NCT04982965 Brain Mechanisms Supporting Cannabis-induced Pain Relief
| NCT ID | NCT04982965 |
| Status | Recruiting |
| Phase | EARLY_Phase 1 |
| Sponsor | University of California, San Diego |
| Condition | Sciatica |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2021-05-07 |
| Primary Completion | 2027-01-15 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 100 participants in total. It began in 2021-05-07 with a primary completion date of 2027-01-15.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
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, such as bipolar disorder, major depression, psychosis, substance use disorder, or schizophrenia * Any current or history of suicidal ideation or attempt * Overt sensitivity to thermal stimulation * Resting blood pressure \> 140/90 * Resting heart rate \> 100 beats/minute * Prisoner * Institutionalized * Claustrophobia * MRI contraindications * Participation in any new (within 2 weeks prior or any time after enrollment) pain management procedures during the study period * Known history of vasovagal fainting, syncope, or severe adverse reactions associated with blood draws or needle procedures
Contact & Investigator
Frequently Asked Questions
Who can join the NCT04982965 clinical trial?
This trial is open to participants of all sexes, aged 21 Years or older, up to 65 Years, studying Sciatica. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04982965 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT04982965 currently recruiting?
Yes, NCT04982965 is actively recruiting participants. Contact the research team at mameredith@health.ucsd.edu for enrollment information.
Where is the NCT04982965 trial being conducted?
This trial is being conducted at La Jolla, United States.
Who is sponsoring the NCT04982965 clinical trial?
NCT04982965 is sponsored by University of California, San Diego. The trial plans to enroll 100 participants.