Varenicline for Smoking Cessation in Hospitalized Patients With Psychiatric Disorders

• Status: Withdrawn
• Trial end date: 2020-04-01
• Target enrollment: 0
• Participant gender: All

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
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hospital Universitari Vall d'Hebron Research Institute
• Collaborators: Clínica Galatea; Hospital de Sant Pau; Hospital Sant Rafael
• Treatments: Nicotine; Varenicline

Criteria

Inclusion Criteria:

1. Age 18 to 65 years old, inclusive.

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. In case of involuntary admission, a judge will consent the participant is capable to participate.

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.