Status:
RECRUITING
Proof of Concept Trial of Cannabis Derivatives in Neuropathic Pain
Lead Sponsor:
VA Office of Research and Development
Conditions:
Diabetic Neuropathic Pain
Peripheral Neuropathic Pain
Eligibility:
All Genders
21+ years
Phase:
PHASE2
Brief Summary
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 in...
Detailed Description
Chronic pain is a significant burden to United States Veterans and is a particular concern for Veterans. One of the causes of pain is chronic neuropathic pain (CNP). Frontline treatment for CNP, show ...
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
Exclusion
- 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
Key Trial Info
Start Date :
June 21 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2027
Estimated Enrollment :
320 Patients enrolled
Trial Details
Trial ID
NCT05351801
Start Date
June 21 2023
End Date
June 30 2027
Last Update
March 12 2025
Active Locations (5)
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1
VA San Diego Healthcare System, San Diego, CA
San Diego, California, United States, 92161-0002
2
VA Connecticut Healthcare System West Haven Campus, West Haven, CT
West Haven, Connecticut, United States, 06516-2770
3
Providence VA Medical Center, Providence, RI
Providence, Rhode Island, United States, 02908-4734
4
South Texas Health Care System, San Antonio, TX
San Antonio, Texas, United States, 78229-4404