Using low-dose naltrexone to relieve pain in complex regional pain syndrome
Low-Dose Naltrexone for the Treatment of Complex Regional Pain Syndrome
This study is testing if low-dose naltrexone can help people with complex regional pain syndrome feel less pain.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Stanford University Academic / other |
| Locations | 1 site (Palo Alto, California) |
| Trial ID | NCT02502162 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Palo Alto, California
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.