NCT05351801 Proof of Concept Trial of Cannabis Derivatives in Neuropathic Pain
| NCT ID | NCT05351801 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | VA Office of Research and Development |
| Condition | Neuropathic Pain |
| Study Type | INTERVENTIONAL |
| Enrollment | 320 participants |
| Start Date | 2023-06-21 |
| Primary Completion | 2028-09-29 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 320 participants in total. It began in 2023-06-21 with a primary completion date of 2028-09-29.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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.
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
Contact & Investigator
Deepak D'Souza, MD MBBS
PRINCIPAL INVESTIGATOR
VA Connecticut Healthcare System West Haven Campus, West Haven, CT
Frequently Asked Questions
Who can join the NCT05351801 clinical trial?
This trial is open to participants of all sexes, aged 21 Years or older, studying Neuropathic Pain. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05351801 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT05351801 currently recruiting?
Yes, NCT05351801 is actively recruiting participants. Contact the research team at Courtney.DiCocco@va.gov for enrollment information.
Where is the NCT05351801 trial being conducted?
This trial is being conducted at San Diego, United States, West Los Angeles, United States, West Haven, United States, Providence, United States and 2 additional locations.
Who is sponsoring the NCT05351801 clinical trial?
NCT05351801 is sponsored by VA Office of Research and Development. The principal investigator is Deepak D'Souza, MD MBBS at VA Connecticut Healthcare System West Haven Campus, West Haven, CT. The trial plans to enroll 320 participants.