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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02502162
Recruitment Status : Recruiting
First Posted : July 20, 2015
Last Update Posted : April 24, 2023
Sponsor:
Information provided by (Responsible Party):
Sean Mackey, Stanford University

Study Description
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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 Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated 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 : June 2015
Estimated Primary Completion Date : June 2023
Estimated Study Completion Date : June 2023

Resource links provided by the National Library of Medicine

Drug Information available for: Naltrexone

Arms and Interventions
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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
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Primary Outcome Measures :
  1. 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


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02502162


Contacts
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Contact: Birute Gedrimaite (650) 497-0485 birute@stanford.edu

Locations
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United States, California
Stanford University Recruiting
Palo Alto, California, United States, 94304
Contact: Birute Gedrimaite    650-497-0485    birute@stanford.edu   
Principal Investigator: Sean Mackey, MD, PhD         
Sponsors and Collaborators
Stanford University
Investigators
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Principal Investigator: Sean Mackey, MD, PhD Stanford University
More Information
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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: July 20, 2015    Key Record Dates
Last Update Posted: April 24, 2023
Last Verified: April 2023
Additional relevant MeSH terms:
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Complex Regional Pain Syndromes
Reflex Sympathetic Dystrophy
Syndrome
Somatoform Disorders
Disease
Pathologic Processes
 Mental Disorders
Autonomic Nervous System Diseases
Nervous System Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases