Treatment of Patients With Alcoholism and Attention Deficit Disorder
|ClinicalTrials.gov Identifier: NCT00261872|
Recruitment Status : Completed
First Posted : December 5, 2005
Last Update Posted : July 2, 2017
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)
|Condition or disease||Intervention/treatment||Phase|
|Alcoholism Attention Deficit Disorder||Drug: Methylphenidate||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Official Title:||Treatment of Patients With Alcoholism and Attention Deficit Disorder|
|Study Start Date :||December 1, 2005|
|Estimated Study Completion Date :||April 9, 2007|
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00261872
|United States, Maryland|
|National Institutes of Health Clinical Center, 9000 Rockville Pike|
|Bethesda, Maryland, United States, 20892|