Varenicline and Alcohol in Inpatient Addictions Program (IAP)
Condition: Alcoholism; Nicotine Dependence
MeSH terms: Alcoholism; Tobacco Use Disorder
Intervention: Varenicline
Intervention description: 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.
Intervention MeSH terms: Varenicline
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 1.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: Alcohol; Smoking

Summary:

      The overall hypothesis of this line of research is that varenicline will decrease alcohol
      consumption and tobacco use and will increase alcohol and tobacco abstinence rates. In order
      to explore this hypothesis, the investigators will conduct a two-phase study: 1) an open
      label pilot study investigating the effect of varenicline on reduction of and abstinence from
      alcohol and tobacco; and 2) an optional MR spectroscopy to investigate whether glutamate and
      other brain metabolites correlate to measures of alcohol craving severity and/or subsequent
      varenicline treatment response.
    

Eligibility criteria:

        Subjects will be eligible for enrollment if they:

          1. Are > 18 and < 70 years of age

          2. Are admitted to the inpatient addiction program (IAP) in the Generose Building at
             Saint Marys Hospital

          3. Have been diagnosed with alcohol dependence based on DSM-IV-TR criteria and confirmed
             by Psychiatric Research Interview for Substance and Mental Disorders (PRISM)

          4. Smoke at least 10 cigarettes/day for ≥ 6 months

          5. Are able to participate fully in all aspects of the study

          6. Have been provided with, understand, and have signed the informed consent; and

          7. Agree to identify collateral individuals for contact purposes to facilitate follow-up
             appointments.

        Patients will be excluded from participation if they:

          1. Meet DSM-IV criteria of schizophrenia or other non-affective psychotic disorder

          2. Have had psychotic symptoms within the past month

          3. Have an Axis I disorder requiring new pharmacotherapy

          4. Have a predominant Axis II disorder

          5. Have used an investigational drug within 30 days of enrollment

          6. Have started Naltrexone or Acamprosate during this same IAP admission

          7. Have a history (past 3 months) of drug abuse (excluding caffeine and marijuana)

          8. 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

          9. Have a history of medically serious suicide attempt within 5 years

         10. Have a history of any major cardiovascular events including arrhythmias, congestive
             heart failure, unstable angina, acute MI or coronary angioplasty

         11. 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;

         12. Have clinically significant acute or chronic progressive or unstable neurologic,
             hepatic, renal, cardiovascular, respiratory or metabolic disease

         13. Have another household member or relative participating in the study

         14. Have a known allergy to varenicline

         15. Are individuals, in the investigators opinion, unable to comply with study procedures

         16. Are unable to provide written informed consent in English

         17. 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:

          1. Claustrophobia

          2. A history of major head trauma with loss of consciousness > 5 minutes or skull
             fracture

          3. A history of previous neurological event (e.g., epilepsy, stroke, transient ischemic
             attack)

          4. Implanted metal objects (e.g., pacemakers; aneurysm clips; metal prostheses, joints,
             rods, or plates)

          5. Contraindication to MRI scanning.