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Search / Trial NCT06306157

Low Dose Naltrexone Therapy for Complex Regional Pain Syndrome

Launched by HOSPITAL FOR SPECIAL SURGERY, NEW YORK · Mar 5, 2024

Trial Information

Current as of June 26, 2025

Enrolling by invitation

Keywords

Chronic Pain Pain Management Drug Intervention Crps

ClinConnect Summary

Naltrexone, an FDA-approved medication since 1984, is classically prescribed in daily doses of at least 50 mg to mediate opiate and alcohol abuse as part of a comprehensive treatment program. By acting as an antagonist in the body, full-strength naltrexone competitively binds to opioid receptors and blocks the effects of opioid-classified drugs, thereby helping to reduce reliance and addiction. In much lower doses (1.5 - 4.5mg per day), naltrexone has been seen to reduce inflammation and nerve pain by instead blocking a different set of receptors involved in cytokine release and uptake. The...

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • Between 18 and 65 years old
  • Meeting CRPS diagnostic criteria using the Budapest Clinical Diagnostic Criteria
  • CRPS patients with severe pain (NRS\>3) that affects their daily life.
  • CRPS patients with pain and other symptoms for more than 3 months.
  • Exclusion Criteria:
  • Patients with suspected disc herniation, spinal stenosis, myelopathy, and suspected radiculopathy in detailed examinations and examinations (MRI, CT).
  • Systemic or local infection
  • Malignancy
  • Current or planned pregnancy within the study period.
  • Uncontrolled medical and psychiatric condition
  • Patients with known liver issues, including but not limited to end-stage liver disease, severe cirrhosis or an acute hepatic state.
  • Patients who are currently using opioid drugs
  • Patients who are currently using alcohol or considering using alcohol during the study period.
  • Allergy to naltrexone or naloxone

About Hospital For Special Surgery, New York

The Hospital for Special Surgery (HSS) in New York is a world-renowned institution specializing in orthopedic surgery, rheumatology, and rehabilitation. Recognized for its commitment to advancing medical research and improving patient outcomes, HSS serves as a leading clinical trial sponsor, facilitating innovative studies that explore cutting-edge treatments and therapies. With a team of expert clinicians and researchers, HSS aims to enhance clinical practices through rigorous scientific inquiry, ultimately contributing to the advancement of musculoskeletal health and patient care on a global scale.

Locations

New York, New York, United States

Patients applied

0 patients applied

Trial Officials

Semih Gungor, M.D.

Principal Investigator

Hospital for Special Surgery, New York

Alexandra Sideris, PhD

Principal Investigator

Hospital for Special Surgery, New York

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported