Proof of Concept Trial of Cannabis Derivatives in Neuropathic Pain

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 PainSpecial 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

Exclusion Criteria:

• 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 urinetoxicology for THC-COOH as measured and resulted at visit 5 before randomization

• Unwilling to refrain from using cannabis or cannabis-based products through theentire 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 seriouspsychiatric disorders

• Actual change or intent to change is greater than a 20% change (increase ordecrease) in any other medication for pain or non-pharmacological treatment from 4weeks 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 12weeks from enrollment

• Any current unstable or concerning medical condition that would place the patient atincreased risk, including hepatic, respiratory, immunological, cardiovascular,endocrine, or renal disease, or in the opinion of the investigator, preventsadherence with the protocol

• Need for immediate psychiatric hospitalization

• Enrolled in a medical marijuana program

• Federal employee