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Pharmacological Action (PA) | The Effect Methylphenidate Hydrochloride on Pain and Auditory Sensitivity in Healthy Subjects

Pharmacological Action (PA) research study

What is the primary objective of this study?

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.

Who is eligible to participate?

Inclusion Criteria: - 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 Exclusion Criteria: - 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

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Pharmacological Action (PA)

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Drug:methylphenidate hydrochloride

Drug:Sugar pill (placebo)

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

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 pillThe 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.

Study Status

Completed

Start Date: July 2013

Completed Date: September 2014

Phase: Phase 2

Type: Interventional

Design:

Primary Outcome: Experimental pain intensity measured on a visual analogue scale (0-100)

Secondary Outcome: effect of Ritalin on auditory sensitivity, measured by the response to different auditory stimulations

Study sponsors, principal investigator, and references

Principal Investigator: Elon Eisenberg, MD

Lead Sponsor: Rambam Health Care Campus

Collaborator:

More information:https://clinicaltrials.gov/show/NCT01914822

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