Proof of Concept Trial of Cannabis Derivatives in Neuropathic Pain

Part of paid clinical trials in San Diego, California.

Sponsor
VA Office of Research and Development
Study ID
NCT05351801
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • Neuropathic Pain
  • Peripheral Neuropathic Pain

Eligibility Criteria

Sex
ALL
Age
21 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • THC (Syndros) — DRUG
    Participants will receive a target dose of 10mg per day of THC (Syndros).
  • CBD (Epidolex) — DRUG
    Participants will receive a target dose of 800 mg per day of CBD (Epidolex).
  • THC + CBD (Nabiximols) — DRUG
    Participants will receive a target dose of 10.8 mg / 10 mg per day of THC + CBD (Nabiximols).
  • Placebo — DRUG
    Placebo

Study Details

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.

Key Dates

Start date
Jun 21, 2023
Status verified
Feb 2026
Primary completion
Sep 29, 2028
Completion
May 31, 2029

Study Design

Enrollment
320 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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.

Primary Outcome Measure

To compare the short-term efficacy of THC, CBD, or THC+CBD vs Placebo on Neuropathic Pain as measured by the Numeric Rating Scale of Pain [ Time Frame: Baseline, Week 6 ]

Central Contacts

Locations (6)

FacilityCityStateZIPSite coordinators
VA San Diego Healthcare System, San Diego, CASan DiegoCalifornia92161-0002
Albert Leung, MD
[email protected]
858-642-3029
VA Greater Los Angeles Healthcare System, West Los Angeles, CAWest Los AngelesCalifornia90073-1003-
VA Connecticut Healthcare System West Haven Campus, West Haven, CTWest HavenConnecticut06516-2770
Deepak D'Souza, MD MBBS
[email protected]
(203) 932-5711
Deepak D'Souza, MD MBBS (PRINCIPAL_INVESTIGATOR)
Providence VA Medical Center, Providence, RIProvidenceRhode Island02908-4734
Jane Metrik, PhD
[email protected]
401-273-7100
South Texas Health Care System, San Antonio, TXSan AntonioTexas78229-4404
Muhammad Baig, MD
[email protected]
210-617-5300
VA Puget Sound Health Care System Seattle Division, Seattle, WASeattleWashington98108-1532-

Find similar trials in San Diego, CA

By research site
VA San Diego Healthcare System, San Diego, CA· San Diego, CAVA Greater Los Angeles Healthcare System, West Los Angeles, CA· West Los Angeles, CAVA Connecticut Healthcare System West Haven Campus, West Haven, CT· West Haven, CTProvidence VA Medical Center, Providence, RI· Providence, RISouth Texas Health Care System, San Antonio, TX· San Antonio, TXVA Puget Sound Health Care System Seattle Division, Seattle, WA· Seattle, WA

Related Studies