Study Examining Repeat Dosing of OROS® Methylphenidate (CONCERTA®) and Immediate Release Methylphenidate in Healthy Adults

Completed · Phase 3

Conditions studied: Healthy

In brief

There are two specific aims of this study. The first is to document the pharmacokinetics of dopamine transporter (DAT) receptor occupancy of repeated administration of orally administered, therapeutic doses of a short immediate release-methylphenidate hydrochloride (IR-MPH) and a long-acting formulation of MPH (OROS-MPH) using positron emission tomography (PET) scanning with C-11 altropane as the ligand. The investigators hypothesize that central nervous system (CNS) DAT occupancy of the OROS-MPH to IR-MPH sequence will be greater than that of IR-MPH to OROS-MPH sequence at 5 hours after the initial administration and that the CNS DAT occupancy of the other two formulations will be intermediate. The second aim of this study is to assess whether the abuse liability potential of delayed, repeated administrations of different formulations of MPH is moderated by the oral delivery system in which a delivery system with slower onset may be safer than one with more rapid early release.

Key facts

Study ID: NCT00302393
Run by: Massachusetts General Hospital
People needed: 20
Starts: 2006-06-01
Expected to finish: 2008-02-01
Last updated by the study team: 2013-10-22

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.

You may qualify if…

Signed written informed consent to participate in the study
Age: 18 - 55
If female, non-pregnant, non-nursing, using an adequate form of birth control or a negative plasma pregnancy test
Supine and standing blood pressure within the range 110/60 to 150/90 mmHg
Heart rate, after resting for 5 minutes, within the range 46-90 beats/min
Subjects who are within 20% of the ideal weight for height
Right handed

You may not qualify if…

Subjects with marked anxiety, tension, and agitation since the drug may aggravate these symptoms
Subjects with known hypersensitivity to methylphenidate or other components of Concerta or Ritalin
Subjects with glaucoma
Subjects with motor tics or with a family history or diagnosis of Tourette's syndrome
Subjects treated with monoamine oxidase inhibitors (MAOIs) or within 14 days of discontinuation of treatment with MAOIs
Diagnosis of any psychotic disorder, bipolar disorder, severe depression, severe anxiety, or autism. Subjects with mild mood, oppositional, conduct, and anxiety disorders may be permitted to participate if considered appropriate by the investigator.
Scores of Baseline Scales:
Hamilton Depression Scale > 17 (out of a possible 67 on the 21-item scale) (Hamilton 1960)
Beck Depression Inventory > 19 (out of a possible 63 on the 21-item scale) (Beck et al 1961)
Hamilton Anxiety Scale > 21 (out of a possible 56 on the 14-item scale) (Hamilton 1959)
Diagnosis of ADHD (attention deficit hyperactivity disorder)
History of head trauma with loss of consciousness, organic brain disorders, seizures, or neurosurgical intervention
Any clinically significant chronic medical condition, in the judgment of the investigator
Mental impairment as evidenced by an intelligence quotient (I.Q.) < 75
Exposure to dopamine receptor antagonists within the previous three (3) months
Exposure to radiopharmaceuticals within four (4) weeks prior to PET scan
Subjects receiving psychotropic medication
Any clinically significant abnormality in the screening laboratory tests, vital signs, or 12-lead ECG (electrocardiogram), outside of normal limits
Any woman of childbearing potential who is seeking to become pregnant or suspects that she may be pregnant
Subjects with a known recent history (within the past six [6] months) of illicit drug or alcohol dependence

Where it is running

Massachusetts General Hospital — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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