Treatment of Adult Attention Deficit Hyperactivity Disorder (ADHD) in Methadone Patients - 1 - Full Text View

Sponsored by:	National Institute on Drug Abuse (NIDA)
Information provided by:	National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier:	NCT00061087

Purpose

The purpose of this study is to treat Adult Attention Deficit Hyperactivity Disorder (ADHD) in methadone patients.

Condition	Intervention	Phase
ADHD Opioid-Related Disorders Cocaine Dependence	Drug: Methylphenidate Drug: Bupropion Other: Placebo	Phase II Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Treatment of Adult ADHD in Methadone Patients

Resource links provided by NLM:

MedlinePlus related topics: Attention Deficit Hyperactivity Disorder

Drug Information available for: Bupropion hydrochloride Bupropion Methadone Methylphenidate Methylphenidate hydrochloride Methadone hydrochloride

U.S. FDA Resources

Further study details as provided by National Institute on Drug Abuse (NIDA):

Primary Outcome Measures:

Cocaine use [ Time Frame: 3x/week ] [ Designated as safety issue: No ]
ADHD symptom severity [ Time Frame: 1x/week ] [ Designated as safety issue: No ]
Adverse effects [ Time Frame: 3x/week ] [ Designated as safety issue: Yes ]

Enrollment:	115
Study Start Date:	February 1998
Study Completion Date:	October 2004
Primary Completion Date:	October 2004 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator Methylphenidate	Drug: Methylphenidate
2: Active Comparator Bupropion	Drug: Bupropion Bupropion 400mg/day
3: Placebo Comparator Placebo	Other: Placebo Placebo

Detailed Description:

This project is a three armed double-blind, placebo-controlled, randomized trial comparing the efficacy of MPH and BPR, relative to each other and to placebo, for treating persistent ADHD in methadone-maintained patients. One hundred and twenty subjects, will be randomized to receive either MPH, BPR, or placebo with equal probability. Randomization will be stratified by site, and whether or not cocaine is also being used. Efficacy will be measured by treatment retention, reduction in illicit drug use and drug craving, improvement of ADHD symptoms and overall functional status.

Eligibility

Ages Eligible for Study:	18 Years to 60 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Individuals who meet DSM-IV criteria for opiate dependence and are currently maintained on methadone
Patients must meet DSM-IV criteria for persistent adult ADHD
Must be on stable methadone dose for at least 3 weeks
Individuals positive for HIV will not be excluded.

Exclusion Criteria:

Patients meeting DSM-IV criteria for current psychiatric disorders (other than ADHD or substance abuse) which requires psychiatric intervention
Patients who are physiologically dependent on either sedatives or alcohol such that they experience symptoms requiring medical attention during periods of abstinence or significant reduction in amount of use
Individuals diagnosed with other forms of adult ADHD other than persistent, particularly substance-induced ADHD
Those who have an unstable medical condition which might make participation hazardous, including but not restricted to: uncontrolled hypertension, (SBP >160, DBP>100, PULSE >110), uncontrolled liver disease, uncontrolled diabetes, acute hepatitis, uncontrolled heart disease as indicated by history or abnormal ECG, glaucoma, or history of urinary retention or seizures, or advanced AIDS will not be included
Patients who are taking prescription psychotropic medications other than methadone
Patients who have exhibited suicidal or homicidal behavior within the past two years
Patients with known sensitivity to MPH or BPR
Patients with cognitive impairment or who cannot read or understand the self-report assessment forms unaided or are so severely disabled they cannot comply with the requirements of the study.
Patients unable to give full and informed consent
Patients with a history of an eating disorder
Patients recently convicted of a violent crime. (last two years)
Nursing mothers and pregnant women

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00061087

Locations

United States, New York
Research Foundation for Mental Hygiene, Inc.
New York, New York, United States, 10032

Sponsors and Collaborators

National Institute on Drug Abuse (NIDA)

Investigators

Principal Investigator:

Frances R Levin, M.D.

Research Foundation for Mental Hygiene, Inc.

More Information

Additional Information:

Substance and Research Service of the Division on Substance Abuse of the NYSPI This link exits the ClinicalTrials.gov site

Publications:

Levin FR, Evans SM, Brooks DJ, Kalbag AS, Garawi F, Nunes EV. Treatment of methadone-maintained patients with adult ADHD: double-blind comparison of methylphenidate, bupropion and placebo. Drug Alcohol Depend. 2006 Feb 1;81(2):137-48. Epub 2005 Aug 15.

Brooks DJ, Vosburg SK, Evans SM, Levin FR. Assessment of cognitive functioning of methadone-maintenance patients: impact of adult ADHD and current cocaine dependence. J Addict Dis. 2006;25(4):15-25.

Responsible Party:	NYPSI ( Frances R. Levin, M.D )
Study ID Numbers:	NIDA-11444-1, R01-11444-1
Study First Received:	May 21, 2003
Last Updated:	April 6, 2009
ClinicalTrials.gov Identifier:	NCT00061087 History of Changes
Health Authority:	United States: Federal Government; United States: Food and Drug Administration

Keywords provided by National Institute on Drug Abuse (NIDA):

ADHD
Cocaine
Treatment
Methadone

Study placed in the following topic categories:

Dopamine Uptake Inhibitors
Neurotransmitter Agents
Psychotropic Drugs
Methylphenidate
Disorders of Environmental Origin
Opioid-Related Disorders
Naphazoline
Dopamine
Attention Deficit Disorder with Hyperactivity
Mental Disorders
Mental Disorders Diagnosed in Childhood
Substance-Related Disorders
Hyperkinesis
Phenylpropanolamine
Analgesics

Antidepressive Agents, Second-Generation
Cocaine
Antidepressive Agents
Analgesics, Opioid
Cocaine-Related Disorders
Attention Deficit and Disruptive Behavior Disorders
Central Nervous System Depressants
Central Nervous System Stimulants
Narcotics
Methadone
Guaifenesin
Bupropion
Dopamine Agents
Peripheral Nervous System Agents

Additional relevant MeSH terms:

Dopamine Uptake Inhibitors
Respiratory System Agents
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Psychotropic Drugs
Methylphenidate
Disorders of Environmental Origin
Opioid-Related Disorders
Pathologic Processes
Attention Deficit Disorder with Hyperactivity
Mental Disorders
Sensory System Agents
Therapeutic Uses

Mental Disorders Diagnosed in Childhood
Substance-Related Disorders
Analgesics
Antidepressive Agents, Second-Generation
Antidepressive Agents
Analgesics, Opioid
Cocaine-Related Disorders
Disease
Attention Deficit and Disruptive Behavior Disorders
Central Nervous System Depressants
Central Nervous System Stimulants
Narcotics
Pharmacologic Actions
Methadone
Bupropion

ClinicalTrials.gov processed this record on July 02, 2009