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

NCT01011907 | Completed Results

• 2 other identifiers: EGCRC0109RC2AA019429
• Study Type: interventional
• Target: 99
• Locations: 1 country
• Sites: 1

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.

Conditions

Substance Dependence

Outcome Measures

Primary Outcomes (1)

• Average Number of Cigarettes Smoked Between the Varenicline and Placebo Groups for Completers Through Week 12.

  Weeks 1-12

Secondary Outcomes (2)

• Average Number of Alcoholic Drinks Consumed Between the Varenicline and Placebo Groups for Completers of the Study Through Week 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.

  Week 1 to Week 12

Study Arms (2)

varenicline

EXPERIMENTAL

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

placebo

PLACEBO COMPARATOR

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

Drug: placebo

Interventions

varenicline 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).

Also known as: Chantix

varenicline

placebo DRUG

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

placebo

Eligibility Criteria

• Age: 21 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of California, San Francisco: lead
• National Institute on Alcohol Abuse and Alcoholism (NIAAA): collaborator

Study Sites (1)

UCSF: Ernest Gallo Clinic and Research Center

Emeryville, California, 94608, United States

Location

Related 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.

  PMID: 22547331 RESULT

MeSH Terms

Conditions

Substance-Related Disorders

Interventions

Varenicline

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Quinoxalines

Results Point of Contact

• Title: Jennifer Mitchell, Clinical Project Director
• Organization: UCSF: EGCRC

jmitchell@gallo.ucsf.edu

510-985-3100

Study Officials

• Howard Fields, MD PhD

  UCSF: Ernest Gallo CLinic and Research Center

  PRINCIPAL INVESTIGATOR

• Jennifer Mitchell, PhD

  UCSF: Ernest Gallo Clinic and Research Center

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 9, 2009
• First Posted: November 11, 2009
• Study Start: January 1, 2010
• Primary Completion: July 1, 2011
• Study Completion: June 1, 2012
• Last Updated: February 25, 2013
• Results First Posted: February 25, 2013

Record last verified: 2013-02

Locations

US (1)