Actively Recruiting
The Role of Brain Dopamine in Chronic Pain
Led by University of Rochester · Updated on 2025-01-15
10
Participants Needed
1
Research Sites
103 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
The Role of Brain Dopamine in Chronic Pain
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 18 years old or older
- Equal numbers of men and women, with racial and ethnic makeup representative of the surrounding area
- Able to speak, read, and understand English
- Generally in stable health
- Signed informed consent
- Experience chronic pain for more than 1 year
- Pain rated at 40 or higher on a 0-100 scale
You will not qualify if you...
- Significant medical diseases such as unstable diabetes, heart failure, vascular disease, lung disease, or cancer
- History of traumatic brain injury
- Current misuse or dependence on substances including alcohol
- Major psychiatric disorder within the past 6 months
- Abnormal laboratory values including low or high white blood cell count, low hemoglobin or hematocrit, abnormal platelets, high creatine, glucose, liver enzymes, or bilirubin
- Presence of intra-axial implants like spinal cord stimulators or pumps
- Inability to perform required finger-span visual tracking task
- MRI contraindications including metallic implants, brain or skull abnormalities, large tattoos, pregnancy, or claustrophobia
- Unable or unwilling to follow study protocol
- Self-reported gambling addiction
- Allergic reactions to methylphenidate or levodopa/carbidopa
- For healthy controls: current pain complaints or pain history longer than 4 weeks in the last year
- For chronic pain patients: pain with systemic symptoms, certain rheumatologic or spinal conditions, involvement in litigation or disability claims related to pain, or treatment with methadone for opioid use disorder
AI-Screening
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Trial Site Locations
Total: 1 location
1
University of Rochester Medical Center
Rochester, New York, United States, 14642
Actively Recruiting
Research Team
P
Pain Lab
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
3
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