An effectiveness and safety study of Varenicline for smoking cessation in hospitalized patients with psychiatric disorders.

Fundació Hospital Universitari Vall d’Hebron-Institut de Recerca (VHIR)0 个研究点目标入组 124 人开始时间: 2018年4月9日最近更新: 2019年4月30日

适应症

试验速览

暂无简介。

•1. Age 18-65 years old.
•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.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 124
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•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.

发起方

Fundació Hospital Universitari Vall d’Hebron-Institut de Recerca (VHIR)