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

Part of paid clinical trials in Palo Alto, California.

Sponsor
Stanford University
Study ID
NCT02502162
Status
Recruiting

Conditions

  • Complex Regional Pain Syndrome

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • LDN — DRUG
  • Placebo — DRUG
    Sugar pill

Study Details

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.

Key Dates

Start date
Jun 30, 2015
Status verified
May 2025
Primary completion
Jul 31, 2027
Completion
Jul 31, 2027

Study Design

Enrollment
120 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: LDN
    Naltrexone HCL, 4.5 mg, Once a day.
  • Placebo Comparator: Placebo
    Sugar pill

Primary Outcome Measure

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

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Stanford UniversityPalo AltoCalifornia94304
Birute Gedrimaite
650-497-0485
Sean Mackey, MD, PhD (PRINCIPAL_INVESTIGATOR)

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