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

Pharmacological Action (PA) Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01914822
• Other study ID #: 275-13-RMB
• Secondary ID: Ritalin version
• Status: Completed
• Phase: Phase 2
• First received: July 31, 2013
• Last updated: September 11, 2017
• Start date: July 2013
• Est. completion date: September 2014

Study information

• Verified date: September 2017
• Source: Rambam Health Care Campus
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: September 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 20 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Pharmacological Action (PA)

Intervention

Drug:
• methylphenidate hydrochloride

• Sugar pill (placebo)

Locations

Country	Name	City	State
Israel	Rambam Healthcare Campus	Haifa

Sponsors (1)

Lead Sponsor	Collaborator
Rambam Health Care Campus

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Experimental pain intensity measured on a visual analogue scale (0-100)		4 hours
Secondary	effect of Ritalin on auditory sensitivity, measured by the response to different auditory stimulations		4 hours
Secondary	pain intensity (NPS 0-100) in response to thermal stimuli and the measures of the auditory tests.		4 hours