The Role of Brain Dopamine in Chronic Pain

Part of paid clinical trials in Rochester, New York.

Sponsor
University of Rochester
Study ID
NCT05285683
Phase
PHASE2
Status
Recruiting
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Conditions

  • Chronic Pain

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Methylphenidate — DRUG
    0.5 mg/kg
  • carbidopa-levodopa — DRUG
    25 mg/100 mg
  • Placebo — DRUG
    oral pill

Study Details

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.

Key Dates

Start date
Jan 31, 2024
Status verified
May 2026
Primary completion
Dec 22, 2027
Completion
Dec 22, 2027

Study Design

Enrollment
10 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Active Comparator: Methylphenidate
    0.5mg/kg
  • Active Comparator: Carbidopa/levodopa,
    25mg/100mg
  • Placebo Comparator: Placebo
    Oral Pill

Primary Outcome Measure

mean change in amygdala volume [ Time Frame: baseline to 3 hours ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Rochester Medical CenterRochesterNew York14642-

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By research site
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