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

February 22, 2013 updated by: University of California, San Francisco

Characterizing Alpha5 Nicotinic Receptors in Alcohol and Nicotine Dependence

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

99

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Emeryville, California, United States, 94608
        • UCSF: Ernest Gallo Clinic and Research Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Average Number of Cigarettes Smoked Between the Varenicline and Placebo Groups for Completers Through Week 12.
Time Frame: Weeks 1-12
Weeks 1-12

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Weeks 1-12
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
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.
Week 1 to Week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, San Francisco

Collaborators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2010

Primary Completion (Actual)

July 1, 2011

Study Completion (Actual)

June 1, 2012

Study Registration Dates

First Submitted

November 9, 2009

First Submitted That Met QC Criteria

November 10, 2009

First Posted (Estimate)

November 11, 2009

Study Record Updates

Last Update Posted (Estimate)

February 25, 2013

Last Update Submitted That Met QC Criteria

February 22, 2013

Last Verified

February 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EGCRC0109
  • RC2AA019429 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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