Proof of Concept Trial of Cannabis Derivatives in Neuropathic Pain

Description

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

Diabetic Neuropathic Pain, Peripheral Neuropathic Pain

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Study Overview

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Study Details

Study overview

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.

Proof of Concept Trial of Cannabis Derivatives in Neuropathic Pain

Proof of Concept Trial of Cannabis Derivatives in Neuropathic Pain

Condition
Diabetic Neuropathic Pain
Intervention / Treatment

-

Contacts and Locations

San Diego

VA San Diego Healthcare System, San Diego, CA, San Diego, California, United States, 92161-0002

West Haven

VA Connecticut Healthcare System West Haven Campus, West Haven, CT, West Haven, Connecticut, United States, 06516-2770

Providence

Providence VA Medical Center, Providence, RI, Providence, Rhode Island, United States, 02908-4734

San Antonio

South Texas Health Care System, San Antonio, TX, San Antonio, Texas, United States, 78229-4404

Seattle

VA Puget Sound Health Care System Seattle Division, Seattle, WA, Seattle, Washington, United States, 98108-1532

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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

Ages Eligible for Study

21 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

VA Office of Research and Development,

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

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

Study Record Dates

2027-06-30