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NCT Number: NCT02502162

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

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.

Recruiting

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Key information

Conditions

Complex Regional Pain Syndrome Autonomic Nervous System Diseases Complex Regional Pain Syndromes Nervous System Diseases Neuromuscular Diseases Peripheral Nervous System Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Stanford University

Palo Alto, California, 94304, United States

Location status: Recruiting

Location contact

Birute Gedrimaite

CONTACT

[email protected]

650-497-0485

Sean Mackey, MD, PhD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

LDN

Drug

Placebo

Drug

Sugar pill

Primary outcomes

  1. Changes in pain severity

    Time frame: Approximately 4 weeks after conclusion of treatment.

    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 contacts

Contact information is provided by the study sponsor or research team.

Birute Gedrimaite

CONTACT

[email protected]

(650) 497-0485

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Registry information

Acronym: LDN-CRPS

Important dates

Study start
2015
Primary completion
2027
Study completion
2027
First posted
Jul 20, 2015
Registry last updated
May 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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