This site became the new ClinicalTrials.gov on June 19th. Learn more.
Show more
ClinicalTrials.gov Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu
Give us feedback

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

This study is currently recruiting participants.
See Contacts and Locations
Verified April 2016 by Sean Mackey, Stanford University
Sponsor:
Information provided by (Responsible Party):
Sean Mackey, Stanford University
ClinicalTrials.gov Identifier:
NCT02502162
First received: July 15, 2015
Last updated: April 28, 2016
Last verified: April 2016
  Purpose
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 Intervention
Complex Regional Pain Syndrome Drug: LDN Drug: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Low-Dose Naltrexone for the Treatment of Complex Regional Pain Syndrome

Resource links provided by NLM:


Further study details as provided by Sean Mackey, Stanford University:

Primary Outcome Measures:
  • 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


Estimated Enrollment: 40
Study Start Date: June 2015
Estimated Study Completion Date: June 2019
Estimated Primary Completion Date: June 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: LDN
Naltrexone HCL, 4.5 mg, Once a day.
Drug: LDN
Placebo Comparator: Placebo
Sugar pill
Drug: Placebo
Sugar pill

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years   (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02502162

Contacts
Contact: Maria L Adelus (650) 724-9320 madelus@stanford.edu

Locations
United States, California
Stanford University Recruiting
Palo Alto, California, United States, 94304
Contact: Maria L Adelus    408-386-2143    madelus@stanford.edu   
Principal Investigator: Sean Mackey, MD, PhD         
Sponsors and Collaborators
Stanford University
Investigators
Principal Investigator: Sean Mackey, MD, PhD Stanford University
  More Information

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     History of Changes
Other Study ID Numbers: 33607
Study First Received: July 15, 2015
Last Updated: April 28, 2016

Additional relevant MeSH terms:
Syndrome
Somatoform Disorders
Complex Regional Pain Syndromes
Reflex Sympathetic Dystrophy
Disease
Pathologic Processes
Mental Disorders
Autonomic Nervous System Diseases
Nervous System Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
Naltrexone
Narcotic Antagonists
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on June 28, 2017