Status:
COMPLETED
Treatment of Patients With Alcoholism and Attention Deficit Disorder
Lead Sponsor:
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Conditions:
Alcoholism
Attention Deficit Disorder
Eligibility:
All Genders
21-65 years
Phase:
PHASE4
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 ...
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...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- 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
- EXCLUSION CRITERIA:
- 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):
- 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):
- 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
Exclusion
Key Trial Info
Start Date :
December 1 2005
Trial Type :
INTERVENTIONAL
End Date :
April 9 2007
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT00261872
Start Date
December 1 2005
End Date
April 9 2007
Last Update
July 2 2017
Active Locations (1)
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1
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892