Treatment of Patients With Alcoholism and Attention Deficit Disorder

NCT00261872 | Completed Phase 4

• 2 other identifiers: 06000406-AA-0004
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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 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)

Conditions

Alcoholism; Attention Deficit Disorder

Keywords

Alcoholism; Attention Deficit Disorder; ADHD

Interventions

Methylphenidate DRUG

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• People who present with complicated medical problems requiring intensive medical or diagnostic management, such as hypertensive emergency, serious GI bleeding, major organ or body system dysfunction such as decompensated liver disease, renal failure, myocardial ischemia, congestive heart failure or cerebrovascular disease, major endocrine problems such as uncontrolled diabetes, pancreatic or thyroid disease.
• People who are infected with the Human Immunodeficiency Virus (HIV).
• Serious neuro-psychiatric conditions which impair judgment or cognitive function to an extent that precludes them from providing informed consent or complying with treatment, such as psychotic illness or severe dementia (incompetent individuals).
• People who are unlikely or unable to complete the treatment program because they become or are likely to be incarcerated while on the protocol.
• People who are required to receive treatment by a court of law or who are involuntarily committed to treatment.
• People with uncontrolled hypertension
• People with a history of withdrawal seizures
• Study specific exlusion criteria:
• Pregnancy or lactation (negative pregnancy test required)
• Past DSM-IV diagnosis of dependence (but not abuse, or reported occasional use of) drugs of abuse other than alcohol.
• Present DSM-IV diagnosis (but not sporadic use) of dependence on any central stimulant
• Present use of guanethidine or yohimbine
• \. known supersensitivity to the drug
• \. acute hepatitis (any transaminase great than 3 x upper normal interval limit)
• \. ongoing (within last month) use of opid analgesics, or illicit opiates

Sponsors & Collaborators

• National Institute on Alcohol Abuse and Alcoholism (NIAAA): lead

Study Sites (1)

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Related Publications (1)

• 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. doi: 10.1097/01.ALC.0000078020.92938.0B.

  PMID: 12878918 BACKGROUND

MeSH Terms

Conditions

Alcoholism; Attention Deficit Disorder with Hyperactivity

Interventions

Methylphenidate

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders

Intervention Hierarchy (Ancestors)

Phenylacetates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 4
• Purpose: TREATMENT
• Sponsor Type: NIH

Study Record Dates

• First Submitted: December 3, 2005
• First Posted: December 5, 2005
• Study Start: December 1, 2005
• Study Completion: April 9, 2007
• Last Updated: July 2, 2017

Record last verified: 2007-04-09

Locations

US (1)