Please select the eligibility criteria that correspond to the clinical trial below.
Title: Randomized Clinical Trial Comparing a Medication, i.e., Sustained-Release Bupropion (Zyban®) With an Ultrashort (1 1/2 d) Manual-Based Psychotherapeutic Intervention, Psychodynamic Model Training®
Brief Summary: Background

Smokers often reject drugs as smoking cessation aids. Nonpharmacological interventions are notoriously under-evaluated.

Methods

We conducted a randomized clinical trial in which we compared a medication, i.e., sustained-release bupropion (Zyban®; 413 subjects), at the time of the trial the most efficacious pharmacological smoking cessation aid, with an ultrashort psychotherapeutic intervention, Psychodynamic Model Training® (366 subjects), a manual-based psychodynamically oriented 1 ½ day autosuggestion training. Outcome criterion was 12-month self-reported continuous abstinence confirmed by urine cotinine levels below the level of detection (13 ng/ml) or, in an independent analysis, by exhaled carbon monoxide of 10 ppm or less at all interviews conducted at 3, 6, and 12 months.


Options:
A: Inclusion Criteria:

* Smoke 10 or more cigarettes per day
* Motivated to quit
* No physical or mental health issues that would prevent participation
* Not pregnant or willing to prevent pregnancy during treatment

Exclusion Criteria:

* Carbon monoxide (CO) breath test score below 10 parts per million (ppm)
* Center for Epidemiologic Studies Depression Scale (CES-D) score greater than 16
* Heavy alcohol use
* History of eating disorder
* Suicidality
B: Inclusion Criteria:

* males and females
* over age 18
* used smokeless tobacco every day for the past year (confirmed with urinary cotinine)
* residing within 100km of New Dehli for the next 4 months
* interested in quitting use of smokeless tobacco.

Exclusion Criteria:

* currently enrolled or plan to enroll in another tobacco cessation program in the next 4 months
* plan to use other smoking cessation treatments in the next 4 months
* smoke cigarettes
* have current substance abuse (e.g., opioids, cocaine, marijuana) verified by urine drug screen
* have current (last 6-months) alcohol consumption that exceeds 25 standard drinks/week (if past abuse, must be symptom free for ≥ the past 12 months)
* Current use or discontinuation within last 14 days of:

  1. smoking cessation medications (bupropion, Varenicline, NRT);
  2. antipsychotics, atypicals, mood-stabilizers, anti-depressants (tricyclics, SSRIs, MAOIs), anti-panic agents, anti-obsessive agents, anti-anxiety agents, stimulants;
  3. Anti-coagulants;
  4. Daily medication for asthma or diabetes (eligible with physician approval);
* are pregnant, planning a pregnancy, or lactating
* have a history or current diagnosis of psychosis, general anxiety disorder,bipolar disorder, or schizophrenia
* have a current diagnosis of depression (if past diagnosis, must be symptom free for ≥ the past 12 months)
* have an allergy to Varenicline
* ever contemplated or attempted suicide
* have serious/unstable disease within the past 6 months (e.g., cancer \[but melanoma\], heart disease, HIV/AIDS)
* have a history of epilepsy or seizure disorder
* have a history or diagnosis within the last 6 months of abnormal rhythms and/or tachycardia (\>100 beats/minute)
* have a history or current diagnosis of COPD; cardiovascular disease (stroke, angina); heart attack in the last 6 months; and/or uncontrolled hypertension (SBP\>150 or DBP\>90)16)
* have a history of kidney or liver failure
* have any medical condition or medication that could compromise safety as determined by a study physician
* cannot provide informed consent or complete the study tasks as determined by the Principal Investigator or study physician.
C: DISEASE CHARACTERISTICS:

* African American who has smoked ≤ 10 cigarettes per day for ≥ 2 years AND has smoked for ≥ 25 days within the past month

  * Not a heavy smoker
  * No other forms of tobacco within the past 30 days
* Must be interested in stopping smoking
* No other smoker in the household enrolled in this study

PATIENT CHARACTERISTICS:

* Has a home address and a functioning telephone number
* Not planning to move from the Kansas City metro area within the next 12 months
* Not pregnant or nursing
* Negative pregnancy test
* No alcohol or substance abuse within the past year
* Not currently drinking ≥ 14 alcoholic drinks per week
* No binge drinking (5 or more drinks on one occasion) on at least two occasions within the past month
* No history of seizures or head trauma
* No history of bulimia or anorexia nervosa
* No myocardial infarction within the past 30 days
* No reported use of opiates, cocaine, or stimulants
* No diabetes requiring oral hypoglycemics or insulin

PRIOR CONCURRENT THERAPY:

* More than 30 days since prior nicotine replacement therapy, fluoxetine, clonidine, buspirone, or doxepin
* No other concurrent medication that contains bupropion hydrochloride
* No concurrent psychoactive medications
D: Inclusion Criteria:

* An age of at least 18 years,
* A cigarette consumption of at least 15 cigarettes per day in the last 3 months, and
* The willingness to contribute EUR 70 to the treatment costs, regardless of the treatment modality.

Exclusion Criteria:

* Any psychiatric diagnosis except nicotine or caffeine dependence,
* Any current psychopharmacological treatment,
* Known hypersensitivity to bupropion,
* Epilepsy,
* Liver cirrhosis,
* Brain tumor,
* Pregnancy (verified by an immunological test at the intake interview and 3 weeks after the first day of the first menses occurring within treatment),
* Lactation,
* Any serious or unstable cardiac,
* Renal,
* Hypertensive,
* Pulmonary,
* Endocrine, or neurologic disorder,
* Ulcers,
* Dermatologic disorders,
* Current use of other smoking cessation treatments, and
* Regular use of any noncigarette tobacco product

Answer: D