RECRUITING

Proof of Concept Trial of Cannabis Derivatives in Neuropathic Pain

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

Proof of Concept Trial of Cannabis Derivatives in Neuropathic Pain

Quick Facts

Study Start:2023-06-21
Study Completion:2027-06-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05351801

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.

Ages Eligible for Study:21 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Able to provide written consent
  2. * Veterans 21 years and older at the date of screening
  3. * 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)
  4. * Meet criteria for persistent, high-impact pain criteria.
  5. * Presence of allodynia confirmed by one of the screening dynamic brush tests
  1. * Peripheral neuropathy is not a primary source of neuropathic pain
  2. * Hypersensitivity to THC, CBD, or THC/CBD
  3. * 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
  4. * Unwilling to refrain from using cannabis or cannabis-based products through the entire duration of the study
  5. * Diagnosis of DSM-5 Cannabis Use Disorder in the past 6 months
  6. * Current DSM-5 diagnosis of cannabis use disorder, substance use disorder or serious psychiatric disorders
  7. * 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)
  8. * Opioid doses \> 400 mg MME (morphine milligram equivalent)
  9. * Women who are pregnant or breastfeeding, or who intend to become pregnant in the 12 weeks from enrollment
  10. * 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
  11. * Need for immediate psychiatric hospitalization
  12. * Enrolled in a medical marijuana program
  13. * Federal employee

Contacts and Locations

Study Contact

Courtney C DiCocco
CONTACT
(203) 932-5711
Courtney.DiCocco@va.gov
Mohini Ranganathan, MD
CONTACT
(203) 932-5711
Mohini.Ranganathan@va.gov

Principal Investigator

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 Locations (Sites)

VA San Diego Healthcare System, San Diego, CA
San Diego, California, 92161-0002
United States
VA Connecticut Healthcare System West Haven Campus, West Haven, CT
West Haven, Connecticut, 06516-2770
United States
Providence VA Medical Center, Providence, RI
Providence, Rhode Island, 02908-4734
United States
South Texas Health Care System, San Antonio, TX
San Antonio, Texas, 78229-4404
United States
VA Puget Sound Health Care System Seattle Division, Seattle, WA
Seattle, Washington, 98108-1532
United States

Collaborators and Investigators

Sponsor: 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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-06-21
Study Completion Date2027-06-30

Study Record Updates

Study Start Date2023-06-21
Study Completion Date2027-06-30

Terms related to this study

Additional Relevant MeSH Terms

  • Diabetic Neuropathic Pain
  • Peripheral Neuropathic Pain