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

Primary Purpose

Pharmacological Action (PA)

Status
Completed
Phase
Phase 2
Locations
Israel
Study Type
Interventional
Intervention
methylphenidate hydrochloride
Sugar pill (placebo)
Sponsored by
Rambam Health Care Campus
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pharmacological Action (PA) focused on measuring Ritalin, methylphenidate hydrochloride, experimental pain

Eligibility Criteria

20 Years - 40 Years (Adult)MaleAccepts Healthy Volunteers

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

Sites / Locations

  • Rambam Healthcare Campus

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

methylphenidate hydrochloride

Sugar pill

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

effect of Ritalin on auditory sensitivity, measured by the response to different auditory stimulations
pain intensity (NPS 0-100) in response to thermal stimuli and the measures of the auditory tests.

Full Information

First Posted
July 31, 2013
Last Updated
September 11, 2017
Sponsor
Rambam Health Care Campus
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1. Study Identification

Unique Protocol Identification Number
NCT01914822
Brief Title
The Effect Methylphenidate Hydrochloride on Pain and Auditory Sensitivity in Healthy Subjects
Official Title
The Effect of Ritalin (Methylphenidate Hydrochloride) on Pain and Auditory Sensitivity: an Exploratory Double-blind Randomized Controlled Trial on Healthy Subjects
Study Type
Interventional

2. Study Status

Record Verification Date
September 2017
Overall Recruitment Status
Completed
Study Start Date
July 2013 (undefined)
Primary Completion Date
September 2014 (Actual)
Study Completion Date
September 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rambam Health Care Campus

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pharmacological Action (PA)
Keywords
Ritalin, methylphenidate hydrochloride, experimental pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
41 (Actual)

8. Arms, Groups, and Interventions

Arm Title
methylphenidate hydrochloride
Arm Type
Experimental
Arm Description
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.
Arm Title
Sugar pill
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
methylphenidate hydrochloride
Intervention Type
Drug
Intervention Name(s)
Sugar pill (placebo)
Primary Outcome Measure Information:
Title
Experimental pain intensity measured on a visual analogue scale (0-100)
Time Frame
4 hours
Secondary Outcome Measure Information:
Title
effect of Ritalin on auditory sensitivity, measured by the response to different auditory stimulations
Time Frame
4 hours
Title
pain intensity (NPS 0-100) in response to thermal stimuli and the measures of the auditory tests.
Time Frame
4 hours

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elon Eisenberg, MD
Organizational Affiliation
Rambam Helthcare Campus, Haifa, Israel 31096
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rambam Healthcare Campus
City
Haifa
ZIP/Postal Code
31096
Country
Israel

12. IPD Sharing Statement

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

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