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

NCT01914822 | Completed Phase 2

• 2 other identifiers: 275-13-RMBRitalin version 5
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

Brief Summary

1. 1.To examine whether Ritalin has analgesic properties in healthy subjects.
2. 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.

Conditions

Pharmacological Action (PA)

Keywords

Ritalin; methylphenidate hydrochloride; experimental pain

Outcome Measures

Primary Outcomes (1)

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

  4 hours

Secondary Outcomes (2)

• 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

Study Arms (2)

methylphenidate hydrochloride

EXPERIMENTAL

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

Sugar pill

PLACEBO COMPARATOR

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)

Interventions

methylphenidate hydrochloride DRUG

methylphenidate hydrochloride

Sugar pill (placebo) DRUG

Sugar pill

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Rambam Health Care Campus: lead

Study Sites (1)

Rambam Healthcare Campus

Haifa, 31096, Israel

Location

MeSH Terms

Interventions

Methylphenidate; Sugars

Intervention Hierarchy (Ancestors)

Phenylacetates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Carbohydrates

Study Officials

• Elon Eisenberg, MD

  Rambam Helthcare Campus, Haifa, Israel 31096

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Pain research Unit

Study Record Dates

• First Submitted: July 31, 2013
• First Posted: August 2, 2013
• Study Start: July 1, 2013
• Primary Completion: September 1, 2014
• Study Completion: September 1, 2014
• Last Updated: September 12, 2017

Record last verified: 2017-09

Locations

IL (1)