Please select the eligibility criteria that correspond to the clinical trial below.
Title: Smoking Young Asthmatics: Change of Inflammation During Tobacco Cessation and Steroid Treatment
Brief Summary: This is a study describing changes in inflammation of the airways in asthmatics before and after smoking cessation and steroid treatment.


Options:
A: Inclusion Criteria:

* Eligible participants will be 68 (34 male and 34 female) smokers aged 18-65, who smoke ≥ 10 cigarettes per day, provide a baseline CO reading ≥ 10 ppm and who plan to live in the area for the next 6-months.

Exclusion Criteria:

* Smoking Behavior

  1. Use of chewing tobacco or snuff
  2. Current enrollment or plans to enroll in another smoking cessation program in the next 5 months
  3. Plan to use other nicotine substitutes or smoking cessation treatments in the next 5 months
  4. Provide a baseline CO reading \< 10 ppm

Alcohol/Drug Exclusion Criteria

1. History of substance abuse and/or currently receiving treatment for substance abuse (e.g., alcohol, opioids, cocaine, marijuana, or stimulants)
2. Current alcohol consumption that exceeds \>25 standard drinks/week

Medication Exclusion Criteria

1. Current use or recent discontinuation (within last 14-days) of the following medications:

1. Any form of smoking cessation medication (zyban, wellbutrin, wellbutrin SR, Chantix, NRT)
2. Any form of anti-psychotic medications that includes:

   * antipsychotics,
   * atypical antipsychotics,
   * mood-stabilizers,
   * anti-depressants (tricyclics, SSRI's, MAOI's),
   * anti-panic agents,
   * anti-obsessive agents,
   * anti-anxiety agents, and
   * stimulants (e.g., Provigil, Ritalin).
3. Medication for chronic pain
4. Anti-coagulants
5. Any heart medications
6. Daily medication for asthma

Medical Exclusion Criteria

1. Women who are pregnant, planning a pregnancy, or lactating.
2. History or current diagnosis of psychosis, major depression or bipolar disorder, schizophrenia, or any Axis 1 disorder as identified by the SCID.
3. Serious or unstable disease within the past 6 months (e.g., cancer \[except melanoma\], heart disease, HIV).
4. History of epilepsy or a seizure disorder.
5. History or current diagnosis (last 6-months) of abnormal rhythms and/or tachycardia (\>100 beats/minute); history or current diagnosis of COPD, cardiovascular disease (stroke, angina, coronary heart disease), heart attack in the last 6 months, uncontrolled hypertension (SBP\>150 or DBP\>90)
6. History of Kidney and/or liver failure (including transplant).
7. Wears a device to aid in hearing (hearing aid, cochlear implant, etc.).
8. Hearing threshold \< 40 dB SPL at 1000 Hz.
9. Color blindness.

General Exclusion

1. Any medical condition or concomitant medication that could compromise participant safety or treatment, as determined by the Principal Investigator and/or Study Physician.
2. Inability to provide informed consent or complete any of the study tasks as determined by the Principal Investigator and/or Study Physician.
3. Any physical or visual impairment that may prevent the individual from using a computer keyboard or completing any study tasks.
B: Inclusion Criteria:

* Males and females between 18 and 55 years old will be eligible for this study. Females must not be pregnant as determined by pregnancy screening, nor breast feeding, and must be using acceptable birth control methods during study participation.
* Current opioid dependence as evidenced by documentation of prior treatment for opioid dependence or signs of withdrawal, self-reported history of opioid dependence for consecutive 12 month period and a positive urine for opiates.
* Subjects must fulfill Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) criteria for opioid dependence.
* Subjects must have a history of cocaine use, with a reported street cocaine use of a minimum of 1/2 gram during the preceding 30 days.
* Subjects must meet DSM-IV criteria for cocaine dependence or abuse, and have laboratory confirmation of recent cocaine use (positive urine for cocaine) during the month prior to study entry.
* Subjects must be treatment-seekers for opioid and cocaine use.
* Subjects must have smoked at least 10 cigarette per day for at least one year. Varenicline's safety has only been studied in smokers.

Exclusion Criteria:

* History of heart disease, left ventricular hypertrophy, ischemic ECG changes, chest pain, arrhythmia, hypertension.
* History of severe renal or hepatic diseases.
* History of psychosis, schizophrenia, bipolar or major depressive disorder.
* History of seizure disorder.
* Current diagnosis of alcohol, benzodiazepine and other drug abuse or dependence (other than opiates, cocaine, and nicotine).
* Current use of over-the-counter or prescription psychoactive drugs (antidepressant, anxiolytics, antipsychotics, mood stabilizers, psychostimulants).
* Liver function tests (ALT or AST) greater than 3 times normal.
* Known allergy to varenicline or methadone.
C: Inclusion Criteria:

* Smoke at least 10 cigarettes per day for the previous 6 months - Expired CO \> 9 ppm - Motivated to quit smoking - Able to read and write English - Willing to complete required study assessments

Exclusion Criteria:

* Uncontrolled hypertension (systolic \>180mm Hg or diastolic \>110mm Hg) - History of bipolar disorder or psychosis - Myocardial infarction or other serious cardiac problem in the previous 4 weeks - History of diagnosed anorexia and/or bulimia - Diagnosis of Alcohol Dependence in the previous 6 months by participant self-report or drinking 6 or more drinks on six or more days a week - History of seizure and/or serious head injury involving loss of consciousness - Use of contraindicated medications (MAO inhibitors, bupropion, lithium, anticonvulsants, antipsychotics) - Currently pregnant or breast-feeding - Unwilling to use effective contraception during the treatment phase - More than one participant from the same household - Allergic reactions to 3 or more classes of drugs
D: Inclusion Criteria:

Asthmatic symptoms during the last year and at least one criterion of the below:

1. current FEV1-increase of minimum 12% after b2-agonist,
2. positiv Methacholintest,
3. Day-to-day FEV1-variation of at least 20% during a two-week period.
4. Positive mannitol test.

Furthermore, all of the below inclusion criteria:

* At least 10 packyears
* At least 10 cigarettes per day within the last year
* Age 18-40 years

Exclusion Criteria:

1. Asthmatics who have been treated with inhaled corticosteroids (ICS), systemic corticosteroids, leukotrien-antagonists (LTA), long-lasting b2-agonists, anticholinergic medicine or varenicline within the last 3 months
2. Lower respiratory tract infections, including pneumonia, within the last 6 weeks.
3. Patients suffering from other chronic respiratory disease than asthma, such as sarcoidosis and COPD will also be excluded.
4. Pregnant and nursing women will be excluded as well as women planning pregnancy during the study period.
5. A history of allergy towards study drugs will lead to exclusion.

Patients who during the study period develop lower respiratory infections or due to severe uncontrolled asthma receive treatment with any of the above listed types of medicine will be excluded. Patients who are diagnosed with other chronic respiratory disease than asthma during the study period will also be excluded, as well as patients who during the study period require more asthma medicine than the planned study medication.

Any participant who wishes to leave the study, for any reason, including unacceptable side-effects, during the study period will be excluded, as well as anyone who wants to withdraw their recorded data from the project after the study period has ended.

In case of unacceptable side-effects to varenicline resulting in immediate cessation of treatment with this drug, the participant will continue visits unchanged, but he/she will be excluded from the calculations of tobacco cessation succes-rate. However, varenicline cessation up to 4 weeks after treatment start with varenicline will result in exclusion and replacement of the participant.

Cessation of treatment with budesonide will result in exclusion from the rest the study. The person will not be replaced. The data recorded from the participant until the last visit before cessation will be used.

Allergic reactions towards study drugs will result in immediate cessation of the drug, and possible exclusion, as described in the above.

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Answer: D