The Effect Methylphenidate Hydrochloride on Pain and Auditory Sensitivity in Healthy Subjects

Study Overview
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Brief Summary
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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.

Official Title
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The Effect of Ritalin (Methylphenidate Hydrochloride) on Pain and Auditory Sensitivity: an Exploratory Double-blind Randomized Controlled Trial on Healthy Subjects

Conditions
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Pharmacological Action (PA)

Intervention / Treatment
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* Drug: methylphenidate hydrochloride
* Drug: Sugar pill (placebo)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: methylphenidate hydrochloride<br>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. | Drug: methylphenidate hydrochloride<br> <br> |
| Placebo Comparator: Sugar pill<br>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. | Drug: Sugar pill (placebo)<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Experimental pain intensity measured on a visual analogue scale (0-100) |  | 4 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| effect of Ritalin on auditory sensitivity, measured by the response to different auditory stimulations |  | 4 hours | 
| pain intensity (NPS 0-100) in response to thermal stimuli and the measures of the auditory tests. |  | 4 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ritalin, methylphenidate hydrochloride, experimental pain