HealthyPhase 4NCT00302458
A Study of Repeat Dosing of OROS® Methylphenidate Hydrochloride (CONCERTA®) and Immediate Release Methylphenidate Hydrochloride in Healthy Adults
A Phase 4 study testing OROS-Methylphenidate and Immediate Release Methylphenidate in people with Healthy, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- OROS-Methylphenidate and Immediate Release Methylphenidate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 44 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2006to Jun 2007
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Males or non-pregnant, non-lactating females. With the exception of women who have been post-menopausal for a minimum of 12 months prior to screening and those who have undergone hysterectomy or bilateral oophorectomy, all female subjects must have a negative urine pregnancy test at both screening and at each admission to the research unit. All male and female subjects must have used a medically acceptable form of birth control for at least one month prior to screening and be willing to continue use during the study. Medically acceptable forms of birth control include abstinence, hormonal contraceptives, diaphragm with spermicide, condom with spermicide, intrauterine device, or surgical sterilization (including vasectomy of male partner[s]).
- Eighteen (18) to 45 years of age, inclusive
- Based on medical history, limited physical examination (neurologic and cardiac) and/or lab results, are considered healthy and free of any conditions that may interfere with participation in the study. Any abnormalities at screening on results of electrocardiogram (ECG) or any laboratory test must be determined to be not clinically significant by an investigator.
- Agree to not use prescription stimulants (except for the study medication) during the study
- Have venous access sufficient for blood sampling as determined by clinical examination
- Weigh at least 100 pounds at screening
- Agree and are available to return to the study center for five full-day (approximately 18 hours) study visits held five to 30 days apart within a 22-week period, and willing to complete all protocol-specified assessments.
- Able to read and comprehend English
Who cannot join
- Marked anxiety, tension, and agitation since the drug may aggravate these symptoms
- Known hypersensitivity to methylphenidate or other components of Concerta or Ritalin
- Subjects with glaucoma
- Motor tics or with a family history or diagnosis of Tourette's syndrome
- Treated with monoamine oxidase inhibitors (MAOIs) or within 14 days of discontinuation of treatment with MAOIs
- Presence or history of any medically diagnosed, clinically significant Axis I psychiatric disorder (including substance use disorders, bipolar disorder, any psychotic disorder)
Show all 31Show fewer
- 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)
- Any clinically significant chronic disease or unstable medical abnormality by history or physical examination, including hypertension, 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:
- Values > 20% above the upper range of the laboratory standard of a basic metabolic screen and complete blood count
- Exclusionary blood pressure > 140 (systolic) and 90 (diastolic).
- Exclusionary ECG parameters: QTC > 460 msec, QRS > 120 msec, and PR > 200 msec. Subjects having ECG evidence of ischemia or arrhythmia as reviewed by an independent cardiologist
- 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
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
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
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.
Read the detailed description
The main goal 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. To this end, the investigators will compare repeated administration of orally administered, therapeutic doses of a short (IR-MPH) and a long-acting formulation of MPH (OROS-MPH) in the following areas:
- pharmacokinetic profile of MPH assessing rate of onset of MPH action (indexed through change in plasma level) and
- abuse liability (indexed through detection and likeability).
The investigators will test all combinations of initial administration and then delayed (repeated) administration of the two formulations: IR-MPH to IR-MPH; IR-MPH to OROS-MPH; OROS-MPH to IR-MPH; OROS-MPH to OROS-MPH, and placebo to placebo.
- Conditions
- Healthy
- Being tested
- OROS-Methylphenidate, Immediate Release Methylphenidate, Placebo
- Keywords
- healthy volunteers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OROS-MethylphenidateDrug
Also called Concerta, OROS MPH
Each dose of OROS MPH will be 72 mg which will be supplied as two 36 mg overencapsulated capsules
Immediate Release MethylphenidateDrug
Also called IR MPH, Ritalin
Each dose of IR MPH will be 40 mg which will be supplied as two 20 mg overencapsulated capsules
PlaceboDrug
Placebo will be administered during the first part of the day, and again during the second part of the day.
| Study group | Role | What they receive |
|---|---|---|
| OROS-MPH + OROS-MPH | Experimental | OROS-Methylphenidate Will be administered during the first part of the day, and again during the separate part of the day. Receives: Drug: OROS-Methylphenidate |
| IR MPH + IR MPH | Experimental | Immediate release methylphenidate will be administered in the first part of the day followed by Immediate release methylphenidate in the second part of the day. Receives: Drug: Immediate Release Methylphenidate |
| Plabebo + Placebo | Placebo comparator | Placebo will be administered during the first part of the day, and again during the second part of the day. Receives: Drug: Placebo |
| OROS MPH+ IR MPH | Experimental | Concerta will be administered in the first part of the day, followed by Immediate Release Methylphenidate in the second part of the day. Receives: Drug: OROS-Methylphenidate; Drug: Immediate Release Methylphenidate |
| IR MPH + OROS MPH | Experimental | Immediate release Methylphenidate will be administered in the first part of the day, followed by Concerta in the second part of the day Receives: Drug: OROS-Methylphenidate; Drug: Immediate Release Methylphenidate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak Plasma Concentration of d-Methylphenidate
Objective measure determined from blood samples, measured 4 hours after the dose
Measured: 4 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2006 (estimated)
- Study startJan 2006
- Primary completionJun 2007
- Study completionJun 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Ortho-McNeil Janssen Scientific Affairs, LLC
- Responsible party
- Principal investigator, Thomas J. Spencer, MD, Massachusetts General Hospital
- Investigators
- Thomas Spencer, MD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00302458
- Sponsor's protocol ID
- 2005-P-001812
- Status last verified
- Feb 2016
- First submitted
- 13 Mar 2006
- Last updated
- 29 Feb 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Spencer TJ, Biederman J, Martin JM, Moorehead TM, Mirto T, Clarke A, Batchelder H, Faraone SV. Importance of pharmacokinetic profile and timing of coadministration of short- and long-acting formulations of methylphenidate on patterns of subjective responses and abuse potential. Postgrad Med. 2012 Jan;124(1):166-73. doi: 10.3810/pgm.2012.01.2529.
PubMed 22314126
Study at a glance
From the registry record, last updated by the sponsor on 29 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00302458
- Acronym / sponsor ID
- 2005-P-001812
- Conditions
- Healthy
- Keywords
- healthy volunteers
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- Ortho-McNeil Janssen Scientific Affairs, LLC
- Study start
- Jan 2006
- Primary completion
- Jun 2007 (actual)
- Study completion
- Jun 2007 (actual)
- First posted
- 14 Mar 2006 (estimated)
- Results
- Posted 7 Jan 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The main goal 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. To this end, the investigators will compare repeated administration of orally administered, therapeutic doses of a short (IR-MPH) and a long-acting formulation of MPH (OROS-MPH) in the following areas:
- pharmacokinetic profile of MPH assessing rate of onset of MPH action (indexed through change in plasma level) and
- abuse liability (indexed through detection and likeability).
The investigators will test all combinations of initial administration and then delayed (repeated) administration of the two formulations: IR-MPH to IR-MPH; IR-MPH to OROS-MPH; OROS-MPH to IR-MPH; OROS-MPH to OROS-MPH, and placebo to placebo.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| OROS-MPH + OROS-MPH | Experimental | Drug: OROS-MethylphenidateOROS-Methylphenidate Will be administered during the first part of the day, and again during the separate part of the day. |
| IR MPH + IR MPH | Experimental | Drug: Immediate Release MethylphenidateImmediate release methylphenidate will be administered in the first part of the day followed by Immediate release methylphenidate in the second part of the day. |
| Plabebo + Placebo | Placebo comparator | Drug: PlaceboPlacebo will be administered during the first part of the day, and again during the second part of the day. |
| OROS MPH+ IR MPH | Experimental | Drug: OROS-Methylphenidate, Drug: Immediate Release MethylphenidateConcerta will be administered in the first part of the day, followed by Immediate Release Methylphenidate in the second part of the day. |
| IR MPH + OROS MPH | Experimental | Drug: OROS-Methylphenidate, Drug: Immediate Release MethylphenidateImmediate release Methylphenidate will be administered in the first part of the day, followed by Concerta in the second part of the day |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Males or non-pregnant, non-lactating females. With the exception of women who have been post-menopausal for a minimum of 12 months prior to screening and those who have undergone hysterectomy or bilateral oophorectomy, all female subjects must have a negative urine pregnancy test at both screening and at each admission to the research unit. All male and female subjects must have used a medically acceptable form of birth control for at least one month prior to screening and be willing to continue use during the study. Medically acceptable forms of birth control include abstinence, hormonal contraceptives, diaphragm with spermicide, condom with spermicide, intrauterine device, or surgical sterilization (including vasectomy of male partner[s]).
- Eighteen (18) to 45 years of age, inclusive
- Based on medical history, limited physical examination (neurologic and cardiac) and/or lab results, are considered healthy and free of any conditions that may interfere with participation in the study. Any abnormalities at screening on results of electrocardiogram (ECG) or any laboratory test must be determined to be not clinically significant by an investigator.
- Agree to not use prescription stimulants (except for the study medication) during the study
- Have venous access sufficient for blood sampling as determined by clinical examination
Key exclusion criteria (31 listed)
- Marked anxiety, tension, and agitation since the drug may aggravate these symptoms
- Known hypersensitivity to methylphenidate or other components of Concerta or Ritalin
- Subjects with glaucoma
- Motor tics or with a family history or diagnosis of Tourette's syndrome
- Treated with monoamine oxidase inhibitors (MAOIs) or within 14 days of discontinuation of treatment with MAOIs
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OROS-MethylphenidateAlso: Concerta, OROS MPHEach dose of OROS MPH will be 72 mg which will be supplied as two 36 mg overencapsulated capsules | Drug | IR MPH + OROS MPH, OROS MPH+ IR MPH, OROS-MPH + OROS-MPH |
| Immediate Release MethylphenidateAlso: IR MPH, RitalinEach dose of IR MPH will be 40 mg which will be supplied as two 20 mg overencapsulated capsules | Drug | IR MPH + IR MPH, IR MPH + OROS MPH, OROS MPH+ IR MPH |
| PlaceboPlacebo will be administered during the first part of the day, and again during the second part of the day. | Drug | Plabebo + Placebo |
Primary outcome
Peak Plasma Concentration of d-Methylphenidate
Time frame: 4 hours
Objective measure determined from blood samples, measured 4 hours after the dose
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Feb 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 22314126Spencer TJ, Biederman J, Martin JM, Moorehead TM, Mirto T, Clarke A, Batchelder H, Faraone SV. Importance of pharmacokinetic profile and timing of coadministration of short- and long-acting formulations of methylphenidate on patterns of subjective responses and abuse potential. Postgrad Med. 2012 Jan;124(1):166-73. doi: 10.3810/pgm.2012.01.2529.
Related trials for Healthy
Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomas Spencer, MD principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing OROS-Methylphenidate and Immediate Release Methylphenidate in people with Healthy, run by Massachusetts General Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 31 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 Jan 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Peak Plasma Concentration of d-Methylphenidate (time frame: 4 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00302458, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Feb 2016.