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Low Dose Naltrexone Therapy for Complex Regional Pain Syndrome

Study acronym: LDN-CRPS
StatusEnrolling by Invitation
PhasePhase 4
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated June 18, 2026 (before its estimated August 2026 completion). Its status may not reflect the trial's current state.

Record History

See every version on ClinicalTrials.gov ↗

  1. Minor Eligibility criteria revisedv8
  2. Minor Re-verified, no change to tracked fieldsv7
  3. Minor Start date changed from estimate of Oct 2024 to Jan 2, 2024v6
  4. Minor Trial status: Recruiting to Enrolling by Invitation
    • Site details revised
    v5
  5. Notable Start date: Aug 2024 to Oct 2024v4
Show 2 earlier versionsHide 2 earlier versions
  1. Notable Start date: Jun 2024 to Aug 2024v3
  2. Notable Trial status: Not Yet Recruiting to Recruitingv2 Show 4 more changesShow less
    • Start date: Apr 2024 to Jun 2024
    • Primary completion date: Jul 2026 to Aug 2026
    • Study completion date: Oct 2026 to Nov 2026
    • Site details revised
  1. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06306157
Lead Sponsor Hospital for Special Surgery, New York
Conditions
(from sponsor)
Complex Regional Pain Syndrome, Chronic Pain, Causalgia, Complex Regional Pain Syndrome Type I, Complex Regional Pain Syndrome Type II
Related terms Agnosia, Causalgia, Chronic Pain, Complex Regional Pain Syndromes
Enrollment 40 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov