Neuroimaging Study on the Effect of Transdermal Buprenorphine in Complex Regional Pain Syndrome Patients

NCT ID: NCT03977012

Last Updated: 2023-04-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-06-11

Study Completion Date

2024-05-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

In the present study, we aim to investigate the effect of buprenorphine on neuroinflammation in patients with complex regional pain syndrome, using \[11C\]-(R)-PK11195 PET.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Complex Regional Pain Syndromes

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Patients with CRPS Type I

Patients diagnosed with Complex Regional Pain Syndrome Type I who are anticipated to recieve a 8 weeks regime of buprenorphine as a part of routine medical care.

-drug name: norspan patch 5\~20 mcg dosage form: patch frequency: every weeks duration: 8 weeks

Buprenorphine

Intervention Type DRUG

5\~20 mcg

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Buprenorphine

5\~20 mcg

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

norspan patch

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. Patients diagnosed with complex regional pain syndrome Type I (Budapest Criteria) and persistent back pain (VAS ≥ 4).
2. Patients who can stop benzodiazepine treatment 2 weeks before study
3. Patients who initially decided to use buprenorphine according to clinical judgment
4. Patients who are able to understand the purpose and procedure of the study

Exclusion Criteria

1. Patients with an impaired cognitive function such as psychosis, dementia, or mental retardation
2. Patients with neurologic disease, cerebrovascular disease, history of brain tumor, history of severe head trauma, history of convulsive disease
3. Patients with cardiovascular disease, liver, respiratory or renal dysfunction
4. Patients with biliary disease
5. Patients who could not undergo the PET/magnetic resonance imaging (MRI) process.
6. Patients who have a risk of suicide or show aggressive behavior
7. Patients who have drug dependence (DSM-IV criteria) or history (past 6 months or older)
8. Employees of researchers or clinical research institutes
9. Patients with hypersensitivity or contraindication to buprenorphine
Minimum Eligible Age

20 Years

Maximum Eligible Age

64 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Seoul National University Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Soo-Hee Choi

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Seoul National University Hospital

Seoul, Jongno-gu, South Korea

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

South Korea

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Soo-Hee Choi, MD,PhD

Role: CONTACT

+82 2-2072-2302

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Soo-Hee Choi, MD,PhD

Role: primary

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

NOR17-KR-IIT

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

18F-AV-1451 PET Imaging in TBI
NCT02512029 WITHDRAWN PHASE1
Xyrem and Brain Dopamine in Narcolepsy
NCT02637076 COMPLETED PHASE4