Actively Recruiting
The Role of Dopamine in the Brain's Response to Chronic Pain A Randomized Study of Carbidopa/Levodopa and Methylphenidate Effects
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
Researchers are investigating how dopamine affects the brain's response to chronic pain, focusing on key brain areas like the amygdala, hippocampus, thalamus, and nucleus accumbens. This Phase 2 study aims to understand changes in dopamine activity in the limbic system of people with chronic pain, which may influence motivation and pain experience. The study uses brain imaging to measure brain activity and volume changes related to dopamine modulation. Participants with chronic pain will attend four visits involving brain scans. The first visit serves as a baseline without any medication. During the next three visits, participants will receive one of three treatments in randomized order: carbidopa-levodopa, methylphenidate, or a placebo. After taking each oral medication or placebo, participants will wait three hours before completing brain scans and motivation tests. The study is double-blind, so neither patients nor researchers know which treatment is given at each visit. Throughout the study, participants will complete questionnaires about pain, mood, anxiety, trauma, and motivation. Their pain levels will be assessed before and after drug administration using scales like the Visual Analogue Scale (VAS). Brain imaging will measure changes in activity and volume of specific brain areas from baseline to three hours post-treatment. The study also monitors safety and side effects. Total participation includes these four visits with brain scans and assessments.
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
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
3
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here