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

November 15, 2023 updated by: Sean Mackey, Stanford University
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • California
      • Palo Alto, California, United States, 94304
        • Recruiting
        • Stanford University
        • Contact:
        • Principal Investigator:
          • Sean Mackey, MD, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in pain severity
Time Frame: 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
Approximately 4 weeks after conclusion of treatment.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Stanford University

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2015

Primary Completion (Estimated)

June 1, 2025

Study Completion (Estimated)

June 1, 2025

Study Registration Dates

First Submitted

July 15, 2015

First Submitted That Met QC Criteria

July 16, 2015

First Posted (Estimated)

July 20, 2015

Study Record Updates

Last Update Posted (Estimated)

November 17, 2023

Last Update Submitted That Met QC Criteria

November 15, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 33607

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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