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

R

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

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)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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