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This study is currently on hold.
Low-Dose Naltrexone (LDN) for the Treatment of Complex Regional Pain Syndrome (CRPS) is currently enrolling participants.
LDN for the Treatment of CRPS is a philanthropically funded study designed to test if LDN can reduce some or all of the signs and symptoms of CRPS/RSD.
Study procedures and treatment are at no cost and you may be compensated for participation.
Principle Investigator: Sean Mackey, MD, PhD
Project Leader: Maria Adelus, MPH
Sponsor: Reflex Sympathetic Dystrophy Syndrome Association (RSDSA)
Naltrexone has been a FDA-approved drug for nearly three decades. There is significant evidence to suggest that at low doses it can effectively treat certain types of pain, fatigue, and sleep disorders. This will be the first official study of the effectiveness of LDN for CRPS. All participants will be given the opportunity to receive LDN treatment at no cost.
The duration of the study lasts 14 to 28 weeks and involves eight in-person visits to Stanford, in addition to weekly questionnaires and daily pain scores which can be done remotely.
Eligibility requirements include any person with CRPS or RSD who:
- 1. Is between the ages of 18 and 65.
- 2. Is not pregnant or planning to become pregnant.
- 3. Has had CRPS for at least 1 year.
- 4. Has upper and/or lower extremity CRPS.
- 5. Has been on stable treatment for 1 month.
- 6. Is not using opioid analgesics or narcotics for up to 1 month prior to enrollment and throughout participation in the study.
- 7. Does not have any known allergy to naltrexone or naloxone.
For questions regarding participant’s rights, contact 1-866-680-2906