Ignite Creation Date:
2024-05-06 @ 6:23 PM
Last Modification Date:
2024-10-26 @ 2:47 PM
Study NCT ID:
NCT05644054
Status:
RECRUITING
Last Update Posted:
2024-03-26
First Post:
2022-11-21
Brief Title:
The Impact of THC on Pain Modulation in Fibromyalgia
Sponsor:
Tel Aviv Medical Center
Organization:
Tel Aviv Medical Center
Study Overview
Official Title:
The Impact of THC on Pain Modulation in Fibromyalgia A Cross-Over Randomized Double-Blind Placebo-Controlled Study
Status:
RECRUITING
Status Verified Date:
2024-03
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:
The objective of this cross-sectional double-blind placebo-controlled clinical trial is to enhance our understanding of the pain modulation mechanisms in females diagnosed with Fibromyalgia syndrome FMS
This study is designed to address several key questions
1 Is there a discernible difference in the effectiveness of the two prevalent pain modulation approaches namely Conditioned Pain Modulation CPM and Offset Analgesia OA in individuals with FMS To answer this both FMS patients and an age- and sex-matched healthy control group will engage in these paradigms outside of the MRI scanner
2 How does Tetrahydrocannabinol THC influence CPM and OA in FMS patients Here the study will observe the performance of FMS patients in both paradigms after receiving treatments with THC and a placebo conducted outside the scanner
3 What neural alterations in pain modulation circuits are triggered by THC To investigate this FMS patients will undergo the OA test inside the MRI scanner following both THC and placebo treatments
4 How does THC affect resting-state brain function in FMS patients This part of the study involves resting-state brain scans to measure changes in functional connectivity following treatments with THC and a placebo
This study is designed to address several key questions
1 Is there a discernible difference in the effectiveness of the two prevalent pain modulation approaches namely Conditioned Pain Modulation CPM and Offset Analgesia OA in individuals with FMS To answer this both FMS patients and an age- and sex-matched healthy control group will engage in these paradigms outside of the MRI scanner
2 How does Tetrahydrocannabinol THC influence CPM and OA in FMS patients Here the study will observe the performance of FMS patients in both paradigms after receiving treatments with THC and a placebo conducted outside the scanner
3 What neural alterations in pain modulation circuits are triggered by THC To investigate this FMS patients will undergo the OA test inside the MRI scanner following both THC and placebo treatments
4 How does THC affect resting-state brain function in FMS patients This part of the study involves resting-state brain scans to measure changes in functional connectivity following treatments with THC and a placebo
Detailed Description:
Fibromyalgia syndrome FMS is a condition marked by pervasive chronic pain throughout the musculoskeletal system often accompanied by chronic sleep disturbances fatigue memory challenges and more Despite significant advancements in the understanding of pain mechanisms due to breakthroughs in neuroscience and pain medicine current treatments for FMS fall short of providing adequate relief leaving many patients battling ongoing pain and related symptoms
The complete pathophysiology of FMS remains elusive but there is substantial evidence indicating the involvement of various factors including central sensitization and impaired descending pain modulation pathways as evidenced by functional imaging studies and sensory tests such as conditioned pain modulation CPM and offset analgesia OA Given this comprehending the pathophysiology of FMS and the mechanisms involved is crucial Additionally it is critical to understand how new treatments can influence pain modulation in FMS
Recent research increasingly supports the use of cannabis particularly Tetrahydrocannabinol THC for alleviating chronic pain in various syndromes Yet theres a lack of extensive research exploring its effectiveness in randomized double-blind trials Exploring THCs effects in clinical pain models could enhance our understanding of pain regulation in FMS
The current study aims to deepen our understanding of sensory and neural mechanisms in FMS employing quantitative sensory testing such as CPM and OA and fMRI A key objective is to ascertain the impact of THC on pain modulation in FMS within a double-blind controlled framework
The complete pathophysiology of FMS remains elusive but there is substantial evidence indicating the involvement of various factors including central sensitization and impaired descending pain modulation pathways as evidenced by functional imaging studies and sensory tests such as conditioned pain modulation CPM and offset analgesia OA Given this comprehending the pathophysiology of FMS and the mechanisms involved is crucial Additionally it is critical to understand how new treatments can influence pain modulation in FMS
Recent research increasingly supports the use of cannabis particularly Tetrahydrocannabinol THC for alleviating chronic pain in various syndromes Yet theres a lack of extensive research exploring its effectiveness in randomized double-blind trials Exploring THCs effects in clinical pain models could enhance our understanding of pain regulation in FMS
The current study aims to deepen our understanding of sensory and neural mechanisms in FMS employing quantitative sensory testing such as CPM and OA and fMRI A key objective is to ascertain the impact of THC on pain modulation in FMS within a double-blind controlled framework
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None