Please select the eligibility criteria that correspond to the clinical trial below.
Title: Testing a Full Substitution Therapy Approach As Treatment of Tobacco Dependence
Brief Summary: This study will test a new medication strategy designed to help smokers quit. It will combine selegiline, a drug currently approved and available for the treatment of Parkinson's disease, with a nicotine skin patch. Forty nicotine-dependent smokers will enrolled in this study. Twenty will receive placebo (inactive pill) plus nicotine patch, and twenty will receive selegiline plus nicotine patch. Once enrolled in the study, subjects will visit the Nicotine Dependence Clinic at CAMH on a weekly basis for assessment of smoking behavior, a brief health check, collection of breath and urine samples (necessary to drug levels and nicotine levels), and receive brief individual counseling designed to help them stop smoking. The medication phase of this study lasts 9 weeks. A follow-up visit will be conducted six months after trial completion. At that point, health and behavioral measures will be re-assessed.


Options:
A: Inclusion Criteria:

* Meet DSM-IV criteria for nicotine dependence with FTND score \> 5.
* Smoke at least 15 cigarettes (3/4 pack) daily (averaged over 1 week, in the past 1 month).
* At the time of initial evaluation, are motivated to quit smoking in the next 30 days.
* Have made at least one unsuccessful attempt to quit smoking in the past year.
* At baseline, have expired breath CO level \> 10.
* Are between ages 18-70 years old.
* Weigh at least 100 lbs (45.5 kg, selegiline dose \< 0.22 mg/kg).
* No previous use of nicotine replacement products in the one month prior to randomization.
* Have the capacity to give informed consent, and are English-speaking.

Exclusion Criteria:

* Have present or past diagnoses of schizophrenia, bipolar disorder, PTSD, BPD or major depressive illness.
* Have abused alcohol or other drugs of abuse (cocaine, opiates, benzodiazepines, etc) in 6 months prior to randomization into the trial (based on clinical evaluation including self-report, and confirmed by positive urine).
* Demonstrate serious medical conditions (i.e. abnormal liver function \[as evidenced by AST, ALT or bilirubin values 2x ULN\], unstable cardiovascular disease, significant blood abnormalities).
* Exhibit or have history of clinical hypertension.
* Exhibit active peptic ulcer disease.
* Are pregnant, are trying to become pregnant, or are currently breastfeeding.
* Are on current medication regimes that include antidepressants, or sympathomimetic agents, or meperidine and other meperidine-opioids which may have interactions with selegiline.
* Known hypersensitivity to selegiline or NRT.
* Are from the same household as another study participant.
B: Inclusion Criteria:

* Cigarette smokers who are motivated to stop smoking and have smoked an average of at least 10 cigarettes per day

Exclusion Criteria:

* Subjects who have used a nicotine replacement product within 30 days of the study screening visit or intend to use it during the study.
C: Inclusion Criteria:

* Subjects will be 144 smokers who have experienced at least one episode of major depressive disorder and 206 smokers who lack a lifetime history of major depressive disorder.
* None will currently meet diagnostic criteria for major depression, nor will they have met criteria in the past 6 months.
* All will be male and female community members between the ages of 18 and 65 who have smoker at least 10 cigarettes a day for the past year.

Exclusion Criteria:

Subjects may not enter the trial if they:

1. have taken monoamine oxidase inhibitors, antidepressants, anti-anxiety agents, lithium, tryptophan or phenothiazines within the past month;
2. are being treated for hypertension with guanethidine, reserpine, thiazide diuretics, beta blockers, or clonidine;
3. are taking Type IC antiarrhythmics (e.g., propafenone and flecanide) or a highly protein-bound drug (e.g., warfarin, digitoxin);
4. have a medically unstable condition or had a major health event in the past 6 months (e.g., myocardial infarct or major surgery);
5. have CBC values more than 10% outside the normal limits, or liver enzymes exceeding 40% of the upper limit of normal;
6. have a history of severe allergies, multiple adverse drug reactions or known allergy to fluoxetine;
7. are actively abusing alcohol or drugs or received inpatient treatment for substance abuse within the past year;
8. are using nicotine replacements;
9. are pregnant, lactating, or of childbearing potential;
10. present current evidence of organic brain disease, definite or subclinical major depressive disorder or serious suicidal risk post-traumatic stress disorder, or premenstrual dysphoric disorder;
11. have a score greater than 14 on the 21-item Hamilton Depression Rating Scale or greater than 15 on the Beck Depression Inventory;
12. have a history of seizures, mania or hypomania, or psychosis. Individuals with bipolar disorder, PTSD, or schizophrenia will be excluded because they might respond adversely to fluoxetine.

Subjects with dysthymic disorder or anxiety disorders will be studied if their current symptoms are not sequelae of an episode of major depression. Excluding such cases would purify the sample by removing mild degrees of dysphoria, but would greatly restrict our ability to generalize any treatment implications to the current population that smokers.
D: Inclusion Criteria:

* Smoked at least one puff in the past 7 days
* Confirmed viable gestation

Exclusion Criteria:

* All patients found to have a non-viable fetus or major congenital anomaly
* History of seizure disorder
* Family history of seizure disorder
* History of severe head trauma
* History of anorexia nervosa or bulimia
* Current use of nicotine-replacement therapy
* Unstable medical or psychiatric condition
* Current use of an monoamine oxidase inhibitor or bupropion hydrochloride products

Answer: A