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Central Nervous System Stimulant

Methylphenidate for Pain

Phase 2

Recruiting

Led By Andrew D Vigotsky, MS

Research Sponsored by Northwestern University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months

Awards & highlights

Study Summary

This trial will investigate how dopamine affects the disconnect between pain caused by a stimulus and the pain felt, with the aim of understanding chronic pain better.

Who is the study for?

This trial is for individuals experiencing acute pain but not chronic pain. Participants should have no history of neurological or psychiatric diagnoses and must not be pregnant.Check my eligibility

What is being tested?

The study investigates how the brain responds to changes in painful stimuli by comparing Methylphenidate, a stimulant medication, with a placebo (a substance with no active drug).See study design

What are the potential side effects?

Methylphenidate may cause side effects like nervousness, trouble sleeping, loss of appetite, weight loss, dizziness, nausea, and possibly increased heart rate.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Effect of methylphenidate on acute pain dynamics

Nucleus accumbens activation with acute pain dynamics

Side effects data

From 2020 Phase 4 trial • 267 Patients • NCT02039908

51%

Appetite Loss

40%

Insomnia

33%

Irritability

29%

Picking at skin, nailbiting

21%

Worried/Anxious

21%

Dull, tired, listless

19%

Tearful, depressed

18%

Stomachache

13%

Headache

13%

Motor Tics

12%

Buccal-lingual movements

10%

Social Withdrawal

Hospitalized

100%

80%

60%

40%

20%

Study treatment Arm

Phase 1-Medication First

Phase 1 - Placebo First

Phase 2 - 7-Day Dosing

Phase 2 - 5-Day Dosing

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: MethylphenidateExperimental Treatment1 Intervention

Group II: PlaceboPlacebo Group1 Intervention

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Methylphenidate

2014

Completed Phase 4

~431850

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Northwestern UniversityLead Sponsor

1,585 Previous Clinical Trials

917,201 Total Patients Enrolled

46 Trials studying Pain

3,730 Patients Enrolled for Pain

National Institute of Neurological Disorders and Stroke (NINDS)NIH

1,339 Previous Clinical Trials

649,360 Total Patients Enrolled

17 Trials studying Pain

3,585 Patients Enrolled for Pain

Andrew D Vigotsky, MSPrincipal InvestigatorNorthwestern University

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this medical experiment accept enrollees aged 45 and up?

"This clinical study is in search of participants that are over 18 years old and below 65."

Answered by AI

Who meets the specified criteria to participate in this clinical experiment?

"To qualify for this research project, applicants must experience pain and be between 18 to 65 years of age. The team is aiming to recruit around 30 participants in total."

Answered by AI

Has the Federal Drug Administration approved Methylphenidate for use?

"Our team at Power assigned Methylphenidate a safety score of 2, as this is a Phase 2 trial and while there are some data points attesting to its safety, none have yet been collected which support its efficacy."

Answered by AI

Is recruitment for this trial still open?

"Clinicaltrials.gov records assert that this medical investigation is in search of participants, with the original post being made on September 19th 2022 and updated most recently on December 30th 2022."

Answered by AI

How many individuals are being studied as part of this medical investigation?

"Affirmative, the info hosted on clinicaltrials.gov shows that this medical study is actively looking for subjects to join. This trial was first published on September 19th 2022 and has been latest revised at December 30th of the same year. The researchers are aiming to enrol a total of thirty individuals across one location."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Neural Correlates of Acute Pain Dynamics

Andrew Vigotsky 2022. "Neural Correlates of Acute Pain Dynamics". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05669924.

All > Acute Pain