Varenicline and Alcohol in Inpatient Addictions Program (IAP)

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
Mark Frye, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT01169610
First received: July 22, 2010
Last updated: July 19, 2013
Last verified: July 2013
  Purpose

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.


Condition Intervention Phase
Alcoholism
Nicotine Dependence
Drug: Varenicline
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A 24-week Open-Label Feasibility Trial of Varenicline for Alcoholic Cigarette Smokers

Resource links provided by NLM:


Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • Continuous Alcohol Abstinence [ Time Frame: Two years ] [ Designated as safety issue: No ]
    No consumption of alcohol (not even a single drink) during the specified interval of time. This will be a self-reported outcome.

  • Heavy Drinking Days [ Time Frame: Two years ] [ Designated as safety issue: No ]
    Number of drinking days > 5 drinks/day for men and > 4 drink/day for women. This will be a self-reported outcome.


Secondary Outcome Measures:
  • 7-day Point Prevalence Smoking Abstinence [ Time Frame: Two years ] [ Designated as safety issue: No ]
    Negative response to the question, "Have you used any type of tobacco, even a puff, in the past 7 days." This will be a self-reported outcome biochemically-confirmed with exhaled-air carbon monoxide (CO) < 8 parts per million (ppm) during the medication phase.

  • Prolonged Smoking Abstinence [ Time Frame: Two years ] [ Designated as safety issue: No ]

    Self-reported all tobacco abstinence since two weeks after target quit date (TQD) which will be during their 28-day stay in the IAP on day 8 of varenicline therapy. Negative response to the question, "Have you used any type of tobacco, even a puff, for 7 consecutive days or at least once each week on two consecutive weeks since xx/xx/xxxx?" Note: xx/xx/xxxx corresponds to the date two weeks after the target quit date (TQD).

    Biochemically-confirmed abstinence at the visit for which prolonged abstinence is being obtained.


  • Tolerability [ Time Frame: Two years ] [ Designated as safety issue: Yes ]
    Tolerability will be defined by the number of adverse events experienced by patients.


Enrollment: 1
Study Start Date: January 2011
Study Completion Date: June 2013
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Open Label Drug: 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.
Other Name: Chantix

Detailed Description:

The goal of this proposal is to explore the potential efficacy of varenicline for reducing alcohol consumption among alcohol-dependent cigarette smokers. The hypothesis for the current study is that 24 weeks of varenicline will increase alcohol abstinence rates among smokers and decrease alcohol consumption among patients receiving inpatient addiction treatment for alcoholism. The investigators will also explore whether varenicline has a beneficial effect on tobacco abstinence rates in this population of tobacco users.

The investigators will conduct an open-label pilot study to determine clinical efficacy and employ neuroimaging techniques to evaluate how glutamate and other brain metabolites correlate to measures of alcohol craving severity and/or subsequent varenicline treatment response. The investigators will enroll 20 subjects receiving treatment in the Mayo Clinic Inpatient Addictions Program (IAP) and compare outcomes with patients participating in a similar 6-month open-label study of acamprosate.

The Primary aims of this study are:

  1. To obtain preliminary evidence of efficacy of varenicline (0.5 mg once daily for 3 days, 0.5 mg twice daily for days 4-7, 1 mg twice a day for remaining 23 weeks) for increasing continuous alcohol abstinence rates at 3 and 6 months among patients with alcohol and tobacco dependence who have completed treatment at the Mayo Clinic IAP.
  2. To obtain preliminary evidence of efficacy of varenicline (0.5 mg once daily for 3 days, 0.5 mg twice daily for days 4-7, 1 mg twice a day for remaining 23 weeks) for decreasing the number of heavy drinking days (> 5 drinks/day for men and > 4 drink/day for women) at 3 and 6 months among patients with alcohol and tobacco dependence who have completed treatment at the Mayo Clinic IAP.
  3. To obtain preliminary data on baseline and baseline to endpoint change in CSF volume corrected concentrations of the dorsal striatal glutamate, glutamate + glutamine, and NAA measures through MR spectroscopy before and after 30 days of varenicline treatment among patients with alcohol and tobacco dependence who have completed treatment at the Mayo Clinic IAP.

Secondary aims:

  1. To obtain preliminary evidence of efficacy of varenicline (0.5 mg once daily for 3 days, 0.5 mg twice daily for days 4-7, 1 mg twice a day for remaining 23 weeks) for increasing the 7-day point prevalence smoking abstinence rates and prolonged smoking abstinence at 3 and 6 months among patients with alcohol and tobacco dependence who have completed treatment at the Mayo Clinic IAP.
  2. To assess the tolerability of varenicline (0.5 mg once daily for 3 days, 0.5 mg twice daily for days 4-7, 1 mg twice a day for remaining 23 weeks).
  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01169610

Locations
United States, Minnesota
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Investigators
Principal Investigator: Mark Frye, MD Mayo Clinic
  More Information

No publications provided

Responsible Party: Mark Frye, PI, Mayo Clinic
ClinicalTrials.gov Identifier: NCT01169610     History of Changes
Other Study ID Numbers: 10-002699
Study First Received: July 22, 2010
Results First Received: July 19, 2013
Last Updated: July 19, 2013
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by Mayo Clinic:
Alcohol
Smoking

Additional relevant MeSH terms:
Alcoholism
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Varenicline
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 30, 2014