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Trial record 52 of 441 for:    Methylphenidate

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

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ClinicalTrials.gov Identifier: NCT01914822
Recruitment Status : Completed
First Posted : August 2, 2013
Last Update Posted : September 12, 2017
Sponsor:
Information provided by (Responsible Party):
Eisenberg Elon MD, Rambam Health Care Campus

Brief 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.

Condition or disease Intervention/treatment Phase
Pharmacological Action (PA) Drug: methylphenidate hydrochloride Drug: Sugar pill (placebo) Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 41 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: The Effect of Ritalin (Methylphenidate Hydrochloride) on Pain and Auditory Sensitivity: an Exploratory Double-blind Randomized Controlled Trial on Healthy Subjects
Study Start Date : July 2013
Actual Primary Completion Date : September 2014
Actual Study Completion Date : September 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Allergy

Arm Intervention/treatment
Experimental: methylphenidate hydrochloride
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
Placebo Comparator: Sugar pill
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)



Primary Outcome Measures :
  1. Experimental pain intensity measured on a visual analogue scale (0-100) [ Time Frame: 4 hours ]

Secondary Outcome Measures :
  1. effect of Ritalin on auditory sensitivity, measured by the response to different auditory stimulations [ Time Frame: 4 hours ]
  2. pain intensity (NPS 0-100) in response to thermal stimuli and the measures of the auditory tests. [ Time Frame: 4 hours ]


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01914822


Locations
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Israel
Rambam Healthcare Campus
Haifa, Israel, 31096
Sponsors and Collaborators
Rambam Health Care Campus
Investigators
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Principal Investigator: Elon Eisenberg, MD Rambam Helthcare Campus, Haifa, Israel 31096

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Responsible Party: Eisenberg Elon MD, Director, Pain research Unit, Rambam Health Care Campus
ClinicalTrials.gov Identifier: NCT01914822     History of Changes
Other Study ID Numbers: 275-13-RMB
Ritalin version 5 ( Other Identifier: Rambam Healthcare Campus )
First Posted: August 2, 2013    Key Record Dates
Last Update Posted: September 12, 2017
Last Verified: September 2017
Keywords provided by Eisenberg Elon MD, Rambam Health Care Campus:
Ritalin
methylphenidate hydrochloride
experimental pain
Additional relevant MeSH terms:
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Methylphenidate
Hypersensitivity
Immune System Diseases
Central Nervous System Stimulants
Physiological Effects of Drugs
Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Dopamine Agents
Neurotransmitter Agents