Recruiting NCT02502162
Low-Dose Naltrexone for the Treatment of Complex Regional Pain Syndrome
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: LDN, Placebo.
- Who it may be relevant to
- Registry conditions: Complex Regional Pain Syndrome. Basic parameters: 18 years — 70 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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
- Drug LDN
- Drug Placebo
Sugar pill
Primary outcome measures
- Changes in pain severity [Time frame: Approximately 4 weeks after conclusion of treatment.]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Stanford University — Palo Alto
Identifiers
NCT: NCT02502162 · 33607