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Varenicline for Alcohol Dependence (NCIG 003)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01146613
Recruitment Status : Completed
First Posted : June 17, 2010
Results First Posted : August 11, 2014
Last Update Posted : August 27, 2014
Sponsor:
Information provided by (Responsible Party):
National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Brief Summary:
The primary objective of this study is to assess the efficacy of varenicline in reducing the proportion of heavy drinking days during the last 8 weeks of treatment in subjects with alcohol dependence confirmed by Diagnostic and Statistical Manual of Mental Disorders-IV-Text Revision (DSM-IV-TR) criteria and who frequently consume 10 or more drinks per drinking day for men and 8 or more drinks for women (designated as "very heavy" drinkers).

Condition or disease Intervention/treatment Phase
Alcoholism Drug: Varenicline Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 2, Double Blind, Placebo Controlled Trial to Assess the Efficacy of Varenicline Tartrate for Alcohol Dependence in Very Heavy Drinkers
Study Start Date : February 2011
Actual Primary Completion Date : June 2012
Actual Study Completion Date : July 2012

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Varenicline
Varenicline Tartrate
Drug: Varenicline
0.5mg capsules x 2, 2x a day for 12 weeks
Other Name: Chantix

Placebo Comparator: Sugar Pill Drug: Placebo
identical matched placebo x 2, 2xday, 13 weeks




Primary Outcome Measures :
  1. Weekly Percentage of Heavy Drinking Days [ Time Frame: Weeks 2-13* ]
    Protocol: The primary outcome measure examines the hypothesis that varenicline will decrease the weekly proportion of heavy drinking days during Study Weeks 2 through 13 as compared to placebo.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Be at least 18 years of age.
  2. Have a current (past 12 months) DSM-IV-TR diagnosis of alcohol dependence.
  3. Be seeking treatment for alcohol dependence and desire a reduction or cessation of drinking.
  4. Be able to verbalize an understanding of the consent form, able to provide written informed consent, verbalize willingness to complete study procedures, able to understand written and oral instructions in English and able to complete the questionnaires required by the protocol.
  5. Agree (if the subject is female and of child bearing potential) to use at least one of the following methods of birth control, unless she is surgically sterile, partner is surgically sterile or she is postmenopausal:

    1. oral contraceptives,
    2. contraceptive sponge,
    3. patch,
    4. double barrier (diaphragm/spermicidal or condom/spermicidal),
    5. intrauterine contraceptive system,
    6. levonorgestrel implant,
    7. medroxyprogesterone acetate contraceptive injection,
    8. complete abstinence from sexual intercourse,
    9. hormonal vaginal contraceptive ring, and/or
  6. Be able to take oral medication and be willing to adhere to the medication regimen
  7. Complete all assessments required at screening and baseline.
  8. Provide evidence of stable residence in the last 2 months prior to randomization, have reasonable transportation arrangements to the study site, and have no plans to move within the next 3 months or unresolved legal problems. Subjects must provide contact information of someone, such as a family member, spouse, or significant other, who may be able to contact the subject in case of a missed clinic appointment.
  9. Be willing to discontinue the use of nicotine replacement therapies prior to randomization and refrain from using nicotine replacement therapies during the course of the study.
  10. Have a blood alcohol content (BAC) by breathalyzer equal to 0.000 when s/he signed the informed consent document.
  11. Be someone who in the opinion of the investigator would be expected to complete the study protocol.
  12. Agree to the schedule of visits, verbally acknowledge that s/he will be able to attend each scheduled visit, participate in phone visits and that s/he does not have any already scheduled events or a job that may interfere with study participation.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01146613


Locations
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United States, Maryland
Johns Hopkins University School of Medicine
Baltimore, Maryland, United States, 21224
United States, Massachusetts
Boston Medical Center
Boston, Massachusetts, United States, 02118
United States, New Hampshire
Dartmouth Medical School
Bedford, New Hampshire, United States, 03110
Dartmouth Medical School
Hanover, New Hampshire, United States, 03755
United States, Pennsylvania
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19103
United States, Virginia
University of Virginia
Charlottesville, Virginia, United States, 22911
University of Virginia
Richmond, Virginia, United States, 23294
Sponsors and Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Investigators
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Study Director: Raye Z. Litten, PhD National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Principal Investigator: Joanne Fertig, PhD National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Principal Investigator: Daniel E Falk, PhD National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
ClinicalTrials.gov Identifier: NCT01146613     History of Changes
Other Study ID Numbers: NIAAA-DTRR-2010-LITTEN-003
First Posted: June 17, 2010    Key Record Dates
Results First Posted: August 11, 2014
Last Update Posted: August 27, 2014
Last Verified: August 2014

Keywords provided by National Institute on Alcohol Abuse and Alcoholism (NIAAA):
Alcohol
Alcohol abuse
Alcoholism
Alcohol Dependence
Varenicline
Drinking

Additional relevant MeSH terms:
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Varenicline
Alcoholism
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Ethanol
Anti-Infective Agents, Local
Anti-Infective Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action