NCT05644054

The Impact of THC on Pain Modulation in Fibromyalgia

The Impact of THC on Pain Modulation in Fibromyalgia: A Cross-Over, Randomized, Double-Blind Placebo-Controlled Study

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Tel Aviv Medical Center · Academic / Other
• Sex: Female
• Age: 20 Years – 60 Years
• Healthy volunteers: Not accepted

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.

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, there's a lack of extensive research exploring its effectiveness in randomized, double-blind trials. Exploring THC's 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.

Conditions

• Fibromyalgia, Primary

Interventions

Type	Name	Description
DRUG	THC	Patients will be administered a one-time dosage of 0.2 mg/kg THC oil (AXIBAN, T10/C2, manufactured by Panaxia Pharmaceuticals, Lod, Israel)
DRUG	Placebo	Patients will be administered a one-time dosage of 0.2 mg/kg of a placebo consisting of an inactive oil.

Timeline

• Start date: 2023-01-01
• Primary completion: 2024-04-01
• Completion: 2024-12-01
• First posted: 2022-12-09
• Last updated: 2024-03-26

Locations

1 site across 1 country: Israel