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

NCT ID: NCT01011907

Last Updated: 2013-02-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 99 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-01-31
• Study Completion Date: 2012-06-30

Brief Summary

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.

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.

Conditions

Substance Dependence

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: TRIPLE

Study Groups

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).

Group Type: EXPERIMENTAL

varenicline

Intervention Type: DRUG

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).

placebo

Drug: placebo for varenicline 12 weeks of oral tablet treatment in an escalating dosing regimen (1 - 2x daily).

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: DRUG

12 weeks of oral tablet treatment in an escalating dosing regimen (1 - 2x daily).

Interventions

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).

Intervention Type: DRUG

placebo

12 weeks of oral tablet treatment in an escalating dosing regimen (1 - 2x daily).

Intervention Type: DRUG

Other Intervention Names

Chantix

Eligibility 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.

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

NIH

Sponsor Role: collaborator

University of California, San Francisco

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Howard Fields, MD PhD

Role: PRINCIPAL_INVESTIGATOR

UCSF: Ernest Gallo CLinic and Research Center

Jennifer Mitchell, PhD

Role: STUDY_DIRECTOR

UCSF: Ernest Gallo Clinic and Research Center

Locations

UCSF: Ernest Gallo Clinic and Research Center

Emeryville, California, United States

Countries

United States

References

Mitchell JM, Teague CH, Kayser AS, Bartlett SE, Fields HL. Varenicline decreases alcohol consumption in heavy-drinking smokers. Psychopharmacology (Berl). 2012 Oct;223(3):299-306. doi: 10.1007/s00213-012-2717-x. Epub 2012 May 1.

Reference Type: RESULT

PMID: 22547331 (View on PubMed)

Other Identifiers

RC2AA019429

Identifier Type: NIH

Identifier Source: secondary_id

View Link

EGCRC0109

Identifier Type: -

Identifier Source: org_study_id