Varenicline for Smoking Cessation in Hospitalized Patients With Psychiatric Disorders

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.

Conditions

• Tobacco Use Cessation
• Psychiatric Disorders

Interventions

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.

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.

Sponsors & Collaborators

• Clínica Galatea

  collaborator UNKNOWN

• Hospital Sant Rafael

  collaborator UNKNOWN

• Hospital de Sant Pau

  collaborator OTHER

• Hospital Universitari Vall d'Hebron Research Institute

  lead OTHER

Principal Investigators

• Eugeni Bruguera, MD · Vall d'Hebron Institute of Research, Galatea Clinic

• Dolores Braquehais, PhD · Galatea Clinic

• Naia Sáez-Francàs, PhD · Sant Rafael Hospital

• Cristina Pinet, MD · Hospital de Sant Pau

• Gemma Nieva, PhD · Vall d'Hebron Institute of Research, Galatea Clinic

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2019-01-31

Primary Completion

2020-04-30

Completion

2020-04-30

Countries

• Spain

Study Locations