Please select the eligibility criteria that correspond to the clinical trial below.
Title: Efficacy of Varenicline in Methadone-Stabilized Cocaine Users
Brief Summary: Cocaine addiction continues to be an important public health problem in the US with a significant cost to the individual and society. Among substance abusers, cocaine use has been recognized as a significant problem especially in methadone-maintenance patients. In several studies, rates of cocaine use have been reported to range from 30 to over 60 percent of those in methadone maintenance programs (Condelli et al. 1991; Hunt et al. 1984; Kidorf and Stitzer 1993; Kosten et al. 1988). In these patients, cocaine use seems to be a predictor of poor clinical outcome (Hartel et al. 1995; Kosten et al. 1987a). The development of effective pharmacotherapies for cocaine use disorders, especially in the opioid-dependent population is of great importance. Unfortunately, such effective pharmacotherapies do not exist.

1. To determine the safety and tolerability of varenicline in cocaine-using methadone-stabilized subjects.
2. To determine if varenicline is efficacious in reducing cocaine-use in methadone-stabilized subjects.


Options:
A: Inclusion criteria:

* Males and females at least 18 years old.
* English speaking.
* Meets criteria for alcohol dependence or alcohol abuse.
* Must complete an alcohol detoxification program prior to entering the study.
* Currently smoking 15 or more cigarettes per day and have at least a 3 year history of smoking.
* Have a current desire to stop smoking and stop drinking.
* Willing to complete followup assessments up to 12 months after treatment.
* Willing to provide names of 2 people who can help locate the subject at followup and the name of one person who can verify information about alcohol and tobacco use.
* One person per household.

Exclusion Criteria:

* Allergy to nicotine patch or nicotine gum.
* Weigh less than 100 pounds.
* Use other nicotine products, such as cigars, pipes or smokeless tobacco.
* Severe skin disorder.
* Active peptic ulcer.
* Active joint disease.
* Heart attack within 3 months prior to entering the study.
* Pregnant or breastfeeding female who are not on birth control.
* Currently taking medication to treat alcoholism or smoking, such as naltrexone, disulfiram or bupropion.
* Poor vision or hearing that would interfere with using a cell phone.
* Lack of transportation to the treatment site or live at least one hour from the treatment site.
* Homeless.
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:

* Males or females, ages 18 to 69, with a DSM-IV diagnosis of Schizophrenia or Schizoaffective Disorder, receiving outpatient psychiatric treatment
* Currently taking antipsychotic medication for at least 4 weeks (medication is prescribed, compliance assessed based on self-report and collateral information)
* Current DSM-IV diagnosis of Nicotine Dependence
* Current DSM-IV diagnosis of Alcohol Dependence
* Subject expresses a desire to cut down or quit smoking and drinking (based on assessment with contemplation ladder)
* An average of at least one pack of cigarettes per day (\>=20 cigarettes/day) over the 7 days prior to intake
* An average of at least 7 drinks over the 7 days prior to intake

Exclusion Criteria:

* Inability to give adequate informed consent
* Currently taking sustained - release bupropion (Zyban) or receiving any other form of bupropion, such as Wellbutrin or Wellbutrin SR; receiving another form of pharmacological smoking cessation treatment (e.g., nicotine gum or patch); or participating in another structured, formal smoking cessation program.
* Currently taking naltrexone (ReVia), Campral or Antabuse
* Participation in a clinical trial less than 3 months prior to intake
* History of suicide attempt in the past year
* History of hospitalization due to suicidal ideation in the past year
* Suicidal ideation at baseline
* Known allergic reaction to varenicline
* Female patients of childbearing potential who are sexually active, not sterile, and who deny using a form of birth control.
* Female patients who are pregnant or nursing.
* Significant unstable medical problems (e.g. impaired renal function).
* Significant unstable psychiatric disorders.
* Subjects who do not attend all required screening appointments.
* Subjects who have pending legal proceedings whose outcome may lead to incarceration within 3 months of intake.
* Positive urine drug screen for cocaine, opioids or amphetamine at baseline
* Current DSM-IV diagnosis of Cocaine, Opioid or Cannabis Dependence (1 month prior to enrollment)
* Metal implants or devices (e.g. aneurysm clips, cochlear implants, neural stimulators, cardiac pacemakers)
* Weight over 250 lbs
* Claustrophobia
D: Inclusion Criteria:

* Age 18 or older
* English speaking
* Smoked at least 100 cigarettes/lifetime
* Smokes 5 or more cigarettes per day
* Interested in quitting smoking (preparation or contemplation state of change)
* Enrolled in Einstein/Montefiore methadone program for 3 or more months
* Stable methadone dose for 2 weeks
* Agree to use contraception throughout the trial (among women with reproductive potential)
* Willing to participate in all study components
* Able to provide informed consent

Exclusion Criteria:

* Serious or unstable HIV/AIDS, liver, cardiovascular, or pulmonary disease
* Psychiatric instability
* Women who are pregnant, breastfeeding, or contemplating pregnancy
* Creatinine clearance less than 30 mL/min

Answer: B