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Cannabinoid
Cannabis Derivatives for Diabetic Neuropathy
Phase 2
Waitlist Available
Led By Deepak D'Souza, MD MBBS
Research Sponsored by VA Office of Research and Development
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Meet criteria for persistent, high-impact pain criteria.
Veterans 21 years and older at the date of screening
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, week 1, week 2, week 3, week 4, week 5, week 6, week 7, week 8
Awards & highlights
Study Summary
This trial will help to understand if cannabis derivatives could help veterans with diabetes who experience disabling chronic diabetic neuropathic pain.
Who is the study for?
This trial is for Veterans aged 21+ with diabetic neuropathic pain who can consent to participate. They must have allodynia, meet NEURODIAB criteria for painful diabetic peripheral neuropathy, and experience persistent high-impact pain. Excluded are federal employees, those needing psychiatric hospitalization, pregnant or breastfeeding women, individuals using cannabis products or with a recent history of Cannabis Use Disorder.Check my eligibility
What is being tested?
The study tests the effects of THC (Dronabinol), CBD (Epidolex), their combination (Nabiximols), and placebo on chronic diabetic neuropathic pain in Veterans. It's a phase II trial with four groups randomly assigned in a double-blind manner to determine potential benefits and adverse effects.See study design
What are the potential side effects?
Possible side effects include hypersensitivity reactions to THC/CBD, changes in mood or behavior due to THC use such as euphoria or sedation, digestive issues like nausea or diarrhea from CBD intake, and general discomfort that may arise from either substance.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I experience constant, severe pain.
Select...
I am a veteran aged 21 or older.
Select...
I have been diagnosed with painful nerve damage due to diabetes.
Select...
I experience constant, severe pain.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, week 1, week 2, week 3, week 4, week 5, week 6, week 7, week 8
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, week 1, week 2, week 3, week 4, week 5, week 6, week 7, week 8
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
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
Secondary outcome measures
Cannabidiol
To assess the efficacy of THC, CBD, or THC+CBD vs Placebo in disability and function as measured by the Gait Speed Test
To assess the efficacy of THC, CBD, or THC+CBD vs Placebo in disability and function as measured by the Neuropathic Pain Scale.
+8 moreTrial Design
4Treatment groups
Active Control
Placebo Group
Group I: THC (Dronabinol)Active Control2 Interventions
Target dose of 10mg per day.
Group II: CBD (Epidolex)Active Control2 Interventions
Target dose of 800 mg per day.
Group III: THC + CBD (Nabiximols)Active Control2 Interventions
Target dose of 10.8 mg / 10 mg per day.
Group IV: PlaceboPlacebo Group1 Intervention
Identical in appearance to the three active comparators.
Find a Location
Who is running the clinical trial?
VA Office of Research and DevelopmentLead Sponsor
1,609 Previous Clinical Trials
3,306,582 Total Patients Enrolled
Deepak D'Souza, MD MBBSPrincipal InvestigatorVA Connecticut Healthcare System West Haven Campus, West Haven, CT
1 Previous Clinical Trials
49 Total Patients Enrolled
Donald McGeary, PhDPrincipal InvestigatorSouth Texas Health Care System, San Antonio, TX
1 Previous Clinical Trials
192 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You experience pain when touched lightly with a brush during a screening test.You need to be hospitalized for psychiatric reasons right away.You have been diagnosed with Cannabis Use Disorder in the past 6 months according to DSM-5.I experience constant, severe pain.My main source of pain is not due to diabetic nerve damage.I am a veteran aged 21 or older.I have been diagnosed with painful nerve damage due to diabetes.I experience constant, severe pain.You have tested positive for marijuana in your urine on two separate occasions before the start of the study.I take more than 400 mg of pain medication in morphine equivalents daily.I am not pregnant, breastfeeding, nor planning to become pregnant soon.You are allergic to THC, CBD, or a combination of THC and CBD.I haven't changed my pain medication or treatment by more than 20% in the last 4 weeks.I do not have any severe health issues that could increase my risk during the trial.You currently have a diagnosis for cannabis or substance use disorder, or serious mental health conditions according to the DSM-5.You are currently part of a medical marijuana program.
Research Study Groups:
This trial has the following groups:- Group 1: THC (Dronabinol)
- Group 2: CBD (Epidolex)
- Group 3: THC + CBD (Nabiximols)
- Group 4: Placebo
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Diabetic Neuropathy Patient Testimony for trial: Trial Name: NCT05351801 — Phase 2
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there still available positions for participants in this experiment?
"From clinicaltrials.gov, it appears that this particular medical trial is not currently accepting participants. Initially posted on December 1st 2022 and last updated August 12th 2022, the study has yet to begin recruiting patients; however, there are still 160 other trials actively doing so."
Answered by AI
How many local venues have been enlisted to conduct this trial?
"This research is currently being conducted at 5 different clinical sites, including San Antonio, West Haven and San Diego. If you choose to participate in the trial, it may be prudent to select a nearby site so as to diminish travel requirements."
Answered by AI
Who else is applying?
What state do they live in?
Texas
California
How old are they?
18 - 65
What site did they apply to?
Providence VA Medical Center, Providence, RI
South Texas Health Care System, San Antonio, TX
VA San Diego Healthcare System, San Diego, CA
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0
Why did patients apply to this trial?
I’m tired of being in pain constantly.
PatientReceived no prior treatments
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