RecruitingEarly Phase 1

Brain Mechanisms Supporting Cannabis-induced Pain Relief

United States100 participantsStarted 2021-05-07

Plain-language summary

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.

Who can participate

Age range

21 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Between 21-65 years old * Currently 30 days cannabis free * Lower back pain for three months or more * Are not taking opioids * If female and of a child bearing potential age, are not pregnant or nursing mothers * Do not have mental or neurological conditions inhibiting sensory/motor functions * Do not have a lifetime history of dependence on cannabis * Do not have a lifetime history of DSM-IV schizophrenia, bipolar disorder, panic disorder, or psychosis * Prior THC-containing cannabis experience within the past two years * Agrees not to use cannabis outside of the study during participation in the study * Agrees not to use opioids or barbiturates during participation in the study * Agrees not to drive a motor vehicle within 4 hours following last use of inhaled cannabis during participation in the study Exclusion Criteria: * Active pulmonary disease * Allergy or past adverse effects or negative past experiences from cannabis * Positive urine drug test for THC, barbiturates, opioids, oxycodone, or methadone * Any significant illness, including cardiovascular disease, diabetes, renal and liver disease. * Any current or history of an immunocompromising disease or condition (such as lupus, psoriasis, multiple sclerosis, etc.) * Any current or history of neurologic conditions, including Parkinson disease, dementia, cognitive impairment, history of seizure disorder, and history of traumatic brain injury/head injury * Any current major psychiatric illness, …

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1This trial is in Early Phase 1 and seems focused on understanding how cannabis affects blood flow in the brain rather than proving it relieves pain — does that mean it's more of a brain-mapping study than a treatment trial, and what does that mean for me personally if I'm hoping to get relief from my sciatica or chronic low back pain?
2Since this study involves cannabis, can you help me understand what risks that might pose given my specific health history, any medications I'm on, or any other conditions I have that could interact with cannabis?
3If I were to join this trial, would I need to stop or pause any current pain treatments I'm using for my lumbar radiculopathy or degenerative disc disease, and how might that affect my day-to-day pain management?
4Are there standard, already-approved treatments for my chronic low back pain that might make more sense to try first before I consider joining a Phase 1 study that's still investigating basic brain mechanisms?
5What does measuring cerebral blood flow actually tell researchers, and at the end of this trial would I or my doctor learn anything specific and useful about how cannabis is or isn't working for my condition?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Cerebral Blood Flow (CBF)

Timeframe: All data will be collected at the single study session (Day 1).

Trial details

NCT IDNCT04982965

SponsorUniversity of California, San Diego

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-01-15

Contact for this trial

Madelynn Meredith, BS

619-431-1850 mameredith@health.ucsd.edu

View on ClinicalTrials.gov More Sciatica trials