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

Primary Purpose

Complex Regional Pain Syndrome

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
LDN
Placebo
Sponsored by
Stanford University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Complex Regional Pain Syndrome

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Stanford UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

LDN

Placebo

Arm Description

Naltrexone HCL, 4.5 mg, Once a day.

Sugar pill

Outcomes

Primary Outcome Measures

Changes in pain severity
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

Secondary Outcome Measures

Full Information

First Posted
July 15, 2015
Last Updated
September 22, 2023
Sponsor
Stanford University
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1. Study Identification

Unique Protocol Identification Number
NCT02502162
Brief Title
Low-Dose Naltrexone for the Treatment of Complex Regional Pain Syndrome
Acronym
LDN-CRPS
Official Title
Low-Dose Naltrexone for the Treatment of Complex Regional Pain Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 2015 (undefined)
Primary Completion Date
June 2025 (Anticipated)
Study Completion Date
June 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stanford University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Complex Regional Pain Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
LDN
Arm Type
Experimental
Arm Description
Naltrexone HCL, 4.5 mg, Once a day.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Sugar pill
Intervention Type
Drug
Intervention Name(s)
LDN
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Sugar pill
Primary Outcome Measure Information:
Title
Changes in pain severity
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
Time Frame
Approximately 4 weeks after conclusion of treatment.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Birute Gedrimaite
Phone
(650) 497-0485
Email
birute@stanford.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sean Mackey, MD, PhD
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stanford University
City
Palo Alto
State/Province
California
ZIP/Postal Code
94304
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Birute Gedrimaite
Phone
650-497-0485
Email
birute@stanford.edu
First Name & Middle Initial & Last Name & Degree
Sean Mackey, MD, PhD

12. IPD Sharing Statement

Learn more about this trial

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

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