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

Substance Dependence Clinical Trial

Official title:

Characterizing Alpha5 Nicotinic Receptors in Alcohol and Nicotine Dependence

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01011907
• Other study ID #: EGCRC0109
• Secondary ID: RC2AA019429
• Status: Completed
• Phase: N/A
• First received: November 9, 2009
• Last updated: February 22, 2013
• Start date: January 2010
• Est. completion date: June 2012

Study information

• Verified date: February 2013
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 99
• Est. completion date: June 2012
• Est. primary completion date: July 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years to 75 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Substance Dependence
• Substance-Related Disorders

Intervention

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

Locations

Country	Name	City	State
United States	UCSF: Ernest Gallo Clinic and Research Center	Emeryville	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, San Francisco	National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Average Number of Cigarettes Smoked Between the Varenicline and Placebo Groups for Completers Through Week 12.		Weeks 1-12	No
Secondary	Average Number of Alcoholic Drinks Consumed Between the Varenicline and Placebo Groups for Completers of the Study Through Week 12.		Weeks 1-12	No
Secondary	Alcohol Craving as Measured by the Obsessive Compulsive Drinking Scale (OCDS) Between Varenicline and Placebo Groups for Completers of the Study.	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	No