EUCTR2017‐004715‐40‐ES 2018.

Study name	An effectiveness and safety study of varenicline for smoking cessation in hospitalised patients with psychiatric disorders
Methods	A 2‐arm, parallel group, randomised controlled trial of varenicline (12‐weeks) relative to nicotine patch (active comparator) for smoking cessation in hospitalised patients with psychiatric disorders. Blinding/Masking: None (Open‐Label)
Participants	Psychiatric population: aged 18 ‐ 65 years with at least 1 psychiatric disorder, hospitalised at 1 of 3 acute psychiatric facilities
Interventions	Trade Name: CHANTIX (varenicline) tablets, for oral use, Pharmaceutical form: film‐coated tablet, INN or proposed INN: VARENICLINE, CAS Number: 375815‐87‐5; Dose: 3 days of 0.5 mg, followed by 4 days of 1 mg, followed by 2 mg of varenicline until week 12. Trade Name: NICOTINELL TTS, Pharmaceutical Form: Cutaneous patch, INN or Proposed INN: NICOTINE, CAS Number: 54‐11‐5. Dose: 8 weeks of 21 mg patch, followed by 2 weeks of 14 mg patch and 2 weeks of 7 mg patch
Outcomes	Primary outcome(s). 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 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 1 treatment‐emergent 'severe' neuropsychiatric event during or after hospitalisation. In case of a pre‐existing 'severe' neuropsychiatric event, only a worsening of this event will be reported. Time point(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 objective: N/A. Secondary outcome(s)/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 hospitalisation; 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
Starting date	Date of first enrolment: 04 July 2018
Contact information	Name: Psychiatry Department Vall d’Hebron, Address: Pg. de la Vall d’Hebron, 119‐129 08035 Barcelona Spain, Telephone: 3493489 42 95, Email: ebruguer@vhebron.net, Affiliation: Fundació Hospital Universitari Vall d’Hebron‐Institut de Recerca (VHIR)
Notes	Registry ID: EUCTR2017‐004715‐40‐ES Funding source: Pfizer Declaration of interests: none specified