nctId: NCT06306157 id: 2023-0667 briefTitle: Low Dose Naltrexone Therapy for Complex Regional Pain Syndrome acronym: LDN-CRPS overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2026-07 date: 2026-10 date: 2024-03-12 date: 2024-03-12 name: Hospital for Special Surgery, New York class: OTHER briefSummary: 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. conditions: Complex Regional Pain Syndrome conditions: Chronic Pain conditions: Causalgia conditions: Complex Regional Pain Syndrome Type I conditions: Complex Regional Pain Syndrome Type II studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: This is a feasibility, randomized, placebo-controlled interventional drug study. primaryPurpose: TREATMENT masking: QUADRUPLE maskingDescription: A quadruple blinded study where the patient, research team, treating clinician, and outcomes assessor are unaware of the randomization results until after study conclusion. The research pharmacy will not be blinded and will be responsible for preparing the medication and securely handing it off to the research assistant according to the pre-approved dispensation plan. whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 40 type: ESTIMATED name: Low dose naltrexone name: Placebo sugar capsules measure: Number of study patients enrolled measure: Number of study patients randomized measure: Number of study patients who received the study medication measure: Incidence of side effects/adverse events measure: Average NRS pain measure: CRPS symptom severity measure: PROMIS-10 score measure: S-LANSS score measure: Blinding assessment measure: Enrollment rate measure: Study medication compliance measure: Reasons for study medication non-compliance measure: Drop-out rate measure: Reasons for drop-out sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Hospital for Special Surgery city: New York state: New York zip: 10021 country: United States name: Marlena Komatz role: CONTACT phone: 646-714-2901 email: komatzm@hss.edu lat: 40.71427 lon: -74.00597 hasResults: False