A Study of the Use of Varenicline to Treat Smoking Addiction in Patients with Alcoholism

Overview

  • Study type

    Interventional
  • Study phase

    III
  • Study IDs

  • Describes the nature of a clinical study. Types include:

    • Observational study — observes people and measures outcomes without affecting results.
    • Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
    • Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
  • During the early phases (phases 1 and 2), researchers assess safety, side effects, optimal dosages and risks/benefits. In the later phase (phase 3), researchers study whether the treatment works better than the current standard therapy. They also compare the safety of the new treatment with that of current treatments. Phase 3 trials include large numbers of people to make sure that the result is valid. There are also less common very early (phase 0) and later (phase 4) phases. Phase 0 trials are small trials that help researchers decide if a new agent should be tested in a phase 1 trial. Phase 4 trials look at long-term safety and effectiveness, after a new treatment has been approved and is on the market.

  • Site IRB
    • Rochester, Minnesota: 10-002699
    NCT ID: NCT01169610
    Sponsor Protocol Number: 10-002699

About this study

The purpose of this study is to see if varenicline will decrease alcohol consumption and increase alcohol abstinence rates when given to alcoholic patients for both alcohol and smoking cesation treatment.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. If you need assistance understanding the eligibility criteria, please contact the study team.

See eligibility criteria

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

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location Status

Rochester, Minn.

Mayo Clinic principal investigator

Mark Frye, M.D.

Closed for enrollment

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CLS-20312637

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