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Proof of Concept Trial of Cannabis Derivatives in Neuropathic Pain

RecruitingPhase 2

Who can join

Ages 21 and older · All sexes

Full eligibility criteria
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 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

About the study

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.

What is being tested

Sponsor: VA Office of Research and Development · Participants: 320 · Started: Jun 21, 2023

Contact the study team

Official record on ClinicalTrials.gov — NCT05351801

Locations in the U.S.

CaliforniaVA San Diego Healthcare System, San Diego, CA, San Diego
ConnecticutVA Connecticut Healthcare System West Haven Campus, West Haven, CT, West Haven
Rhode IslandProvidence VA Medical Center, Providence, RI, Providence
TexasSouth Texas Health Care System, San Antonio, TX, San Antonio

Conditions

From ClinicalTrials.gov, data retrieved Oct 2, 2026. Each study sets its own eligibility; the study team decides who can join.