Actively Recruiting
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
34 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Chronic neuropathic pain (CNP) is a disabling condition that particularly affects United States Veterans. Current frontline treatments for CNP have inconsistent results and often cause dissatisfaction. Veterans and clinicians have shown strong interest in cannabis derivatives like THC and CBD for pain control, but well-controlled trials are lacking to guide expectations about benefits and side effects. This randomized phase II trial aims to evaluate cannabis constituents in Veterans with CNP, addressing a vital need given their unique pain profiles and treatment challenges. The trial compares three cannabis-based treatments—THC, CBD, and a combination of THC plus CBD—with a placebo. Participants will receive target doses of 10 mg per day of THC, 800 mg per day of CBD, or 10.8 mg/10 mg per day of the THC+CBD combination. The study uses a quadruple-masked, randomized design with four arms to assess these treatments over a short-term period. The placebo looks identical to the active treatments to maintain masking. Participants are adult Veterans diagnosed with high-impact neuropathic pain who are stable on current treatments and not using cannabis currently. The study involves multiple assessments including pain ratings using the Numeric Rating Scale, sensory testing, function and disability scales, gait speed tests, quality of life surveys, and mental health questionnaires. These are conducted at baseline and at intervals up to 8 weeks. The trial measures both benefits and adverse effects of cannabinoids, with close monitoring of participant adherence and health.
CONDITIONS
Brief Title
Proof of Concept Trial of Cannabis Derivatives in Neuropathic Pain
Who Can Participate
Eligibility Criteria
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 NeuPSIG
- Meet criteria for persistent, high-impact pain
- Presence of allodynia confirmed by a screening dynamic brush test
- Women of childbearing potential must agree to contraceptive requirements
You will not qualify if you...
- Currently engaged in or planning invasive non-drug pain treatments
- Peripheral neuropathy is not the primary source of pain
- Hypersensitivity to THC, CBD, or their combination
- Cannabis use during screening confirmed by urine test
- Unwillingness to avoid cannabis during the study
- Diagnosis of Cannabis Use Disorder in past 6 months
- Current serious psychiatric or substance use disorders
- Change over 20% in pain medications or treatments from 4 weeks before screening until study completion
- Opioid dose over 400 mg morphine equivalent
- Women who are pregnant, breastfeeding, or plan pregnancy within 12 weeks of enrollment
- Unstable or concerning medical conditions increasing risk
- Need for immediate psychiatric hospitalization
- Enrollment in a medical marijuana program
- Federal employees are excluded
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 8 weeks
Participants receive a daily dose of THC, CBD, THC+CBD, or placebo to assess their effects on neuropathic pain.
Weekly visits for up to 8 weeks
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
Research Team
C
Courtney C DiCocco
M
Mohini Ranganathan, MD
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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