Status:
WITHDRAWN
Varenicline for Smoking Cessation in Hospitalized Patients With Psychiatric Disorders
Lead Sponsor:
Hospital Universitari Vall d'Hebron Research Institute
Collaborating Sponsors:
Clínica Galatea
Hospital Sant Rafael
Conditions:
Tobacco Use Cessation
Psychiatric Disorders
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
Brief Summary
Varenicline increases smoking abstinence rates compared to bupropion, nicotine patch or placebo in outpatients with psychiatric disorders. The American Psychiatric Association identifies psychiatric h...
Detailed Description
Varenicline has shown to increase abstinence rates compared to other pharmacological interventions (including nicotine patch) or placebo in outpatients with psychiatric disorders. Safety of vareniclin...
Eligibility Criteria
Inclusion
- Age 18 to 65 years old, inclusive.
- Good understanding of protocol to informed consent.
- Hospitalized for a mental health condition at one of the three acute psychiatric facilities who participate in this study.
- Having at least a psychiatric disorder according to DSM-5.
- Living in Barcelona city or in the metropolitan area.
- Not being at high risk of self-injury or suicidal behavior, in the opinion of the Investigator.
- Smoking an average of at least 10 cigarettes per day during the year before hospital admission.
- 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.
- Able to comply with schedule visits, treatment plan and study procedures.
- 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
- History of suicide attempt in the previous year.
- Not agree to abstain from cannabis.
- Taking bupropion.
- Recent (less than two months) myocardial infarction.
- 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.
- Severe renal insufficiency.
- Pregnancy or lactation.
- Other severe acute or chronic medical or psychiatric condition that would make the subject inappropriate for entry into this study.
Key Trial Info
Start Date :
January 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2020
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT03809897
Start Date
January 1 2019
End Date
April 1 2020
Last Update
March 12 2019
Active Locations (4)
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1
Galatea Clinic
Barcelona, Spain, 08017
2
Sant Rafael Hospital
Barcelona, Spain, 08035
3
Vall d'Hebron Institute of Research
Barcelona, Spain, 08035
4
Hospital de Sant Pau
Barcelona, Spain, 08041