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

NCT ID: NCT02502162

Last Updated: 2025-05-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-06-30

Study Completion Date

2027-07-31

Brief Summary

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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

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Conditions

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Complex Regional Pain Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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LDN

Naltrexone HCL, 4.5 mg, Once a day.

Group Type EXPERIMENTAL

LDN

Intervention Type DRUG

Placebo

Sugar pill

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Sugar pill

Interventions

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LDN

Intervention Type DRUG

Placebo

Sugar pill

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Stanford University

OTHER

Sponsor Role lead

Responsible Party

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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

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Sean Mackey, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

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Stanford University

Palo Alto, California, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Birute Gedrimaite

Role: CONTACT

(650) 497-0485

Facility Contacts

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Birute Gedrimaite

Role: primary

650-497-0485

Other Identifiers

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33607

Identifier Type: -

Identifier Source: org_study_id

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