Low Dose Naltrexone Therapy for Complex Regional Pain Syndrome
United States40 participantsStarted 2024-01-02
Plain-language summary
Complex Regional Pain Syndrome (CRPS) is a rare and often debilitating chronic pain condition whereby individuals may experience extreme sensitivity, discoloration, and swelling of the affected area -- along with numerous other painful symptoms. There are currently a limited number of treatment options available to those suffering with the condition, with various treatments including nerve blocks, neuropathic medications, and desensitization physical therapy modules. There is budding interesting in the role naltrexone, an opiate antagonist, may play in the pain management of CRPS when prescribed in very low doses. This study aims to collect preliminary data on pain scores, symptom severity, and side-effects in patients with Complex Regional Pain Syndrome randomized to receive low dose naltrexone or placebo capsules. Enrollment of 40 patients total will occur over two years from study start to study end. Each patient will be randomized to receive placebo capsules or active low dose naltrexone capsules, with both the patient and treating clinician blind to the randomization. Each patient will be actively enrolled in the study for six months and will take the medication daily at the instructed dose for the respective duration of time. Following the initial visit and study enrollment, the investigators are asking each patient to return for three (3) in-person follow-up office visits. These office visits will occur 1 month after the patient starts the medication, 3 months afterwards, and 6 months afterwards. The final 6-month office visit will mark the conclusion of the patient's active participation in the study.
Who can participate
Age range
18 Years – 85 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Between 18 and 85 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is testing low-dose naltrexone for CRPS, which is a Phase 4 study — meaning the drug itself is already approved for other uses, but not specifically for CRPS. What does my doctor think about the current evidence for using naltrexone off-label for my type of CRPS pain?
2The trial is 'enrolling by invitation only' — can my doctor find out whether I might be eligible to be referred or invited to participate, and who is running this study so we can make contact?
3The primary outcomes listed seem to be about tracking enrollment and whether patients actually received the medication, rather than measuring pain relief directly — so what would my doctor say about what this trial is actually trying to learn, and how that might or might not benefit me personally?
4Since low-dose naltrexone is already used off-label by some doctors for chronic pain conditions, is there any reason my doctor might consider prescribing it outside of a trial rather than waiting to see if I can get into this study?
5Given that I have CRPS, what standard or established treatments does my doctor think I should consider first, and how would joining a trial like this fit alongside or instead of those options?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of study patients enrolled
Timeframe: Within 2 years of study start
2
Number of study patients randomized
Timeframe: At initial time of enrollment
3
Number of study patients who received the study medication
Timeframe: At initial time of enrollment and at 3 months.