← Back to Search

Other

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
Must not have
For healthy control subjects, current complaint(s) of pain, or a history of pain lasting >4 weeks in the last year
Inability to adequately perform the finger-span visual tracking task
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to 3 hours
Awards & highlights
Approved for 10 Other Conditions
All Individual Drugs Already Approved

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.
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.
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 below
Select...
I have been experiencing chronic pain for over a year.
Select...
My pain level is at least 40 out of 100.
Select...
I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have been experiencing pain for more than 4 weeks in the past year.
Select...
I struggle with tasks that require following movements with my eyes.
Select...
I have had a traumatic brain injury in the past.
Select...
I have a history of specific back issues or tumors.
Select...
I am taking methadone for opioid addiction, not just for pain.
Select...
I do not have major health issues like unstable diabetes, heart failure, or severe lung disease.
Select...
I have chronic pain and am allergic to methylphenidate or levodopa/carbidopa.
Select...
I have pain that comes with fever or chills.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to 3 hours
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to 3 hours for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
mean change in Nucleus Accumbens activity
mean change in Nucleus accumbens volume
mean change in amygdala activity
+5 more
Secondary study objectives
Effort Expenditure for Reward Task (EEfRT)

Awards & Highlights

Approved for 10 Other Conditions
This treatment demonstrated efficacy for 10 other conditions.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

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
870 Previous Clinical Trials
549,778 Total Patients Enrolled
4 Trials studying Chronic Pain
77 Patients Enrolled for Chronic Pain

Media Library

Carbidopa-Levodopa (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05285683 — Phase 2
Chronic Pain Research Study Groups: Methylphenidate, Carbidopa/levodopa,, Placebo
Chronic Pain Clinical Trial 2023: Carbidopa-Levodopa Highlights & Side Effects. Trial Name: NCT05285683 — Phase 2
Carbidopa-Levodopa (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05285683 — Phase 2
~0 spots leftby Dec 2024
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top