# Proof of Concept Trial of Cannabis Derivatives in Neuropathic Pain.

> **NIH VA I01** · VA CONNECTICUT HEALTHCARE SYSTEM · 2024 · —

## Abstract

ABSTRACT
Chronic pain is a significant burden to United States Veterans and is a particular concern for Veterans with
diabetes. Diabetic Veterans have a higher risk of chronic diabetic peripheral neuropathy (CDNP) than civilians
with diabetes, and CDNP is more disabling for Veterans than it is for civilians. Frontline treatment for CDNP,
including enhanced glycemic control, exercise, and pharmacotherapies, show inconsistent outcomes for
individuals with CDNP due to poor adherence and side effects. The ongoing opioid crisis has led to significant
interest in safe and effective alternatives for pain control, and there is a significant need for research on
desirable options for pain control that are likely to improve treatment adherence and outcomes. Veterans
groups and Veterans Affairs clinicians have expressed significant interest in cannabis and its principal
constituents (delta-9-tetrathydrocannabinol, THC; cannabidiol, CBD) for pain management, but the extant
research describing the potential risks and benefits of cannabis for pain is weak. The present study represents
the first significant effort to examine the potential benefits and risks of cannabinoids for Veterans with CDNP
through a collaboration between a nationally-recognized cannabis research expert (Dr. D’Souza), a Veteran
chronic pain research expert (Dr. McGeary), the Hines Cooperative Studies Program Coordinating Center, and
the Albuquerque Cooperative Studies Program Clinical Research Pharmacy Coordinating Center. This
research collaboration was developed to meaningfully expand on the extant research using a 4-arm,
randomized, double-blind, placebo-controlled, parallel group design. This randomized trial was developed as a
proof of concept study to determine if cannabis constituents (THC, CBD) or their combination (THC+CBD) are
superior to placebo in reducing pain in Veterans with CDNP. Additionally, this will weigh the safety and
tolerability of the interventions against the identified efficacy. The investigators will work with 5 VAMCs to
recruit a sample of 320 adult Veterans who meet diagnostic criteria for high-impact CDNP, are on stable
treatment(s) for CDNP, are not current cannabis users and who do not meet diagnostic criteria for Cannabis
Use Disorder. Enrolled Veterans will be randomly assigned to one of four study arms: 1) 5 mg THC P.O BID; 2)
400 mg CBD P.O BID; 3) 5mg THC + 5 mg CBD P.O BID; or 4) placebo P.O BID. Participants will complete a
2-week titration phase (to minimize side effects and improve tolerability) followed by 4 weeks on the target
treatment dose and a subsequent 2-week down titration (to minimize cannabis withdrawal symptoms). The
primary outcome of this research is mean change in Numeric Rating Scale of pain (NRS) based on a
standardized pain diary completed three times daily producing an average daily pain score. Secondary
outcomes include measures of pain quality, functioning/disability, health-related quality of life, perceived
improvement and tr...

## Key facts

- **NIH application ID:** 10928077
- **Project number:** 5I01CX002378-03
- **Recipient organization:** VA CONNECTICUT HEALTHCARE SYSTEM
- **Principal Investigator:** DEEPAK Cyril D'SOUZA
- **Activity code:** I01 (R01, R21, SBIR, etc.)
- **Funding institute:** VA
- **Fiscal year:** 2024
- **Award amount:** —
- **Award type:** 5
- **Project period:** 2022-04-01 → 2027-03-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10928077

## Citation

> US National Institutes of Health, RePORTER application 10928077, Proof of Concept Trial of Cannabis Derivatives in Neuropathic Pain. (5I01CX002378-03). Retrieved via AI Analytics 2026-05-24 from https://api.ai-analytics.org/grant/nih/10928077. Licensed CC0.

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