Exploring THC's effects on pain modulation in fibromyalgia
The Impact of THC on Pain Modulation in Fibromyalgia: A Cross-Over, Randomized, Double-Blind Placebo-Controlled Study
NA · Tel Aviv Medical Center · NCT05644054
This study is testing whether THC can help reduce pain in women with fibromyalgia by comparing its effects to a placebo while also looking at changes in the brain.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 20 Years to 60 Years |
| Sex | Female |
| Sponsor | Tel Aviv Medical Center (other) |
| Locations | 1 site (Tel Aviv) |
| Trial ID | NCT05644054 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates how Tetrahydrocannabinol (THC) affects pain modulation in females diagnosed with fibromyalgia syndrome (FMS). It employs a cross-sectional, double-blind, placebo-controlled design to compare the effectiveness of two pain modulation approaches, Conditioned Pain Modulation (CPM) and Offset Analgesia (OA). Participants will undergo sensory testing outside of an MRI scanner after receiving either THC or a placebo, with additional MRI assessments to observe neural changes. The study aims to enhance understanding of the mechanisms behind pain in FMS and the potential role of THC in treatment.
Who should consider this trial
Good fit: Ideal candidates are females diagnosed with fibromyalgia for over three months who experience medium to high levels of pain and have not responded well to analgesic medications.
Not a fit: Patients with other pain-related syndromes, significant anxiety, or those currently using cannabis may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide new insights into effective pain management strategies for patients with fibromyalgia.
How similar studies have performed: While there is growing interest in THC for chronic pain management, this specific approach in fibromyalgia is relatively novel and has not been extensively tested in randomized trials.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Tel Aviv
- Tel Aviv Medical Center — Tel Aviv, Israel (RECRUITING)
Study contacts
- Principal investigator: Jacob Ablin, MD — Tel-Aviv Sourasky Medical Center
- Study coordinator: Yara Agbaria
- Email: yaraa@tlvmc.gov.il
- Phone: 972522839351
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Fibromyalgia, Primary