BACKGROUND: Access to specialty alcoholism treatment in rural environments is limited and new treatment approaches are needed. The objective was to evaluate the efficacy of naltrexone alone and in combination with sertraline among Alaska Natives and other Alaskans living in rural settings. An exploratory aim examined whether the Asn40Asp polymorphism of the mu-opioid receptor gene (OPRM1) predicted response to naltrexone, as had been reported in Caucasians. METHODS: Randomized, controlled trial enrolling 101 Alaskans with alcohol dependence, including 68 American Indians/Alaska Natives. Participants received 16 weeks of either (1) placebo (placebo naltrexone + placebo sertraline), (2) naltrexone monotherapy (50 mg naltrexone + sertraline placebo) and (3) naltrexone + sertraline (100 mg) plus nine sessions of medical management and supportive advice. Primary outcomes included Time to First Heavy Drinking Day and Total Abstinence. RESULTS:Naltrexone monotherapy demonstrated significantly higher total abstinence (35%) compared with placebo (12%, p = 0027) and longer, but not statistically different, Time to First Heavy Drinking Day (p = 0.093). On secondary measures, naltrexone compared with placebo demonstrated significant improvements in percent days abstinent (p = 0.024) and drinking-related consequences (p = 0.02). Combined sertraline and naltrexone did not differ from naltrexone alone. The pattern of findings was generally similar for the American Indian/Alaska Native subsample. Naltrexone treatment response was significant within the group of 75 individuals who were homozygous for OPRM1 Asn40 allele. There was a small number of Asp40 carriers, precluding statistical testing of the effect of this allele on response. CONCLUSIONS:Naltrexone can be used effectively to treat alcoholism in remote and rural communities, with evidence of benefit for American Indians and Alaska Natives. New models of care incorporating pharmacotherapy could reduce important health disparities related to alcoholism.
RCT Entities:
BACKGROUND: Access to specialty alcoholism treatment in rural environments is limited and new treatment approaches are needed. The objective was to evaluate the efficacy of naltrexone alone and in combination with sertraline among Alaska Natives and other Alaskans living in rural settings. An exploratory aim examined whether the Asn40Asp polymorphism of the mu-opioid receptor gene (OPRM1) predicted response to naltrexone, as had been reported in Caucasians. METHODS: Randomized, controlled trial enrolling 101 Alaskans with alcohol dependence, including 68 American Indians/Alaska Natives. Participants received 16 weeks of either (1) placebo (placebo naltrexone + placebo sertraline), (2) naltrexone monotherapy (50 mg naltrexone + sertraline placebo) and (3) naltrexone + sertraline (100 mg) plus nine sessions of medical management and supportive advice. Primary outcomes included Time to First Heavy Drinking Day and Total Abstinence. RESULTS:Naltrexone monotherapy demonstrated significantly higher total abstinence (35%) compared with placebo (12%, p = 0027) and longer, but not statistically different, Time to First Heavy Drinking Day (p = 0.093). On secondary measures, naltrexone compared with placebo demonstrated significant improvements in percent days abstinent (p = 0.024) and drinking-related consequences (p = 0.02). Combined sertraline and naltrexone did not differ from naltrexone alone. The pattern of findings was generally similar for the American Indian/Alaska Native subsample. Naltrexone treatment response was significant within the group of 75 individuals who were homozygous for OPRM1Asn40 allele. There was a small number of Asp40 carriers, precluding statistical testing of the effect of this allele on response. CONCLUSIONS:Naltrexone can be used effectively to treat alcoholism in remote and rural communities, with evidence of benefit for American Indians and Alaska Natives. New models of care incorporating pharmacotherapy could reduce important health disparities related to alcoholism.
Authors: Helen M Pettinati; Charles P O'Brien; Amanda R Rabinowitz; Shoshana P Wortman; David W Oslin; Kyle M Kampman; Charles A Dackis Journal: J Clin Psychopharmacol Date: 2006-12 Impact factor: 3.153
Authors: Raymond F Anton; Stephanie S O'Malley; Domenic A Ciraulo; Ron A Cisler; David Couper; Dennis M Donovan; David R Gastfriend; James D Hosking; Bankole A Johnson; Joseph S LoCastro; Richard Longabaugh; Barbara J Mason; Margaret E Mattson; William R Miller; Helen M Pettinati; Carrie L Randall; Robert Swift; Roger D Weiss; Lauren D Williams; Allen Zweben Journal: JAMA Date: 2006-05-03 Impact factor: 56.272
Authors: Stephanie S O'Malley; Bruce J Rounsaville; Conor Farren; Kee Namkoong; Ran Wu; Jane Robinson; Patrick G O'Connor Journal: Arch Intern Med Date: 2003-07-28
Authors: C Bond; K S LaForge; M Tian; D Melia; S Zhang; L Borg; J Gong; J Schluger; J A Strong; S M Leal; J A Tischfield; M J Kreek; L Yu Journal: Proc Natl Acad Sci U S A Date: 1998-08-04 Impact factor: 11.205
Authors: Ralitza Gueorguieva; Ran Wu; Dennis Donovan; Bruce J Rounsaville; David Couper; John H Krystal; Stephanie S O'Malley Journal: Alcohol Clin Exp Res Date: 2010-12-08 Impact factor: 3.455
Authors: Raye Z Litten; I-Jen P Castle; Daniel Falk; Megan Ryan; Joanne Fertig; Chiung M Chen; Hsiao-ye Yi Journal: Alcohol Clin Exp Res Date: 2013-07-24 Impact factor: 3.455
Authors: Ekaterina Burduli; Jordan Skalisky; Katherine Hirchak; Michael F Orr; Albert Foote; Alexandria Granbois; Richard Ries; John M Roll; Dedra Buchwald; Michael G McDonell; Sterling M McPherson Journal: Clin Trials Date: 2018-08-29 Impact factor: 2.486
Authors: Natalya C Maisel; Janet C Blodgett; Paula L Wilbourne; Keith Humphreys; John W Finney Journal: Addiction Date: 2012-10-17 Impact factor: 6.526
Authors: Huiping Zhang; Aryeh I Herman; Henry R Kranzler; Raymond F Anton; Arthur A Simen; Joel Gelernter Journal: J Hum Genet Date: 2012-08-23 Impact factor: 3.172