Recruiting
Phase 2

Cannabis Derivatives

Sponsor:

VA Office of Research and Development

Code:

NCT05351801

Conditions

Neuropathic Pain

Peripheral Neuropathic Pain

Eligibility Criteria

Sex: All

Age: 21+

Healthy Volunteers: Not accepted

Interventions

THC (Syndros)

CBD (Epidolex)

THC + CBD (Nabiximols)

Placebo

Study Details

Brief 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

Study ID

NCT05351801

Start date

Jun 21, 2023

Status verified date

Feb, 2026

Completion date

May 31, 2029

Anticipated

Primary completion date

Sep 29, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

320 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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.

Interventions

THC (Syndros)

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

CBD (Epidolex)

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

THC + CBD (Nabiximols)

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

Placebo

Placebo

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 and Locations

Central contacts

Courtney C DiCocco

(203) 932-5711Courtney.DiCocco@va.gov

Mohini Ranganathan, MD

(203) 932-5711Mohini.Ranganathan@va.gov

Locations

VA San Diego Healthcare System, San Diego, CA

Recruiting

San Diego, California, United States, 92161-0002

Contacts

Albert Leung, MD

858-642-3029albert.leung@va.gov

VA Connecticut Healthcare System West Haven Campus, West Haven, CT

Recruiting

West Haven, Connecticut, United States, 06516-2770

Contacts

Deepak D'Souza, MD MBBS

(203) 932-5711Deepak.DSouza@va.gov

Principal Investigator:

Deepak D'Souza, MD MBBS

Providence VA Medical Center, Providence, RI

Recruiting

Providence, Rhode Island, United States, 02908-4734

Contacts

Jane Metrik, PhD

401-273-7100jane.metrik@va.gov

South Texas Health Care System, San Antonio, TX

Recruiting

San Antonio, Texas, United States, 78229-4404

Contacts

Muhammad Baig, MD

210-617-5300muhammad.baig@va.gov

More Information

Sponsor

VA Office of Research and Development

Last update posted

Feb 27, 2026

Last verified

Feb, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by VA Office of Research and Development on 2026-02-27.