Ignite Creation Date:
2024-05-05 @ 12:10 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00261872
Status:
COMPLETED
Last Update Posted:
2017-07-02
First Post:
2005-12-03
Brief Title:
Treatment of Patients With Alcoholism and Attention Deficit Disorder
Sponsor:
National Institute on Alcohol Abuse and Alcoholism NIAAA
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Treatment of Patients With Alcoholism and Attention Deficit Disorder
Status:
COMPLETED
Status Verified Date:
2007-04-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 deficithyperactivity 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 NIAAAs 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 persons 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
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 NIAAAs 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 persons 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 eg 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 06-AA-0004 | None | None | None |