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Varenicline for Smoking Cessation in Hospitalized Patients With Psychiatric Disorders

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ClinicalTrials.gov Identifier: NCT03809897
Recruitment Status : Withdrawn (Budget not sufficient to cover the study scope proposed and recruitment rates expected to be no sufficient.)
First Posted : January 18, 2019
Last Update Posted : March 12, 2019
Sponsor:
Collaborators:
Clínica Galatea
Hospital Sant Rafael
Hospital de Sant Pau
Information provided by (Responsible Party):
Hospital Universitari Vall d'Hebron Research Institute

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Tobacco Use Cessation Psychiatric Disorders Drug: Varenicline Drug: Nicotine patch Phase 4

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Participants will be randomized to receive varenicline or nicotine patch during 12 weeks.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Effectiveness and Safety Study of Varenicline for Smoking Cessation in Hospitalized Patients With Psychiatric Disorders
Estimated Study Start Date : January 2019
Estimated Primary Completion Date : April 2020
Estimated Study Completion Date : April 2020


Arm Intervention/treatment
Experimental: Varenicline
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.
Drug: Varenicline
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.
Other Name: Champix

Active Comparator: Nicotine patch
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.
Drug: Nicotine patch
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.
Other Name: Nicotinell




Primary Outcome Measures :
  1. Assessment of effectiveness: smoking abstinence rates [ Time Frame: Between week 9 and week 16 ]
    To compare smoking abstinence rates of varenicline relative to nicotine patch measured by CO-confirmed continuous abstinence rate.

  2. Assessment of safety: incidence of emergent "severe" neuropsychiatric event [ Time Frame: Randomization day ]
    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).

  3. Assessment of safety: incidence of emergent "severe" neuropsychiatric event [ Time Frame: Week 1 ]
    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).

  4. Assessment of safety: incidence of emergent "severe" neuropsychiatric event [ Time Frame: Week 2 ]
    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).

  5. Assessment of safety: incidence of emergent "severe" neuropsychiatric event [ Time Frame: Week 3 ]
    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).

  6. Assessment of safety: incidence of emergent "severe" neuropsychiatric event [ Time Frame: Week 4 ]
    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).

  7. Assessment of safety: incidence of emergent "severe" neuropsychiatric event [ Time Frame: Week 5 ]
    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).

  8. Assessment of safety: incidence of emergent "severe" neuropsychiatric event [ Time Frame: Week 6 ]
    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).

  9. Assessment of safety: incidence of emergent "severe" neuropsychiatric event [ Time Frame: Week 7 ]
    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).

  10. Assessment of safety: incidence of emergent "severe" neuropsychiatric event [ Time Frame: Week 8 ]
    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).

  11. Assessment of safety: incidence of emergent "severe" neuropsychiatric event [ Time Frame: Week 9 ]
    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).

  12. Assessment of safety: incidence of emergent "severe" neuropsychiatric event [ Time Frame: Week 10 ]
    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).

  13. Assessment of safety: incidence of emergent "severe" neuropsychiatric event [ Time Frame: Week 11 ]
    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).

  14. Assessment of safety: incidence of emergent "severe" neuropsychiatric event [ Time Frame: Week 12 ]
    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).

  15. Assessment of safety: incidence of emergent "severe" neuropsychiatric event [ Time Frame: Week 13 ]
    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).

  16. 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. ]
    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.

  17. Clinical Global Impression of Severity (baseline) [ Time Frame: It is assessed in the randomization day (day 1) ]
    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.

  18. 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. ]
    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).

  19. 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. ]
    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.

  20. 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. ]

    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.

    1. wish to be dead
    2. 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.


  21. 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. ]

    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.


  22. 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. ]

    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.


  23. Fagerström test for Cigarette Dependence (FTCD) [ Time Frame: It is assessed in the randomization day (day 1) ]
    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.

  24. 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. ]
    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.



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:

  1. Age 18 to 65 years old, inclusive.
  2. Good understanding of protocol to informed consent.
  3. Hospitalized for a mental health condition at one of the three acute psychiatric facilities who participate in this study.
  4. Having at least a psychiatric disorder according to DSM-5.
  5. Living in Barcelona city or in the metropolitan area.
  6. Not being at high risk of self-injury or suicidal behavior, in the opinion of the Investigator.
  7. Smoking an average of at least 10 cigarettes per day during the year before hospital admission.
  8. Females who are not childbearing potential (surgical sterilized or at least 2 years postmenopausal) and who are not nursing may be included. Females who are childbearing potential may be included if they agree to avoid pregnancy during the study, and agree to use a birth control method.
  9. Able to comply with schedule visits, treatment plan and study procedures.
  10. Signed and dated informed consent indicating that the participant has been informed of all aspects of the study. In case of involuntary admission, a judge will consent the participant is capable to participate.

Exclusion Criteria:

  1. History of suicide attempt in the previous year.
  2. Not agree to abstain from cannabis.
  3. Taking bupropion.
  4. Recent (less than two months) myocardial infarction.
  5. Previous adverse reaction that the investigator considers due to varenicline/nicotine patch and of sufficient concern that further exposure to varenicline/nicotine patch would be inadvisable.
  6. Severe renal insufficiency.
  7. Pregnancy or lactation.
  8. Other severe acute or chronic medical or psychiatric condition that would make the subject inappropriate for entry into this study.

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): NCT03809897


Locations
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Spain
Galatea Clinic
Barcelona, Spain, 08017
Sant Rafael Hospital
Barcelona, Spain, 08035
Vall d'Hebron Institute of Research
Barcelona, Spain, 08035
Hospital de Sant Pau
Barcelona, Spain, 08041
Sponsors and Collaborators
Hospital Universitari Vall d'Hebron Research Institute
Clínica Galatea
Hospital Sant Rafael
Hospital de Sant Pau
Investigators
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Principal Investigator: Eugeni Bruguera, MD Vall d'Hebron Institute of Research, Galatea Clinic
Principal Investigator: Dolores Braquehais, PhD Galatea Clinic
Principal Investigator: Naia Sáez-Francàs, PhD Sant Rafael Hospital
Principal Investigator: Cristina Pinet, MD Hospital de Sant Pau
Principal Investigator: Gemma Nieva, PhD Vall d'Hebron Institute of Research, Galatea Clinic

Additional Information:
Publications:

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Responsible Party: Hospital Universitari Vall d'Hebron Research Institute
ClinicalTrials.gov Identifier: NCT03809897     History of Changes
Other Study ID Numbers: BRU-VCN-2017
First Posted: January 18, 2019    Key Record Dates
Last Update Posted: March 12, 2019
Last Verified: January 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Disease
Mental Disorders
Problem Behavior
Pathologic Processes
Behavioral Symptoms
Nicotine
Varenicline
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action