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Pro-Dopaminergic Drugs for Chronic Pain
Phase 2
Recruiting
Research Sponsored by University of Rochester
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Chronic pain patients must report chronic pain for more than 1 year
Chronic pain patients must have reported pain rated at ≥ 40/100
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to 3 hours
Awards & highlights
Study Summary
This trial is studying how giving patients with chronic pain pro-dopaminergic drugs affects their brain signature.
Who is the study for?
Adults over 18, in stable health, who have experienced chronic pain for more than a year and rate their pain at least 40/100. Participants must speak English and represent the local demographic diversity. Excluded are those with certain implants, major psychiatric disorders or abnormal lab values, severe medical conditions, substance misuse or gambling addiction, specific allergic reactions to trial drugs, involvement in pain-related litigation or claims.Check my eligibility
What is being tested?
The study tests how brain dopamine affects chronic pain by using imaging to observe changes after taking pro-dopaminergic medications (carbidopa-levodopa and methylphenidate) versus placebo. It's randomized and double-blind: participants won't know if they're getting real meds or a dummy pill.See study design
What are the potential side effects?
Potential side effects of carbidopa-levodopa include nausea, dizziness, headache; while methylphenidate may cause insomnia, increased heart rate/blood pressure, appetite loss. Placebo typically has no active ingredients but can lead to perceived side effects due to expectation.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been experiencing chronic pain for over a year.
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My pain level is at least 40 out of 100.
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I am 18 years old or older.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline to 3 hours
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to 3 hours
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
mean change in Nucleus Accumbens activity
mean change in Nucleus accumbens volume
mean change in amygdala activity
+5 moreSecondary outcome measures
Effort Expenditure for Reward Task (EEfRT)
Trial Design
3Treatment groups
Active Control
Placebo Group
Group I: MethylphenidateActive Control1 Intervention
0.5mg/kg
Group II: Carbidopa/levodopa,Active Control1 Intervention
25mg/100mg
Group III: PlaceboPlacebo Group1 Intervention
Oral Pill
Find a Location
Who is running the clinical trial?
University of RochesterLead Sponsor
840 Previous Clinical Trials
534,240 Total Patients Enrolled
4 Trials studying Chronic Pain
77 Patients Enrolled for Chronic Pain
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You are involved in a lawsuit related to your pain, have filed for disability, are receiving workman's compensation, or are seeking any of these because of your pain.I represent the gender and racial/ethnic diversity of my area.I have been experiencing pain for more than 4 weeks in the past year.I struggle with tasks that require following movements with my eyes.I have been experiencing chronic pain for over a year.I have had a traumatic brain injury in the past.I have a history of specific back issues or tumors.Your blood test results are significantly outside the normal range for white blood cells, hemoglobin, hematocrit, platelets, creatinine, glucose, AST, ALT, or bilirubin.My pain level is at least 40 out of 100.I am taking methadone for opioid addiction, not just for pain.You have implants inside your body, such as spinal cord stimulators or pumps.I do not have major health issues like unstable diabetes, heart failure, or severe lung disease.You have had a serious mental illness in the past 6 months.I am 18 years old or older.You are currently struggling with addiction to alcohol or other substances.I have chronic pain and am allergic to methylphenidate or levodopa/carbidopa.You have reported having a gambling addiction during the screening process.I have pain that comes with fever or chills.You have metal implants, brain or skull issues, large tattoos, are pregnant, or have a fear of small spaces that would prevent you from having an MRI.
Research Study Groups:
This trial has the following groups:- Group 1: Methylphenidate
- Group 2: Carbidopa/levodopa,
- Group 3: Placebo
Awards:
This trial has 2 awards, including:- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- Approved for 10 Other Conditions - This treatment demonstrated efficacy for 10 other conditions.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has Methylphenidate been granted regulatory clearance by the FDA?
"Methylphenidate was given a score of 2 due to the limited data available regarding its efficacy, though there is some evidence which suggests it is safe."
Answered by AI
Is the enrollment process for this trial currently available?
"Affirmative. Clinicaltrials.gov reveals that recruitment for this medical trial is current, with the first posting on October 1st 2022 and most recent update occurring September 6th 2022. The research team requires 10 patients to be recruited from a single site."
Answered by AI
How many individuals are receiving the treatment as part of this clinical trial?
"Affirmative. According to clinicaltrials.gov, the medical trial which went live on October 1st 2022 is currently open for enrollment. The data indicates that 10 patients will be accepted from a single location."
Answered by AI
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