MedTrace Logo

Proof of Concept Trial of Cannabis Derivatives in Neuropathic Pain

NCT05351801 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 320

Last updated 2026-02-27

No results posted yet for this study

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.

Conditions

  • Neuropathic Pain
  • Peripheral Neuropathic Pain

Interventions

DRUG

THC (Syndros)

Participants will receive a target dose of 10mg per day of THC (Syndros).

DRUG

CBD (Epidolex)

Participants will receive a target dose of 800 mg per day of CBD (Epidolex).

DRUG

THC + CBD (Nabiximols)

Participants will receive a target dose of 10.8 mg / 10 mg per day of THC + CBD (Nabiximols).

DRUG

Placebo

Placebo

Sponsors & Collaborators

  • VA Office of Research and Development

    lead FED

Principal Investigators

  • Deepak D'Souza, MD MBBS · VA Connecticut Healthcare System West Haven Campus, West Haven, CT

  • Donald McGeary, PhD · South Texas Health Care System, San Antonio, TX

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-06-21
Primary Completion
2028-09-29
Completion
2029-05-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05351801 on ClinicalTrials.gov