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Varenicline (Chantix™) for the Treatment of Alcohol Dependence (ChA)

This study has been completed.
Sponsor:
Information provided by:
National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier:
NCT00705523
First received: June 24, 2008
Last updated: June 16, 2010
Last verified: June 2010
  Purpose

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


Condition Intervention Phase
Alcoholism
Drug: varenicline
Drug: placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase II, Randomized, Double-Blind Pilot Trial of Varenicline (Chantix™) for the Treatment of Alcohol Dependence

Resource links provided by NLM:


Further study details as provided by National Institute on Drug Abuse (NIDA):

Primary Outcome Measures:
  • Rate of heavy drinking (defined as five drinks per day for men, four drinks per day for women) days as determined by self-report on the time-line follow-back (TLFB). [ Time Frame: 12 weeks of treatment and one month follow-up ] [ Designated as safety issue: No ]

Enrollment: 40
Study Start Date: June 2008
Study Completion Date: March 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1 Drug: varenicline
1.0 mg BID for 12 weeks
Other Name: Chantix
Placebo Comparator: 2 Drug: placebo
BID 12 weeks

Detailed Description:

By both providing a low level of reinforcement and down-grading any "high" associated with concurrent administration of the abused drug, combined agonist/antagonist therapies promote both initial and sustained abstinence. Based on varenicline's specific affinity for the nicotinic acetylcholine receptors that are implicated in alcohol reward circuitry, it appears to be a good candidate for treatment of alcohol dependence. Alcohol can exert its reinforcing and dopamine-enhancing effects through activation of nicotinic receptors. In addition to its partial agonist activity at heteromeric α4β2 nicotinic acetylcholine receptors, varenicline has also been shown to be a full agonist at homomeric α7 nicotinic acetylcholine receptors. That full agonism at α7 may be key in reducing alcohol withdrawal and craving during early alcohol abstinence, and thus reducing relapse, as α7 receptors are implicated in the neural reward circuitry activated by alcohol use.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 1. Males and females, 18-70 years old.
  • 2. Meets DSM-IV criteria for current diagnoses of alcohol dependence, determined by the SCID-IV (First, 1996).
  • 3. 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.
  • 4. 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.
  • 5. Lives a commutable distance from the TRC and agrees to attend all research visits including follow-up visits.
  • Speaks, understands, and prints in English.

Exclusion Criteria:

  • 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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00705523

Locations
United States, Pennsylvania
University of Pennsylvania Treatment Research Center
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
Investigators
Principal Investigator: Jennifer G Plebani, PhD University of Pennsylvania, Treatment Research Center
  More Information

No publications provided

Responsible Party: Jennifer G. Plebani, Ph.D., University of Pennsylvania
ClinicalTrials.gov Identifier: NCT00705523     History of Changes
Other Study ID Numbers: ChA - 807226
Study First Received: June 24, 2008
Last Updated: June 16, 2010
Health Authority: United States: Federal Government
United States: Institutional Review Board

Keywords provided by National Institute on Drug Abuse (NIDA):
alcohol
treatment
nicotinic acetylcholine receptors
pharmacotherapy
outpatient

Additional relevant MeSH terms:
Alcoholism
Alcohol-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Substance-Related Disorders
Varenicline
Cholinergic Agents
Cholinergic Agonists
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Nicotinic Agonists
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on November 19, 2014