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

Rambam Health Care Campus

Status and phase: Completed; Phase 2

Conditions: Pharmacological Action (PA)

Treatments: Drug: methylphenidate hydrochloride; Drug: Sugar pill (placebo)

Study type: Interventional

Funder types: Other

Identifiers

NCT01914822

Ritalin version 5 (Other Identifier)

275-13-RMB

Details and patient eligibility

About

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.

Enrollment: 41 patients

Sex: Male

Ages: 20 to 40 years old

Volunteers: Accepts 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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41 participants in 2 patient groups, including a placebo group

methylphenidate hydrochloride

Experimental group

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.

Treatment:

Drug: methylphenidate hydrochloride

Sugar pill

Placebo Comparator group

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.

Treatment:

Drug: Sugar pill (placebo)