Testing cannabis derivatives for neuropathic pain in Veterans
Proof of Concept Trial of Cannabis Derivatives in Neuropathic Pain
This study is testing whether cannabis products like THC and CBD can help reduce chronic nerve pain in Veterans who are not currently using cannabis.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 320 (estimated) |
| Ages | 21 Years and up |
| Sex | All |
| Sponsor | VA Office of Research and Development Federal |
| Locations | 6 sites (San Diego, California and 5 other locations) |
| Trial ID | NCT05351801 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effectiveness of cannabis derivatives, specifically THC and CBD, in reducing chronic neuropathic pain among Veterans. It is a randomized phase II trial that will compare the pain relief provided by these cannabis constituents against a placebo. The study will recruit 320 adult Veterans who experience high-impact chronic neuropathic pain and are not current cannabis users. By focusing on this specific population, the trial seeks to provide valuable insights into the potential benefits and risks of cannabis for pain management in Veterans.
Who should consider this trial
Good fit: Ideal candidates for this study are Veterans aged 21 and older who meet the diagnostic criteria for high-impact chronic neuropathic pain.
Not a fit: Patients with peripheral neuropathy not primarily causing their neuropathic pain or those with a history of cannabis use disorder may not benefit from this study.
Why it matters
Potential benefit: If successful, this trial could offer a new, effective treatment option for Veterans suffering from chronic neuropathic pain.
How similar studies have performed: While there is limited controlled research on cannabis for neuropathic pain, the interest from Veterans and clinicians suggests a potential for success in this novel approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
San Diego, California and 5 other locations
- VA San Diego Healthcare System, San Diego, CA — San Diego, California, United States (Recruiting)
- VA Greater Los Angeles Healthcare System, West Los Angeles, CA — West Los Angeles, California, United States (Active_not_recruiting)
- VA Connecticut Healthcare System West Haven Campus, West Haven, CT — West Haven, Connecticut, United States (Recruiting)
- Providence VA Medical Center, Providence, RI — Providence, Rhode Island, United States (Recruiting)
- South Texas Health Care System, San Antonio, TX — San Antonio, Texas, United States (Recruiting)
- VA Puget Sound Health Care System Seattle Division, Seattle, WA — Seattle, Washington, United States (Terminated)
Study contacts
- Principal investigator: Deepak D'Souza, MD MBBS — VA Connecticut Healthcare System West Haven Campus, West Haven, CT
- Study coordinator: Courtney C DiCocco
- Email: Courtney.DiCocco@va.gov
- Phone: (203) 932-5711
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.