Proof of Concept Trial of Cannabis Derivatives in Neuropathic Pain
Status: Recruiting
Location: See all (5) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 21
Healthy Volunteers: f
View:
• 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
Locations
United States
California
VA San Diego Healthcare System, San Diego, CA
RECRUITING
San Diego
Connecticut
VA Connecticut Healthcare System West Haven Campus, West Haven, CT
RECRUITING
West Haven
Rhode Island
Providence VA Medical Center, Providence, RI
RECRUITING
Providence
Texas
South Texas Health Care System, San Antonio, TX
RECRUITING
San Antonio
Washington
VA Puget Sound Health Care System Seattle Division, Seattle, WA
TERMINATED
Seattle
Contact Information
Primary
Courtney C DiCocco
Courtney.DiCocco@va.gov
(203) 932-5711
Backup
Mohini Ranganathan, MD
Mohini.Ranganathan@va.gov
(203) 932-5711
Time Frame
Start Date:2023-06-21
Estimated Completion Date:2027-06-30
Participants
Target number of participants:320
Treatments
Active_comparator: THC (Syndros)
Target dose of 10mg per day.
Active_comparator: CBD (Epidolex)
Target dose of 800 mg per day.
Active_comparator: THC + CBD (Nabiximols)
Target dose of 10.8 mg / 10 mg per day.
Placebo_comparator: Placebo
Identical in appearance to the three active comparators.