Reduction of alcohol drinking in young adults by naltrexone: a double-blind, placebo-controlled, randomized clinical trial of efficacy and safety

The Journal of Clinical Psychiatry
Stephanie S O'MalleyHenry R Kranzler

Abstract

Naltrexone, an opioid antagonist, may facilitate reduction in drinking among young adults. We compared the efficacy and safety of naltrexone administered daily plus targeted dosing with placebo to reduce drinking in young adults who engage in heavy drinking. A randomized, double-blind, placebo-controlled study was conducted in an outpatient research center in March 2008-January 2012. Participants were aged 18-25 years and reported ≥ 4 heavy drinking days in the prior 4 weeks. Interventions included naltrexone 25 mg daily plus 25 mg targeted (at most daily) in anticipation of drinking (n = 61) or daily/targeted placebo (n = 67). All participants received a personalized feedback session and brief counseling every other week. Primary outcomes were percent heavy drinking days and percent days abstinent over the 8-week treatment period. Secondary outcomes included number of drinks per drinking day and percentage of days with estimated blood alcohol concentration (BAC) levels ≥ 0.08 g/dL. Of 140 randomized patients, 128 began treatment, comprising the evaluable sample. During treatment, percent heavy drinking days (naltrexone: mean = 21.60, SD = 16.05; placebo: mean = 22.90, SD = 13.20) (P = .58) and percent days abstinent (naltrexon...Continue Reading

Associated Clinical Trials

Citations

Jan 6, 2017·Alcoholism, Clinical and Experimental Research·Janice C FroehlichLogan C Rademacher
Apr 13, 2017·Alcoholism, Clinical and Experimental Research·Christopher W KahlerStephanie S O'Malley
Dec 26, 2016·Peptides·Richard J Bodnar
Feb 17, 2017·CNS Drugs·Benjamin Rolland, Mickaël Naassila
Aug 30, 2016·Current Addiction Reports·Robert Miranda, Hayley Treloar
Jul 29, 2018·Alcoholism, Clinical and Experimental Research·Stephanie S O'MalleyBernard L Silverman
Oct 31, 2018·The American Journal of Drug and Alcohol Abuse·Lara A RayKaren Miotto
Apr 23, 2019·Journal of Child and Adolescent Psychopharmacology·Lindsay M SquegliaKevin M Gray
Apr 26, 2019·Expert Review of Gastroenterology & Hepatology·Hannes Hagström, Anna Andreasson
Sep 16, 2019·Current Psychiatry Reports·Matthew C FadusKevin M Gray
Jun 3, 2015·Alcoholism, Clinical and Experimental Research·Kyle R MenaryStephanie S O'Malley
Jul 13, 2016·CNS Drugs·Elias Aboujaoude, Wael O Salame
Dec 10, 2017·Alcoholism, Clinical and Experimental Research·Emily R NicholsonJanice C Froehlich
Nov 21, 2019·Alcohol and Alcoholism : International Journal of the Medical Council on Alcoholism·T Jordan WalterJ C Garbutt
Feb 19, 2020·Addiction Biology·Kathleen A GarrisonStephanie S O'Malley
Jun 30, 2018·The Mental Health Clinician·Allison Beatty, Christopher Stock
Feb 24, 2021·Addiction·Corey R RoosStephanie S O'Malley

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