Please select the eligibility criteria that correspond to the clinical trial below.
Title: An International, Seven-week, Double-blind, Placebo-controlled, Two Parallel Group Study to Assess the Efficacy of Dianicline 40 mg Bid as an Aid to Smoking Cessation in Cigarette Smokers
Brief Summary: The primary study objective is to demonstrate the efficacy of dianicline as an aid to smoking cessation in cigarette smokers. The main secondary objectives are to assess the: craving for cigarettes, nicotine withdrawal symptoms, and safety of dianicline.


Options:
A: 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.
B: 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.
C: Inclusion Criteria:

* Current cigarette smoker of at least 10 cigarettes per day
* Interested in quitting at some time
* Not currently interested in quitting smoking
* Access to telephone (home or work) for 6 month study period

Exclusion Criteria:

* Monthly cigar, pipe, or smokeless tobacco use
* Current pregnancy or breastfeeding
* Recent cardiovascular distress
* Phenylketonuria (PKU)
* Previous use of nicotine replacement therapy (gum, patch, lozenge, inhaler, or nasal spray)
D: 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.

Answer: B