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Cannabis Derivatives for Neuropathic Pain

This study is testing if cannabis-derived medications can help Veterans with chronic neuropathic pain (nerve pain). Researchers will compare the effectiveness of three different cannabis-derived drugs—THC (Syndros), CBD (Epidolex), and a combination of THC + CBD (Nabiximols)—against a placebo (an inactive substance). The main goal is to see if any of these treatments reduce pain more than the placebo after six weeks, as measured by a pain rating scale. You may be eligible if you are a Veteran aged 21 or older, have been diagnosed with neuropathic pain, and are not currently using cannabis. The study aims to enroll 320 participants, but its current status is unclear.

Study design
This is an interventional study comparing three cannabis-derived drugs to a placebo. It plans to enroll 320 adult Veterans.
What's involved
Participants will receive one of the study drugs or a placebo and have their pain measured at the beginning and after six weeks.
Compensation
Not stated in the trial record.
Follow-up
Pain will be measured at baseline and at Week 6, indicating a short-term follow-up period.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05351801

Proof of Concept Trial of Cannabis Derivatives in Neuropathic Pain

Recruiting
PHASE2Ages 21+InterventionalTreatment
VA Office of Research and Development
~320 participants
Updated 2026-02-27 on ClinicalTrials.gov
What's tested:THC (Syndros)CBD (Epidolex)THC + CBD (Nabiximols)Placebo

At a glance

Recruiting sites
4 of 6 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
To compare the short-term efficacy of THC, CBD, or THC+CBD vs Placebo on Neuropathic Pain as measured by the Numeric Rating Scale of Pain
Measured over Baseline, Week 6

Conditions

Neuropathic Pain
Peripheral Neuropathic Pain

Explore related trials

Neuropathic PainPeripheral neuropathic pain

Where it's being run

6 sites across 5 states
California2
Connecticut1
Rhode Island1
Texas1
Washington1

Study leadership

  • Deepak D'Souza, MD MBBS · PRINCIPAL_INVESTIGATOR · VA Connecticut Healthcare System West Haven Campus, West Haven, CT
  • Donald McGeary, PhD · PRINCIPAL_INVESTIGATOR · South Texas Health Care System, San Antonio, TX

Who to contact

Courtney C DiCocco
[email protected]
(203) 932-5711
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • To compare the short-term efficacy of THC, CBD, or THC+CBD vs Placebo on Neuropathic Pain as measured by the Numeric Rating Scale of PainBaseline, Week 6

    The mean change in the weekly average of daily Numeric Rating Scale (NRS) pain score (0-10 scale; 0=no pain, 10=worst possible pain) from baseline to week 6.