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A Pilot Clinical Trial of Varenicline as a Treatment for Alcohol Dependence

This study has been completed.
Sponsor:
Collaborator:
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Information provided by (Responsible Party):
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT01011907
First received: November 9, 2009
Last updated: February 22, 2013
Last verified: February 2013
History of Changes
  Purpose

Purpose: This is an outpatient, randomized, double-blinded, placebo-controlled study in which either varenicline (twice daily) or placebo will be administered over a 12 week study period to examine genetic influences on treatment response to varenicline for reduction of hazardous drinking.


Condition Intervention
Substance Dependence
 Drug: varenicline
Drug: placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Basic Science
Official Title: Characterizing Alpha5 Nicotinic Receptors in Alcohol and Nicotine Dependence

Resource links provided by NLM:

MedlinePlus related topics: Alcoholism
U.S. FDA Resources

Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:
  • Average Number of Cigarettes Smoked Between the Varenicline and Placebo Groups for Completers Through Week 12. [ Time Frame: Weeks 1-12 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Average Number of Alcoholic Drinks Consumed Between the Varenicline and Placebo Groups for Completers of the Study Through Week 12. [ Time Frame: Weeks 1-12 ] [ Designated as safety issue: No ]
  • Alcohol Craving as Measured by the Obsessive Compulsive Drinking Scale (OCDS) Between Varenicline and Placebo Groups for Completers of the Study. [ Time Frame: Week 1 to Week 12 ] [ Designated as safety issue: No ]
    Higher scores on the OCDS indicate increased craving. OCDS possible score range = 0 - 40. Difference in average OCDS scores from week 1 to week 12 were reported for the varenicline and placebo groups in subjects that completed the study.


Enrollment: 99
Study Start Date: January 2010
Study Completion Date: June 2012
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: varenicline
Drug: varenicline (Chantix) 12 weeks of oral tablet treatment in an escalating dosing regimen (0.5 mg 1x daily, days 1-3; 0.5mg 2x daily, days 4-7, 1.0 mg 2x daily, days 8-84).
 Drug: varenicline
12 weeks of oral tablet treatment in an escalating dosing regimen (0.5 mg 1x daily, days 1-3; 0.5mg 2x daily, days 4-7, 1.0 mg 2x daily, days 8-84).
Other Name: Chantix
Placebo Comparator: placebo
Drug: placebo for varenicline 12 weeks of oral tablet treatment in an escalating dosing regimen (1 - 2x daily).
 Drug: placebo
12 weeks of oral tablet treatment in an escalating dosing regimen (1 - 2x daily).
Other Name: Placebo

Detailed Description:

Hazardous alcohol use and alcohol use disorders (AUDs) are an area of large unmet medical needs. Although there has been some progress with pharmacotherapy for alcohol-dependent individuals, a critical need for the development of novel and additional therapeutic approaches remains. Pharmacotherapy development for AUDs as a therapeutic area has had several recent advancements, where clinically as well as commercially successful additions to available treatment options are available and several more are expected in the near future. Based on recent preclinical work, we believe that varenicline has potential to become one of the first among those newly evolving treatments.

In this study, participants with nicotine dependence will receive standard varenicline or placebo treatment over the recommended course of 12 weeks. Since our research question addresses whether alcohol drinking also diminishes with varenicline treatment, we will not ask participants to alter alcohol use; we will simply follow their use over time. Study visits will take place at the Ernest Gallo Clinic and Research Center. The procedures to be completed include vital signs, blood samples at screening and end of study, urine toxicology screening and the completion of standard questionnaires. No special facilities are required for these procedures. Group therapy (which is not a research procedure, but part of standard nicotine dependence treatment) will take place at the Gallo Center.

  Eligibility

Ages Eligible for Study:   21 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age between 21 and 75 years.
  • Currently seeking treatment for nicotine dependence (smoke at least 10 cigarettes daily) and found to have problem drinking, alcohol abuse or alcohol dependence (non-physiological) as determined by amount of alcohol consumed weekly (Average weekly alcohol consumption (last 30 days), >7 standard drinks (for women) or >14 standard drinks (for men), clinical interview, and AUDIT score > 8.
  • Generally healthy, without serious or unstable medical/mental illness(es).
  • Smokers only will be included (degree of nicotine dependence will be assessed and included in analysis).
  • Able to give voluntary, written, informed consent

Exclusion Criteria:

  • More than 30 days of abstinence from alcohol in the prior 90 days.
  • History of major alcohol-related complications within the preceding 2 years (liver failure/cirrhosis, pancreatitis, esophageal varices, liver function tests > 3 X ULN).
  • Intolerance to the study medication.
  • Current psychiatric disorder(s) requiring clinical treatment.
  • Any recent history (i.e. within the preceding 5 years) of suicide attempt or current suicidal ideation.
  • Use of illicit or non-prescribed psychotropic drug use (opiates, benzodiazepines, cocaine, PCP, methamphetamine, cocaine, or marijuana more than twice a week).
  • A history of complicated alcohol or other drug withdrawal syndrome(s), e.g.: delirium tremens or seizures.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01011907

Locations
United States, California
UCSF: Ernest Gallo Clinic and Research Center
Emeryville, California, United States, 94608
Sponsors and Collaborators
University of California, San Francisco
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Investigators
Principal Investigator: Howard Fields, MD PhD UCSF: Ernest Gallo CLinic and Research Center
Study Director: Jennifer Mitchell, PhD UCSF: Ernest Gallo Clinic and Research Center
  More Information

Publications:

Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT01011907     History of Changes
Other Study ID Numbers: EGCRC0109, RC2AA019429
Study First Received: November 9, 2009
Results First Received: January 14, 2013
Last Updated: February 22, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Alcoholism
Tobacco Use Disorder
Substance-Related Disorders
Alcohol-Related 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 May 16, 2013