Cannabis for Pain

Recruiting at 1 trial location

Age: 18+

Sex: Any

Trial Phase: Phase < 1

Sponsor: University of California, San Diego

Must not be taking: Opioids, Barbiturates, Methadone, others

Disqualifiers: Pulmonary disease, Pregnancy, Cognitive impairment, others

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

Duration: 1 day

100 Participants Needed

Trial Summary

What is the purpose of this trial?

The American Academy of Pain Medicine has labeled pain as a "silent epidemic" due to its staggering costs to society (over $500 billion/year) and widespread prevalence (affects over 100 million Americans). Thus, it is imperative to test and validate cost-effective pain therapies. To this extent, cannabis is characterized as one of the most promising therapies to treat a wide spectrum of pain conditions. However, the clinical applicability of cannabis-based pain therapies has been limited due to lacking mechanistic characterization in human-focused studies. Of critical importance, the neural mechanisms supporting cannabis induced pain relief remain unknown. The primary objective of the proposed pilot study is to identify the brain mechanisms supporting the direct alleviation of acutely evoked pain through vaporized cannabis.

Will I have to stop taking my current medications?

The trial requires that you do not use opioids or barbiturates during participation. Other medications are not specifically mentioned, so it's best to discuss your current medications with the study team.

What data supports the effectiveness of the drug Cannabis for Pain?

Research shows that medical cannabis can improve pain, function, and quality of life in patients with chronic orthopedic pain, with many reducing or stopping their use of prescription drugs like opioids and benzodiazepines. Additionally, studies indicate that cannabis may provide modest pain relief and is considered safe and effective within a few months of use for various medical conditions. ^{1 2 3 4 5}

Is cannabis safe for use in humans?

Research shows that medical cannabis is generally safe for use in humans, with most adverse effects being mild to moderate. However, there are some risks, including potential cardiovascular and neuropsychiatric effects, and more frequent non-serious adverse events compared to non-users. ^{5 6 7 8 9}

How is medical cannabis unique for treating pain?

Medical cannabis is unique for treating pain because it offers an alternative to traditional pain medications, potentially reducing the need for opioids, and it has been used historically for pain management. It works through cannabinoids, which interact with the body's endocannabinoid system to help alleviate pain. ^{2 10 11 12 13}

Eligibility Criteria

This trial is for adults aged 21-65 who have used cannabis before but are not currently dependent on it or using any form. They must be free from major medical conditions, psychiatric disorders like schizophrenia or bipolar disorder, and cannot be pregnant or nursing. Participants agree to avoid opioids, barbiturates, and driving within 4 hours after using study cannabis.

Inclusion Criteria

You have never had a problem with being addicted to marijuana (cannabis) in your entire life.

You have used cannabis in the past.

You are not using cannabis currently.

Exclusion Criteria

You are afraid of being in small, enclosed spaces.

MRI contraindications

Prisoner

Timeline

Screening

Participants are screened for eligibility to participate in the trial

Up to 2 weeks

Phone screening

Baseline Assessment

Participants undergo baseline psychophysical training and pain testing, including familiarization with thermal stimuli and VAS training.

1 day

1 visit (in-person)

Treatment

Participants receive vaporized cannabis or placebo and undergo fMRI and pain testing.

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment.

2 weeks

Treatment Details

Interventions

• Active Cannabis
• Placebo Cannabis

Trial Overview The study is testing how vaporized cannabis (active ingredient THC) versus a placebo (no active ingredient) affects pain relief by looking at the brain's response to acute pain. Researchers aim to understand the neural mechanisms behind why cannabis might alleviate pain.

Participant Groups

Group I: Active THC Experimental Treatment 1 Intervention

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

Group II: Placebo THC Placebo Group 1 Intervention

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

Active Cannabis is already approved in United States, Canada, European Union for the following indications:

Approved in United States as Cannabis for:

• Chronic pain
• Neuropathic pain
• Seizures associated with Lennox-Gastaut syndrome and Dravet syndrome

Approved in Canada as Cannabis for:

• Chronic pain
• Nausea and vomiting associated with cancer chemotherapy
• Spasticity associated with multiple sclerosis

Approved in European Union as Cannabis for:

• Spasticity associated with multiple sclerosis
• Nausea and vomiting associated with cancer chemotherapy

Who Is Running the Clinical Trial?

University of California, San Diego

Lead Sponsor

Trials

1,215

Recruited

1,593,000+

Findings from Research

In a prospective observational study of orthopedic pain patients using medical cannabis, 73% reported a decrease or cessation of opioid use, and 31% stopped using benzodiazepines, indicating significant reductions in prescription drug reliance.

The study found that 52% of patients did not experience intoxication as a side effect, and clinical improvements in pain and quality of life were observed within 3 months of starting cannabis therapy, suggesting its efficacy and safety in managing chronic pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Perceived Efficacy, Reduced Prescription Drug Use, and Minimal Side Effects of Cannabis in Patients with Chronic Orthopedic Pain. Greis, A., Larsen, E., Liu, C., et al.[2023]

Medicinal cannabis has a long history of use for pain treatment, particularly in chronic pain management, where its analgesic effects have been supported by numerous studies.

The review highlights a gap in research regarding the effectiveness of medical cannabis for acute pain management, indicating that more clinical studies are needed to explore its potential benefits in this area.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Medicinal cannabis products for the treatment of acute pain. Fiore, M., Alfieri, A., Di Franco, S., et al.[2023]

A systematic review of 9 randomized controlled trials involving 222 patients found that cannabinoids are as effective as codeine for managing pain, but they also have common psychotropic side effects that can limit their use.

The study concluded that cannabinoids should not be widely introduced for pain management, especially in acute postoperative pain, and emphasized the need for more rigorous trials before considering their use for other types of pain like spasticity and neuropathic pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Are cannabinoids an effective and safe treatment option in the management of pain? A qualitative systematic review. Campbell, FA., Tramèr, MR., Carroll, D., et al.[2022]

Cannabis shows modest evidence for pain management based on a recent meta-analysis, but the clinical evidence is not as extensive as needed to fully support its use as a primary treatment.

There is a potential for medical cannabis to reduce reliance on opioid medications for pain relief, highlighting the importance of further research to understand its efficacy and safety in pain management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cannabis and Pain: A Clinical Review. Hill, KP., Palastro, MD., Johnson, B., et al.[2023]

In a 4-year study involving 2991 adult patients using medical cannabis, significant improvements in pain severity, symptom relief, and quality of life were observed within 3 months, with benefits maintained or enhanced over 12 months.

The study reported a low incidence of adverse events, with only 8 out of 79 reported events deemed likely related to medical cannabis, suggesting that it is a safe treatment option when used under physician guidance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Quebec Cannabis Registry: Investigating the Safety and Effectiveness of Medical Cannabis. Vigano, A., Moride, Y., Hachem, Y., et al.[2023]

A review of 34 studies, including 30 randomized controlled trials, found that cannabis-based medications are most effective as an additional treatment for refractory multiple sclerosis pain, with some promising results for chronic rheumatic pain.

While cannabis can help with pain relief, especially in certain conditions, it is associated with more adverse effects when using tetrahydrocannabinol (THC) herbal strains compared to other cannabis-derived products.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Scoping Review on Clinical Trials of Pain Reduction With Cannabis Administration in Adults. Haleem, R., Wright, R.[2020]

Cannabis use is increasing due to decriminalization and legalization, but its adverse effects, including cardiovascular and pulmonary issues, as well as links to malignancy and neuropsychiatric disorders, are becoming more evident despite limited research.

The rise in cannabis use among minors has led to more cases of overdose and toxicity, highlighting concerns about its safety, particularly regarding impaired driving and motor vehicle accidents.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse Impact of Cannabis on Human Health. Chandy, M., Nishiga, M., Wei, TT., et al.[2023]

A study involving 431 individuals with chronic non-cancer pain found that using a standardized herbal cannabis product for one year did not increase the risk of serious adverse events compared to non-users, suggesting a reasonable safety profile for medical cannabis.

However, cannabis users experienced a higher rate of non-serious adverse events, mostly mild to moderate, indicating that while cannabis may be safe for serious complications, it can still lead to some side effects that need to be monitored.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cannabis for the Management of Pain: Assessment of Safety Study (COMPASS). Ware, MA., Wang, T., Shapiro, S., et al.[2022]

This systematic review analyzed 10 systematic reviews of randomized controlled trials and found inconsistent evidence regarding the efficacy of cannabis-based medicines for managing chronic pain, particularly in neuropathic pain and painful spasms associated with multiple sclerosis.

There is a consensus that there is insufficient evidence to support the use of cannabis-based medicines for pain management in rheumatic diseases and cancer pain, highlighting the need for further rigorous studies in this area.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy, tolerability and safety of cannabis-based medicines for chronic pain management - An overview of systematic reviews. Häuser, W., Petzke, F., Fitzcharles, MA.[2022]

There has been a significant rise in prescriptions for cannabis-based medicines since their legalization for medical use, indicating growing acceptance and demand for these treatments.

This article reviews clinical evidence on the effectiveness of cannabis and cannabinoids in treating both acute and chronic pain, providing guidance for healthcare professionals in making informed treatment decisions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Cannabis and cannabinoids for the treatment of acute and chronic pain]. Schäfer, M., Tafelski, S.[2022]

In a study of 29 patients with chronic pain, medical cannabis significantly improved quality of life and reduced pain levels after 3 months, as shown by substantial changes in EQ-5D and Pain Quality Assessment Scale scores.

The use of medical cannabis also led to a reduction in opioid consumption and associated costs, with only 10% of subjects reporting adverse effects, suggesting it may be a safe alternative for pain management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preliminary evaluation of the efficacy, safety, and costs associated with the treatment of chronic pain with medical cannabis. Bellnier, T., Brown, GW., Ortega, TR.[2022]

In a survey of 1,321 medical cannabis users with chronic pain, about 80% reported substituting cannabis for traditional pain medications, particularly opioids, due to fewer side effects and better symptom management.

Experienced cannabis users (≥1 year) reported improved health and were less likely to take other pain medications compared to novice users (<1 year), suggesting that longer use may enhance the therapeutic benefits of cannabis in managing chronic pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pills to Pot: Observational Analyses of Cannabis Substitution Among Medical Cannabis Users With Chronic Pain. Boehnke, KF., Scott, JR., Litinas, E., et al.[2020]

In a study of 338 patients over 12 months, the use of a 19% cannabis decoction significantly reduced pain intensity, pain disability, and symptoms of anxiety and depression, indicating its potential effectiveness in managing chronic pain.

Cannabis therapy, when used alongside traditional pain medications, may enhance the overall management of chronic pain and its psychological effects, although further randomized controlled trials are necessary to validate these findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Medical Cannabis in Patients with Chronic Pain: Effect on Pain Relief, Pain Disability, and Psychological aspects. A Prospective Non randomized Single Arm Clinical Trial. Poli, P., Crestani, F., Salvadori, C., et al.[2018]

References

1. United States pubmed.ncbi.nlm.nih.gov

Perceived Efficacy, Reduced Prescription Drug Use, and Minimal Side Effects of Cannabis in Patients with Chronic Orthopedic Pain. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Medicinal cannabis products for the treatment of acute pain. [2023]

3. England pubmed.ncbi.nlm.nih.gov

Are cannabinoids an effective and safe treatment option in the management of pain? A qualitative systematic review. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Cannabis and Pain: A Clinical Review. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

The Quebec Cannabis Registry: Investigating the Safety and Effectiveness of Medical Cannabis. [2023]

6. Canada pubmed.ncbi.nlm.nih.gov

A Scoping Review on Clinical Trials of Pain Reduction With Cannabis Administration in Adults. [2020]

7. United States pubmed.ncbi.nlm.nih.gov

Adverse Impact of Cannabis on Human Health. [2023]

8. United States pubmed.ncbi.nlm.nih.gov

Cannabis for the Management of Pain: Assessment of Safety Study (COMPASS). [2022]

9. England pubmed.ncbi.nlm.nih.gov

Efficacy, tolerability and safety of cannabis-based medicines for chronic pain management - An overview of systematic reviews. [2022]

10. Germany pubmed.ncbi.nlm.nih.gov

[Cannabis and cannabinoids for the treatment of acute and chronic pain]. [2022]

11. United States pubmed.ncbi.nlm.nih.gov

Preliminary evaluation of the efficacy, safety, and costs associated with the treatment of chronic pain with medical cannabis. [2022]

12. United States pubmed.ncbi.nlm.nih.gov

Pills to Pot: Observational Analyses of Cannabis Substitution Among Medical Cannabis Users With Chronic Pain. [2020]

13. Italy pubmed.ncbi.nlm.nih.gov

Medical Cannabis in Patients with Chronic Pain: Effect on Pain Relief, Pain Disability, and Psychological aspects. A Prospective Non randomized Single Arm Clinical Trial. [2018]