Proof of Concept Trial of Cannabis Derivatives in Neuropathic Pain
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age21+
SponsorVA Office of Research and Development
About this trial
Chronic neuropathic pain (CNP) is disabling. Research on frontline treatments for CNP, shows inconsistent outcomes and dissatisfaction among Veterans. Veterans and clinicians have shown significant interest in cannabis derivatives (THC, CBD) for neuropathic pain control, but there are no well-controlled trials guiding expectations for benefit and adverse outcomes associated with cannabis for CNP. Because Veterans are likely to present with pain and pain-related polymorbidity significantly differing from that of civilians, a well-structured clinical trial of cannabinoids for Veterans with CNP is vital.
Eligibility criteria
Qualifiers
Able to provide written consent
Veterans 21 years and older at the date of screening
Meet diagnostic criteria for neuropathic pain as defined by the Neuropathic Pain Special Interest Group of the International Association for the Study of Pain (NeuPSIG)
Meet criteria for persistent, high-impact pain criteria.
Disqualifiers
Actively engaged in or planning to enter a program of non-pharmacological invasive intervention for pain at the time of enrollment
Peripheral neuropathy is not a primary source of neuropathic pain
Hypersensitivity to THC, CBD, or THC/CBD
Self-report of cannabis use during screening phase confirmed by positive urine toxicology for THC-COOH as measured and resulted at visit 5 before randomization
Trial design
Treatments tested in this trial
- THC (Syndros)
- CBD (Epidolex)
- THC + CBD (Nabiximols)
- Placebo
Treatment groups
320 Participants
are divided into 4 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov