Ensayos clínicos

Inclusion Criteria

• Age > 18 and < 70 years
• Admitted to the inpatient addiction program (IAP) in the Generose Building at Saint Marys Hospital
• Diagnosed with alcohol dependence based on DSM-IV-TR criteria and confirmed by Psychiatric Research Interview for Substance and Mental Disorders (PRISM)
• Has smoked at least 10 cigarettes/day for ≥ 6 months
• Able to participate fully in all aspects of the study
• Has been provided with, understands, and has signed the informed consent
• Agrees to identify collateral individuals for contact purposes to facilitate follow-up appointments

Exclusion Criteria

• Meets DSM-IV criteria of schizophrenia or other non-affective psychotic disorder
• Has had psychotic symptoms within the past month
• Has an Axis I disorder requiring new pharmacotherapy
• Has a predominant Axis II disorder
• Has used an investigational drug within 30 days of enrollment
• Has started Naltrexone or Acamprosate during this same IAP admission
• Has a history (past 3 months) of drug abuse (excluding caffeine and marijuana)
• Has active suicidality as measured by screening questions from the Columbia-Suicide Severity Rating Scale (C-SSRS)(Posner 2008)
  • "Yes" response to questions 1, 2, or 3 with significant intensity level endorsed as
    • Frequency score of 4 or 5 
    • Duration score of 3, 4 or 5
    • Controllability score of 0, 4, or 5
    • Deterrents score of 0, 4 or 5
    • Reasons for Ideation score of 1, 2, 3, 4 or 5
  • "Yes" response to question 4 c
  • "Yes" response to question 5
• History of medically serious suicide attempt within 5 years
• History of any major cardiovascular events including arrhythmias, congestive heart failure, unstable angina, acute MI or coronary angioplasty
• Pregnant or lactating
• Of child bearing potential, likely to become pregnant during the medication phase and not willing to use a reliable form of contraception
  • Reliable forms of contraception include diaphragm or condom (with spermicidal), injections, intrauterine device [IUD], surgical sterilization and abstinence
• Has clinically significant acute or chronic progressive or unstable neurologic, hepatic, renal, cardiovascular, respiratory or metabolic disease
• Has another household member or relative participating in the study
• Has a known allergy to varenicline
• In the investigators opinion, unable to comply with study procedures
• Unable to provide written informed consent in English
• On hemodialysis or has a history of kidney disease
• Cannot participate in the MR spectroscopy because of 
  • Claustrophobia
  • A history of major head trauma with loss of consciousness > 5 minutes or skull fracture
  • A history of previous neurological event (e.g., epilepsy, stroke, transient ischemic attack)
  • Implanted metal objects (e.g., pacemakers; aneurysm clips; metal prostheses, joints, rods, or plates)
  • Other contraindication to MRI scanning