Recruiting

Low-Dose Naltrexone

Sponsor:

Stanford University

Code:

NCT02502162

Conditions

Complex Regional Pain Syndrome

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Not accepted

Interventions

LDN

Placebo

Study Details

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.

Conditions

Complex Regional Pain Syndrome

Study ID

NCT02502162

Start date

Jun, 2015

Status verified date

May, 2025

Completion date

Jul, 2027

Anticipated

Primary completion date

Jul, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

120 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: LDN

Naltrexone HCL, 4.5 mg, Once a day.

placebo comparator: Placebo

Sugar pill

Interventions

LDN

Placebo

Sugar pill

Primary outcome measure

  • Changes in pain severity [ Time Frame: Approximately 4 weeks after conclusion of treatment. ]

Central Contacts and Locations

Central contacts

Birute Gedrimaite

(650) 497-0485birute@stanford.edu

Locations

Stanford University

Recruiting

Palo Alto, California, United States, 94304

Contacts

Birute Gedrimaite

650-497-0485birute@stanford.edu

Principal Investigator:

Sean Mackey, MD, PhD

More Information

Sponsor

Stanford University

Last update posted

May 29, 2025

Last verified

May, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Stanford University on 2025-05-29.