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

NCT ID: NCT01914822

Last Updated: 2017-09-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

41 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-07-31

Study Completion Date

2014-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Pharmacological Action (PA)

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

methylphenidate hydrochloride

Intervention Type DRUG

Sugar pill

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.

Group Type PLACEBO_COMPARATOR

Sugar pill (placebo)

Intervention Type DRUG

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

methylphenidate hydrochloride

Intervention Type DRUG

Sugar pill (placebo)

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

20 Years

Maximum Eligible Age

40 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Rambam Health Care Campus

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Eisenberg Elon MD

Director, Pain research Unit

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Elon Eisenberg, MD

Role: PRINCIPAL_INVESTIGATOR

Rambam Helthcare Campus, Haifa, Israel 31096

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Rambam Healthcare Campus

Haifa, , Israel

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Israel

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

Ritalin version 5

Identifier Type: OTHER

Identifier Source: secondary_id

275-13-RMB

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Stimulant Effects on Brain Activity
NCT02453698 COMPLETED PHASE1
Motivation and Methylphenidate
NCT03190681 COMPLETED EARLY_PHASE1
Neural Correlates of Acute Pain Dynamics
NCT05669924 COMPLETED PHASE2