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

Phase 2

Completed

• Conditions: Pharmacological Action (PA)
• Interventions: Drug: Sugar pill (placebo); Drug: methylphenidate hydrochloride

• Registration Number: NCT01914822
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-07
• Study First Submitted: 2013-07-31
• Study First Submitted QC: 2013-08-01
• Study First Posted: 2013-08-02
• Primary Completion: 2014-09
• Study Completion: 2014-09
• Status Verified: 2017-09
• Last Update Submitted: 2017-09-11
• Last Update Posted: 2017-09-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 41

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Sugar pill	Sugar pill (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.
methylphenidate hydrochloride	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.

Primary Outcome Measures

Name	Time	Method
Experimental pain intensity measured on a visual analogue scale (0-100)	4 hours

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Rambam Healthcare Campus; 🇮🇱 Haifa, Israel