Varenicline for Alcohol Dependence

NCT01146613 | Completed Phase 2 Results

• 1 other identifier: NIAAA-DTRR-2010-LITTEN-003
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 7

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).

Conditions

Alcoholism

Keywords

Alcohol; Alcohol abuse; Alcoholism; Alcohol Dependence; Varenicline; Drinking

Outcome Measures

Primary Outcomes (1)

• Weekly Percentage of Heavy Drinking Days

  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.

  Weeks 2-13*

Study Arms (2)

Varenicline

ACTIVE COMPARATOR

Varenicline Tartrate

Drug: Varenicline

Sugar Pill

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Varenicline DRUG

0.5mg capsules x 2, 2x a day for 12 weeks

Also known as: Chantix

Varenicline

Placebo DRUG

identical matched placebo x 2, 2xday, 13 weeks

Sugar Pill

Eligibility Criteria

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

You may qualify if:

• 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

Sponsors & Collaborators

• National Institute on Alcohol Abuse and Alcoholism (NIAAA): lead

Study Sites (7)

Johns Hopkins University School of Medicine

Baltimore, Maryland, 21224, United States

Location

Boston Medical Center

Boston, Massachusetts, 02118, United States

Location

Dartmouth Medical School

Bedford, New Hampshire, 03110, United States

Location

Dartmouth Medical School

Hanover, New Hampshire, 03755, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19103, United States

Location

University of Virginia

Charlottesville, Virginia, 22911, United States

Location

University of Virginia

Richmond, Virginia, 23294, United States

Location

Related Publications (3)

• 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.

  PMID: 30865232 DERIVED

• 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.

  PMID: 26083958 DERIVED

• 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.

  PMID: 23728065 DERIVED

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: Megan Ryan, M.B.A.
• Organization: NIAAA

mryan1@mail.nih.gov

301-443-4225

Study Officials

• Raye Z. Litten, PhD

  National Institute on Alcohol Abuse and Alcoholism (NIAAA)

  STUDY DIRECTOR

• 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)

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

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: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 16, 2010
• First Posted: June 17, 2010
• Study Start: February 1, 2011
• Primary Completion: June 1, 2012
• Study Completion: July 1, 2012
• Last Updated: August 27, 2014
• Results First Posted: August 11, 2014

Record last verified: 2014-08

Locations

US (7)