Brain Mechanisms Supporting Cannabis-induced Pain Relief

NCT04982965 | Recruiting Early Phase 1 FDA Drug

• 1 other identifier: 200011
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Lower Back Pain; Degenerative Disc Disease; Chronic Low-back Pain (cLBP); Back Pain; Sciatica; Lumbar Radiculopathy; Chronic Low Back and Leg Pain

Keywords

Cannabis; Vaporized cannabis; THC; chronic low back pain

Outcome Measures

Primary Outcomes (1)

• Cerebral Blood Flow (CBF)

  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.

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

Secondary Outcomes (1)

• Pain Ratings

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

Other Outcomes (3)

• Neurochemical Metabolites

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

• Respiration Rate

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

• THC Concentrations

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

Study Arms (2)

Active THC

EXPERIMENTAL

Participants will be administered 400mg of vaporized cannabis (5.1%) before pain testing and fMRI.

Drug: Active Cannabis

Placebo THC

PLACEBO COMPARATOR

Participants will be administered 400mg of vaporized cannabis (\<.1%) before pain testing and fMRI.

Drug: Placebo Cannabis

Interventions

Active Cannabis DRUG

400 mg of vaporized and inhaled active cannabis (5.1%)

Active THC

Placebo Cannabis DRUG

400 mg of vaporized and inhaled placebo cannabis (\<.1%)

Also known as: Non-Active cannabis

Placebo THC

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, San Diego: lead

Study Sites (1)

Center for Functional MRI - W.M.Keck Building

La Jolla, California, 92093, United States

RECRUITING

MeSH Terms

Conditions

Sciatica; Radiculopathy; Low Back Pain; Intervertebral Disc Degeneration; Back Pain; Marijuana Abuse

Condition Hierarchy (Ancestors)

Sciatic Neuropathy; Mononeuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Neuralgia; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Central Study Contacts

Madelynn Meredith, BS

CONTACT

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

Yasmeen Esshaki, MA

CONTACT

619-786-0375; yesshaki@health.ucsd.edu

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Participants and outcome assessor will not be made aware if they are receiving active or placebo marijuana.
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Anesthesiology

Study Record Dates

• First Submitted: July 7, 2021
• First Posted: July 29, 2021
• Study Start: May 7, 2021
• Primary Completion (Estimated): January 15, 2027
• Study Completion (Estimated): March 15, 2027
• Last Updated: June 3, 2026

Record last verified: 2026-01

Locations

US (1)