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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 : March 18, 2020
Sponsor:
Information provided by (Responsible Party):
Sean Mackey, Stanford University

Tracking Information
First Submitted Date  ICMJE July 15, 2015
First Posted Date  ICMJE July 20, 2015
Last Update Posted Date March 18, 2020
Study Start Date  ICMJE June 2015
Estimated Primary Completion Date June 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 16, 2015)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Low-Dose Naltrexone for the Treatment of Complex Regional Pain Syndrome
Official Title  ICMJE Low-Dose Naltrexone for the Treatment of Complex Regional Pain Syndrome
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Complex Regional Pain Syndrome
Intervention  ICMJE
  • Drug: LDN
  • Drug: Placebo
    Sugar pill
Study Arms  ICMJE
  • Experimental: LDN
    Naltrexone HCL, 4.5 mg, Once a day.
    Intervention: Drug: LDN
  • Placebo Comparator: Placebo
    Sugar pill
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: July 16, 2015)
40
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2021
Estimated Primary Completion Date June 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Aaron Yue, MD (650) 497-0485 xuanyue@stanford.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02502162
Other Study ID Numbers  ICMJE 33607
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Sean Mackey, Stanford University
Study Sponsor  ICMJE Stanford University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Sean Mackey, MD, PhD Stanford University
PRS Account Stanford University
Verification Date March 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP