Treatment of Patients With Alcoholism and Attention Deficit Disorder
Condition: Alcoholism; Attention Deficit Disorder
MeSH terms: Alcoholism; Attention Deficit Disorder with Hyperactivity
Study type: Interventional
Phase: Phase 4

Summary: 
      This study of persons with both alcoholism and ADHD will determine whether adding the drug
      methylphenidate to a standard treatment program will decrease alcohol use. In approximately
      half of patients with ADHD, symptoms persist into adulthood, and the untreated condition is
      associated with a significantly increased incidence of substance use disorder. Also, more
      than one-third of adults with substance use disorder have symptoms of ADHD. This study will
      evaluate the effectiveness of adding methylphenidate to a standard alcohol treatment program
      in improving patients' treatment compliance and decreasing adverse consequences of drinking,
      as well as monitoring their attention deficit/hyperactivity symptoms,

      People 21 to 65 years of age with alcoholism and attention deficit hyperactivity disorder
      (ADHD) may be eligible for this study.

      Participants are randomly assigned to receive either slow-release methylphenidate (an
      approved medication for ADHD) or placebo. All subjects participate in NIAAA's alcohol
      treatment program, which includes a standardized 12-week behavioral therapy course and
      treatment with naltrexone, a medication to prevent relapse. Patients are assessed once a week
      with the standard NIAAA treatment evaluation battery, including:

        -  Timeline Followback: A validated self-report method to assess a person's drinking over a
           defined interval in time

        -  Addiction Severity Index: A validated interview that measures problem severity in seven
           areas related to drug and alcohol abuse

        -  Biomarkers for alcohol abuse

        -  Conners Adult ADHD Rating Scale (a rating scale for ADHD symptoms and severity)
    

Detailed description: 
      Background: Several pharmacological therapies for relapse prevention in alcoholism have now
      been documented for efficacy. A key issue that has emerged is the role of patient compliance
      with medication in mediating efficacy. Psychological traits common among alcoholics interact
      with treatment compliance. Thus, a considerable proportion of alcoholics, e.g. more than one
      third of treatment seeking populations, display signs and symptoms of adult ADHD. The
      impaired ability for long term planning and sustained goal-oriented behaviors in this group
      is likely to impair compliance with pharmacological treatment, thus reducing its potential
      beneficial effects.

      Well documented pharmacological treatments are also available for ADHD. Among these,
      methylphenidate has a strong documentation, and has been demonstrated to be as efficacious in
      adult ADHD as in the childhood condition. A recently introduced slow release preparation of
      methylphenidate appears to offer considerable advantages, in that it eliminates most of the
      abuse potential, and allows once daily administration.

      Aims: The aim of this study is to evaluate whether addition of methylphenidate to a state of
      the art treatment program for alcohol dependence will improve clinically relevant treatment
      outcomes such as validated measures of alcohol drinking.

      Methods: The hypothesis will be addressed in a 12 week randomized, placebo controlled double
      blind add-on trial. Participation will be offered to subjects with alcohol dependence, aged
      21-65 years, who enter the NIAAA alcohol treatment program, do not have any severe
      psychiatric or physical morbidity, and meet criteria for adult ADHD. All patients who are
      included will be given a standardized state of the art 12 week behavioral treatment package,
      as well as naltexone, an approved medication for relapse prevention. In addition subjects
      will be randomized to slow release methylphenidate or corresponding placebo. Patients will be
      evaluated upon weekly visits using the standard NIAAA treatment evaluation battery TLFB, ASI,
      biomarkers, as well as the established CAARS rating scale for attention deficit /
      hyperactivity. Primary outcome will be measures of drinking obtained by the TLFB methodology.
      Secondary outcomes will measures of attention deficit and hyperactivity, as measured by the
      CAARS scores.
    

Intervention name(s): Methylphenidate
Intervention type(s): Drug
Intervention MeSH terms: Methylphenidate
Primary purpose: Treatment
Keywords: Alcoholism; Attention Deficit Disorder; ADHD