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

September 11, 2017 updated by: Eisenberg Elon MD, Rambam Health Care Campus

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

  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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

41

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Haifa, Israel, 31096
        • Rambam Healthcare Campus

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 40 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: DOUBLE

Arms and Interventions

Participant Group / 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)

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rambam Health Care Campus

Investigators

  • Principal Investigator: Elon Eisenberg, MD, Rambam Helthcare Campus, Haifa, Israel 31096

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2013

Primary Completion (ACTUAL)

September 1, 2014

Study Completion (ACTUAL)

September 1, 2014

Study Registration Dates

First Submitted

July 31, 2013

First Submitted That Met QC Criteria

August 1, 2013

First Posted (ESTIMATE)

August 2, 2013

Study Record Updates

Last Update Posted (ACTUAL)

September 12, 2017

Last Update Submitted That Met QC Criteria

September 11, 2017

Last Verified

September 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 275-13-RMB
  • Ritalin version 5 (OTHER: Rambam Healthcare Campus)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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