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The Role of Brain Dopamine in Chronic Pain

StatusRecruiting
PhasePhase 2
Started
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Record History

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  1. Primary completion date: Dec 22, 2025 to Dec 22, 2027
    • Study completion date: Jan 22, 2026 to Dec 22, 2027
    v7
  2. Primary completion date: Dec 22, 2024 to Dec 22, 2025v6 Show 4 more changesShow less
    • Study completion date: Jan 22, 2025 to Jan 22, 2026
    • Start date: Feb 2, 2024 to Jan 31, 2024
    • Eligibility criteria revised
    • Study description shortened, about 26 words
  3. Primary completion date: Apr 30, 2024 to Dec 22, 2024
    • Start date: Jan 1, 2023 to Feb 2, 2024
    • Study completion date: Apr 30, 2024 to Jan 22, 2025
    v5
  4. Start date changed from estimate of Oct 1, 2022 to Jan 1, 2023v4
  5. Trial status: Not Yet Recruiting to Recruiting
    • Start date: May 1, 2022 to Oct 1, 2022
    • Site details revised
    v3
  6. Start date: Mar 15, 2022 to May 1, 2022
    • Primary and study completion dates: Mar 14, 2024 to Apr 30, 2024
    v2
  7. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05285683
Lead Sponsor University of Rochester
Conditions
(from sponsor)		 Chronic Pain
Related terms Chronic Pain
Enrollment 10 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov