RECRUITING

The Role of Brain Dopamine in Chronic Pain

Conditions

Chronic Pain dopamine loss of motivation chronic back pain

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

The Role of Dopamine in the Central Neural Signature of Chronic Pain

Quick Facts

Study Start:2024-01-31

Study Completion:2026-01-22

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05285683

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. 18 years old or older 2. Equal numbers of men and women, as well as racial and ethnic makeup representative of surrounding area 3. Able to speak, read, and understand English 4. In generally stable health 5. Sign informed consent document 1. Patients must report chronic pain for more than 1 year. 2. The reported pain should be rated at ≥ 40/100	1. Significant other medical disease, such as unstable diabetes mellitus, congestive heart failure, coronary or peripheral vascular disease, chronic obstructive lung disease, or malignancy 2. History of traumatic brain injury (TBI) 3. Current misuse/dependence on substance(s), including alcohol, at the time of study enrollment 4. Major psychiatric disorder during the past 6 months 5. Significantly abnormal laboratory values, which include, but are not limited to, the following: 1. White blood cell (WBC) \< 1.5 or \>15.0 x 10\^3/μL 2. Hemoglobin (Hgb) \< 8 gm/dL 3. Hematocrit (Hct) \< 24% or \> 50% 4. Platelets (Plts) \<50 or \> 1000 x10\^3 5. Creatine \> 2 mg/dL 6. Glucose \> 125 mg/dL 7. Aspartate aminotransferase (AST) \> 250 U/L 8. Alanine Transaminase (ALT) \> 250 U/L 9. Bilirubin \> 3 mg/dL 6. Intra-axial implants (e.g. - spinal cord stimulators or pumps) 7. Inability to adequately perform the finger-span visual tracking task (training for rotating pain perception, see Brain Imaging Details). 8. All MRI exclusionary criteria: any metallic implants, brain or skull abnormalities, tattoos on large body parts, pregnancy, and claustrophobia. 9. In the judgement of the investigator, unable or unwilling to follow the protocol and instructions. 10. Gambling addiction self-reported during screening process (ensure computer-based games do not cause psychological or emotional problems) 11. Chronic pain patients with past history of allergic reactions to methylphenidate or levodopa/carbidopa. 1. Pain that is associated with any systemic signs or symptoms (e.g. - fever, chills) 2. Evidence of rheumatoid arthritis, ankylosing spondylitis, acute vertebral fractures, fibromyalgia, history of tumor(s) in the back. 3. Involvement in litigation regarding their pain, or having a disability claim, or receiving workman's compensation, or seeking either because of their pain. 4. Treated with methadone for opioid use disorder (i.e. - not just for pain)

Inclusion Criteria

Exclusion Criteria

1. 18 years old or older
2. Equal numbers of men and women, as well as racial and ethnic makeup representative of surrounding area
3. Able to speak, read, and understand English
4. In generally stable health
5. Sign informed consent document
1. Patients must report chronic pain for more than 1 year.
2. The reported pain should be rated at ≥ 40/100

1. Significant other medical disease, such as unstable diabetes mellitus, congestive heart failure, coronary or peripheral vascular disease, chronic obstructive lung disease, or malignancy
2. History of traumatic brain injury (TBI)
3. Current misuse/dependence on substance(s), including alcohol, at the time of study enrollment
4. Major psychiatric disorder during the past 6 months
5. Significantly abnormal laboratory values, which include, but are not limited to, the following:
1. White blood cell (WBC) \< 1.5 or \>15.0 x 10\^3/μL
2. Hemoglobin (Hgb) \< 8 gm/dL
3. Hematocrit (Hct) \< 24% or \> 50%
4. Platelets (Plts) \<50 or \> 1000 x10\^3
5. Creatine \> 2 mg/dL
6. Glucose \> 125 mg/dL
7. Aspartate aminotransferase (AST) \> 250 U/L
8. Alanine Transaminase (ALT) \> 250 U/L
9. Bilirubin \> 3 mg/dL
6. Intra-axial implants (e.g. - spinal cord stimulators or pumps)
7. Inability to adequately perform the finger-span visual tracking task (training for rotating pain perception, see Brain Imaging Details).
8. All MRI exclusionary criteria: any metallic implants, brain or skull abnormalities, tattoos on large body parts, pregnancy, and claustrophobia.
9. In the judgement of the investigator, unable or unwilling to follow the protocol and instructions.
10. Gambling addiction self-reported during screening process (ensure computer-based games do not cause psychological or emotional problems)
11. Chronic pain patients with past history of allergic reactions to methylphenidate or levodopa/carbidopa.
1. Pain that is associated with any systemic signs or symptoms (e.g. - fever, chills)
2. Evidence of rheumatoid arthritis, ankylosing spondylitis, acute vertebral fractures, fibromyalgia, history of tumor(s) in the back.
3. Involvement in litigation regarding their pain, or having a disability claim, or receiving workman's compensation, or seeking either because of their pain.
4. Treated with methadone for opioid use disorder (i.e. - not just for pain)

Contacts and Locations

Study Contact

Pain Lab

CONTACT

585-275-4424

painlab@urmc.rochester.edu

Study Locations (Sites)

University of Rochester Medical Center

Rochester, New York, 14642

United States

Collaborators and Investigators

Sponsor: University of Rochester

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-01-31

Study Completion Date2026-01-22

Study Record Updates

Study Start Date2024-01-31

Study Completion Date2026-01-22

Terms related to this study

Keywords Provided by Researchers

dopamine
loss of motivation
chronic back pain

Additional Relevant MeSH Terms

Chronic Pain