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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: Recruiting Phase 2 study of Chronic Pain, sponsored by University of Rochester.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Amygdala volume will be measured using T1w MPRAGE structural images. The mean change in amygdala volume will be the volume of amygdala before administering the drug or placebo minus the volume of amygdala after administering the drug or placebo.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Methylphenidate
- DRUG carbidopa-levodopa
Study Locations (1)
New York
- University of Rochester Medical Center - Rochester
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2024-01-31 |
| Est. Completion | 2026-01-22 |
| Phase | Phase 2 |
What NCT05285683 shows while recruiting
NCT05285683 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 10 participants, a relatively small participant target, below the 772-participant average among 301 other Chronic Pain trials with a reported enrollment target (99% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
Similar trials for Chronic Pain
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05285683's enrollment target sits among peer trials
10 292nd of 301 higher than 4 of 301 other Chronic Pain trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Chronic Pain trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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