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| Name | Class |
|---|---|
| McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc. | INDUSTRY |
This is a double-blind, placebo-controlled study, three-period crossover study to examine the likeability of a single dose of OROS MPH (CONCERTAÃ’ 90mg) and a single dose of Long-acting MPH (RITALIN LAÃ’ 90mg). Hypotheses are as follows:
Hypothesis 1: OROS-MPH (CONCERTAÃ’) will be later than SODOS-MPH (RITALIN LAÃ’) in its Tmax (time to Cmax).
Hypothesis 2: The subjective feelings of detection and likeability would be greater for SODOS-MPH (RITALIN LAÃ’) than for an equivalent total dose of OROS-MPH (CONCERTAÃ’).
Our recent work has suggested that the potential euphoriant risk associated with MPH may be moderated by the oral delivery system in which a longer delivery system may be safer than the immediate release one. OROS-MPH's pharmacokinetic profile uses an increasing delivery of MPH over the day (ascending pharmacokinetic curve). It was designed to replace IR-MPH TID treatment. Another new long-acting MPH formulation is the spheroidal oral drug absorption system (SODAS). SODAS-MPH consists of capsules with two types of beads in a 1 to 1 ratio. Evaluating whether different long acting formulations of MPH will differ in their rate of onset of MPH action (plasma level) is of high clinical, scientific and public health relevance. Since the rate of delivery of MPH is a key factor previously associated with detection and likeability of MPH.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| OROS methylphenidate HCl | Drug | |||
| SODAS methylphenidate HCl | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Objective measures provided by hourly d and l ritalinic acid and methylphenidate levels from pre-dose and hours 1,2,3,4,5,6,7,8,10, and 12. |
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Inclusion Criteria:
Exclusion Criteria:
Known hypersensitivity to methylphenidate or components of CONCERTA or RITALIN, or to the sympathomimetic amines.
Presence or history of any medically diagnosed, clinically significant Axis I psychiatric disorder (including substance use disorders, bipolar disorder, any psychotic disorder, Tourette's disorder or family history of Tourette's)
Any clinically significant chronic disease or unstable medical abnormality by history or physical examination, including hypertension, glaucoma, hyperthyroidism, a seizure disorder, history of myocardial infarction or stroke, or history of cardiac arrhythmia or heart murmur (other than uncomplicated mitral valve prolapse).
Clinically significant abnormal baseline laboratory values which include the following:
Currently taking a monoamine oxidase inhibitor or have taken a monoamine oxidase inhibitor in the 14 days before initiation of study medication.
Currently taking or require any of the following medications: clonidine or other alpha-2 adrenergic receptor agonists, tricyclic antidepressants, selective serotonin reuptake inhibitors (SSRIs), theophylline, coumarin anticoagulants, anticonvulsants, or prescription stimulants.
Have taken an SSRI in the 35 days before initiation of the study medication.
Currently physically dependent on benzodiazepines, opiates or alcohol as determined by clinical evaluation or positive urine drug screen at screening.
Preexisting severe gastrointestinal narrowing (pathologic or iatrogenic, for example: small bowel inflammatory disease, "short gut" syndrome due to adhesions or decreased transit time, past history of peritonitis, cystic fibrosis, chronic intestinal pseudoabsorption, or Meckel's diverticulum).
Unable to swallow the study medication whole.
Have had a significant blood loss (>500 mL) or donated blood in the 30 days preceding dosing.
Have a positive urine drug screen at screening.
Have taken an investigational medication or product within the past 30 days.
Have taken prescription medications (with the exception of birth control methods) within seven days of screening or is anticipated to need any medications, over-the- counter products (other than acetaminophen), or herbal supplements during the study.
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| Name | Affiliation | Role |
|---|---|---|
| Thomas Spencer, MD | Massachusetts General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital | Cambridge | Massachusetts | 02138 | United States |
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