Brain Mechanisms Supporting Cannabis-induced Pain Relief

Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age21-65
SponsorUniversity of California, San Diego

About this trial

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

This trial accepts healthy volunteers

Qualifiers

Between 21-65 years old

Currently 30 days cannabis free

Lower back pain for three months or more

Are not taking opioids

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Active Cannabis

    Drug

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

  • Placebo Cannabis

    Drug

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

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: Active THCExperimental treatment 1 intervention
Group B: Placebo THCPlacebo comparator 1 intervention

Trial outcomes

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.

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

Secondary outcomes

1

Pain Ratings

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).

Other outcomes

1

Neurochemical Metabolites

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).
2

Respiration Rate

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).
3

THC Concentrations

THC concentrations will be measured to evaluate the relationship between THC levels and pain relief.

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

Sponsors and contacts

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