Ignite Creation Date:
2024-05-06 @ 5:34 PM
Last Modification Date:
2024-10-26 @ 2:31 PM
Study NCT ID:
NCT05351801
Status:
RECRUITING
Last Update Posted:
2023-12-29
First Post:
2022-04-08
Brief Title:
Proof of Concept Trial of Cannabis Derivatives in Neuropathic Pain
Sponsor:
VA Office of Research and Development
Organization:
VA Office of Research and Development
Study Overview
Official Title:
Proof of Concept Trial of Cannabis Derivatives in Neuropathic Pain
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
Detailed Description:
Chronic pain is a significant burden to United States Veterans and is a particular concern for Veterans One of the causes of pain is chronic neuropathic pain CNP Frontline treatment for CNP show inconsistent outcomes and have significant side effects The ongoing opioid crisis has led to significant interest in safe and effective alternatives for pain control and there is a significant need for research on desirable options for pain control that are likely to improve treatment adherence and outcomes Veterans groups and Veterans Affairs clinicians have expressed significant interest in cannabis and its principal constituents delta-9-tetrahydrocannabinol THC cannabidiol CBD for pain management but the extant research describing the potential risks and benefits of cannabis for pain is weak This randomized trial was developed as a proof of concept study to determine if cannabis constituents THC CBD and THCCBD are superior to placebo in reducing pain in Veterans with CNP The study is to recruit a sample of 320 adult Veterans who meet diagnostic criteria for high-impact CNP are on stable treatments for CNP are not current cannabis users and who do not meet diagnostic criteria for Cannabis Use Disorder This randomized phase II 4-arm clinical trial aims to determine if cannabis constituents THC CBD or their combination THCCBD are superior to placebo in reducing pain in Veterans with CNP This trial will offer the first evidence describing the potential benefits and adverse effects of cannabinoids for CNP in Veterans
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None