What is the mechanism of action of this treatment?

Delta-9-Tetrahydrocannabinol (THC) primarily acts as a CB1 receptor agonist, modulating pain perception and reducing pain by affecting the central nervous system. Cannabidiol (CBD) is a multi-receptor modulator that interacts with CB1, CB2, and serotonin receptors, contributing to its anti-inflammatory, analgesic, and anxiolytic effects. These mechanisms are particularly relevant for fibromyalgia patients, who often suffer from chronic pain, inflammation, and anxiety. Understanding these mechanisms helps in tailoring treatments that can address multiple symptoms simultaneously, potentially improving overall quality of life.

What side effects are associated with this type of intervention?

Common side effects of cannabinoid-based treatments for fibromyalgia, such as Delta-9-Tetrahydrocannabinol (THC) and Cannabidiol (CBD), include dizziness, dry mouth, euphoria, and cognitive impairment for THC, and fatigue, diarrhea, and changes in appetite or weight for CBD. Both cannabinoids may also interact with other medications, potentially altering drug metabolism.

What prior FDA approvals exist?

The FDA has approved three drugs for the treatment of fibromyalgia: pregabalin (Lyrica), duloxetine (Cymbalta), and milnacipran (Savella). Pregabalin is an anticonvulsant that modulates calcium channels to reduce neurotransmitter release, while duloxetine and milnacipran are serotonin-norepinephrine reuptake inhibitors (SNRIs) that increase the levels of these neurotransmitters to help manage pain and mood symptoms. Although these drugs do not directly target cannabinoid receptors like THC and CBD, they share a common goal of modulating neurotransmitter systems to alleviate fibromyalgia symptoms.

What other types of research exist?

Promising novel alternatives to THC and CBD for fibromyalgia patients include synthetic cannabinoids like nabilone and dronabinol, which have shown potential in pain management. Additionally, non-cannabinoid treatments such as low-dose naltrexone, which modulates the immune system and reduces inflammation, and duloxetine, a serotonin-norepinephrine reuptake inhibitor (SNRI), have demonstrated efficacy in fibromyalgia management. These alternatives offer different mechanisms of action and may provide relief for patients who do not respond well to traditional cannabinoids.

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Cannabinoid

CBD + THC for Chronic Pain

Phase < 1

Recruiting

Led By Deborah Yurgelun-Todd, Ph.D.

Research Sponsored by University of Utah

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Chronic musculoskeletal and joint pain for at least 3 months or longer

Age between 18-50 yrs

Must not have

Type I and type II diabetes

Current or past neurological illness

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 7 days

Summary

This trial is testing THC and CBD on people with chronic non-cancer pain. THC can help reduce pain by affecting brain areas that process pain signals, while CBD may help by reducing inflammation and interacting with pain receptors. THC and CBD have been studied for their potential to manage chronic pain, with THC showing effectiveness in reducing pain signals and CBD being noted for its anti-inflammatory properties.

Who is the study for?

This trial is for adults aged 18-50 with a history of cannabis use who suffer from chronic musculoskeletal and joint pain lasting at least 3 months. Participants must live within 60 miles of Salt Lake City, Utah.

What is being tested?

The study compares the effects on chronic non-cancer pain between three options: Delta-9-Tetrahydrocannabinol (THC), Cannabidiol (CBD), and a placebo to see which is more effective in managing pain.

What are the potential side effects?

Potential side effects may include dizziness, dry mouth, changes in appetite or mood, fatigue, and possibly altered mental state due to THC's psychoactive properties.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have had joint or muscle pain for 3 months or more.

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I am between 18 and 50 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have diabetes.

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I have a history of neurological illness.

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I have had seizures or serious head injuries in the past.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 7 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~7 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and 7 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Brain

Secondary study objectives

Pain

Other study objectives

Neurocognitive performance

Trial Design

3Treatment groups

Active Control

Placebo Group

Group I: Delta-9-Tetrahydrocannabinol's (Delta-9-THC) effects on painActive Control1 Intervention

This arm will be testing the analgesic effects of orally dosed Delta-9-Tetrahydrocannabinol on subjects with chronic non-cancer pain.

Group II: Cannabidiol's (CBD) effects on painActive Control1 Intervention

This arm will be testing the analgesic effects of orally dosed Cannabidiol on subjects with chronic non-cancer pain.

Group III: PlaceboPlacebo Group1 Intervention

This Placebo arm will act as the control as standard of care medications will be continued through the study. This arm will allow us to compare the analgesic effects of the other two arms with the standard of care treatments for chronic non-cancer pain.

0 / 5Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Delta-9-Tetrahydrocannabinol (THC) primarily acts as a CB1 receptor agonist, modulating pain perception and reducing pain by affecting the central nervous system. Cannabidiol (CBD) is a multi-receptor modulator that interacts with CB1, CB2, and serotonin receptors, contributing to its anti-inflammatory, analgesic, and anxiolytic effects. These mechanisms are particularly relevant for fibromyalgia patients, who often suffer from chronic pain, inflammation, and anxiety. Understanding these mechanisms helps in tailoring treatments that can address multiple symptoms simultaneously, potentially improving overall quality of life.

Cannabis and orofacial pain: a systematic review.