Proof of Concept Trial of Cannabis Derivatives in Neuropathic Pain
VA Office of Research and Development
Summary
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.
Description
Chronic pain is a significant burden to United States Veterans and is a particular concern for Veterans. One of the causes of pain is chronic neuropathic pain (CNP). Frontline treatment for CNP, show inconsistent outcomes and have significant side effects. The ongoing opioid crisis has led to significant interest in safe and effective alternatives for pain control, and there is a significant need for research on desirable options for pain control that are likely to improve treatment adherence and outcomes. Veterans groups and Veterans Affairs clinicians have expressed significant interest in c…
Eligibility
- Age range
- 21+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * 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. * Presence of allodynia confirmed by one of the screening dynamic brush tests * women of childbearing potential who agree to abide by contraceptive requirements Exclusion Criteria: * Actively engaged in or planning to enter a program of non-pharmacological i…
Interventions
- DrugTHC (Syndros)
Participants will receive a target dose of 10mg per day of THC (Syndros).
- DrugCBD (Epidolex)
Participants will receive a target dose of 800 mg per day of CBD (Epidolex).
- DrugTHC + CBD (Nabiximols)
Participants will receive a target dose of 10.8 mg / 10 mg per day of THC + CBD (Nabiximols).
- DrugPlacebo
Placebo
Locations (6)
- VA San Diego Healthcare System, San Diego, CASan Diego, California
- VA Greater Los Angeles Healthcare System, West Los Angeles, CAWest Los Angeles, California
- VA Connecticut Healthcare System West Haven Campus, West Haven, CTWest Haven, Connecticut
- Providence VA Medical Center, Providence, RIProvidence, Rhode Island
- South Texas Health Care System, San Antonio, TXSan Antonio, Texas
- VA Puget Sound Health Care System Seattle Division, Seattle, WASeattle, Washington