Tobacco Use CessationPhase 4NCT03809897

Varenicline for Smoking Cessation in Hospitalized Patients With Psychiatric Disorders

A Phase 4 study testing Varenicline and Nicotine patch in people with Tobacco Use Cessation and Psychiatric Disorders, run by Hospital Universitari Vall d'Hebron Research Institute at 4 sites in Spain.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record

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Trial summary

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Tobacco Use Cessation, Psychiatric Disorders
What is being tested?: Varenicline and Nicotine patch
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 0 participants
Where: 4 sitesSpain
Study dates: Jan 2019to Apr 2020
Phase: Phase 4
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Age 18 to 65 years old, inclusive.
Good understanding of protocol to informed consent.
Hospitalized for a mental health condition at one of the three acute psychiatric facilities who participate in this study.
Having at least a psychiatric disorder according to DSM-5.
Living in Barcelona city or in the metropolitan area.
Not being at high risk of self-injury or suicidal behavior, in the opinion of the Investigator.

Show all 10Show fewer

Smoking an average of at least 10 cigarettes per day during the year before hospital admission.
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.
Able to comply with schedule visits, treatment plan and study procedures.
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.

Who cannot join

History of suicide attempt in the previous year.
Not agree to abstain from cannabis.
Taking bupropion.
Recent (less than two months) myocardial infarction.
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.
Severe renal insufficiency.
Pregnancy or lactation.
Other severe acute or chronic medical or psychiatric condition that would make the subject inappropriate for entry into this study.

Trial locations and contacts

4 sites in 1 country.

Spain4 sites

Galatea Clinic
Barcelona, 08017
Sant Rafael Hospital
Barcelona, 08035
Vall d'Hebron Institute of Research
Barcelona, 08035
Hospital de Sant Pau
Barcelona, 08041

Other trials in Spain

About this study

Official title: An Effectiveness and Safety Study of Varenicline for Smoking Cessation in Hospitalized Patients With Psychiatric Disorders

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.

Read the detailed description

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).

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.
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.
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.
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.
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.

Conditions: Tobacco Use Cessation, Psychiatric Disorders
Being tested: Varenicline, Nicotine patch
Medical subject headings: Tobacco Use Cessation, Mental Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

VareniclineDrug
Also called Champix
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.
Nicotine patchDrug
Also called Nicotinell
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.

Study groups in NCT03809897
Study group	Role	What they receive
Varenicline	Experimental	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. Receives: Drug: Varenicline
Nicotine patch	Active comparator	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. Receives: Drug: Nicotine patch

What is being measured

The primary outcome is the main question the study is designed to answer.

Assessment of effectiveness: smoking abstinence rates
To compare smoking abstinence rates of varenicline relative to nicotine patch measured by CO-confirmed continuous abstinence rate.
Measured: Between week 9 and week 16
Assessment of safety: incidence of emergent "severe" neuropsychiatric event
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).
Measured: Randomization day
Assessment of safety: incidence of emergent "severe" neuropsychiatric event
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).
Measured: Week 1
Assessment of safety: incidence of emergent "severe" neuropsychiatric event
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).
Measured: Week 2
Assessment of safety: incidence of emergent "severe" neuropsychiatric event
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).
Measured: Week 3
Assessment of safety: incidence of emergent "severe" neuropsychiatric event
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).
Measured: Week 4
Assessment of safety: incidence of emergent "severe" neuropsychiatric event
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).
Measured: Week 5
Assessment of safety: incidence of emergent "severe" neuropsychiatric event
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).
Measured: Week 6
Assessment of safety: incidence of emergent "severe" neuropsychiatric event
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).
Measured: Week 7
Assessment of safety: incidence of emergent "severe" neuropsychiatric event
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).
Measured: Week 8
Assessment of safety: incidence of emergent "severe" neuropsychiatric event
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).
Measured: Week 9
Assessment of safety: incidence of emergent "severe" neuropsychiatric event
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).
Measured: Week 10
Assessment of safety: incidence of emergent "severe" neuropsychiatric event
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).
Measured: Week 11
Assessment of safety: incidence of emergent "severe" neuropsychiatric event
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).
Measured: Week 12
Assessment of safety: incidence of emergent "severe" neuropsychiatric event
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).
Measured: Week 13
Psychiatric Evaluation done by a psychiatrist
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.
Measured: 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.
Clinical Global Impression of Severity (baseline)
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.
Measured: It is assessed in the randomization day (day 1)
Clinical Global Impression of Improvement
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).
Measured: During hospitalization, from week 1 to week 4, and on the post-discharge weeks 5, 7, 9, 12 and 16.
The Hospital Anxiety and Depression Scale (HADS)
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.
Measured: From the randomization day, weekly during hospitalization (week 1 to week 4) and on the post-discharge weeks 5, 7, 9, 12 and 16.
Columbia Suicide-Severity Rating Scale (C-SSRS)
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.
Measured: 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.
Measurement of Nicotine Use Inventory (NUI)
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.
Measured: 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.
Minessota Nicotine Withdrawal Scale (MNWS)
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.
Measured: From the randomization day, weekly during hospitalization (week 1 to week 4) and on the post-discharge weeks 5, 7, 9, 12 and 16.
Fagerström test for Cigarette Dependence (FTCD)
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.
Measured: It is assessed in the randomization day (day 1)
End-expiratory exhaled carbon monoxid (exhaled CO)
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.
Measured: From the randomization day, weekly during hospitalization (week 1 to week 4) and on the post-discharge weeks 5, 7, 9, 12 and 16.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2019Apr 2020

First posted18 Jan 2019
Study startJan 2019 (estimated)
Primary completionApr 2020 (estimated)
Study completionApr 2020 (estimated)

Why it stopped: Budget not sufficient to cover the study scope proposed and recruitment rates expected to be no sufficient.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (8)Papers the sponsor has linked to this study.
Other trials for Tobacco Use CessationStudies of the same condition, open and under way.
More trials run by Hospital Universitari Vall d'Hebron Research InstituteThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: Participants will be randomized to receive varenicline or nicotine patch during 12 weeks.
Masking: None (open label)
Enrolment: 0 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03809897
Sponsor's protocol ID: BRU-VCN-2017
Status last verified: Jan 2019
First submitted: 21 Nov 2018
Last updated: 12 Mar 2019
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Publications

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.
PubMed 16539783
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.
PubMed 24139811
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.
PubMed 20336177
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.
PubMed 16449089
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.
PubMed 23948001
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.
PubMed 21931239
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.
PubMed 11086367
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.
PubMed 24939916

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 12 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Effectiveness and Safety Study of Varenicline for Smoking Cessation in Hospitalized Patients With Psychiatric Disorders
ClinicalTrials.gov ID: NCT03809897
Acronym / sponsor ID: BRU-VCN-2017
Conditions: Tobacco Use Cessation, Psychiatric Disorders
Phase: Phase 4
Study type: Interventional
Recruitment status: WithdrawnReason stopped: Budget not sufficient to cover the study scope proposed and recruitment rates expected to be no sufficient.
Enrolment: 0 participants (actual)
Lead sponsor: Hospital Universitari Vall d'Hebron Research InstituteUniversity, hospital or other
Collaborators: Clínica Galatea, Hospital Sant Rafael, Hospital de Sant Pau
Study start: Jan 2019 (estimated)
Primary completion: Apr 2020 (estimated)
Study completion: Apr 2020 (estimated)
First posted: 18 Jan 2019 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Participants will be randomized to receive varenicline or nicotine patch during 12 weeks. All participants will receive smoking cessation counseling.

Detailed description

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).

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.
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.
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.
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.
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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2
Model description: Participants will be randomized to receive varenicline or nicotine patch during 12 weeks.

Arm	Type	Receives
Varenicline	Experimental	Drug: VareniclinePatients 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.
Nicotine patch	Active comparator	Drug: Nicotine patchPatients 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.

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (10 listed)

Age 18 to 65 years old, inclusive.
Good understanding of protocol to informed consent.
Hospitalized for a mental health condition at one of the three acute psychiatric facilities who participate in this study.
Having at least a psychiatric disorder according to DSM-5.
Living in Barcelona city or in the metropolitan area.

Key exclusion criteria (8 listed)

History of suicide attempt in the previous year.
Not agree to abstain from cannabis.
Taking bupropion.
Recent (less than two months) myocardial infarction.
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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
VareniclineAlso: ChampixAll 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.	Drug	Varenicline
Nicotine patchAlso: NicotinellPatients 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.	Drug	Nicotine patch

Primary outcome

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.
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).
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).
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).
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).
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).
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).
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).
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).
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).
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).
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).
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).
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).
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).
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.
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.
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).
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.
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.
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.
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.
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.
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.

Results and safety

The study was withdrawn before enrolling participants, so there are no results.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2019.
Background: PubMed 16539783Colton 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.
Background: PubMed 24139811Callaghan 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.
Background: PubMed 20336177Prochaska 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.
Background: PubMed 16449089Prochaska 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.
Background: PubMed 23948001Prochaska 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.
Background: PubMed 21931239Hickman 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.
Background: PubMed 11086367Lasser 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.
Background: PubMed 24939916Stockings 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.
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.Link provided by the sponsor.
Learning about healthy livingLink provided by the sponsor.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Eugeni Bruguera, MD principal investigator

Vall d'Hebron Institute of Research, Galatea Clinic

Dolores Braquehais, PhD principal investigator

Galatea Clinic

Naia Sáez-Francàs, PhD principal investigator

Sant Rafael Hospital

4 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 12 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Assessment of effectiveness: smoking abstinence rates (time frame: Between week 9 and week 16). The study lists 24 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03809897, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2019.