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New treatment option for Neuropathic Pain
Official title Proof of Concept Trial of Cannabis Derivatives in Neuropathic Pain
ClinicalTrials.gov ID: NCT05351801
What this study is testing
What is THC (Syndros)?
THC (Syndros) is an investigational medicine, being studied as a potential treatment for neuropathic pain.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Chronic neuropathic pain (CNP) is disabling. Research on frontline treatments for CNP, shows inconsistent outcomes and dissatisfaction among Veterans.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 21 and older
You may be able to join if
- 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...
- Meet criteria for persistent, high-impact pain criteria.
- Presence of allodynia confirmed by one of the screening dynamic brush tests
You likely can't join if
- 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...
- 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
See the full 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
- women of childbearing potential who agree to abide by contraceptive requirements
- 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...
- 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...
- Need for immediate psychiatric hospitalization
- Enrolled in a medical marijuana program
- Federal employee
The study team makes the final eligibility decision.
Where it's taking place
- San Diego, California, United States
- West Los Angeles, California, United States
- West Haven, Connecticut, United States
- Providence, Rhode Island, United States
- San Antonio, Texas, United States
- Seattle, Washington, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 21 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include San Diego, California, United States; West Los Angeles, California, United States; West Haven, Connecticut, United States; Providence, Rhode Island, United States; San Antonio, Texas, United States; Seattle, Washington, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.