Low-Dose Naltrexone for the Treatment of Complex Regional... | NCT02502162

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

NCT02502162

Sponsor

Stanford University

Status

Recruiting

Last Update Posted

May 29, 2025Actual

Enrollment

120Estimated

Phase

Not Applicable

Conditions

Complex Regional Pain Syndrome

Interventions

LDN
Placebo

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2015

Primary Completion Date

Jul 2027Estimated

Completion Date

Jul 2027Estimated

First Submitted Date

Jul 15, 2015

First Submission Date that Met QC Criteria

Jul 16, 2015

First Posted Date

Jul 20, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 27, 2025

Last Update Posted Date

May 29, 2025Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

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 UniversityPrincipal Investigator

Lead Sponsor

Stanford UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 attend either in-person or virtual study visits and complete questionnaires.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

120Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
LDN	Experimental	Naltrexone HCL, 4.5 mg, Once a day.	Drug: LDN
Placebo	Placebo Comparator	Sugar pill	Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
LDN	Drug		LDN
Placebo	Drug

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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	Approximately 4 weeks after conclusion of treatment.

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Upper and/or lower extremity CRPS
On stable treatment for 1 month
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 or planned pregnancy.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Birute Gedrimaite	Contact	(650) 497-0485		birute@stanford.edu

Overall Officials

Name	Affiliation	Role
Sean Mackey, MD, PhD	Stanford University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Stanford University	Recruiting	Palo Alto	California	94304	United States

Condition Browse Module

MeSH Terms

ID	Term
D020918	Complex Regional Pain Syndromes

Ancestor Terms

ID	Term
D001342	Autonomic Nervous System Diseases
D009422	Nervous System Diseases
D010523	Peripheral Nervous System Diseases
D009468	Neuromuscular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided