title: Longitudinal findings from a randomized clinical trial of naltrexone for young adult heavy drinkers.
abstract: OBJECTIVE
  Behavioral interventions for young adults show limited effects 1-year posttreatment. Few studies have examined the longitudinal outcomes of pharmacotherapy trials to reduce heavy drinking. This study examined the posttreatment, longitudinal effects of the first placebo-controlled trial of naltrexone in young adult heavy drinkers.
  
  
  METHODS
  Randomized, double-blind, placebo-controlled, 8-week trial. Follow-up assessments at posttreatment (8 weeks [8W]), 3 months [3M], 6 months [6M], and 12 months [12M]). Participants were young adults ages 18-25 (N = 118) who reported ≥4 heavy drinking days in the prior 4 weeks. Outcomes were percent days heavy drinking (PHDD), percent days abstinent (PDA), and drinks per drinking day (DPDD).
  
  
  RESULTS
  There were no time effects on PHDD. Treatment improvements were maintained posttreatment. A main effect of time was found for PDA. Both conditions continued to increase PDA posttreatment. For DPDD, a Treatment ×Time interaction emerged. In the naltrexone condition, DPDD increased from 8W to 6M and decreased from 6M to 12M, resulting in no net change posttreatment. The placebo group had a nonsignificant decrease in DPDD. The result was a significant benefit of naltrexone at 8W but not 12M.
  
  
  CONCLUSIONS
  Participants showed improvements or no change on most outcomes over 1 year posttreatment. Naltrexone had significant benefits over placebo at 8W. Although differences among groups diminished during follow-up, overall effects were maintained. Behavioral monitoring during treatment may impact long-term outcomes more than a single intervention following discontinuation of active medication. (PsycINFO Database Record
authors.affiliation: Department of Psychiatry, Yale School of Medicine.
authors.forename: Kelly S
authors.initials: KS
authors.lastname: DeMartini
authors.affiliation: Department of Biostatistics, Schools of Public Health and Medicine, Yale University.
authors.forename: Ralitza
authors.initials: R
authors.lastname: Gueorguieva
authors.affiliation: Department of Psychiatry, Yale School of Medicine.
authors.forename: Robert F
authors.initials: RF
authors.lastname: Leeman
authors.affiliation: Department of Psychology, Arizona State University.
authors.forename: William R
authors.initials: WR
authors.lastname: Corbin
authors.affiliation: Department of Psychiatry, Yale School of Medicine.
authors.forename: Lisa M
authors.initials: LM
authors.lastname: Fucito
authors.affiliation: Department of Psychiatry, Perelman School of Medicine, University of Pennsylvania.
authors.forename: Henry R
authors.initials: HR
authors.lastname: Kranzler
authors.affiliation: Department of Psychiatry, Yale School of Medicine.
authors.forename: Stephanie S
authors.initials: SS
authors.lastname: O'Malley
mesh_terms: D000293:Adolescent; D000328:Adult; D019973:Alcohol-Related Disorders / Q000188:drug therapy*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008137:Longitudinal Studies; D008297:Male; D009271:Naltrexone / Q000008:administration & dosage / Q000494:pharmacology*; D009292:Narcotic Antagonists / Q000008:administration & dosage / Q000494:pharmacology*; D017063:Outcome Assessment, Health Care; D055815:Young Adult
chemical_list: D009292:Narcotic Antagonists; D009271:Naltrexone