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

• Sponsor: Stanford University (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT02502162
• Collaborator: (none)
• Enrollment: 40
• Location: 1
• Arms: 2
• Duration (Months): 96
• Patients Per Site Per Month: 0.4

Study Details

Study Description

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 come to several visits, which will include sensory testing, physical assessments, and questionnaires.

Condition or Disease	Intervention/Treatment	Phase
Complex Regional Pain Syndrome	Drug: LDN; Drug: Placebo	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 40 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Low-Dose Naltrexone for the Treatment of Complex Regional Pain Syndrome
• Study Start Date: Jun 1, 2015
• Anticipated Primary Completion Date: Jun 1, 2023
• Anticipated Study Completion Date: Jun 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: LDN Naltrexone HCL, 4.5 mg, Once a day.	Drug: LDN
Placebo Comparator: Placebo Sugar pill	Drug: Placebo; Sugar pill

Outcome Measures

Primary Outcome Measures

1. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Upper and/or lower extremity CRPS

• On stable treatment for 3 months

• CRPS for at least 1 year

• Meet the Budapest criteria for CRPS at time of the study.

Exclusion Criteria:

• Any known allergy to naltrexone or naloxone

• Use of prescription opioid analgesics or illegal opioid use

• Current of planned pregnancy.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Stanford University	Palo Alto	California	United States	94304

Sponsors and Collaborators

• Stanford University

Investigators

• Principal Investigator: Sean Mackey, MD, PhD, Stanford University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Sean Mackey, Redlich Professor Departments of Anesthesiology, Perioperative and Pain Medicine | Neurosciences | Neurology (by courtesy), Chief, Division of Pain Medicine, Director, Stanford Systems Neuroscience and Pain Lab (SNAPL), Stanford University, Stanford University
• ClinicalTrials.gov Identifier: NCT02502162
• Other Study ID Numbers: 33607
• First Posted: Jul 20, 2015
• Last Update Posted: Aug 17, 2022
• Last Verified: Aug 1, 2022

• Additional relevant MeSH terms: Complex Regional Pain Syndromes; Reflex Sympathetic Dystrophy; Syndrome; Somatoform Disorders

Study Results

No Results Posted as of Aug 17, 2022