NCT02502162

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
14mo left

Started Jun 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress90%
Jun 2015Jul 2027

Study Start

First participant enrolled

June 1, 2015

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 15, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 20, 2015

Completed
12 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2027

Last Updated

May 29, 2025

Status Verified

May 1, 2025

Enrollment Period

12.1 years

First QC Date

July 15, 2015

Last Update Submit

May 27, 2025

Conditions

Complex Regional Pain Syndrome

Outcome Measures

Primary Outcomes (1)

  • 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.

Study Arms (2)

LDN

EXPERIMENTAL

Naltrexone HCL, 4.5 mg, Once a day.

Drug: LDN

Placebo

PLACEBO COMPARATOR

Sugar pill

Drug: Placebo

Interventions

LDNDRUG
LDN
PlaceboDRUG

Sugar pill

Placebo

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Any known allergy to naltrexone or naloxone
  • Use of prescription opioid analgesics or illegal opioid use
  • Current or planned pregnancy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stanford University

Palo Alto, California, 94304, United States

RECRUITING

MeSH Terms

Conditions

Complex Regional Pain Syndromes

Condition Hierarchy (Ancestors)

Autonomic Nervous System DiseasesNervous System DiseasesPeripheral Nervous System DiseasesNeuromuscular Diseases

Study Officials

  • Sean Mackey, MD, PhD

    Stanford University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Birute Gedrimaite

CONTACT

(650) 497-0485birute@stanford.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
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

Study Record Dates

First Submitted

July 15, 2015

First Posted

July 20, 2015

Study Start

June 1, 2015

Primary Completion (Estimated)

July 1, 2027

Study Completion (Estimated)

July 1, 2027

Last Updated

May 29, 2025

Record last verified: 2025-05

Locations

US(1)