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A Double-Blind, Placebo-Controlled Trial Assessing the Efficacy of Varenicline Tartrate for Alcohol Dependence

Litten, Raye Z. PhD; Ryan, Megan L. MBA; Fertig, Joanne B. PhD; Falk, Daniel E. PhD; Johnson, Bankole MD; Dunn, Kelly E. PhD; Green, Alan I. MD; Pettinati, Helen M. PhD; Ciraulo, Domenic A. MD; Sarid-Segal, Ofra MD; Kampman, Kyle MD; Brunette, Mary F. MD; Strain, Eric C. MD; Tiouririne, Nassima A. MD; Ransom, Janet PhD; Scott, Charles PhD; Stout, Robert PhD; for the NCIG (National Institute on Alcohol Abuse and Alcoholism Clinical Investigations Group) Study Group

doi: 10.1097/ADM.0b013e31829623f4
Original Research

Objectives: To assess the efficacy and safety of varenicline (Chantix) for the treatment of alcohol dependence. Varenicline is a partial α4β2 nicotinic acetylcholine agonist approved by the Food and Drug Administration for smoking cessation. It has reduced drinking in animal studies and in small studies of humans who were both heavy drinkers and smokers. This is the first multisite clinical trial of varenicline in a population of smokers and nonsmokers with alcohol dependence.

Methods: Men and women (n = 200) meeting the criteria for alcohol dependence were recruited across 5 clinical sites. Patients received double-blind varenicline or placebo and a computerized behavioral intervention. Varenicline was titrated during the first week to 2 mg/d, which was maintained during weeks 2 to 13.

Results: The varenicline group had significantly lower weekly percent heavy drinking days (primary outcome) (adjusted mean difference = 10.4), drinks per day, drinks per drinking day, and alcohol craving compared with the placebo group (P < 0.05). The average treatment effect on alcohol use was similar for smokers and nonsmokers. Varenicline was well-tolerated; adverse events were expected and mild.

Conclusions: Varenicline significantly reduced alcohol consumption and craving, making it a potentially viable option for the treatment of alcohol dependence.

From the Division of Treatment and Recovery Research (RZL, MLR, JBF DEF), National Institute on Alcohol Abuse and Alcoholism, Bethesda, MD; Department of Psychiatric Medicine (BJ, NAT), University of Virginia, Charlottesville, VA; Johns Hopkins University School of Medicine (KED, ECS), Baltimore, MD; Geisel School of Medicine at Dartmouth (AIG, MFB), Lebanon, NH; University of Pennsylvania Treatment Research Center (HMP, KK), Philadelphia, PA; Boston University School of Medicine (DAC, OS-S), Boston, MA; Fast Track Drugs and Biologics (JR, CS), North Potomac, MD; and Decision Sciences Institute/Pacific Institute for Research and Evaluation (RS), Pawtucket, RI. NCIG Study Group members are as follows: Boston Medical Center, Boston, MA and Quincy, MA (Joanna Piechniczek-Buczek, MD, Chris Streeter, MD, Eric Devine, PhD, Courtney Richambault, Laurie Sickles-Colaneri, RN); University of Virginia, Charlottesville, VA (Eva Jenkins-Mendoza, Sean Sembrowich, RN, Jennifer Kim Penberthy, PhD, Amanda Nizam, Nicole Fischer, Shari Steinman, Mindy Borszich); University of Virginia, Richmond, VA (Esther Makanjuola, RN, Tricia Schirmer, Kathryn Polak, Christina Hill, Kathryn Conley, Alison Eonta, Kasy Serdar, Aubrey Gartner, Amy Madigan); Geisel School of Medicine at Dartmouth, Hanover, NH and Bedford, NH (Audrey Kern, MD, Christopher O'Keefe, MS, Mirranda Boshart, Suzanne Miller, Shannon Rondeau, RN, Marjorie Weeks, Pamela Geiger); University of Pennsylvania, Treatment Research Center, Philadelphia, PA (Jennifer Plebani, PhD, William Dundon, PhD, Elizabeth Mahoney, MA, Gail Kaempf, CRPN, Brenda Beitler, APRN, Cynthia Clark, CPRN, Kelly Griffin, Joshua Lachewitz, Elizabeth Wilson, Margo Hendrickson, Tamara Roth, Laurie Downing, NP); and Johns Hopkins University School of Medicine (Joseph Harrison, MS, Kimberly Nelson, LPN, Ashley Bathgate, Connie Lowery, RN, Elana Schwartz, Torran Claiborne, Sarah Hersh).

Send correspondence and reprint requests to Raye Z. Litten, PhD, Division of Treatment and Recovery Research, National Institute on Alcohol Abuse and Alcoholism, 5635 Fishers Lane, Bethesda, MD 20892. E-mail: rlitten@mail.nih.gov.

Supported by the National Institute on Alcohol Abuse and Alcoholism (NIAAA) (Contract No. HHSN27200900005C); ClinicalTrials.gov NCT 01146613.

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The authors declare no conflicts of interest.

Received January 24, 2013

Accepted April 06, 2013

© 2013 American Society of Addiction Medicine