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

TLV-16-320

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.

2023-01-01

2024-04-01

2024-12-01

Recruiting

40

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

{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'A Cross-Over, Double-Blind Placebo-Controlled Study', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'maskingDescription': 'Neither the participants nor the investigators will be aware of the drug being administered.', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 40, 'type': 'ESTIMATED'}}

2024-03-26