Brain Mechanisms Supporting Cannabis-induced Pain Relief | Clinical Trial | StuddyBuddy@endsection
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NCT04982965
Brain Mechanisms Supporting Cannabis-induced Pain Relief
Conditions: Sciatica, Lumbar Radiculopathy, Lower Back Pain, Degenerative Disc Disease, Chronic Low-back Pain (cLBP), Chronic Low Back and Leg Pain, Back Pain
Sex: All
Ages: 21 Years – 65 Years
Healthy volunteers: Yes
Phase: EARLY_PHASE1
Enrollment: 100
Sponsor: University of California, San Diego
Location: Center for Functional MRI - W.M.Keck Building La Jolla California
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
Source: ClinicalTrials.gov (NCT04982965). StuddyBuddy aggregates publicly available trial information.