We try to assess the effectiveness and safety of Varenicline for smoking cessation in hospitalized patients with psychiatric disorders.

An effectiveness and safety study of Varenicline for smoking cessation in hospitalized patients with psychiatric disorders.

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2017-004715-40-ES

Enrollment

124

Registered

2018-04-09

Start date

2018-07-04

Completion date

Unknown

Last updated

2019-04-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Smoking cessation in hospitalized patients with psychiatric disorders.

Interventions

Trade Name: CHANTIX (varenicline) tablets, for oral use Pharmaceutical Form: Film-coated tablet INN or Proposed INN: VARENICLINE CAS Number: 375815-87-5

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Age 18-65 years old. 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. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 124 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

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.

Design outcomes

Primary

Measure	Time frame
Main Objective: This study will compare varenicline to nicotine patch initiated in-hospital on smoking abstinence rates post-discharge. In addition, safety will be assessed by comparing the incidence of severe neuropsychiatric adverse events in participants with varenicline or nicotine patch.;Secondary Objective: Not applicable; Primary end point(s): EFFICACY 1.To compare smoking abstinence rates of varenicline relative to nicotine patch measured by CO-confirmed continuous abstinence rate (CAR) between week 9 and week 12. 2. To compare smoking abstinence rates of varenicline relative to nicotine patch measured by CO-confirmed continuous abstinence rate (CAR) between week 12 and week 16. SAFETY 1. The primary safety endpoint is the occurrence of at least one treatment emergent “severe” neuropsychiatric event during or after hospitalization. In case of a preexisting "severe" neuropsychiatric event, only a worsening of this event will be reported. ; Timepoint(s) of evaluation of this end point: Efficacy: week 9-12 and week 12-16 Safety: number of severe neuropsychiatric events from the screening to the end of study.	—

Measure

Time frame

Main Objective: This study will compare varenicline to nicotine patch initiated in-hospital on smoking abstinence rates post-discharge. In addition, safety will be assessed by comparing the incidence of severe neuropsychiatric adverse events in participants with varenicline or nicotine patch.;Secondary Objective: Not applicable; Primary end point(s): EFFICACY 1.To compare smoking abstinence rates of varenicline relative to nicotine patch measured by CO-confirmed continuous abstinence rate (CAR) between week 9 and week 12. 2. To compare smoking abstinence rates of varenicline relative to nicotine patch measured by CO-confirmed continuous abstinence rate (CAR) between week 12 and week 16. SAFETY 1. The primary safety endpoint is the occurrence of at least one treatment emergent “severe” neuropsychiatric event during or after hospitalization. In case of a preexisting "severe" neuropsychiatric event, only a worsening of this event will be reported. ; Timepoint(s) of evaluation of this end point: Efficacy: week 9-12 and week 12-16 Safety: number of severe neuropsychiatric events from the screening to the end of study.

—

Secondary

Measure	Time frame
Secondary end point(s): EFFICACY 1. To compare smoking abstinence rates of varenicline relative to nicotine patch measured by 7-day CO-confirmed abstinence at week 16. 2. To compare smoking withdrawal symptoms of varenicline relative to nicotine patch during and after hospitalization. SAFETY It will be individual subscales scores on the following questionnaires: - Hospital Anxiety and Depression Scale (HADS), - Columbia Suicide Severity Rating Scale (C-SSRS), - Clinical Global Impression of Improvement (CGI-I) ;Timepoint(s) of evaluation of this end point: 0, week 1, week 2, week 3, week 4, week 5, week 7, week 9, week 12, week 16.	—

Measure

Time frame

Secondary end point(s): EFFICACY 1. To compare smoking abstinence rates of varenicline relative to nicotine patch measured by 7-day CO-confirmed abstinence at week 16. 2. To compare smoking withdrawal symptoms of varenicline relative to nicotine patch during and after hospitalization. SAFETY It will be individual subscales scores on the following questionnaires: - Hospital Anxiety and Depression Scale (HADS), - Columbia Suicide Severity Rating Scale (C-SSRS), - Clinical Global Impression of Improvement (CGI-I) ;Timepoint(s) of evaluation of this end point: 0, week 1, week 2, week 3, week 4, week 5, week 7, week 9, week 12, week 16.

—

Countries

Spain

Contacts

Public ContactPsychiatry Department Vall d’Hebron

Fundació Hospital Universitari Vall d’Hebron-Institut de Recerca (VHIR)

ebruguer@vhebron.net3493489 42 95

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026