Palo Alto, California 94304


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.


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.


Study is Available At:


Original ID:

33607


NCT ID:

NCT02502162


Secondary ID:


Study Acronym:

LDN-CRPS


Brief Title:

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


Official Title:

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


Overall Status:

Recruiting


Study Phase:

N/A


Genders:

N/A


Minimum Age:

18 Years


Maximum Age:

65 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Stanford University


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:


Study Type:

Interventional


Study Design:


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

40


Enrollment Type:

Anticipated


Overall Contact Information

Official Name:Sean Mackey, MD, PhD
Principal Investigator
Stanford University
Primary Contact:Aaron Yue, MD
(650) 497-0485
xuanyue@stanford.edu

Study Dates

Start Date:June 2015
Completion Date:June 2019
Completion Type:Anticipated
Primary Completion Date:June 2019
Primary Completion Type:Anticipated
Verification Date:March 2019
Last Changed Date:March 18, 2019
First Received Date:July 15, 2015

Study Outcomes

Outcome Type:Primary Outcome
Measure:Changes in pain severity
Time Frame:Approximately 4 weeks after conclusion of treatment.
Safety Issues:False
Description: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

Study Interventions

Intervention Type:Drug
Name:LDN
Arm Name:LDN
Intervention Type:Drug
Name:Placebo
Description:Sugar pill
Arm Name:Placebo

Study Arms

Study Arm Type:Placebo Comparator
Arm Name:Placebo
Description:Sugar pill
Study Arm Type:Experimental
Arm Name:LDN
Description:Naltrexone HCL, 4.5 mg, Once a day.

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Stanford University

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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