Intervention: Varenicline
Trial phase: Phase 3
ATC code: N07BA03 | S01XA28
SMILES: c1cnc2cc3c(cc2n1)C1CNCC3C1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 1
Group description: Varenicline : Varenicline is an oral medication with a recommended dosage of 0.5 mg once daily for 3 days, increasing to 0.5 mg twice daily for days 4 to 7, and then to the maintenance dose of 1 mg twice daily for the remaining 23 weeks of treatment. All subjects will receive open-label varenicline in blister packs.
Eligibility criteria:
Subjects will be eligible for enrollment if they:

Are > 18 and < 70 years of age
Are admitted to the inpatient addiction program (IAP) in the Generose Building at Saint Marys Hospital
Have been diagnosed with alcohol dependence based on DSM-IV-TR criteria and confirmed by Psychiatric Research Interview for Substance and Mental Disorders (PRISM)
Smoke at least 10 cigarettes/day for ≥ 6 months
Are able to participate fully in all aspects of the study
Have been provided with, understand, and have signed the informed consent; and
Agree to identify collateral individuals for contact purposes to facilitate follow-up appointments.

Patients will be excluded from participation if they:

Meet DSM-IV criteria of schizophrenia or other non-affective psychotic disorder
Have had psychotic symptoms within the past month
Have an Axis I disorder requiring new pharmacotherapy
Have a predominant Axis II disorder
Have used an investigational drug within 30 days of enrollment
Have started Naltrexone or Acamprosate during this same IAP admission
Have a history (past 3 months) of drug abuse (excluding caffeine and marijuana)

Have active suicidality as measured by screening questions from the Columbia-Suicide Severity Rating Scale (C-SSRS), (Posner 2008) outlined below:

a. "Yes" response to questions 1, 2, or 3 with significant intensity level endorsed as: i. Frequency: score of 4 or 5 ii. Duration: score of 3, 4 or 5 iii. Controllability: score of 0, 4, or 5 iv. Deterrents: score of 0, 4 or 5 v. Reasons for Ideation: score of 1, 2, 3, 4 or 5 b. "Yes" response to question 4 c. "Yes" response to question 5

Have a history of medically serious suicide attempt within 5 years
Have a history of any major cardiovascular events including arrhythmias, congestive heart failure, unstable angina, acute MI or coronary angioplasty
Are pregnant, lactating, or 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;
Have clinically significant acute or chronic progressive or unstable neurologic, hepatic, renal, cardiovascular, respiratory or metabolic disease
Have another household member or relative participating in the study
Have a known allergy to varenicline
Are individuals, in the investigators opinion, unable to comply with study procedures
Are unable to provide written informed consent in English
Are on hemodialysis or have a history of kidney disease.

Patients will be excluded from participation in the MR spectroscopy portion of the study if they have:

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)
Contraindication to MRI scanning.