Proof of Concept Trial of Cannabis Derivatives in Neuropathic Pain
VA Office of Research and Development
320 participants
Jun 21, 2023
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria6
- 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 Criteria14
- 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
- Unwilling to refrain from using cannabis or cannabis-based products through the entire duration of the study
- Diagnosis of DSM-5 Cannabis Use Disorder in the past 6 months
- Current DSM-5 diagnosis of cannabis use disorder, substance use disorder or serious psychiatric disorders
- Actual change or intent to change is greater than a 20% change (increase or decrease) in any other medication for pain or non-pharmacological treatment from 4 weeks before the screening appointment until completion of study (i.e., visit 13)
- Opioid doses \> 400 mg MME (morphine milligram equivalent)
- Women who are pregnant or breastfeeding, or who intend to become pregnant in the 12 weeks from enrollment
- Any current unstable or concerning medical condition that would place the patient at increased risk, including hepatic, respiratory, immunological, cardiovascular, endocrine, or renal disease, or in the opinion of the investigator, prevents adherence with the protocol
- Need for immediate psychiatric hospitalization
- Enrolled in a medical marijuana program
- Federal employee
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Interventions
Participants will receive a target dose of 10mg per day of THC (Syndros).
Participants will receive a target dose of 800 mg per day of CBD (Epidolex).
Participants will receive a target dose of 10.8 mg / 10 mg per day of THC + CBD (Nabiximols).
Placebo
Locations(6)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05351801