Pharmacological Action (PA)Phase 2NCT01914822
The Effect Methylphenidate Hydrochloride on Pain and Auditory Sensitivity in Healthy Subjects
A Phase 2 study testing methylphenidate hydrochloride in people with Pharmacological Action (PA), run by Rambam Health Care Campus at 1 site in Israel.
Trial summary
1. To examine whether Ritalin has analgesic properties in healthy subjects. 2. To examine if Ritalin analgesic effect is a pain specific phenomenon or a part of a broader, non-specific effect on high mental functions. Read more about this study
- Who is it for?
- Ages 20 to 40 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Pharmacological Action (PA)
- What is being tested?
- methylphenidate hydrochloride
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 41 participants
- Where
- 1 siteIsrael
- Study dates
- Jul 2013to Sep 2014
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 20 to 40 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male subjects between the ages of 20 to 40
- Healthy subjects without known disease and without any chronic pain
- Subjects without known cognitive problems, which can understand the research and its goals
- Subjects who are not taking any medications
- Subjects without hearing problems
- Subjects without attention deficit disorder (ADHD) problems
Who cannot join
- Subjects who are known to suffer from any disease or any chronic pain
- Subjects taking psychotropic drugs (except Ritalin) or any analgesics
- Subjects who have any contradictions for ritalin administration
- subjects with suspected cognitive disability
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Ritalin (Methylphenidate Hydrochloride) on Pain and Auditory Sensitivity: an Exploratory Double-blind Randomized Controlled Trial on Healthy Subjects
- To examine whether Ritalin has analgesic properties in healthy subjects.
- To examine if Ritalin analgesic effect is a pain specific phenomenon or a part of a broader, non-specific effect on high mental functions.
- Conditions
- Pharmacological Action (PA)
- Being tested
- methylphenidate hydrochloride, Sugar pill (placebo)
- Keywords
- Ritalin, methylphenidate hydrochloride, experimental pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
methylphenidate hydrochlorideDrug
Sugar pill (placebo)Drug
| Study group | Role | What they receive |
|---|---|---|
| methylphenidate hydrochloride | Experimental | The study will include two sessions which will be conducted at the same time of the day, one week apart from each other. Each session will last approximately 6 hours. In each session subjects will be exposed to baseline experimental pain models and auditory tests. Then they will receive either one MP SR 20 mg tablet or an identical looking placebo. Receives: Drug: methylphenidate hydrochloride |
| Sugar pill | Placebo comparator | The study will include two sessions which will be conducted at the same time of the day, one week apart from each other. Each session will last approximately 6 hours. In each session subjects will be exposed to baseline experimental pain models and auditory tests. Then they will receive either one MP SR 20 mg tablet or an identical looking placebo. Receives: Drug: Sugar pill (placebo) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Experimental pain intensity measured on a visual analogue scale (0-100)
Measured: 4 hours
Secondary outcomes (2)
effect of Ritalin on auditory sensitivity, measured by the response to different auditory stimulations
Measured: 4 hours
pain intensity (NPS 0-100) in response to thermal stimuli and the measures of the auditory tests.
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 posted2 Aug 2013 (estimated)
- Study startJul 2013
- Primary completionSep 2014
- Study completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pharmacological Action (PA)Studies of the same condition, open and under way.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rambam Health Care Campus
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eisenberg Elon MD, Rambam Health Care Campus
- Investigators
- Elon Eisenberg, MD, Principal investigator, Rambam Helthcare Campus, Haifa, Israel 31096
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01914822
- Sponsor's protocol ID
- 275-13-RMB
- Other IDs
- Ritalin version 5
- Status last verified
- Sep 2017
- First submitted
- 31 Jul 2013
- Last updated
- 12 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Ritalin (Methylphenidate Hydrochloride) on Pain and Auditory Sensitivity: an Exploratory Double-blind Randomized Controlled Trial on Healthy Subjects
- ClinicalTrials.gov ID
- NCT01914822
- Acronym / sponsor ID
- 275-13-RMB
- Conditions
- Pharmacological Action (PA)
- Keywords
- Ritalin, methylphenidate hydrochloride, experimental pain
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Rambam Health Care CampusUniversity, hospital or other
- Study start
- Jul 2013
- Primary completion
- Sep 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 2 Aug 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- To examine whether Ritalin has analgesic properties in healthy subjects.
- To examine if Ritalin analgesic effect is a pain specific phenomenon or a part of a broader, non-specific effect on high mental functions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| methylphenidate hydrochloride | Experimental | Drug: methylphenidate hydrochlorideThe study will include two sessions which will be conducted at the same time of the day, one week apart from each other. Each session will last approximately 6 hours. In each session subjects will be exposed to baseline experimental pain models and auditory tests. Then they will receive either one MP SR 20 mg tablet or an identical looking placebo. |
| Sugar pill | Placebo comparator | Drug: Sugar pill (placebo)The study will include two sessions which will be conducted at the same time of the day, one week apart from each other. Each session will last approximately 6 hours. In each session subjects will be exposed to baseline experimental pain models and auditory tests. Then they will receive either one MP SR 20 mg tablet or an identical looking placebo. |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Male subjects between the ages of 20 to 40
- Healthy subjects without known disease and without any chronic pain
- Subjects without known cognitive problems, which can understand the research and its goals
- Subjects who are not taking any medications
- Subjects without hearing problems
Key exclusion criteria (4 listed)
- Subjects who are known to suffer from any disease or any chronic pain
- Subjects taking psychotropic drugs (except Ritalin) or any analgesics
- Subjects who have any contradictions for ritalin administration
- subjects with suspected cognitive disability
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 |
|---|---|---|
| methylphenidate hydrochloride | Drug | methylphenidate hydrochloride |
| Sugar pill (placebo) | Drug | Sugar pill |
Primary outcome
Experimental pain intensity measured on a visual analogue scale (0-100)
Time frame: 4 hours
2 secondary outcomes
effect of Ritalin on auditory sensitivity, measured by the response to different auditory stimulations
Time frame: 4 hours
pain intensity (NPS 0-100) in response to thermal stimuli and the measures of the auditory tests.
Time frame: 4 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Sep 2017.
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.
Elon Eisenberg, MD principal investigator
Rambam Helthcare Campus, Haifa, Israel 31096
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing methylphenidate hydrochloride in people with Pharmacological Action (PA), run by Rambam Health Care Campus at 1 site in Israel.
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 6 inclusion and 4 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 12 Sep 2017. 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 Israel. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Experimental pain intensity measured on a visual analogue scale (0-100) (time frame: 4 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Sep 2017.