Center for Functional MRI - W.M.Keck Building
La Jolla, California, 92093, United States
Location status: Recruiting
Location contact
Fadel Zeidan, PhD
PRINCIPAL_INVESTIGATOR
Madelynn Meredith, BS
CONTACT
Yasmeen Esshaki, MA
CONTACT
NCT Number: NCT04982965
Chronic low back pain is a common and disabling condition that affects millions of people in the United States. Many people with chronic low back pain do not get enough relief from current treatments. Cannabis may help reduce pain, but researchers do not fully understand how it affects the brain in people with chronic pain. The purpose of this study is to examine how inhaled cannabis changes brain activity and reduces pain in people with chronic low back pain. Results from this study may help researchers better understand how cannabis works for pain and support the development of improved pain treatments.
Interested in participating?
Request Info21 year–65 year
All sexes
Interventional
Early Phase 1
La Jolla, California, 92093, United States
Location status: Recruiting
Fadel Zeidan, PhD
PRINCIPAL_INVESTIGATOR
Madelynn Meredith, BS
CONTACT
Yasmeen Esshaki, MA
CONTACT
Chronic low back pain is one of the most common causes of pain and disability in adults. Unfortunately, treatments that can directly reduce chronic low back pain remain limited. Cannabis has shown promise for pain relief, but researchers do not yet fully understand how it affects the brain or reduces pain in people with chronic pain.
The purpose of this study is to examine how inhaled (vaporized, not smoked) cannabis affects pain responses and brain activity in adults with chronic low back pain. Researchers will compare the effects of cannabis containing tetrahydrocannabinol (THC) to a placebo cannabis containing 0% THC.
This study involves one visit to the Keck Center for Functional MRI at UC San Diego. Participants will complete screening procedures, questionnaires, and pain testing using heat stimulation applied to the calf. Participants will be trained to rate their pain intensity and unpleasantness. A straight leg raise maneuver will also be performed to assess low back pain and any pain radiating down the leg.
Participants will inhale either THC-containing cannabis or placebo cannabis (no THC) using a vaporization device under study staff supervision. Brain imaging, heat pain testing, leg raise assessments, and pain ratings will be collected before and after cannabis administration to evaluate changes in pain processing and brain activity. Researchers will also assess self-reported pain, mood, sleep, stress, and cannabis-related effects using standardized questionnaires.
This study may improve understanding of how cannabis influences the brain and pain systems in people with chronic low back pain, and findings may help support the development of improved treatments for chronic pain.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
400 mg of vaporized and inhaled active cannabis (5.1%)
400 mg of vaporized and inhaled placebo cannabis (<.1%)
Other names: Non-Active cannabis
Time frame: All data will be collected at the single study session (Day 1).
Changes in brain blood flow and oxygen levels will be measured using non-invasive MRI-based brain imaging methods. These scans will assess how much blood is reaching brain tissue and how oxygen levels in the brain change over time.
Time frame: All data will be collected at the single study session (Day 1).
Pain ratings will be assessed in response to noxious heat stimulation. Pain intensity and pain unpleasantness will be measured using a 0-10 Visual Analog Scale (VAS), where 0 indicates "no pain" and 10 indicates "most intense imaginable pain" or "most unpleasant imaginable pain." Higher scores indicate greater pain intensity or unpleasantness. Subjective response to cannabis will be assessed using a 0-10 Numeric Rating Scale (NRS), with higher scores indicating greater subjective effects.
Time frame: All data will be collected at the single study session (Day 1).
We will use a specialized, non-invasive brain scan called proton magnetic resonance spectroscopy (1H-MRS) to measure certain brain chemicals linked to pain processing, including glutamate, GABA, and myo-inositol. The scan uses radiofrequency signals (sim
Time frame: All data will be collected at the single study session (Day 1).
Changes in breathing rate may be associated with pain relief and improved well-being. Breathing rate will be monitored continuously in real time to ensure accurate data collection.
Time frame: All data will be collected at the single study session (Day 1).
THC concentrations will be measured to evaluate the relationship between THC levels and pain relief.
Contact information is provided by the study sponsor or research team.
Madelynn Meredith, BS
CONTACT
Yasmeen Esshaki, MA
CONTACT
University of California, San Diego
Other
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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