Low-Dose Naltrexone for the Treatment of Complex Regional Pain Syndrome (LDN-CRPS)

Stanford University

Status: Enrolling

Conditions: Complex Regional Pain Syndrome

Treatments: Drug: Placebo; Drug: LDN

Study type: Interventional

Funder types: Other

Identifiers

NCT02502162

33607

Details and patient eligibility

About

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.

Enrollment: 120 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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120 participants in 2 patient groups, including a placebo group

LDN

Experimental group

Description:

Naltrexone HCL, 4.5 mg, Once a day.

Treatment:

Drug: LDN

Placebo

Placebo Comparator group

Description:

Sugar pill

Treatment:

Drug: Placebo