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A double-blind, placebo-controlled trial assessing the efficacy of varenicline tartrate for alcohol dependence. 2013
Raye Z Litten, and
Megan L Ryan, and
Joanne B Fertig, and
Daniel E Falk, and
Bankole Johnson, and
Kelly E Dunn, and
Alan I Green, and
Helen M Pettinati, and
Domenic A Ciraulo, and
Ofra Sarid-Segal, and
Kyle Kampman, and
Mary F Brunette, and
Eric C Strain, and
Nassima A Tiouririne, and
Janet Ransom, and
Charles Scott, and
Robert Stout, and
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).
OBJECTIVE 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.
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