Fibromyalgia, Primary Clinical Trial
Official title:
The Impact of THC on Pain Modulation in Fibromyalgia: A Cross-Over, Randomized, Double-Blind Placebo-Controlled Study
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.
Status | Recruiting |
Enrollment | 40 |
Est. completion date | December 2024 |
Est. primary completion date | April 2024 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 20 Years to 60 Years |
Eligibility | Inclusion Criteria: 1. Diagnosed with fibromyalgia for over 3 months according to American college of rheumatology 2. Do not respond well to analgesic medications and or have severe side effects 3. Medium to high level of pain (over 40 on visual analogue scale scale) 4. Does not have other pain-related syndromes 5. Not treated regularly with cannabis. 6. Is ready to stop taking central nervous system medications 3 days prior to the experiment. Exclusion Criteria: 1. alleviated levels of anxiety (above 52 in STAI) 2. Psychiatric medications due to psychiatric diagnoses (depression, bi-polar syndrome, etc.). 3. Cardiovascular problems 4. Neurological diseases (other than migraine). 5. Pregnancy or breastfeeding 6. Alcoholism or substance abuse 7. Cancer 8. Blood pressure problems 9. Patients that used cannabis in the past month 10. Illegibility to MRI |
Country | Name | City | State |
---|---|---|---|
Israel | Tel Aviv Medical Center | Tel Aviv |
Lead Sponsor | Collaborator |
---|---|
Tel Aviv Medical Center |
Israel,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Functional Connectivity (FC) | The variations in FC measured during the resting-state scan will be assessed using within-between network connectivity at baseline and following treatments with either THC or a placebo in FMS patients. | 2 hours after drug administration | |
Primary | Blood Oxygenation Level (BOLD) | The variations in BOLD activity measured during the sensory test will be assessed using ROI to ROI analysis at baseline and following treatments with either THC or a placebo in FMS patients. | 2 hours after drug administration | |
Primary | Quantitative Sensory Tests: Conditioned pain modulation (CPM) and offset analgesia (OA) magnitude | Baseline assessments of CPM and OA magnitude will be conducted for both FMS patients and their corresponding healthy control group. Furthermore, the magnitude of these tests will also be evaluated after administering either THC or placebo treatments in FMS patients. | 2 hours after drug administration |
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