"Dejar de Fumar" "Smoking cessation" MedDRA version: 12.1 Level: LLT Classification code 10053325 Term: Smoking cessation therapy
Conditions
Interventions
Trade Name: CHAMPIX 0,5 mg comprimidos recubiertos con película
Pharmaceutical Form: Tablet
INN or Proposed INN: VARENICLINA
Other descriptive name: VARENICLINA
Concentration unit: mg milligram(s)
Con
Sponsors
PFIZER
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Subject?s eligibility should be reviewed and documented by an appropriately qualified member of the investigator?s study team before subjects are included in the study. In addition, subjects shall only be included if they agree that their treating physicians, who are not involved in the study, will be informed of their study participation. Subjects must meet all of the following inclusion criteria to be eligible for enrollment into the study: 1. Male or female cigarette smokers, 18-75 years, motivated to stop smoking and considered suitable for a smoking cessation attempt. 2. Smoked an average of at least 10 cigarettes per day during past year and over past month, and exhaled carbon monoxide (CO) >10 ppm at screening. 3. Current or past diagnosis of MDD without psychotic features, either single or recurrent, using DSM IV TR based on clinical assessment and confirmed by SCID and at least one of the following: ? On stable antidepressant treatment for MDD (stable dose for at least 2 months); ? Major depressive episode, using DSM IV TR, in the past 2 years successfully treated. 4. Females who are not of childbearing potential (ie, who are surgically sterilized or at least 2 years postmenopausal) and who are not nursing may be included. Females who are of childbearing potential may be included provided that they are not pregnant, not nursing, and meet all of the following criteria: ? Are instructed and agree to avoid pregnancy through 30 days after the last dose of study medication; ? Have a negative pregnancy test (?-hCG) at Screening and Baseline and ? Agree to use at least one of the birth control methods listed below: ? An oral contraceptive agent, an intrauterine device (IUD), an implantable contraceptive (eg, Norplant), or an injectable contraceptive (eg, Depo Provera) for at least 1 month prior to entering the study and will continue its use through at least 30 days after the last dose of study medication or ? A barrier method of contraception, eg, condom and/or diaphragm with spermicide while participating in the study through at least 30 days after the last dose of study medication or abstinence 5. Evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study. 6. Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures. 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 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Subjects presenting with any of the following will be excluded from the study: 1. Current or past diagnosis of dementia, schizophrenia, schizoaffective disorder, or other psychotic disorder, bipolar I disorder, bipolar II disorder or any other Axis I disorders. Exceptions for the following comorbid Axis I conditions are allowable: GAD, Dysthymia, Specific Phobia and Social Phobia. 2. Subjects with antisocial, schizotypal, or any other personality disorder severe enough to compromise the subject?s ability to comply with the study requirements. 3. Current use of either bupropion or nortryptiline. 4. Current use of medications prescribed for mania or psychosis. 5. Subjects who are believed to have a suicidal or homicidal risk (eg, after an assessment by a qualified mental health professional if the SBQ-R and C-SSRS screening assessment warranted suicidal risk assessment interview). 6. Subjects who, in the investigator's judgment, would require treatment with any additional or different treatment modality, or with antipsychotics, or would require a change in intensity of psychotherapy, or an additional treatment with any other psychotherapeutic drugs during the course of the trial. 7. Evidence of substance abuse/misuse severe enough to compromise the subject?s ability to comply with the study requirements (eg, consecutive positive urine drug screens). 8. Subjects taking an investigational drug within 30 days before the Baseline visit. 9. Subjects who have clinically significant medical disorders or laboratory test abnormalities. 10. Subjects previously enrolled in a study that included varenicline (CP-526,555) or subjects who have previously taken Chantix/Champix. 11. Subjects who intend to donate blood or blood components while receiving study drug or within 1 month of the completion of the treatment phase of the study. 12. Subjects with severe chronic obstructive pulmonary disease (COPD). 13. Subjects with a recent (5 years) history of cancer may be considered pending discussion with the study clinician. Subjects with cured basal cell or squamous cell carcinoma of the skin are allowed. 14. Subjects with evidence or history of clinically significant allergic reactions to drugs (eg, severe cutaneous and/or systemic allergic reactions). 15. Any subject at screening with an SGOT (AST) or SGPT (ALT) greater than 3 times the upper limit of normal and/or total bilirubin greater than 2 times the upper limit of normal (ULN). 16. Subjects with clinically significant cardiovascular disease in the past 6 months, such as myocardial infarction, coronary artery graft (CABG), percutaneous transluminal angioplasty (PTCA), severe or unstable angina, a serious arrhythmia, clinical significant ECG conduction abnormalities, or heart failure. 17. Subjects with clinically significant cerebrovascular disease in the past 6 months, such as cerebrovascular incident (CVA), stroke, or documented transient ischemic attack (TIA). 18. Subjects taking a concomitant medication that is prohibited by this protocol 19. Subjects who do not agree to abstain from using non-cigarette tobacco products (including, eg, pipe tobacco, cigars, snuff, chewing tobacco, etc.) or marijuana during study participation. 20. Subjects with a body mass index (BMI) less than 15 or greater than 38, wearing indoor clothing without shoes and determined using a Body Mass Index (BMI) Table. (Appendix 1) No subject will be enrolled with a weight
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Compare 12 weeks of varenicline treatment to placebo for end of treatment smoking cessation efficacy in smokers with depression.;Secondary Objective: ?Compare 12 weeks of varenicline to placebo for long-term smoking abstinence through Week 52 in smokers with depression; ?Summarize safety and tolerability data, including effects on psychiatric rating scales, for 12 weeks of treatment with either varenicline or placebo.;Primary end point(s): The primary endpoint is the 4-week Continuous Quit Rate (CQR) for Weeks 9 through 12. The key secondary endpoint is the Continuous Abstinence rate from Week 9 through Week 52. Additional secondary endpoints include: ? Continuous Abstinence rate from Week 9 through Week 24; ? 7-day point prevalence of abstinence at Weeks 12, 24, and 52; ? 4-week point prevalence of abstinence at Week 52. | — |
Countries
Germany, Hungary, Spain
Outcome results
None listed