Actively Recruiting

Phase 2
Age: 21Years +
All Genders
NCT05351801

Proof of Concept Trial of Cannabis Derivatives in Neuropathic Pain

Led by VA Office of Research and Development · Updated on 2026-02-27

320

Participants Needed

6

Research Sites

310 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Proof of Concept Trial of Cannabis Derivatives in Neuropathic Pain

Who Can Participate

Age: 21Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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
  • Presence of allodynia confirmed by a screening dynamic brush test
  • Women of childbearing potential who agree to follow contraceptive requirements
Not Eligible

You will not qualify if you...

  • Actively engaged in or planning non-pharmacological invasive treatment for pain at enrollment
  • Peripheral neuropathy is not the primary cause of neuropathic pain
  • Hypersensitivity to THC, CBD, or THC/CBD
  • Cannabis use during screening phase confirmed by positive urine test for THC-COOH
  • Unwilling to avoid cannabis or cannabis-based products throughout the study
  • Diagnosis of Cannabis Use Disorder in the past 6 months
  • Current diagnosis of cannabis use disorder, substance use disorder, or serious psychiatric disorders
  • Changes greater than 20% in pain medication or non-pharmacological treatment from 4 weeks before screening until study completion
  • Opioid dose over 400 mg morphine milligram equivalent
  • Pregnant, breastfeeding, or intending pregnancy within 12 weeks from enrollment
  • Current unstable or concerning medical conditions increasing risk or preventing protocol adherence
  • Need for immediate psychiatric hospitalization
  • Enrolled in a medical marijuana program
  • Federal employee

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 6 locations

1

VA San Diego Healthcare System, San Diego, CA

San Diego, California, United States, 92161-0002

Actively Recruiting

2

VA Greater Los Angeles Healthcare System, West Los Angeles, CA

West Los Angeles, California, United States, 90073-1003

Active, Not Recruiting

3

VA Connecticut Healthcare System West Haven Campus, West Haven, CT

West Haven, Connecticut, United States, 06516-2770

Actively Recruiting

4

Providence VA Medical Center, Providence, RI

Providence, Rhode Island, United States, 02908-4734

Actively Recruiting

5

South Texas Health Care System, San Antonio, TX

San Antonio, Texas, United States, 78229-4404

Actively Recruiting

6

VA Puget Sound Health Care System Seattle Division, Seattle, WA

Seattle, Washington, United States, 98108-1532

Terminated

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Research Team

C

Courtney C DiCocco

CONTACT

M

Mohini Ranganathan, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

4

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