Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
200 participants
INTERVENTIONAL
2011-02-28
2012-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Varenicline
Varenicline Tartrate
Varenicline
0.5mg capsules x 2, 2x a day for 12 weeks
Sugar Pill
Placebo
identical matched placebo x 2, 2xday, 13 weeks
Interventions
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Varenicline
0.5mg capsules x 2, 2x a day for 12 weeks
Placebo
identical matched placebo x 2, 2xday, 13 weeks
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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.
18 Years
ALL
No
Sponsors
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National Institute on Alcohol Abuse and Alcoholism (NIAAA)
NIH
Responsible Party
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Principal Investigators
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Raye Z. Litten, PhD
Role: STUDY_DIRECTOR
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Joanne Fertig, PhD
Role: PRINCIPAL_INVESTIGATOR
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Daniel E Falk, PhD
Role: PRINCIPAL_INVESTIGATOR
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Locations
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Johns Hopkins University School of Medicine
Baltimore, Maryland, United States
Boston Medical Center
Boston, Massachusetts, United States
Dartmouth Medical School
Bedford, New Hampshire, United States
Dartmouth Medical School
Hanover, New Hampshire, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
University of Virginia
Charlottesville, Virginia, United States
University of Virginia
Richmond, Virginia, United States
Countries
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References
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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.
Other Identifiers
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NIAAA-DTRR-2010-LITTEN-003
Identifier Type: -
Identifier Source: org_study_id
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