Please select the eligibility criteria that correspond to the clinical trial below.
Title: Varenicline Treatment in Alcohol and Nicotine Dependent Patients With Schizophrenia - a Double Blind, Placebo Controlled Trial
Brief Summary: The aim of the proposed pilot study is to find out whether varenicline (ChantixTM) treatment decreases alcohol use and smoking in patients with schizophrenia or schizoaffective disorder. Varenicline may also improve cognition (memory and concentration) and negative symptoms (e.g. poor attention, poverty of speech, apathy, affective flattening, anhedonia) in patients with schizophrenia and comorbid nicotine and alcohol dependence.


Options:
A: Inclusion Criteria:

* DSM-IV criteria for alcohol abuse or dependence
* Age 18 or older
* English speaking
* Smoking 1 or more cigarettes/day
* Male or female veterans eligible for VA healthcare
* Female nonveterans also eligible

Exclusion Criteria:

* Allergy or hypersensitivity to nicotine or adhesives used in nicotine patch
* Weigh less than 100 lbs
* Lack of interest in stopping smoking
* Pregnant or lactating females or females not practicing acceptable form of contraception
B: 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
C: 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.
D: 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.

Answer: B