Phase 2 Peripheral Neuropathy Trial, Recruiting NCT05351801 Sponsor: VA Office of Research and Development Condition: Peripheral Neuropathy
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Phase 2 Peripheral Neuropathy Trial, Recruiting

NCT05351801
Recruiting Phase 2

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • People who are able to give written consent to participate
  • Veterans aged 21 years or older at the time of screening
  • People who have been diagnosed with neuropathic pain (nerve pain) according to the criteria set by the Neuropathic Pain Special Interest Group of the International Association for the Study of Pain
  • People whose pain is persistent and has a high impact on daily life
  • People who have allodynia (pain caused by things that do not normally cause pain, such as light touch) confirmed by a specific brush test done during screening
  • Women who are able to become pregnant and agree to follow the contraception requirements of the trial

Who may not be able to join:

  • People who are currently using, or planning to start, an invasive non-medication treatment for pain at the time of enrolment
  • People whose neuropathic pain is not primarily caused by damage to the nerves in the peripheral nervous system (the nerves outside the brain and spinal cord)
  • People who have a known sensitivity or allergic reaction to THC, CBD, or a combination of THC and CBD
  • People who report using cannabis during the screening phase, or whose urine test at visit 5 (before randomisation) shows evidence of cannabis use
  • People who are unwilling to avoid cannabis or cannabis-based products for the entire duration of the study
  • People who have been diagnosed with Cannabis Use Disorder (as defined by DSM-5) in the past 6 months
  • People who currently have a DSM-5 diagnosis of cannabis use disorder, any other substance use disorder, or a serious psychiatric condition
  • People whose pain medications or non-medication pain treatments have changed, or are planned to change, by more than 20% (either up or down) in the 4 weeks before screening through to the end of the study
  • People taking opioid medications at a total daily dose above 400 mg morphine milligram equivalent (a standard measure used to compare opioid doses)
  • Women who are pregnant, breastfeeding, or who plan to become pregnant within 12 weeks of enrolment
  • People with any current unstable or significant medical condition that could increase health risks, including conditions affecting the liver, lungs, immune system, heart, hormonal system, or kidneys — or any condition that, in the investigator's judgement, would make it difficult to follow the study protocol
  • People who need immediate admission to a psychiatric facility
  • People who are currently enrolled in a medical marijuana programme
  • People who are employed as federal employees

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 9 July 2026
Phase 2: approximately ~30% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Principal Investigator: Deepak D'Souza, MD MBBS, VA Connecticut Healthcare System West Haven Campus, West Haven, CT

Phone: (203) 932-5711

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 2
Registry
ClinicalTrials.gov
Start date
21 June 2023
Est. completion
29 September 2028

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

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

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 9 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov