Varenicline (Chantix™) for the Treatment of Alcohol Dependence

NCT00705523 | Completed Phase 2 Results DMC

• 2 other identifiers: ChA - 807226P60DA005186
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine the efficacy of varenicline (Chantix™) for the treatment of alcohol dependence.

Conditions

Alcoholism

Keywords

alcohol; treatment; nicotinic acetylcholine receptors; pharmacotherapy; outpatient

Outcome Measures

Primary Outcomes (1)

• Rate of Heavy Drinking Days Per Week.

  Rate of heavy drinking days per week (defined as five drinks per day for men, four drinks per day for women) as determined by self-report on the time-line follow-back (TLFB).

  12 weeks of treatment and one month follow-up

Secondary Outcomes (1)

• Addiction Severity Index (ASI) Alcohol Composite Score at End of Study.

  12 weeks of treatment, with a follow-up one month after treatment

Study Arms (2)

1

ACTIVE COMPARATOR

Drug: varenicline

2

PLACEBO COMPARATOR

Drug: placebo

Interventions

varenicline DRUG

1.0 mg BID for 12 weeks

Also known as: Chantix

1

placebo DRUG

BID 12 weeks

2

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Males and females, 18-70 years old.
• \. Meets DSM-IV criteria for current diagnoses of alcohol dependence, determined by the SCID-IV (First, 1996).
• \. Meets the following drinking criteria as measured by the Timeline Followback (TLFB) (Sobell, 1995)
• drank within 30 days of intake day,
• reports a minimum of 48 standard alcoholic drinks (avg. 12 drinks/wk) in a consecutive 30-day period over the 90-day period prior to starting intake (i.e., a minimum of 40% days drinking), and
• has 2 or more days of heavy drinking (defined as 5 or more drinks per day in males and 4 or more drinks per day in females) in this same pre-treatment period.
• \. Three consecutive days of abstinence from alcohol, determined by self-reports and confirmed by a negative breathalyzer tests immediately before the day of randomization, and a Clinical Institute Withdrawal Scale for Alcohol (CIWA-AR) (Sullivan, 1989) score below eight on the day of randomization.
• \. Lives a commutable distance from the TRC and agrees to attend all research visits including follow-up visits.
• Speaks, understands, and prints in English.

You may not qualify if:

• Has evidence of dependence on a substance other than alcohol (except nicotine or marijuana); or tests positive on the urine drug screen and on a single allowed retest, during the screening week, with the exception of a THC positive urine, and/or a).positive result for benzodiazepines prescribed by a doctor for medically indicated detox (prescription required).
• Has hepatocellular disease indicated by elevations of SGPT (ALT) and SGOT (AST) of at least 4.5 times normal after the required 3 days of abstinence, or elevated bilirubin (\>1.3) (one retest allowed at the discretion of the Medical Director).
• Meets diagnostic criteria for a current unstable or serious psychiatric or medical illness. For example, bipolar affective disorder, schizophrenia or any other psychotic disorder, or organic mental disorder; has serious heart, lung, kidney, immune system, GI tract (ulcerative colitis, regional enteritis, or gastrointestinal bleeding) disease.
• Has taken any psychotropic medications (including disulfiram, naltrexone or acamprosate) regularly within the last 2 weeks or needs immediate treatment with a psychotropic medication (with the exception of detoxification medications or benadryl used sparingly for sleep).
• Tests positive on a pregnancy test, is contemplating pregnancy in the next 12 months, is nursing, or is not using an effective contraceptive method if the subject is of child-bearing potential.
• Has participated in any investigational drug trial within 30 days prior to the study. Subjects mandated to treatment based upon a legal decision or as a condition of employment. This will be assessed by the subject's self-report.
• Known hypersensitivity to varenicline.
• Subjects with known AIDS or other serious illnesses that may require hospitalization during the study.
• Clinical laboratory tests (CBC, blood chemistries, urinalysis) outside normal limits that are clinically unacceptable to the Principal Investigator. (ECG 1st degree heart block, sinus tachycardia, left axis deviation, and nonspecific ST or T wave changes are allowed; liver function tests \[LFTs\] \<5 x ULN are acceptable).

Sponsors & Collaborators

• University of Pennsylvania: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

University of Pennsylvania Treatment Research Center

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Alcoholism

Interventions

Varenicline

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; 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: Dr. Jennifer Plebani
• Organization: UPenn

jplebani@mail.med.upenn.edu

215-222-3200

Study Officials

• Jennifer G Plebani, PhD

  University of Pennsylvania, Treatment Research Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 24, 2008
• First Posted: June 26, 2008
• Study Start: June 1, 2008
• Primary Completion: March 1, 2010
• Study Completion: December 1, 2011
• Last Updated: June 2, 2015
• Results First Posted: June 2, 2015

Record last verified: 2015-06

Locations

US (1)