- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00015054
Methylphendidate Treatment of Cocaine Dependent Patients With Attention Deficit Hyperactivity Disorder - 3
January 13, 2017 updated by: National Institute on Drug Abuse (NIDA)
MPD04961-Methylphendidate Treatment of Cocaine Dependent ADHD Patients
The purpose of this study is to demonstrate the feasibility of methylphenidate (MPD) as effective and safe in the outpatient treatment of cocaine-dependent patients with a comorbid DSM-IV diagnosis of Attention Deficit Hyperactivity Disorder (ADHD), to demonstrate the ability of each site to participate in a subsequent anticipated controlled trial of MPD (recruitment and execution), and to gather preliminary data on the ability of sweat patches to detect episodes of cocaine use.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Forty-one participants were enrolled into this multi-site, outpatient, open-label, ten-week trial.
Participants were scheduled to attend three visits per week to allow safety and efficacy measures to be taken.
In addition, participants were given two hours of individual substance abuse therapy during the first four weeks, and one hour per week during the last six weeks, of the trial.
All participants were started on a total daily dose of 20 mg MPD.
The total daily dose was then increased to a maximum daily dose of 60 mg (20 mg TID) or to the maximum dose tolerated by the participant.
Study Type
Interventional
Enrollment
20
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Ohio
-
Cincinnati, Ohio, United States, 45220
- Cincinnati MDRU
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
19 years to 48 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Subject must be between 21 and 50 years of age, male or female, of any race.
- If female, subject cannot be pregnant or lactating.
- Subject must be cocaine-dependent (as determined by the SCID and a clinical interview by a psychiatrist).
- Subject must meet DSM-IV diagnostic criteria for ADHD:
- Subject must have been actively using cocaine, (BE>300 ng/ml) within 30 days of the screening examination.
- Subject must be negative for cocaine metabolites immediately prior to receiving a study treatment number and initial dose of MPD, as determined first by urine testing kit with result later confirmed by laboratory urine toxicology (BE < 300 ng/ml).
- Subject must be willing and able to give informed consent.
Exclusion Criteria:
- Subject has symptoms of AIDS.
- Subject has a chronic medical disorder requiring medication.
- Subject has a SCID Axis-I psychiatric diagnosis requiring medication.
- Subject meets DSM-IV criteria for dependence for any substance except cocaine, alcohol, nicotine, marijuana, caffeine, and has been actively using during the past two weeks.
- Subject is in need of detoxification from alcohol or benzodiazepines
- Subject is taking psychotropic medication (except chloral hydrate for insomnia).
- Subject is female of childbearing age who is at risk for becoming pregnant and is not using adequate contraceptive techniques as determined by the evaluating physician or Principal Investigator.
- Subject has ALT or AST levels above three times laboratory normal
- Subject has renal function tests (creatinine and BUN) or electrolyte levels (K, Na, Cl, HCO3) that are not within normal limits at baseline.
- Subject has an EKG indicating clinically significant arrhythmias or abnormal conduction
- Subject has organic brain syndrome (OBS) as evidenced in the psychiatric evaluation.
- Subject has an acute or chronic medical or psychiatric condition which in the judgment of the evaluating physician would make study participation difficult or unsafe.
- Subject has been enrolled in another research protocol within the past 45 days.
- Subject has narrow angle glaucoma, by history
- Subject has a diagnosis or family history of Tourettes syndrome
- Subject has a history of seizures or seizure disorder
- Subject has had an adverse reaction to methylphenidate
- Subject has abnormal thyroid function (as determined by an abnormal T4 level that is clinically significant)
- Subject has been treated for ADHD with psychomotor stimulants within the past month.
- Subject plans to receive psychosocial treatment external to that designated in the protocol during study participation.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
Retention
|
Cocaine use
|
Global improvement
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Eugene Somoza, M.D., Ph.D., Cincinnati MDRU
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 1998
Primary Completion (Actual)
October 1, 1999
Study Completion (Actual)
November 1, 1999
Study Registration Dates
First Submitted
April 18, 2001
First Submitted That Met QC Criteria
April 17, 2001
First Posted (Estimate)
April 18, 2001
Study Record Updates
Last Update Posted (Estimate)
January 16, 2017
Last Update Submitted That Met QC Criteria
January 13, 2017
Last Verified
February 1, 1999
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Mental Disorders
- Chemically-Induced Disorders
- Substance-Related Disorders
- Cocaine-Related Disorders
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Neurotransmitter Uptake Inhibitors
- Membrane Transport Modulators
- Dopamine Agents
- Dopamine Uptake Inhibitors
- Central Nervous System Stimulants
- Methylphenidate
Other Study ID Numbers
- NIDA-5-0012-3
- Y01-5-0012-3
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Cocaine-Related Disorders
-
Baylor College of MedicineNational Institute on Drug Abuse (NIDA)CompletedSubstance Abuse | Cocaine Dependence | Cocaine Abuse | Cocaine AddictionUnited States
-
Baylor College of MedicineNational Institute on Drug Abuse (NIDA)CompletedSubstance Abuse | Cocaine Dependence | Cocaine Abuse | Cocaine AddictionUnited States
-
Baylor College of MedicineNational Institute on Drug Abuse (NIDA)CompletedSubstance Abuse | Cocaine Dependence | Cocaine Abuse | Cocaine AddictionUnited States
-
New York State Psychiatric InstituteNational Institute on Drug Abuse (NIDA); Columbia UniversityNot yet recruitingCocaine Use Disorder | Cocaine Dependence | Cocaine Use | Cocaine Use Disorder, Moderate | Cocaine Use Disorder, Severe
-
Tonix Pharmaceuticals, Inc.National Institute on Drug Abuse (NIDA); PremierNot yet recruitingCocaine Use | Cocaine Abuse | Cocaine Adverse Reaction | Cocaine Intoxication | Cocaine Toxicity
-
Temple UniversityNational Institute on Drug Abuse (NIDA); University of PennsylvaniaCompletedCocaine-Related Disorders | Cocaine Dependence | Cocaine Abuse | Cocaine AddictionUnited States
-
Baylor College of MedicineNational Institute on Drug Abuse (NIDA)CompletedSubstance Abuse | Cocaine Dependence | Cocaine Abuse | Cocaine AddictionUnited States
-
University of VirginiaRecruitingCocaine Use Disorder | Cocaine Dependence | Ultrasound | Cocaine AbuseUnited States
-
ITAB - Institute for Advanced Biomedical TechnologiesNot yet recruitingCocaine Dependence | Cocaine Use | Cocaine Abuse | NeurotropismItaly
-
University Hospital Center of MartiniqueUnknown
Clinical Trials on Methylphenidate
-
University of ArkansasCompleted
-
Mahidol UniversityNot yet recruiting
-
Massachusetts General HospitalFood and Drug Administration (FDA); Center for Psychiatry And Behavioral Medicine...Completed
-
Florida International UniversityNational Institute of Mental Health (NIMH)CompletedAttention Deficit Disorder With HyperactivityUnited States
-
Ironshore Pharmaceuticals and Development, IncCompletedAttention Deficit Hyperactivity DisorderUnited States
-
Boston Children's HospitalNational Institute of Mental Health (NIMH)CompletedEpilepsy | Attention Deficit Disorder With HyperactivityUnited States
-
Massachusetts General HospitalMcNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.Completed
-
Massachusetts General HospitalMcNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.Completed
-
Tehran University of Medical SciencesUnknownAttention Deficit Hyperactivity DisorderIran, Islamic Republic of
-
Children's Hospital of PhiladelphiaOrtho-McNeil Janssen Scientific Affairs, LLCCompletedAttention Deficit Hyperactivity DisorderUnited States