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Low Dose Naltrexone for Complex Regional Pain Syndrome

This study is looking into whether a low dose of naltrexone can help reduce the pain symptoms of Complex Regional Pain Syndrome (CRPS). Naltrexone is a medication already approved for treating alcohol or opioid addiction, but at much higher doses. In this study, we're exploring if a very small dose (low dose naltrexone or LDN) can help with CRPS pain, even though it's not currently approved for this use. You might be able to join if you are 18-85 years old, have CRPS diagnosed by specific criteria, and experience severe pain that affects your daily life for over three months. The study aims to see how many people enroll, are assigned to a treatment, and receive the study medication.

Study design
This study plans to enroll 40 participants. It will compare low dose naltrexone with a placebo (sugar capsules that look the same).
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The study will track participants receiving medication at the start and at 3 months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06306157

Low Dose Naltrexone Therapy for Complex Regional Pain Syndrome

Enrolling by Invitation
PHASE4Ages 18–85InterventionalTreatment
Hospital for Special Surgery, New York
~40 participants
Updated 2026-06-18 on ClinicalTrials.gov
What's tested:Low dose naltrexonePlacebo sugar capsules

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of study patients enrolled
Measured over Within 2 years of study start
+2 more outcomes measured

Conditions

Complex Regional Pain Syndrome
Chronic Pain
Causalgia
Complex Regional Pain Syndrome Type I
Complex Regional Pain Syndrome Type II

Explore related trials

Complex Regional Pain Syndrome

Where it's being run

1 sites across 1 states
New York1

Study leadership

  • Semih Gungor, M.D. · PRINCIPAL_INVESTIGATOR · Hospital for Special Surgery, New York
  • Alexandra Sideris, PhD · PRINCIPAL_INVESTIGATOR · Hospital for Special Surgery, New York

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Number of study patients enrolledWithin 2 years of study start

    Enrollment of 40 patients within two years is the target (i.e. enrollment of 1-2 patients a month). If 1-2 patients a month is not being met within first 6 months, an invitation to other chronic pain co-investigators with high volume CRPS will be considered. Because this is a feasibility study, determining whether 40 patients can be enrolled with the current inclusion and exclusion criteria within a specified time frame is an essential step in ensuring such a long-term outpatient study can be conducted.

  • Number of study patients randomizedAt initial time of enrollment

    Measured as completed or not. Quadruple blinded randomization of each study patient to one of the two treatment arms after enrollment and before medication dispensation will be deemed successful. Because this is a feasibility study, determining whether 40 patients can be blindly randomized to a group according to the protocol is an essential step in ensuring such a long-term drug study can be conducted.

  • Number of study patients who received the study medicationAt initial time of enrollment and at 3 months.

    Dispensation of medication to all enrolled study patients at point of enrollment and at 3 months will be considered successful. If deemed necessary, dispensation can occur at time points other than the two previously defined and will still be considered successful if patient receives medication on time. Because this is a feasibility study implementing a long-term interventional drug treatment, it is essential that the investigators are measuring whether medication dispensation is occurring on time and according to the protocol.