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Completed Phase 4 Interventional Accepts healthy volunteers Results available

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

ClinicalTrials.gov ID: NCT00302458

Public ClinicalTrials.gov record NCT00302458. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 2, 2026, 5:38 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Double-blind, Randomized, Placebo-controlled, Crossover Study of Repeat Dosing of OROS® Methylphenidate Hydrochloride (CONCERTA®) and Immediate Release Methylphenidate Hydrochloride in Healthy Adults

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

This is a double-blind, randomized, placebo-controlled, five-period crossover study to examine the likability of a repeated administration of immediate release methylphenidate hydrochloride (IR-MPH 40 mg) and OROS®-MPH (CONCERTA® 72 mg) in healthy adults. Hypotheses are as follows: * Hypothesis 1: the subjective feelings of detection and likeability will be greater for periods of IR-MPH administration than after OROS-MPH administration irregardless of sequence; * Hypothesis 2: the greater ratings of feelings of detection and likeability will be associated with the periods of most rapid change in plasma d-MPH and not with the magnitude of plasma d-MPH concentration (other than the OROS-MPH to IR-MPH condition in which they coincide), and * Hypothesis 3: the subjective feelings of dislike will be greatest for the two conditions in which IR-MPH is the second condition.

Study identification

NCT ID
NCT00302458
Recruitment status
Completed
Study type
Interventional
Phase
Phase 4
Enrollment
44 participants

Conditions and interventions

Eligibility (public fields only)

Age range
18 Years to 45 Years
Sex
All
Healthy volunteers
Accepts healthy volunteers

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Dec 31, 2005
Primary completion
May 31, 2007
Completion
May 31, 2007
Last update posted
Feb 28, 2016

2006 – 2007

United States locations

U.S. sites
1
U.S. states
1
U.S. cities
1
Facility City State ZIP Site status
Massachusetts General Hospital Boston Massachusetts 02114

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT00302458, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Feb 28, 2016 · Synced Sep 2, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT00302458 live on ClinicalTrials.gov.

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