Cannabis for Pain Relief

(CanSex Trial)

Overseen By Vincent Acebo

Age: 18 - 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Recruiting

Sponsor: University of California, Los Angeles

Must not be taking: Medical cannabis, Prescription analgesics

Disqualifiers: Substance use disorder, Severe psychiatric illness, others

Trial Summary

What is the purpose of this trial?

This trial is studying the effects of smoking cannabis on pain relief and potential abuse in men and women. Researchers are comparing how different doses affect each sex and how their bodies process THC, the active ingredient in cannabis. The goal is to understand if there are significant differences between men and women in these effects.

Will I have to stop taking my current medications?

Yes, you will need to stop taking any prescription pain medications or medical cannabis, as well as any other medications that might affect the study's results.

What data supports the effectiveness of the drug Cannabis for pain relief?

Research shows that cannabinoids, a component of cannabis, can provide a small but significant reduction in acute pain, especially when administered intramuscularly. Additionally, vaporized cannabis has been found to significantly reduce neuropathic pain in patients with spinal cord injuries. ^{1 2 3 4 5}

Is cannabis safe for pain relief in humans?

Cannabis and cannabis-based medicines have been studied for pain relief, showing some adverse effects like dizziness, but serious side effects are rare. While some studies suggest cannabis may be safe for short-term use, the overall quality of evidence is low, and more research is needed to confirm long-term safety. ^{1 3 6 7 8}

How does the drug cannabis differ from other treatments for pain relief?

Cannabis for pain relief is unique because it involves the use of cannabinoids, which are compounds found in the cannabis plant, and can be administered in various forms such as inhaled or as extracts. Unlike traditional pain medications, cannabis offers a different mechanism of action by interacting with the body's endocannabinoid system, and it includes options like CBD, which does not cause a 'high' and is not a controlled substance. ^{2 3 9 10 11}

Research Team

Ziva D Cooper, PhD

Principal Investigator

University of California, Los Angeles

Eligibility Criteria

This trial is for men and women aged 21-55 who use cannabis weekly but aren't seeking treatment for it. Women must have regular cycles and use non-hormonal birth control. Participants should be healthy, with a BMI of 18.5 - 34kg/m2, and able to do all study tasks.

Inclusion Criteria

I have regular menstrual cycles.

Have a Body Mass Index from 18.5 - 34kg/m2

I can participate in all required study activities.

Exclusion Criteria

I am using hormonal birth control.

History or current evidence of severe psychiatric illness or medical condition judged by the study physician and PI to put the participant at greater risk of experiencing adverse events due to completion of study procedures, interfere with their ability to participate in the study, or their capacity to provide informed consent

I am currently using medical cannabis, painkillers, or other medications that could influence the study.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive smoked cannabis with varying THC strengths to assess analgesic and abuse-related effects

5 hours per session

Multiple sessions

Follow-up

Participants are monitored for safety and effectiveness after treatment

1-2 weeks

Treatment Details

Interventions

• Active Cannabis (Cannabinoid)
• Placebo Cannabis (Placebo)

Trial Overview The CanSex study is testing the effects of actual cannabis versus placebo on pain relief and potential abuse in both men and women to understand if there are sex differences in these responses.

Participant Groups

Group I: Low strength cannabis Experimental Treatment 1 Intervention

Smoked Cannabis (\~4% THC)

Group II: Higher strength cannabis Experimental Treatment 1 Intervention

Smoked Cannabis (\~10% THC)

Group III: Placebo Placebo Group 1 Intervention

Smoked Cannabis (\~0% THC)

Who Is Running the Clinical Trial?

University of California, Los Angeles

Lead Sponsor

Trials

1,594

Recruited

10,430,000+

National Institute on Drug Abuse (NIDA)

Collaborator

Trials

2,658

Recruited

3,409,000+

Findings from Research

A systematic review of six trials involving 678 participants found that cannabinoids provide a small but statistically significant reduction in acute pain compared to placebo, particularly with intramuscular administration, which showed a greater effect.

Serious adverse effects were rare and similar between cannabinoid and placebo groups, suggesting that cannabinoids may be a safe alternative for managing acute pain, although more high-quality studies are needed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cannabinoids in the Management of Acute Pain: A Systematic Review and Meta-analysis. Gazendam, A., Nucci, N., Gouveia, K., 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]

Recent systematic reviews show that while there is moderate quality evidence for cannabis medicines providing moderate relief for neuropathic pain, they are generally considered a third-line treatment option.

The conclusions of these reviews can be influenced by the thoroughness of literature searches and study inclusion criteria, with many studies indicating a lack of efficacy for other types of chronic pain, highlighting the need for more rigorous research in this area.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Evidence of the efficacy and safety of cannabis medicines for chronic pain management : A methodological minefield]. Häuser, W., Petzke, F.[2019]

In a study involving 42 participants with neuropathic pain from spinal cord injury or disease, vaporized cannabis significantly reduced pain intensity compared to placebo, demonstrating its analgesic efficacy.

The lower dose of 2.9% delta 9-THC provided effective pain relief without significantly increasing psychoactive side effects, suggesting a better risk-benefit ratio for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An Exploratory Human Laboratory Experiment Evaluating Vaporized Cannabis in the Treatment of Neuropathic Pain From Spinal Cord Injury and Disease. Wilsey, B., Marcotte, TD., Deutsch, R., et al.[2019]

A systematic review of 36 studies involving 7217 participants found limited evidence supporting the efficacy of cannabinoids, cannabis, and cannabis-based medicines for pain management, with only short-term cannabis use showing a potential benefit.

Most studies had a high or uncertain risk of bias, and adverse events were more common with cannabinoid treatments compared to controls, leading to low confidence in the overall effectiveness and safety of these treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cannabinoids, cannabis, and cannabis-based medicine for pain management: a systematic review of randomised controlled trials. Fisher, E., Moore, RA., Fogarty, AE., 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]

Cannabis-derived medications like dronabinol and nabilone are effective for treating nausea and vomiting from chemotherapy and appetite loss in AIDS patients, while medical cannabis is commonly recommended for pain and muscle spasms, showing significant improvement in these conditions.

While the adverse effects of cannabis are generally mild, such as dizziness, there are serious safety concerns, particularly regarding adolescent use leading to increased schizophrenia risk and cognitive impairments, as well as risks of accidental ingestion in children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The pharmacologic and clinical effects of medical cannabis. Borgelt, LM., Franson, KL., Nussbaum, AM., et al.[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]

Over the past 30 years, many patients have reported that cannabis is effective for pain relief, prompting increased interest in its medical applications.

Expert bodies in the UK have been reviewing the evidence regarding the use of cannabis and its derivatives for managing pain, indicating a growing recognition of its potential therapeutic benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evidence for using cannabis and cannabinoids to manage pain. Wood, S.[2018]

References

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

Cannabinoids in the Management of Acute Pain: A Systematic Review and Meta-analysis. [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. Germany pubmed.ncbi.nlm.nih.gov

[Evidence of the efficacy and safety of cannabis medicines for chronic pain management : A methodological minefield]. [2019]

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

An Exploratory Human Laboratory Experiment Evaluating Vaporized Cannabis in the Treatment of Neuropathic Pain From Spinal Cord Injury and Disease. [2019]

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

Cannabinoids, cannabis, and cannabis-based medicine for pain management: a systematic review of randomised controlled trials. [2023]

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

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

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

The pharmacologic and clinical effects of medical cannabis. [2022]

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

The Role of Cannabis, Cannabidiol and Other Cannabinoids in Chronic Pain. The Perspective of Physicians. [2023]

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

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

11. England pubmed.ncbi.nlm.nih.gov

Evidence for using cannabis and cannabinoids to manage pain. [2018]