Targeted Naltrexone for Problem Drinkers
Condition: Alcoholism; Alcohol Drinking; Alcohol Dependence
MeSH terms: Alcoholism; Alcohol Drinking
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to determine whether naltrexone, combined with brief coping
      skills therapy, is effective in the treatment of heavy drinking.
    

Detailed description: 
      This is a 12-week, placebo-controlled trial of naltrexone (50 mg orally) in 163 problem
      drinkers. Problem drinkers are those individuals whose drinking puts them at risk of a
      variety of psychosocial and medical problems, including alcohol dependence, but who are not
      physically dependent on alcohol. They are estimated to comprise up to 20% of the general
      population. The study employed a factorial design in which the effects of medication
      (naltrexone vs. placebo), schedule of medication administration (i.e., daily vs. targeted),
      and the interaction of these factors on drinking behavior were examined. Targeted
      administration refers to the use of medication to cope with anticipated high-risk drinking
      situations.

      The daily monitoring using interactive voice response technology of mood, desire to drink,
      perceived self-efficacy, and drinking behavior will make it possible to examine in depth the
      processes by which the study variables exert their effects. Daily monitoring was performed
      using automated telephone interviews, with in-person follow-up evaluations conducted at 3 and
      6 months post-treatment to provide a measure of the durability of treatment effects.

      A pharmacogenetic analysis based on preliminary evidence showing that a functional
      polymorphism in the gene encoding the mu-opioid receptor (OPRM1) affects response to
      naltrexone will serve to explore an important source of variation in the response to
      naltrexone treatment. Exploratory analyses involving other potential genetic moderators of
      the response to naltrexone, such as the gene encoding the delta opioid receptor (OPRD1), will
      also be conducted, as will the correlation of genotype data with other phenotypes.

      Careful evaluation of the study hypotheses will provide important information on the efficacy
      and mechanism of the effects of targeted naltrexone in problem drinkers. This study will
      allow us to model effects across multiple levels of analysis in an effort to understand the
      psychopharmacological mechanisms underlying the therapeutic effects of naltrexone in problem
      drinkers and to apply novel genetic findings to understanding the pharmacogenetic mechanisms
      underlying the therapeutic effects of naltrexone in problem drinkers.
    

Intervention name(s): Naltrexone; placebo
Intervention type(s): Drug; Drug
Intervention description(s): naltrexone (50 mg orally) for 12-week treatment period; 3 and 6 months post-treatment follow-up; placebo for 12-week treatment period; 3 and 6 months post-treatment follow-up
Other intervention name(s): ReVia
Intervention MeSH terms: Naltrexone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Randomized Trial; Medication for Heavy Drinking; Naltrexone Treatment; Daily vs. Targeted Administration