Treatment of Patients With Alcoholism and Attention Deficit Disorder
|First Received Date ICMJE||December 3, 2005|
|Last Updated Date||April 10, 2007|
|Start Date ICMJE||December 2005|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE||Not Provided|
|Original Primary Outcome Measures ICMJE||Not Provided|
|Change History||Complete list of historical versions of study NCT00261872 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE||Not Provided|
|Original Secondary Outcome Measures ICMJE||Not Provided|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Treatment of Patients With Alcoholism and Attention Deficit Disorder|
|Official Title ICMJE||Treatment of Patients With Alcoholism and Attention Deficit Disorder|
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:
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 ICMJE||Interventional|
|Study Phase||Phase 4|
|Study Design ICMJE||Primary Purpose: Treatment|
|Intervention ICMJE||Drug: Methylphenidate|
|Study Arm (s)||Not Provided|
|Publications *||COMBINE Study Research Group.. Testing combined pharmacotherapies and behavioral interventions for alcohol dependence (the COMBINE study): a pilot feasibility study. Alcohol Clin Exp Res. 2003 Jul;27(7):1123-31.|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Completed|
|Estimated Completion Date||April 2007|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
Age 21 or older.
DSM-IV diagnosis of alcohol dependence or alcohol abuse on SCID, and alcohol problems as primary complaint among SUD:s
DSM-IV diagnosis of ADHD on SCID, confirmed by CAARS-INV
General exclusion criteria for the NIAAA intramural treatment program:
Study specific exlusion criteria:
1. known supersensitivity to the drug
2. acute hepatitis (any transaminase great than 3 x upper normal interval limit)
3. ongoing (within last month) use of opid analgesics, or illicit opiates
7. Contraindications / warnings for methylphenidate (in addition to those included in the general exclusion criteria):
|Ages||21 Years to 65 Years (Adult)|
|Accepts Healthy Volunteers||No|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Listed Location Countries ICMJE||United States|
|Removed Location Countries|
|NCT Number ICMJE||NCT00261872|
|Other Study ID Numbers ICMJE||060004, 06-AA-0004|
|Has Data Monitoring Committee||Not Provided|
|Plan to Share Data||Not Provided|
|IPD Description||Not Provided|
|Responsible Party||Not Provided|
|Study Sponsor ICMJE||National Institute on Alcohol Abuse and Alcoholism (NIAAA)|
|Collaborators ICMJE||Not Provided|
|Investigators ICMJE||Not Provided|
|Information Provided By||National Institutes of Health Clinical Center (CC)|
|Verification Date||April 2007|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP