Varenicline for Alcohol Dependence (NCIG 003)
August 20, 2014 updated by: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
A Phase 2, Double Blind, Placebo Controlled Trial to Assess the Efficacy of Varenicline Tartrate for Alcohol Dependence in Very Heavy Drinkers
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).
Study Overview
Study Type
Interventional
Enrollment (Actual)
200
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Maryland
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Baltimore, Maryland, United States, 21224
- Johns Hopkins University School Of Medicine
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Massachusetts
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Boston, Massachusetts, United States, 02118
- Boston Medical Center
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New Hampshire
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Bedford, New Hampshire, United States, 03110
- Dartmouth Medical School
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Hanover, New Hampshire, United States, 03755
- Dartmouth Medical School
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19103
- University of Pennsylvania
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Virginia
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Charlottesville, Virginia, United States, 22911
- University of Virginia
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Richmond, Virginia, United States, 23294
- University of Virginia
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Be at least 18 years of age.
- Have a current (past 12 months) DSM-IV-TR diagnosis of alcohol dependence.
- Be seeking treatment for alcohol dependence and desire a reduction or cessation of drinking.
- 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.
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:
- oral contraceptives,
- contraceptive sponge,
- patch,
- double barrier (diaphragm/spermicidal or condom/spermicidal),
- intrauterine contraceptive system,
- levonorgestrel implant,
- medroxyprogesterone acetate contraceptive injection,
- complete abstinence from sexual intercourse,
- hormonal vaginal contraceptive ring, and/or
- Be able to take oral medication and be willing to adhere to the medication regimen
- Complete all assessments required at screening and baseline.
- 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.
- 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.
- Have a blood alcohol content (BAC) by breathalyzer equal to 0.000 when s/he signed the informed consent document.
- Be someone who in the opinion of the investigator would be expected to complete the study protocol.
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Placebo Comparator: Sugar Pill
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identical matched placebo x 2, 2xday, 13 weeks
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Active Comparator: Varenicline
Varenicline Tartrate
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0.5mg capsules x 2, 2x a day for 12 weeks
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Weekly Percentage of Heavy Drinking Days
Time Frame: Weeks 2-13*
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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.
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Weeks 2-13*
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- 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 and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Falk DE, O'Malley SS, Witkiewitz K, Anton RF, Litten RZ, Slater M, Kranzler HR, Mann KF, Hasin DS, Johnson B, Meulien D, Ryan M, Fertig J; Alcohol Clinical Trials Initiative (ACTIVE) Workgroup. Evaluation of Drinking Risk Levels as Outcomes in Alcohol Pharmacotherapy Trials: A Secondary Analysis of 3 Randomized Clinical Trials. JAMA Psychiatry. 2019 Apr 1;76(4):374-381. doi: 10.1001/jamapsychiatry.2018.3079.
- Falk DE, Castle IJ, Ryan M, Fertig J, Litten RZ. Moderators of Varenicline Treatment Effects in a Double-Blind, Placebo-Controlled Trial for Alcohol Dependence: An Exploratory Analysis. J Addict Med. 2015 Jul-Aug;9(4):296-303. doi: 10.1097/ADM.0000000000000133.
- Litten RZ, Ryan ML, Fertig JB, Falk DE, Johnson B, Dunn KE, Green AI, Pettinati HM, Ciraulo DA, Sarid-Segal O, Kampman K, Brunette MF, Strain EC, Tiouririne NA, Ransom J, Scott C, Stout R; NCIG (National Institute on Alcohol Abuse and Alcoholism Clinical Investigations Group) Study Group. A double-blind, placebo-controlled trial assessing the efficacy of varenicline tartrate for alcohol dependence. J Addict Med. 2013 Jul-Aug;7(4):277-86. doi: 10.1097/ADM.0b013e31829623f4.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2011
Primary Completion (Actual)
June 1, 2012
Study Completion (Actual)
July 1, 2012
Study Registration Dates
First Submitted
June 16, 2010
First Submitted That Met QC Criteria
June 16, 2010
First Posted (Estimate)
June 17, 2010
Study Record Updates
Last Update Posted (Estimate)
August 27, 2014
Last Update Submitted That Met QC Criteria
August 20, 2014
Last Verified
August 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NIAAA-DTRR-2010-LITTEN-003
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.