Treatment of Adult Attention Deficit Hyperactivity Disorder (ADHD) in Methadone Patients - 1
This study has been completed.
Sponsor:
New York State Psychiatric Institute
Collaborator:
Information provided by (Responsible Party):
New York State Psychiatric Institute
ClinicalTrials.gov Identifier:
NCT00061087
First received: May 21, 2003
Last updated: October 24, 2012
Last verified: October 2012
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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 2 Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| 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:
Methadone
Methylphenidate
Methylphenidate hydrochloride
Methadone hydrochloride
Bupropion hydrochloride
Bupropion
U.S. FDA Resources
Further study details as provided by New York State Psychiatric Institute:
Primary Outcome Measures:
- Cocaine use based on urine toxicology [ Time Frame: collected 3 times per week for 12 weeks of the trial or length of study participation ] [ Designated as safety issue: No ]
- ADHD symptom severity based on the ADHD Rating scale score [ Time Frame: measured once per week for 12 weeks or length of study participation ] [ Designated as safety issue: No ]
| 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 |
|---|---|
|
Active Comparator: METHYLPHENIDATE
Methylphenidate
|
Drug: Methylphenidate
Methylphenidate 80mg/day
|
|
Active Comparator: BUPROPION
Bupropion
|
Drug: Bupropion
Bupropion 400mg/day
|
|
Placebo Comparator: PLACEBO
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
New York State Psychiatric Institute
Investigators
| Principal Investigator: | Frances R Levin, M.D. | Research Foundation for Mental Hygiene, Inc. |
More Information
Additional Information:
Publications:
| Responsible Party: | New York State Psychiatric Institute |
| ClinicalTrials.gov Identifier: | NCT00061087 History of Changes |
| Other Study ID Numbers: | NIDA-011444-1,#4184R, R01DA011444, 4184R |
| Study First Received: | May 21, 2003 |
| Last Updated: | October 24, 2012 |
| Health Authority: | United States: Federal Government United States: Food and Drug Administration |
Keywords provided by New York State Psychiatric Institute:
|
ADHD Cocaine Treatment Methadone |
Additional relevant MeSH terms:
|
Opioid-Related Disorders Cocaine-Related Disorders Attention Deficit Disorder with Hyperactivity Substance-Related Disorders Mental Disorders Attention Deficit and Disruptive Behavior Disorders Mental Disorders Diagnosed in Childhood Methadone Methylphenidate Bupropion Analgesics, Opioid Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs |
Pharmacologic Actions Central Nervous System Agents Therapeutic Uses Central Nervous System Depressants Antitussive Agents Respiratory System Agents Narcotics Dopamine Uptake Inhibitors Dopamine Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Neurotransmitter Uptake Inhibitors Central Nervous System Stimulants Antidepressive Agents, Second-Generation Antidepressive Agents |
ClinicalTrials.gov processed this record on May 16, 2013