protocolSection identificationModule nctId: NCT06306157, orgStudyIdInfo id: 2023-0667, briefTitle: Low Dose Naltrexone Therapy for Complex Regional Pain Syndrome, acronym: LDN-CRPS, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2026-07, completionDateStruct date: 2026-10, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-03-12, sponsorCollaboratorsModule leadSponsor name: Hospital for Special Surgery, New York, class: OTHER, descriptionModule 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., conditionsModule conditions: Complex Regional Pain Syndrome, conditions: Chronic Pain, conditions: Causalgia, conditions: Complex Regional Pain Syndrome Type I, conditions: Complex Regional Pain Syndrome Type II, designModule studyType: INTERVENTIONAL, phases: PHASE4, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: This is a feasibility, randomized, placebo-controlled interventional drug study., primaryPurpose: TREATMENT, maskingInfo 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, enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule interventions name: Low dose naltrexone, interventions name: Placebo sugar capsules, outcomesModule primaryOutcomes measure: Number of study patients enrolled, primaryOutcomes measure: Number of study patients randomized, primaryOutcomes measure: Number of study patients who received the study medication, secondaryOutcomes measure: Incidence of side effects/adverse events, secondaryOutcomes measure: Average NRS pain, secondaryOutcomes measure: CRPS symptom severity, secondaryOutcomes measure: PROMIS-10 score, secondaryOutcomes measure: S-LANSS score, secondaryOutcomes measure: Blinding assessment, otherOutcomes measure: Enrollment rate, otherOutcomes measure: Study medication compliance, otherOutcomes measure: Reasons for study medication non-compliance, otherOutcomes measure: Drop-out rate, otherOutcomes measure: Reasons for drop-out, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Hospital for Special Surgery, city: New York, state: New York, zip: 10021, country: United States, contacts name: Marlena Komatz, role: CONTACT, phone: 646-714-2901, email: komatzm@hss.edu, geoPoint lat: 40.71427, lon: -74.00597, hasResults: False