Low-Dose Naltrexone for the Treatment of Complex Regional Pain Syndrome

Not Applicable

Recruiting

• Conditions: Complex Regional Pain Syndrome
• Interventions: Drug: LDN; Drug: Placebo

• Registration Number: NCT02502162
• Lead Sponsor: Stanford University

Brief Summary

The investigators are testing treatment with low-dose naltrexone (LDN) for symptom relief of complex regional pain syndrome (CRPS). Study participants will be randomly assigned to receive either LDN or placebo for a period of several weeks. During this period participants will be asked to attend either in-person or virtual study visits and complete questionnaires.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-06
• Study First Submitted: 2015-07-15
• Study First Submitted QC: 2015-07-16
• Study First Posted: 2015-07-20
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-26
• Last Update Posted: 2024-12-02
• Primary Completion: 2025-06
• Study Completion: 2025-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

• Upper and/or lower extremity CRPS
• On stable treatment for 1 month
• CRPS for at least 1 year
• Meet the Budapest criteria for CRPS at time of the study.

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Exclusion Criteria

• Any known allergy to naltrexone or naloxone
• Use of prescription opioid analgesics or illegal opioid use
• Current or planned pregnancy.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
LDN	LDN	Naltrexone HCL, 4.5 mg, Once a day.
Placebo	Placebo	Sugar pill

Primary Outcome Measures

Name	Time	Method
Changes in pain severity	Approximately 4 weeks after conclusion of treatment.	Daily pain reports on a 0-10 numerical rating scale for pain, where 0=no pain and 10=pain as bad as you can imagine

Trial Locations

Locations (1)

Stanford University; 🇺🇸 Palo Alto, California, United States