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New treatment option for Chronic Pain
Official title The Role of Brain Dopamine in Chronic Pain
ClinicalTrials.gov ID: NCT05285683
What this study is testing
What is Methylphenidate?
Methylphenidate is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for chronic pain.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- The following must be met for all people 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
You likely can't join if
- General exclusion criteria for all people include:
- Significant other medical disease, such as unstable diabetes mellitus, congestive heart failure, coronary or peripheral vascular disease, chronic...
- 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:
See the full eligibility criteria
- The following must be met for all people 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 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
- General exclusion criteria for all people 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) \ 15.0 x 10\^3/μL
- Hemoglobin (Hgb) \< 8 gm/dL
- Hematocrit (Hct) \ 50%
- Platelets (Plts) \ 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 people, current complaint(s) of pain, or a history of pain lasting \>4 weeks in the last year...
- 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)
The study team makes the final eligibility decision.
Where it's taking place
- Rochester, New York, United States
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Rochester, New York, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.