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Home > "T" Clinical Trials Conditions > Treatment of Adult ADHD in Methadone Patients - 1  Treatment of Adult ADHD in Methadone Patients - 1
Treatment of Adult ADHD in Methadone Patients - 1
For Condition: Opioid-Related Disorders
Status: Recruiting
Sponsor(s): National Institute on Drug Abuse (NIDA) ,
Synopsis: Treatment of Adult ADHD in Methadone Patients
Details: 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:
Study Type: Interventional, Treatment, Double-Blind, Uncontrolled
Minimum Age/Maximum Age: 18 Years/60 Years
Genders: Both
Protocol Entry Criteria: Inclusion Criteria: - Men and women must be between the ages of 18-60 - 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 sensit ivity 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, Structured interview, medical history - Patients recently convicted of a violent crime. (last two years) - Nursing mothers and pregnant women
Total Enrollment: 150
Location and Contact Information:
Overall Study Official:
FrancesLevin, Principal Investigator, Research Foundation for Mental Hygiene, Inc.
Research Foundation for Mental Hygiene, Inc. *Recruiting*
New York City, New York, 10032
United States
Recruiting Frances Levin 212-960-5896
Additional Information:
Study ID Numbers: NIDA-11444-1; R01-11444-1
Study Start Date: February 1998
Record last reviewed: July 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00061087
Other Opioid-Related Disorders Studies:
1. HIV Counseling Intervention for Methadone-Maintained Patients - 2
2. Combining Behavioral Treatment with Agonist Maintenance - 1
3. Differential Acute Tolerance Development to Effects of Nitrous Oxide - 7
4. Neurobiology of Opioid Dependence: 3 - 3
5. Reinforcing Effects of Brief Exposures to Nitrous Oxide - 8
Related Studies:
Other Opioid-Related Disorders Clinical Trials
Other New York Clinical Trials
Other New York City Clinical Trials
Treatment of Adult ADHD in Methadone Patients - 1
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