Low-Dose Naltrexone for the Treatment of Complex Regional Pain Syndrome
ConditionComplex Regional Pain Syndrome
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorStanford University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
Any known allergy to naltrexone or naloxone
Use of prescription opioid analgesics or illegal opioid use
Current or planned pregnancy.
Trial design
Design model
Parallel
Treatments tested in this trial
LDN
DrugPlacebo
DrugSugar pill
Treatment groups
120 Participants
are divided into 2 treatment groupsGroup A: LDNExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Changes in pain severity
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
Time frame
Approximately 4 weeks after conclusion of treatment.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov