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

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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02502162
Acronym
LDN-CRPS
Enrollment
120
Registered
2015-07-20
Start date
2015-06-30
Completion date
2027-07-31
Last updated
2025-05-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Complex Regional Pain Syndrome

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.

Interventions

DRUGLDN
DRUGPlacebo

Sugar pill

Sponsors

Stanford University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Changes in pain severityApproximately 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

Countries

United States

Contacts

Primary ContactBirute Gedrimaite
birute@stanford.edu(650) 497-0485

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026