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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 20
Maximum Age: 60
Healthy Volunteers: f
View:

• Diagnosed with fibromyalgia for over 3 months according to American college of rheumatology

• Do not respond well to analgesic medications and or have severe side effects

• Medium to high level of pain (over 40 on visual analogue scale scale)

• Does not have other pain-related syndromes

• Not treated regularly with cannabis.

• Is ready to stop taking central nervous system medications 3 days prior to the experiment.

Locations
Other Locations
Israel
Tel Aviv Medical Center
RECRUITING
Tel Aviv
Contact Information
Primary
Yara Agbaria
yaraa@tlvmc.gov.il
972522839351
Backup
Jacob Ablin, MD
jacobab@tlvmc.gov.il
972524266774
Time Frame
Start Date: 2023-01-01
Estimated Completion Date: 2024-12
Participants
Target number of participants: 40
Treatments
Experimental: Treatment (THC) - session 1
Patients will attend two sessions in a crossover design, where they will receive one of the drugs in a randomized sequence at each session.
Placebo_comparator: Placebo - session 2
Patients will attend two sessions in a crossover design, where they will receive one of the drugs in a randomized sequence at each session.
Related Therapeutic Areas
Sponsors
Leads: Tel Aviv Medical Center

This content was sourced from clinicaltrials.gov