Please select the eligibility criteria that correspond to the clinical trial below.
Title: Randomized Double-blind Trial of Two Parallel Groups Design to Evaluate the Efficacy of Smoking Cessation With Combined (Varenicline Plus Nicotine Patches) Versus Monotherapy (Varenicline Plus Placebo Patches)
Brief Summary: The purpose of this study is to assess the efficacy of smoking cessation by using varenicline as monotherapy (VRN + placebo patches) or combined therapy (VRN + nicotine patches).


Options:
A: Inclusion Criteria:

* Outpatients, over legal age, smoking at least 10 cigarettes/day as a mean within the 2 months preceding the screening visit.

Exclusion Criteria:

* Patients who have taken an investigational drug within the past six months prior to the screening visit.
* Patients who had a previous quit attempt (= or \>1 day with the aid of pharmacological adjunct) in the previous three months (before screening).
* Patients who have smoked or consumed non-tobacco cigarettes or any form of tobacco product (other than cigarettes such as cigars, pipes, smokeless tobacco, etc) more than 3 times within the 3 months preceding the screening visit.
* Patients who currently present with (based on Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition \[DSM-IV\]):

  * Psychotic disorder
  * Major depressive episode
* Pregnant or breast-feeding women.
* Women of childbearing potential not protected by effective contraceptive method of birth control and/or who are unwilling or unable to be tested for pregnancy. Medically acceptable methods of birth control for this study include approved hormonal contraceptive medications or devices, approved intra-uterine contraceptive devices, use of two combined barrier methods.
* Patients who have suffered from a myocardial infarction, unstable angina or other major cardiovascular event within the past week prior to screening.
* Patients who have a history of multiple allergic reactions to medications in two drug classes.
* Patients who have QTcF \> 500 ms on the electrocardiogram (ECG).
* Patients with mild, moderate or severe renal impairment.
* Patients who have an abnormal laboratory test of potential clinical significance at screening.
B: Inclusion Criteria:

* Male or female cigarette smokers, 18-75 years, motivated to stop smoking and considered suitable for a smoking cessation attempt
* 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
* 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

Exclusion Criteria:

* Current or past diagnosis of dementia, schizophrenia, schizoaffective disorder, or other psychotic disorder, bipolar I disorder, bipolar II disorder.
* Subjects with antisocial, schizotypal, or any other personality disorder severe enough to compromise the subject's ability to comply with the study requirements..
* Current use of either bupropion or nortryptiline.
C: Inclusion Criteria:

1. Age: 18-65 years old
2. Smoking: \>/= 5 cigarettes per day within the 2 months preceding the screening visit and expired CO greater than or equal to 6 ppm.
3. Able to follow verbal and written instructions in English and complete all aspects of the study
4. Have an address and home telephone number where they may be reached
5. Provide informed consent and agree to all assessments and study procedures
6. Be the only participant in their household

Exclusion Criteria:

1. Within the month immediately preceding the screening visit; use of any form of tobacco product other than cigarettes on 3 or more days within a week only if the individual refuses to refrain from non-cigarette tobacco use during the course of this study
2. Within the month immediately preceding the screening visit; use of marijuana in any form on 3 or more days within a week
3. Within the two weeks immediately preceding the screening visit, involvement on more than 3 days in any formal smoking cessation activities
4. Current visual or auditory problems that in the opinion of the investigator would interfere with the completion of study assessments
5. Treatment on a continuous basis within 2 weeks before the screening visit: any contraindicated medication for Varenicline or Bupropion.
6. Uncontrolled hypertension or other major contraindications for Bupropion or Varenicline.
7. Severe renal impairment (CR Clearance \<30 ml/min/1.73 m2).
8. Laboratory evaluations outside normal limits and of potential clinical significance in the opinion of the investigator
9. Meet current criteria for psychiatric disorders or substance abuse as assessed by the MINI for items A, B, D, I, J, K, L, M and N, including a past manic or hypomanic episode as well as a lifetime psychotic disorder.
10. Subject rated as moderate to high on suicidality as assessed by the MINI.
11. Psychiatric hospitalization within 1 year of screening date.
12. A positive urine pregnancy test during the screening period. Women who are two years post menopausal, one year post-tubal ligation, or who have had a partial or full hysterectomy will not be subject to a urine pregnancy test.
13. Pregnant, breast-feeding, or of childbearing potential who is not protected by a medically acceptable, effective method of birth control while enrolled in the study
14. Use of Varenicline or Bupropion within two weeks before the screening visit.
15. History of hypersensitivity or allergic reaction to Varenicline, tricyclic antidepressant, Bupropion (Wellbutrin, Zyban) or similar chemical classes or any component of these formulations.
16. Subject considered by the investigator as unsuitable candidate for receipt of an investigational drug, or unstable to be followed up throughout the entire duration of the study.
D: Inclusion Criteria:

* Aged 18 to 65 years old
* Smoking 20 or more cigarettes per day
* Wants to stop smoking(seeking treatment)
* No period of smoking abstinence longer than 3 months in the past year
* Be able to give informed consent to participate
* Complete the study questionnaires
* Female smokers will be eligible providing they are not breastfeeding, pregnant (negative pregnancy test) or at risk of becoming pregnant

Exclusion Criteria:

* Previous use of nicotine transdermal patches or varenicline (VRN) in the last 6 months
* Cigar, pipe and oral tobacco users who do not smoke 20 or more cigarettes per day
* Those who meet the criteria contra-indicating nicotine patches or VRN use, as described in the Summaries Product Characteristics
* Those with previous severe adverse reactions to nicotine patch or to VRN
* Those currently taking either medication for smoking cessation that they are unwilling to stop or taking medication with a known influence on smoking cessation that they should not stop (e.g. nortriptyline for depression)
* Those who are non-Spanish neither Catalan speakers
* Those deemed unsuitable for the study by their smoking cessation physicians; -- Unstable diseases within the previous 6 months
* Diagnoses of or treatment for major depression last 6 months or psychotic disorder; or drug or alcohol dependence within the previous 12 months
* Skin disorders that cause a difficulty of nicotine absorption by patches as Psoriases as well as general dermatitis
* Clinically significant renal or hepatic impairment or dysfunction
* Pregnant or breast-feeding women
* women who do not use neither want to use any effective anticonceptive method.

Answer: D