Investigating how dopamine affects chronic pain

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to explore the role of dopamine in chronic pain by examining how dopaminergic transmission is altered in the limbic brain of chronic pain patients. Participants will undergo four visits, including baseline and randomized treatment sessions with methylphenidate, carbidopa-levodopa, and placebo. Each visit will involve brain imaging and assessments of pain, mood, and anxiety. The study seeks to understand the relationship between dopamine modulation and chronic pain experiences.

Why it matters

Who can join: the full rules

Inclusion Criteria:

The following inclusion criteria must be met for all subjects to be considered eligible to participate:

1. 18 years old or older
2. Equal numbers of men and women, as well as racial and ethnic makeup representative of surrounding area
3. Able to speak, read, and understand English
4. In generally stable health
5. Sign informed consent document

The following inclusion criteria must be met for chronic pain patients to be considered eligible to participate:

1. Patients must report chronic pain for more than 1 year.
2. The reported pain should be rated at ≥ 40/100

Exclusion Criteria:

General exclusion criteria for all subjects include:

1. Significant other medical disease, such as unstable diabetes mellitus, congestive heart failure, coronary or peripheral vascular disease, chronic obstructive lung disease, or malignancy
2. History of traumatic brain injury (TBI)
3. Current misuse/dependence on substance(s), including alcohol, at the time of study enrollment
4. Major psychiatric disorder during the past 6 months
5. Significantly abnormal laboratory values, which include, but are not limited to, the following:

   1. White blood cell (WBC) \< 1.5 or \>15.0 x 10\^3/μL
   2. Hemoglobin (Hgb) \< 8 gm/dL
   3. Hematocrit (Hct) \< 24% or \> 50%
   4. Platelets (Plts) \<50 or \> 1000 x10\^3
   5. Creatine \> 2 mg/dL
   6. Glucose \> 125 mg/dL
   7. Aspartate aminotransferase (AST) \> 250 U/L
   8. Alanine Transaminase (ALT) \> 250 U/L
   9. Bilirubin \> 3 mg/dL
6. Intra-axial implants (e.g. - spinal cord stimulators or pumps)
7. Inability to adequately perform the finger-span visual tracking task (training for rotating pain perception, see Brain Imaging Details).
8. All MRI exclusionary criteria: any metallic implants, brain or skull abnormalities, tattoos on large body parts, pregnancy, and claustrophobia.
9. In the judgement of the investigator, unable or unwilling to follow the protocol and instructions.
10. Gambling addiction self-reported during screening process (ensure computer-based games do not cause psychological or emotional problems)
11. Chronic pain patients with past history of allergic reactions to methylphenidate or levodopa/carbidopa.

For healthy control subjects, current complaint(s) of pain, or a history of pain lasting \>4 weeks in the last year, will be excluded from participating.

In addition, exclusion criteria for chronic pain subjects also includes:

1. Pain that is associated with any systemic signs or symptoms (e.g. - fever, chills)
2. Evidence of rheumatoid arthritis, ankylosing spondylitis, acute vertebral fractures, fibromyalgia, history of tumor(s) in the back.
3. Involvement in litigation regarding their pain, or having a disability claim, or receiving workman's compensation, or seeking either because of their pain.
4. Treated with methadone for opioid use disorder (i.e. - not just for pain)

Where it's running

• University of Rochester Medical Center
  Rochester, New York, United States Recruiting

Study contacts

• Study coordinator: Pain Lab
• Email: painlab@urmc.rochester.edu
• Phone: 585-275-4424

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.