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NCT05285683 · ClinicalTrials.gov registry record · Phase 2

The Role of Brain Dopamine in Chronic Pain

A Phase 2 study of Chronic Pain, sponsored by University of Rochester.

Recruiting
Registry status
Phase 2
Development phase
10
Enrollment target
1
Study location

NCT05285683 is a Phase 2 study of Chronic Pain that is actively recruiting participants, run by University of Rochester. The registered enrollment target is 10 participants, below the 772-participant average among 301 other Chronic Pain trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT05285683, a Phase 2 study of Chronic Pain, is actively recruiting participants, sponsored by University of Rochester.

RECRUITING
Registry status
Phase 2
Development phase
10 participants
Enrollment target
1
Study location

Study Summary

Chronic pain is associated with plasticity in the brain limbic system composed mainly of the amygdala, hippocampus, ventral striatum, and cingulate cortex (ACC) /medial prefrontal cortex (mPFC). These brain areas, especially the ventral striatum, receive dopaminergic input from the ventral-tegmental area (VTA). Although there is a significant literature now showing that limbic brain tracks chronic pain intensity and predicts the risk of transition from sub-acute to chronic pain, the role of dopaminergic input to the limbic brain and the change thereof which occurs in chronic pain, is still not clear. Given the role of dopamine in motivational control and the loss of motivation associated with chronic pain understanding how dopaminergic transmission is altered in the limbic brain of chronic pain patients is critical to the understanding of the pathophysiology of chronic pain. Therefore, the overall aim of this project is to use brain imaging to study how dopaminergic transmission through the oral administration of pro-dopaminergic medications carbidopa/levodopa (CD/LD) and methylphenidate will modulate the brain signature of chronic pain. Chronic pain subjects will be scanned at baseline (no drug administration) and three times after treatment with the two drugs or placebo. The protocol will follow a randomized double-blind approach.

Conditions Studied

Interventions

  • DRUG Placebo
  • DRUG Methylphenidate
  • DRUG carbidopa-levodopa

Study Locations (1)

New York

  • University of Rochester Medical Center - Rochester

Trial Details

FieldValue
Enrollment Target 10 participants
Start Date 2024-01-31
Est. Completion 2026-01-22
Phase Phase 2

Sponsor

University of Rochester

636 total trials

What the Registry Record Tells You About NCT05285683

The ClinicalTrials.gov registry entry for NCT05285683 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 10 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 772-participant average among 301 other Chronic Pain trials with a reported enrollment target (99% lower). The listed sponsor is University of Rochester, which has 636 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Chronic Pain appearing as the primary indexed condition, and to 3 interventions - of which Placebo is the first listed.

NCT05285683 reports 1 study location spanning 1 distinct geographic area - top geographies include New York.

Frequently Asked Questions

What is clinical trial NCT05285683 about?

NCT05285683 is a clinical study titled "The Role of Brain Dopamine in Chronic Pain". Chronic pain is associated with plasticity in the brain limbic system composed mainly of the amygdala, hippocampus, ventral striatum, and cingulate cortex (ACC) /medial prefrontal cortex (mPFC). These brain areas, especially the ventral striatum, receive dopaminergic input from the ventral-tegmental...

What is the current status of trial NCT05285683?

This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 10 participants. The study started on 2024-01-31. Estimated completion is 2026-01-22.

What conditions does trial NCT05285683 study?

This clinical trial studies the following conditions: Chronic Pain.

What interventions are being tested in trial NCT05285683?

The interventions under investigation include: Placebo (DRUG), Methylphenidate (DRUG), carbidopa-levodopa (DRUG).

Who is sponsoring clinical trial NCT05285683?

This trial is sponsored by University of Rochester, which has 636 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05285683 being conducted?

This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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