Treatment of Patients With Alcoholism and Attention Deficit Disorder

Completed · Phase 4

Conditions studied: Alcoholism, Attention Deficit Disorder

In brief

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)

Key facts

Study ID

NCT00261872

Run by

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

People needed

100

Starts

2005-12-01

Expected to finish

2007-04-09

Last updated by the study team

2017-07-02

Who can join

Age: 21 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

• General exclusion criteria for the NIAAA intramural treatment program:
• 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)
• Use of psychotropic medication (antidepressant, lithium, antipsychotic, anxiolytic, antiepileptic) within last 4 weeks, except when given within the program as part of medically supervised withdrawal. Use of these medications constitutes prima facie evidence of general exclusion category 3 (above). Persons identified with psychiatric conditions deemed exclusionary will be referred to community resources for inpatient or outpatient treatment as indicated. Persons with acute psychiatric emergencies (e.g. bipolar disorder, manic phase, significant depressive symptoms, or active suicidal ideation) will be referred for immediate care to ensure safety and stabilization; such actions will be appropriately documented.
• 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
• Contraindications / warnings for naltrexone (in addition to those included in the general exclusion criteria):
• 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
• Contraindications / warnings for methylphenidate (in addition to those included in the general exclusion criteria):
• known supersensitivity to the drug
• marked anxiety, tension or agitation, since the drug may aggravate these symptoms
• glaucoma
• motor tics, or family history or diagnosis of Tourettes syndrome
• history of seizures
• hypertension, or known disease which can be aggravated by an elevation of blood pressure or increased pulse rate

Where it is running

• National Institutes of Health Clinical Center, 9000 Rockville Pike — Bethesda, Maryland, United States

Full record on ClinicalTrials.gov

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