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Search / Trial NCT05644054

The Impact of THC on Pain Modulation in Fibromyalgia

Launched by TEL AVIV MEDICAL CENTER · Dec 1, 2022

Trial Information

Current as of January 14, 2025

Recruiting

Keywords

ClinConnect Summary

This clinical trial is studying how a compound called Tetrahydrocannabinol (THC), found in cannabis, affects pain in women with fibromyalgia, a condition that causes widespread pain. The researchers want to learn more about how THC changes the way the brain processes pain and whether it can improve pain management compared to a placebo (a treatment with no active ingredients). Participants will take THC or a placebo and undergo various tests to see how well they respond to different pain modulation techniques. They will also have brain scans to observe any changes in brain activity after the treatments.

To be eligible for this study, participants must be women diagnosed with fibromyalgia for at least three months who experience significant pain and have not found relief with other pain medications. They should not be using cannabis or other central nervous system medications before the study. Throughout the trial, participants can expect to take either THC or a placebo, participate in pain tests, and undergo MRI brain scans to help researchers understand how THC might change pain perception and brain function. This trial is actively recruiting participants and aims to provide new insights into pain management for those suffering from fibromyalgia.

Gender

FEMALE

Eligibility 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

Trial Officials

Jacob Ablin, MD

Principal Investigator

Tel-Aviv Sourasky Medical Center

About Tel Aviv Medical Center

Tel Aviv Medical Center is a leading healthcare institution in Israel, renowned for its commitment to advancing medical research and patient care. As a prominent clinical trial sponsor, the center fosters innovative studies across diverse therapeutic areas, leveraging its state-of-the-art facilities and a multidisciplinary team of expert researchers and clinicians. With a strong emphasis on ethical standards and patient safety, Tel Aviv Medical Center aims to contribute significantly to the development of new treatments and technologies that enhance health outcomes and improve the quality of life for patients globally.

Locations

Tel Aviv, , Israel

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0

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