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Searching for Responders to Acamprosate and Naltrexone in Alcoholism Treatment: Rationale and Desig

Searching for Responders to Acamprosate and Naltrexone in Alcoholism Treatment: Rationale and Desig

  1. Ilsa
    Background: Alcoholism represents a major public health issue and treating alcohol dependent
    patients remains an imminent challenge. Evidence based psychotherapies and pharmacotherapies
    are available. However, when administered to heterogeneous populations of patients effect sizes
    are only modest. We present the rationale and design of a double-blind randomized trial compar-
    ing acamprosate, naltrexone, and placebo. Additionally we subtype patients on the basis of bio-
    logical and psychometric measures and explore their treatment response to both acamprosate and
    naltrexone. According to our initial hypothesis, the ‘‘relief drinker ⁄ craver’’ is an endophenotype
    associated with glutamatergic dysfunction who responds to acamprosate. The ‘‘reward drinker ⁄
    craver’’ is mainly associated with alterations in the dopaminergic and opioidergic system and
    responds to naltrexone.
    Methods: The study is planned for 430 patients (2:2:1 for both drugs and placebo) over
    12 weeks of medication. All receive manualized counselling to improve compliance (Medical Man-
    agement) which is extended to 6 months. Subtyping is primarily done using the acoustic startle
    reflex, functional magnetic resonance imaging, positron emission tomography (in a subset of
    patients), and the Inventory of Drinking Situations. Relapsers will be re-randomized into a sec-
    ond study where additional psychotherapy (Cognitive Behavioral Intervention) is used in a
    stepped care approach. Genotyping and additional analyses such as health economy are being
    done as well. The study follows the assessment methods, treatments, and medications used in the
    U.S. based COMBINE study, which will allow for a direct comparison between this U.S. study
    trial and a study performed in Europe.
    Key Words: Alcohol Dependence, Pharmacotherapy, Behavioral Intervention, Predictor, RCT.