Clinical Trials Logo
  1. Home
  2. Complex Regional Pain Syndrome
  3. NCT02502162
  4. Details
NCT02502162 Clinical Trial

Low-Dose Naltrexone for the Treatment of Complex Regional Pain Syndrome

Complex Regional Pain Syndrome Clinical Trial

— LDN-CRPS  

Official title:
Low-Dose Naltrexone for the Treatment of Complex Regional Pain Syndrome

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT02502162
Other study ID # 33607
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date June 2015
Est. completion date June 2025

Study information
Verified date November 2023
Source Stanford University
Contact Birute Gedrimaite
Phone (650) 497-0485
Email birute@stanford.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The investigators are testing treatment with low-dose naltrexone (LDN) for symptom relief of complex regional pain syndrome (CRPS). Study participants will be randomly assigned to receive either LDN or placebo for a period of several weeks. During this period participants will be asked to attend either in-person or virtual study visits and complete questionnaires.

Recruitment information / eligibility
Status Recruiting
Enrollment 120
Est. completion date June 2025
Est. primary completion date June 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years to 70 Years
Eligibility Inclusion Criteria: - Upper and/or lower extremity CRPS - On stable treatment for 1 month - CRPS for at least 1 year - Meet the Budapest criteria for CRPS at time of the study. Exclusion Criteria: - Any known allergy to naltrexone or naloxone - Use of prescription opioid analgesics or illegal opioid use - Current or planned pregnancy.

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• LDN

• Placebo
Sugar pill

Locations
Country Name City State
United States Stanford University Palo Alto California

Sponsors (1)
Lead Sponsor Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Changes in pain severity Daily pain reports on a 0-10 numerical rating scale for pain, where 0=no pain and 10=pain as bad as you can imagine Approximately 4 weeks after conclusion of treatment.
See also
  Status Clinical Trial Phase
Recruiting NCT02753335 - A Comparison of Two Treatments for CRPS and Changes in Resting-State Connectivity of Cerebral Networks. N/A
Recruiting NCT01134289 - Analysis of Photoplethysmographic Signal in Lumbar Sympathetic Block Phase 3
Completed NCT00579085 - Double Blind Placebo Controlled Study of Outpatient Intravenous Ketamine for the Treatment of CRPS Phase 2
Completed NCT02837822 - Effects of Spinal Cord Stimulation on Sensory Perceptions of Chronic Pain Patients N/A
Completed NCT02070367 - Somatosensory Assessment and Rehabilitation of Allodynia (SARA) N/A
Completed NCT00462566 - The Efficacy of Motor Cortex Stimulation for Pain Control N/A
Active, not recruiting NCT03228160 - Light Irradiation and Outcome for Neuropathic Pain N/A
Terminated NCT02094352 - Randomized Controlled Trial of Ketamine Infusion With Continuous Epidural Infusion for Treatment of Complex Regional Pain Syndrome Phase 2
Recruiting NCT06306157 - Low Dose Naltrexone Therapy for Complex Regional Pain Syndrome Phase 4
Recruiting NCT06393101 - The Effects and Mechanisms of a High CBD Cannabis Extract (BRC-002) for the Treatment of Pain and Health in Complex Regional Pain Syndrome Phase 1
Completed NCT03990649 - Study of TAK-935 as an Adjunctive Therapy in Adult Participants With Complex Regional Pain Syndrome (CRPS) Phase 2
Recruiting NCT03616262 - "Efficacy of Botulinum Toxin Injection in Reducing Limb Pain in Patients With Complex Regional Pain Syndrome" Early Phase 1
Active, not recruiting NCT02504008 - CREATE-1: A Study to Assess the Efficacy and Safety of AXS-02 in Patients With CRPS-1 Phase 3
Completed NCT03879538 - Nitrous Oxide for the Treatment of Complex Regional Pain Syndrome Phase 3
Terminated NCT03794024 - Comparison of Dorsal Column Stimulation to Dorsal Root Ganglion Stimulation for Complex Regional Pain Syndrome
Terminated NCT00780390 - Autonomic Dysfunction and Spinal Cord Stimulation in Complex Regional Pain Syndrome N/A
Completed NCT00904202 - A Study Of Lidocaine Patch 5% Alone, Gabapentin Alone, And Lidocaine Patch 5% And Gabapentin In Combination For The Relief Of Pain In Patients With Diverse Peripheral Neuropathic Pain Conditions Phase 4
Recruiting NCT05197959 - Treatment of Complex Regional Pain Syndrome N/A
Completed NCT02753101 - [18F]FTC-146 PET/MRI in Healthy Volunteers and in CRPS and Sciatica Early Phase 1
Withdrawn NCT00414804 - Spinal Cord Stimulation Versus Nerve Blocks and Physical Therapy N/A

External Links