Please select the eligibility criteria that correspond to the clinical trial below.
Title: Smoking Cessation in Patients With COPD (SMOCC) in General Practice
Brief Summary: Background: Smoking cessation is the key element in the treatment of patients with Chronic Obstructive Pulmonary Disease (COPD). The role of the general practice in assisting these patients with successful quitting smoking was suboptimal. Therefore we evaluated the effectiveness of two smoking cessation programs (counseling and nicotine replacement) for smokers with COPD in routine general practice, one with (CNB) and one without (CN) the combination with bupropion-SR, compared to usual care (UC) and explored the role of COPD symptoms in successful smoking cessation.

Method: RCT with 667 patients with COPD, 68 general practices were randomly allocated. The usual care group (UC) consisted of 148 patients (22 practices), the first intervention group (counseling plus nicotine replacement (CN) of 243 patients (21 practices) and the second intervention group of 276 patients (25 practices. Main outcome measure was (biochemically verified) point prevalence.


Options:
A: Inclusion Criteria:

* Inclusion Criteria are:

  1. DSM-IV diagnosis of Schizophrenia or schizoaffective disorder
  2. Age: 18-64
  3. Regular half pack a day smokers
  4. Score of at least 4 on the Nicotine Dependency Test

     Exclusion Criteria:

     Exclusion Criteria are:

  <!-- -->

  1. Seizure disorders, other Neurologic illnesses, or a family history of seizures
  2. A medical condition that could manifest psychiatrically
  3. Currently experiencing a depressive episode
  4. Active substance abuse
  5. Currently receiving bupropion
  6. Pregnant women
  7. Children (\<18 years of age)
  8. Two consecutive sodium levels of 130 mmol/L or less
B: Inclusion Criteria:

1. Subject is at least 18 years of age;
2. Subject has provide written informed consent;
3. Subject is smoking greater than or equal to 10 cigarettes per day for at least 6 months;

3) Subject is able to complete all study visits 4) Subject is in good health as determined by the investigator 5) Subject has the ability to participate fully in all aspects of the study and keep scheduled appointments 6) Subject is motivated to stop smoking.

Exclusion Criteria:

Female and were pregnant, lactating or likely to become pregnant during the trial and not able nor willing to use contraception or had:

1. an unstable medical condition;
2. another household member participating in the study;
3. bupropion or varenicline allergy;
4. current use (previous 30 days) of a tobacco dependence treatment and unable or unwilling to discontinue use;
5. an unstable medical condition or unstable angina, myocardial infarction, or coronary angioplasty (past 3 months) or an untreated cardiac dysrhythmia;
6. a history of renal failure or were on renal dialysis;
7. a history of seizures;
8. as defined by the C-SSRS (Columbia-Suicide Severity Rating Scale), current non-specific suicidal thoughts or lifetime history of a suicidal attempt (defined as "potentially self-injurious act committed with at least some wish to die, as a result of act");
9. a history of closed head trauma associated with \> 30 minutes of loss of consciousness, amnesia, skull fracture, subdural hematoma, or brain contusion;
10. a history or psychosis, bipolar disorder, bulimia or anorexia nervosa;
11. current moderate or severe depression as assessed by a score of ≥ 20 on the Beck Depression Inventory, Second Edition (BDI-II) 10;
12. active substance abuse other than nicotine;
13. current (past 14 days) use of an antipsychotic, monoamine oxidase inhibitors, or drugs known to interact with bupropion SR;
14. a recent dose change of their antidepressant (within last 3 months);
15. untreated hypertension or baseline systolic blood pressure \> 180 or diastolic \> 100;
16. current treatment with another investigational drug for tobacco dependence (previous 30 days); or
17. current use of bupropion or varenicline (previous 30 days).
C: Inclusion Criteria:

1. Regular cigarette smokers smoking at least 5 cigarettes per day as derived by Time-Line Follow-Back method (Sobell et al., 1988). Average number of cigarettes per day (over past 30 days) will be used. Five cigarettes per day may seem low, but based on previous studies, adolescents tend to smoke fewer cigarettes per day as compared to adults.
2. Baseline urine cotinine level greater than 100 ng/ml.
3. Age range of 12 - 21
4. If under 18 yr. of age, parent(s) or guardian(s) able to participate in informed consent and initial assessment, or the participant must provide evidence of emancipated status.
5. For post menarchal female participants: agree to use birth control to avoid pregnancy.

Exclusion Criteria:

1. Active substance abuse/dependence (other than nicotine) within 2 weeks prior to participating in the study
2. Lifetime bipolar affective disorder (BPAD), psychosis, eating disorders. Bupropion may have adverse consequence on participants with these psychiatric diagnoses.
3. Current major depressive disorders. Since bupropion is also an antidepressant, this criteria is to minimize the confound of depressive disorder during the study. History of depressive disorders and current attention deficit hyperactivity disorder (ADHD) will not be an exclusion. We will use permuted block randomization procedure to balance the groups for ADHD.
4. Pregnancy or lactation. The safety of bupropion in pregnancy and during lactation is not well studied.
5. History of seizure disorder or predisposition to seizures (e.g., history of significant head trauma, currently taking medications that lower seizure threshold), since bupropion can lower seizure threshold.
6. History of severe renal, hepatic, neurological, or chronic pulmonary disease. This criterion was chosen due to the hepatic metabolism of bupropion.
7. Unstable medical problems
8. Allergy to bupropion
9. Current treatment with any other medication containing bupropion
10. Current treatment with any monoamine oxidase (MAO) inhibitors currently or within 2 weeks of starting the study since there may be serious and severe medical interactions between MAO inhibitors and bupropion SR.
11. Current treatment with nicotine replacement therapy (NRT)
12. History of intolerance or non-response to bupropion SR.
13. Current (past month) suicide ideation
14. Suicide attempt (past year)
D: Inclusion Criteria:

A software program using Anatomical Therapeutical Chemical (ATC) prescription codes and International Classification of Primary Care (ICPC) diagnosis codes selected potential patients with COPD. Criteria: age \>35 years and a diagnosis recorded as COPD or as ICPC code R95/96, or a prescription of at least three times of bronchodilators (ATC code R03a/bc) and/or prescription of at least two times of inhaled anti-inflammatory medication in the past year (ATC code R03). General practitioners (GPs) had to confirm the diagnosis of the selection. Patients were eligible to participate if they met the following criteria:

* Current smoking
* Suffering from COPD according to the GP's diagnosis
* In command of the Dutch language.

Exclusion Criteria:

* Too ill
* Under control of a chest physician
* Serious physical or psychological comorbidity

Answer: D