <mesh_term>Varenicline</mesh_term>
  </intervention_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/NCT03809897
org study id: BRU-VCN-2017
nct id: NCT03809897
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Varenicline increases smoking abstinence rates compared to bupropion, nicotine patch or
      placebo in outpatients with psychiatric disorders. The American Psychiatric Association
      identifies psychiatric hospitalizations as an ideal opportunity to treat tobacco dependence.
      However, no previous studies have tested whether varenicline may improve smoking cessation
      rates compared to nicotine patch in hospitalized patients with mental illness. Additionally,
      varenicline has shown to be safe for mental health stable outpatients, but safety in
      psychiatric inpatients is unknown.

      Multisite open trial controlled study designed to assess varenicline's effectiveness on
      smoking cessation compared to nicotine patch, in patients who are discharged from a
      psychiatric unit. Treatment will start during hospitalization and last 12 weeks followed by a
      non-treatment follow-up phase for 4 weeks. Safety will be assessed by comparing the incidence
      of adverse events.

      Participants will be randomized to receive varenicline or nicotine patch during 12 weeks. All
      participants will receive smoking cessation counseling.
Varenicline has shown to increase abstinence rates compared to other pharmacological
      interventions (including nicotine patch) or placebo in outpatients with psychiatric
      disorders. Safety of varenicline in this population has also been stated as adverse events
      are similar to other smoking cessation medications.

      Taking into account that varenicline has shown to increase abstinence rates in outpatients
      with psychiatric disorders compared to other smoking cessation medications, and no previous
      studies have measured the impact of initiating varenicline during psychiatric
      hospitalization, this study will compare varenicline to nicotine patch initiated during
      hospitalization on smoking abstinence rates (treatment will last 12 weeks; and there will be
      additional 4 weeks of non-treatment).

      Regarding safety, inpatient wards are probably the best setting to test safety as any adverse
      effect can be reported immediately and in case of an intervention needed, this can be
      provided at once.

      This study will have three phases: screening phase (1), treatment phase (2a and 2b), and
      non-treatment phase (3).

        1. Screening phase: Psychiatrists and psychologists will be responsible for informing to
           potential participants about the study, and check eligibility for each patient.
           Investigators will give informed consent and information sheet to the participant, and
           all doubts will be resolved appropriately. If subject decides to participate the
           informed consent will be signed. The screening period will take place during first 72
           hours after admission and participants will be randomized before 96 hours after
           admission.

        2. Treatment phase: Treatment will take 12 weeks, therefore varenicline and nicotine patch
           will be dispensed during hospitalization and after discharge up to complete 12 weeks.
           All participants randomized to varenicline will be titrated to the full dose during the
           first week and continued up to week 12 following standard dosage. This would be
           independent of time of discharge, so patients will continue the same treatment after
           discharge up to complete the 12 weeks. Patients randomized to nicotine patch will
           receive 8 weeks of 21mg patch followed by 2 weeks of 14 mg patch and 2 weeks of 7 mg
           patch.

             1. During hospitalization: All participants will be assessed regarding their
                psychiatric and drug use history (including smoking) as well as past and current
                psychiatric disorders diagnosed by their psychiatrist. Adverse events (volunteered,
                observed, or solicited) will be also evaluated and recorded by their psychiatrist.
                Serious adverse events will be considered as an untoward medical occurrence at any
                dose that results in death, or is life-threatening, or requires prolongation of the
                hospitalization, or results in persistent or significant disability/incapacity, or
                results in congenital anomaly birth defect (following the same criteria of other
                studies). In case of serious adverse events (SAEs) at any point of the study,
                Principal Investigators will report to Pfizer within 24 hours of first awareness of
                the event. Cigarette Dependence, Tobacco withdrawal, Global Clinical Impression,
                nicotine use, suicide ideation/behavior, anxiety and depression will be assessed
                via scales and questionnaires by a trained smoking cessation psychologist. This
                psychologist will be also in charge of delivering weekly a motivationally tailored
                smoking cessation group counseling (30-45 minutes) following an adaptation of the
                manualized curriculum. A nurse will be responsible for measuring the end-expiratory
                exhaled CO, record body height and weight, vital signs (blood pressure and heart
                rate) and dispense medication.

             2. After discharge: There will be weekly visits until week 5, and visits at weeks 7, 9
                and 12. Post-hospitalization visits will include tobacco use assessment, mental
                health assessment, adverse-events assessment, smoking cessation counseling and
                varenicline or nicotine patch delivery up to following visit. A psychiatrist will
                be responsible for assessing adverse-events and mental health. A psychologist will
                be responsible for delivering smoking cessation counseling tailored to each
                participant's needs according to the manualized curriculum and assessing tobacco
                use, withdrawal, suicide ideation/behavior, Global Clinical Impression, anxiety and
                depression. Counseling and mental health assessment will be conducted by the same
                professional whenever possible. A nurse will be responsible for measuring the
                end-expiratory exhaled CO, record body weight, vital signs (blood pressure and
                heart rate) and dispense medication. Whenever participant does not attend a study
                visit, counseling and Nicotine Use Inventory (NUI) will be delivered by telephone.

        3. Non-treatment phase: This will include a telephone visit at week 14 and a face-to-face
           visit at week 16. Telephone visit will be made by the psychologist and it will include
           tobacco use assessment and smoking cessation counseling. A psychiatrist will be
           responsible for assessing adverse-events and mental health at week 16 visit and a
           psychologist will assess tobacco use, withdrawal, suicide ideation/behavior, Global
           Clinical Impression, anxiety and depression, and deliver smoking cessation counseling.
           Counseling and mental health assessment will be conducted by the same professional
           whenever possible. Also at this point,an End-of-study questionnaire will be completed. A
           nurse will be responsible for measuring the end-expiratory exhaled CO, record body
           weight and vital signs (blood pressure and heart rate). Whenever participant does not
           attend a study visit, NUI will be delivered by telephone. In case of early termination
           at any point of the study, an End-of-study questionnaire will be also completed.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Participants will be randomized to receive varenicline or nicotine patch during 12 weeks.
primary purpose: Treatment
masking: None (Open Label)
measure: Assessment of effectiveness: smoking abstinence rates
time frame: Between week 9 and week 16
description: To compare smoking abstinence rates of varenicline relative to nicotine patch measured by CO-confirmed continuous abstinence rate.
measure: Assessment of safety: incidence of emergent "severe" neuropsychiatric event
time frame: Randomization day
description: Differences in the incidence of emergent "severe" neuropsychiatric event. Solicited neuropsychiatric adverse events (AEs) will be collected by the use of Neuropsychiatric Adverse Event Interview (NAEI).
measure: Assessment of safety: incidence of emergent "severe" neuropsychiatric event
time frame: Week 1
description: Differences in the incidence of emergent "severe" neuropsychiatric event. Solicited neuropsychiatric adverse events (AEs) will be collected by the use of Neuropsychiatric Adverse Event Interview (NAEI).
measure: Assessment of safety: incidence of emergent "severe" neuropsychiatric event
time frame: Week 2
description: Differences in the incidence of emergent "severe" neuropsychiatric event. Solicited neuropsychiatric adverse events (AEs) will be collected by the use of Neuropsychiatric Adverse Event Interview (NAEI).
measure: Assessment of safety: incidence of emergent "severe" neuropsychiatric event
time frame: Week 3
description: Differences in the incidence of emergent "severe" neuropsychiatric event. Solicited neuropsychiatric adverse events (AEs) will be collected by the use of Neuropsychiatric Adverse Event Interview (NAEI).
measure: Assessment of safety: incidence of emergent "severe" neuropsychiatric event
time frame: Week 4
description: Differences in the incidence of emergent "severe" neuropsychiatric event. Solicited neuropsychiatric adverse events (AEs) will be collected by the use of Neuropsychiatric Adverse Event Interview (NAEI).
measure: Assessment of safety: incidence of emergent "severe" neuropsychiatric event
time frame: Week 5
description: Differences in the incidence of emergent "severe" neuropsychiatric event. Solicited neuropsychiatric adverse events (AEs) will be collected by the use of Neuropsychiatric Adverse Event Interview (NAEI).
measure: Assessment of safety: incidence of emergent "severe" neuropsychiatric event
time frame: Week 6
description: Differences in the incidence of emergent "severe" neuropsychiatric event. Solicited neuropsychiatric adverse events (AEs) will be collected by the use of Neuropsychiatric Adverse Event Interview (NAEI).
measure: Assessment of safety: incidence of emergent "severe" neuropsychiatric event
time frame: Week 7
description: Differences in the incidence of emergent "severe" neuropsychiatric event. Solicited neuropsychiatric adverse events (AEs) will be collected by the use of Neuropsychiatric Adverse Event Interview (NAEI).
measure: Assessment of safety: incidence of emergent "severe" neuropsychiatric event
time frame: Week 8
description: Differences in the incidence of emergent "severe" neuropsychiatric event. Solicited neuropsychiatric adverse events (AEs) will be collected by the use of Neuropsychiatric Adverse Event Interview (NAEI).
measure: Assessment of safety: incidence of emergent "severe" neuropsychiatric event
time frame: Week 9
description: Differences in the incidence of emergent "severe" neuropsychiatric event. Solicited neuropsychiatric adverse events (AEs) will be collected by the use of Neuropsychiatric Adverse Event Interview (NAEI).
measure: Assessment of safety: incidence of emergent "severe" neuropsychiatric event
time frame: Week 10
description: Differences in the incidence of emergent "severe" neuropsychiatric event. Solicited neuropsychiatric adverse events (AEs) will be collected by the use of Neuropsychiatric Adverse Event Interview (NAEI).
measure: Assessment of safety: incidence of emergent "severe" neuropsychiatric event
time frame: Week 11
description: Differences in the incidence of emergent "severe" neuropsychiatric event. Solicited neuropsychiatric adverse events (AEs) will be collected by the use of Neuropsychiatric Adverse Event Interview (NAEI).
measure: Assessment of safety: incidence of emergent "severe" neuropsychiatric event
time frame: Week 12
description: Differences in the incidence of emergent "severe" neuropsychiatric event. Solicited neuropsychiatric adverse events (AEs) will be collected by the use of Neuropsychiatric Adverse Event Interview (NAEI).
measure: Assessment of safety: incidence of emergent "severe" neuropsychiatric event
time frame: Week 13
description: Differences in the incidence of emergent "severe" neuropsychiatric event. Solicited neuropsychiatric adverse events (AEs) will be collected by the use of Neuropsychiatric Adverse Event Interview (NAEI).
measure: Psychiatric Evaluation done by a psychiatrist
time frame: From the screening day, on the randomization day, weekly during hospitalization (week 1 to week 4) and on the post-discharge weeks 5, 7, 9, 12 and 16.
description: Psychiatric Evaluation done by a psychiatrist as a measure of Mental health assessment. Although psychiatric assessment will not use a specific tool, an interview with the patient will be delivered in order to assess psychopathology not covered by the instruments of the protocol, deepen in possible adverse events that may arise with the NAEI (Neuropsychiatric Adverse Event Interview) and readjust psychiatric medication if needed.
measure: Clinical Global Impression of Severity (baseline)
time frame: It is assessed in the randomization day (day 1)
description: The CGI-S is a clinician rated instrument measuring the severity of a subject's psychiatric condition on a 7 point scale at time of assessment, relative to clinician's past experience in patients with same diagnosis.
measure: Clinical Global Impression of Improvement
time frame: During hospitalization, from week 1 to week 4, and on the post-discharge weeks 5, 7, 9, 12 and 16.
description: The CGI-I is a clinician rated instrument that measures change in subject's psychiatric condition on a 7 point scale ranging from 1 (very much improved) to 7 (very much worse).
measure: The Hospital Anxiety and Depression Scale (HADS)
time frame: From the randomization day, weekly during hospitalization (week 1 to week 4) and on the post-discharge weeks 5, 7, 9, 12 and 16.
description: The Hospital Anxiety and Depression Scale (HADS) is a subject self-report scale and contains 14 items rated on 4-point Lickert-type scales. Seven of the items relate to anxiety and seven relate to depression. Each item on the questionnaire is scored from 0-3 and this means that a person can score between 0 and 21 for either anxiety or depression, being 0 not having anxiety or depression and 21 very anxious or depressed. The HADS uses a scale and therefore the data returned from the HADS is ordinal.
measure: Columbia Suicide-Severity Rating Scale (C-SSRS)
time frame: From the screening day, on the randomization day, weekly during hospitalization (week 1 to week 4) and on the post-discharge weeks 5, 7, 9, 12 and 16.
description: The Columbia Suicide-Severity Rating Scale (C-SSRS) rates an individual's degree of suicidal ideation which may be indicative of an individual's intent to complete suicide. It contains six "yes" or "no" questions in which respondents are asked to indicate whether they have experienced several thoughts or feelings relating to suicide over the past month and behaviors over their lifetime and past 3 months. Each question addresses a different component of the respondent's suicide ideation severity and behavior.
wish to be dead
non-specific suicidal thoughts 3-5: more specific suicidal thoughts and intent to act
6: suicidal behavior over the respondent's lifetime and past 3 months
An answer of "yes" to any of the six questions may indicate a need for referral to a trained mental health professional and an answer of "yes" to questions 4, 5 or 6 indicate high-risk.
measure: Measurement of Nicotine Use Inventory (NUI)
time frame: From the randomization day, weekly during hospitalization (week 1 to week 4) and on the post-discharge weeks 5, 7, 9, 12, 14 and 16.
description: The Measurement of Nicotine Use Inventory (NUI) is a questionnaire regarding use of cigarettes and other nicotine -containing products during the treatment period or tobacco products during the non-treatment period.
The NUI consists of the following two questions: whether the person has smoked any cigarettes (even a puff) since the last contact and whether he has smoked any other tobacco products (eg, pipe, cigars, snuff, chew) since the last contact.
measure: Minessota Nicotine Withdrawal Scale (MNWS)
time frame: From the randomization day, weekly during hospitalization (week 1 to week 4) and on the post-discharge weeks 5, 7, 9, 12 and 16.
description: The Minessota Nicotine Withdrawal Scale (MNWS) is a subject self-report scale and contains 8 items (e.g., irritability, anxious, depressed mood, difficulty concentrating, increased appetite, insomnia, restless...) on a 5-point Lickert-type scales measuring nicotine withdrawal symptoms.
Subjects were given a score on each item on a scale of 0 (not present) to 4 (severe). Summed (total) score excluding craving represent subject's symptoms of tobacco withdrawal, ranging from 0 to 32. We calculated a craving for tobacco score and a total score of withdrawal symptoms excluding craving. The higher score represent more sever craving and withdrawal.
measure: Fagerström test for Cigarette Dependence (FTCD)
time frame: It is assessed in the randomization day (day 1)
description: Cigarrette dependence was assessed using the Fagerström Test of Nicotine Dependence (FTND), which consists of six questions. Question 1 of the FTND read as follows: "How soon after you wake up do you smoke your first cigarette?" A total score was calculated as a sum of the six questions, with lower scores indicating lower dependence on nicotine: 0-2, very low dependence; 3-4, low dependence; 5, medium dependence; 6-7, high dependence; and 8-10, very high dependence.
measure: End-expiratory exhaled carbon monoxid (exhaled CO)
time frame: From the randomization day, weekly during hospitalization (week 1 to week 4) and on the post-discharge weeks 5, 7, 9, 12 and 16.
description: Breath carbon monoxide is the level of carbon monoxide in a person's exhalation. It can be measured in a breath carbon monoxide test, generally by using a carbon monoxide breath monitor (breath CO monitor), such as for motivation and education for smoking cessation and also as a clinical aid in assessing carbon monoxide poisoning.
arm group label: Varenicline
arm group type: Experimental
description: Patients randomized to the experimental arm will receive 3 days of 0.5 mg of varenicline, followed by 4 days of 1 mg of varenicline (until day 7). Finally, until week 12, they will receive 2 mg of varenicline. Varenicline is supplied in capsules and taken orally.
arm group label: Nicotine patch
arm group type: Active Comparator
description: Patients randomized to nicotine patch will receive 8 weeks of 21 mg patch followed by 2 weeks of 14 mg patch and 2 weeks of 7 mg patch.
intervention type: Drug
intervention name: Varenicline
description: All participants randomized to varenicline will be titrated to the full dose during the first week and continued up to week 12 following standard dosage. This would be independent of time of discharge, so patients will continue the same treatment after discharge up to complete the 12 weeks.
arm group label: Varenicline
other name: Champix
intervention type: Drug
intervention name: Nicotine patch
description: Patients randomized to nicotine patch will receive 8 weeks of 21mg patch followed by 2 weeks of 14 mg patch and 2 weeks of 7 mg patch.
arm group label: Nicotine patch
other name: Nicotinell
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Eugeni Bruguera, MD
role: Principal Investigator
affiliation: Vall d'Hebron Institute of Research, Galatea Clinic
last name: Dolores Braquehais, PhD
role: Principal Investigator
affiliation: Galatea Clinic
last name: Naia Sáez-Francàs, PhD
role: Principal Investigator
affiliation: Sant Rafael Hospital
last name: Cristina Pinet, MD
role: Principal Investigator
affiliation: Hospital de Sant Pau
last name: Gemma Nieva, PhD
role: Principal Investigator
affiliation: Vall d'Hebron Institute of Research, Galatea Clinic
facility: 
facility: 
facility: 
facility: 
country: Spain
url: http://dx.doi.org/10.1016/S0140-6736(16)30272-0
description: Neuropsychiatric safety and efficacy of varenicline, bupropion, and nicotine patch in smokers with and without psychiatric disorders (EAGLES): a double-blind, randomised, placebo-controlled clinical trial.
citation: Colton CW, Manderscheid RW. Congruencies in increased mortality rates, years of potential life lost, and causes of death among public mental health clients in eight states. Prev Chronic Dis. 2006 Apr;3(2):A42. Epub 2006 Mar 15.
PMID: 16539783
citation: Callaghan RC, Veldhuizen S, Jeysingh T, Orlan C, Graham C, Kakouris G, Remington G, Gatley J. Patterns of tobacco-related mortality among individuals diagnosed with schizophrenia, bipolar disorder, or depression. J Psychiatr Res. 2014 Jan;48(1):102-10. doi: 10.1016/j.jpsychires.2013.09.014. Epub 2013 Sep 27.
PMID: 24139811
citation: Prochaska JJ. Ten critical reasons for treating tobacco dependence in inpatient psychiatry. J Am Psychiatr Nurses Assoc. 2009 Dec;15(6):404-9. doi: 10.1177/1078390309355318. No abstract available.
PMID: 20336177
citation: Prochaska JJ, Fletcher L, Hall SE, Hall SM. Return to smoking following a smoke-free psychiatric hospitalization. Am J Addict. 2006 Jan-Feb;15(1):15-22. doi: 10.1080/10550490500419011.
PMID: 16449089
citation: Prochaska JJ, Hall SE, Delucchi K, Hall SM. Efficacy of initiating tobacco dependence treatment in inpatient psychiatry: a randomized controlled trial. Am J Public Health. 2014 Aug;104(8):1557-65. doi: 10.2105/AJPH.2013.301403. Epub 2013 Aug 15.
PMID: 23948001
citation: Hickman NJ, Prochaska JJ, Dunn LB. Screening for understanding of research in the inpatient psychiatry setting. J Empir Res Hum Res Ethics. 2011 Sep;6(3):65-72. doi: 10.1525/jer.2011.6.3.65.
PMID: 21931239
citation: Lasser K, Boyd JW, Woolhandler S, Himmelstein DU, McCormick D, Bor DH. Smoking and mental illness: A population-based prevalence study. JAMA. 2000 Nov 22-29;284(20):2606-10. doi: 10.1001/jama.284.20.2606.
PMID: 11086367
citation: Stockings EA, Bowman JA, Baker AL, Terry M, Clancy R, Wye PM, Knight J, Moore LH, Adams MF, Colyvas K, Wiggers JH. Impact of a postdischarge smoking cessation intervention for smokers admitted to an inpatient psychiatric facility: a randomized controlled trial. Nicotine Tob Res. 2014 Nov;16(11):1417-28. doi: 10.1093/ntr/ntu097. Epub 2014 Jun 17.
PMID: 24939916
responsible party type: Sponsor
mesh term: Mental Disorders
mesh term: Problem Behavior
mesh term: Nicotine
mesh term: Varenicline