Varenicline for Smoking Cessation in Hospitalized Patients With Psychiatric Disorders
Status:
Withdrawn
Trial end date:
2020-04-01
Target enrollment:
Participant gender:
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.
Phase:
Phase 4
Details
Lead Sponsor:
Hospital Universitari Vall d'Hebron Research Institute
Collaborators:
Clínica Galatea Hospital de Sant Pau Hospital Sant Rafael