Using low-dose naltrexone to relieve pain in complex regional pain syndrome
Official title: Low-Dose Naltrexone for the Treatment of Complex Regional Pain Syndrome
Run by Stanford University · NCT02502162 · Data updated 2026-11-12
This study is testing if low-dose naltrexone can help people with complex regional pain syndrome feel less pain.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 70 Years |
| Sex | All |
| Enrollment | 120 (estimated) |
| Sponsor | Stanford University Academic / other |
| Locations | 1 site (Palo Alto, California) |
| Status | Recruiting |
| Started | June 2015 |
| Main results expected | July 2027 |
| Study ends | July 2027 |
| Registry record updated | May 29, 2025 |
| Trial ID | NCT02502162 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are individuals diagnosed with upper and/or lower extremity CRPS who have been stable on treatment for at least one month and have had CRPS for a minimum of one year.
✕Probably not a fit
Patients with known allergies to naltrexone or naloxone, those using prescription opioids, or those who are currently pregnant may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study investigates the effectiveness of low-dose naltrexone (LDN) in alleviating symptoms of complex regional pain syndrome (CRPS). Participants will be randomly assigned to receive either LDN or a placebo over several weeks. They will attend in-person or virtual visits and complete questionnaires to assess their symptoms and overall well-being. The goal is to determine if LDN can provide significant pain relief for individuals suffering from CRPS.
Why it matters
Potential benefit: If successful, this treatment could offer a new, effective option for managing pain in patients with complex regional pain syndrome.
How similar studies have gone: While the use of low-dose naltrexone is gaining interest, this specific application for CRPS is relatively novel and has not been extensively tested in prior studies.
Who can join: the full rules
Show full inclusion / exclusion criteria
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.
Where it's running
-
Stanford University
Palo Alto, California, United States Recruiting
Study contacts
- Principal investigator: Sean Mackey, MD, PhD — Stanford University
- Study coordinator: Birute Gedrimaite
- Email: birute@stanford.edu
- Phone: (650) 497-0485
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Non-invasive brain stimulation to see if it changes pain avoidance in CRPS
This study tests whether a gentle brain stimulation method called tACS can change how people with complex regional pain syndrome avoid activities that might worsen their pain.
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.