Status:
RECRUITING
The Role of Brain Dopamine in Chronic Pain
Lead Sponsor:
University of Rochester
Conditions:
Chronic Pain
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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...
Detailed Description
The proposed study is a single center study investigating the effect of dopamine modulation on the brain signature of chronic pain. The patients will undergo 4 scanning visits (baseline, placebo, LD/C...
Eligibility Criteria
Inclusion
- The following inclusion criteria must be met for all subjects to be considered eligible to participate:
- 18 years old or older
- Equal numbers of men and women, as well as racial and ethnic makeup representative of surrounding area
- Able to speak, read, and understand English
- In generally stable health
- Sign informed consent document
- The following inclusion criteria must be met for chronic pain patients to be considered eligible to participate:
- Patients must report chronic pain for more than 1 year.
- The reported pain should be rated at ≥ 40/100
Exclusion
- General exclusion criteria for all subjects include:
- Significant other medical disease, such as unstable diabetes mellitus, congestive heart failure, coronary or peripheral vascular disease, chronic obstructive lung disease, or malignancy
- History of traumatic brain injury (TBI)
- Current misuse/dependence on substance(s), including alcohol, at the time of study enrollment
- Major psychiatric disorder during the past 6 months
- Significantly abnormal laboratory values, which include, but are not limited to, the following:
- White blood cell (WBC) \< 1.5 or \>15.0 x 10\^3/μL
- Hemoglobin (Hgb) \< 8 gm/dL
- Hematocrit (Hct) \< 24% or \> 50%
- Platelets (Plts) \<50 or \> 1000 x10\^3
- Creatine \> 2 mg/dL
- Glucose \> 125 mg/dL
- Aspartate aminotransferase (AST) \> 250 U/L
- Alanine Transaminase (ALT) \> 250 U/L
- Bilirubin \> 3 mg/dL
- Intra-axial implants (e.g. - spinal cord stimulators or pumps)
- Inability to adequately perform the finger-span visual tracking task (training for rotating pain perception, see Brain Imaging Details).
- All MRI exclusionary criteria: any metallic implants, brain or skull abnormalities, tattoos on large body parts, pregnancy, and claustrophobia.
- In the judgement of the investigator, unable or unwilling to follow the protocol and instructions.
- Gambling addiction self-reported during screening process (ensure computer-based games do not cause psychological or emotional problems)
- 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:
- Pain that is associated with any systemic signs or symptoms (e.g. - fever, chills)
- Evidence of rheumatoid arthritis, ankylosing spondylitis, acute vertebral fractures, fibromyalgia, history of tumor(s) in the back.
- Involvement in litigation regarding their pain, or having a disability claim, or receiving workman's compensation, or seeking either because of their pain.
- Treated with methadone for opioid use disorder (i.e. - not just for pain)
Key Trial Info
Start Date :
January 31 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 22 2026
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT05285683
Start Date
January 31 2024
End Date
January 22 2026
Last Update
January 15 2025
Active Locations (1)
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1
University of Rochester Medical Center
Rochester, New York, United States, 14642