Cannabis for Pain Relief

(CanSex Trial)

Overseen By Ziva Cooper, PhD

Age: 18 - 65

Sex: Any

Trial Phase: Phase 1

Sponsor: University of California, Los Angeles

Must not be taking: Medical cannabis, Prescription analgesics

Disqualifiers: Substance use disorder, Severe psychiatric illness, others

Compensation: Varies

Number of Visits: Unknown

Duration: 5 hours per session

160 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to assess how different strengths of cannabis affect pain relief and potential misuse in men and women. Participants will smoke cannabis containing 0%, approximately 4%, or approximately 10% THC to evaluate its impact. It is ideal for cannabis users who smoke between 1 to 7 times a week and are not currently addressing any cannabis-related issues. Regular cannabis users curious about its effects might find this trial suitable. As a Phase 1 trial, this research focuses on understanding how cannabis works in people, offering participants a chance to be among the first to explore its 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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that cannabis can pose safety concerns, especially with higher THC levels. For cannabis with low THC, studies have found that only about 4.3% of people stopped using low-dose CBD (a compound from cannabis) due to side effects. This is similar to the 3.5% of people who stopped using a placebo, which has no real effect.

Cannabis with higher THC, which can induce a "high," carries more potential risks. Studies indicate that higher THC levels can cause more side effects, such as changes in the brain, and require further research. However, over a year, medical cannabis has generally been safe for chronic pain, with many people tolerating it well, though some experienced adverse effects.

In summary, low-strength cannabis is usually well-tolerated, much like a placebo. Higher-strength cannabis is also generally safe but may cause more side effects due to its higher THC content. These factors are important to consider when thinking about joining a trial. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about using cannabis for pain relief because it offers a natural alternative to traditional painkillers like opioids and NSAIDs, which can have significant side effects and addiction risks. Unlike these standard treatments, cannabis contains active ingredients like THC, which interact with the body's endocannabinoid system to potentially provide pain relief. The trial explores two distinct forms: low strength cannabis with about 4% THC and higher strength cannabis with around 10% THC, offering different potency levels for managing pain. This approach could lead to more personalized pain management options, with the potential for fewer side effects.

What evidence suggests that this trial's treatments could be effective for pain relief?

This trial will compare different strengths of cannabis for pain relief. Studies have shown that cannabis can help reduce pain. Participants may receive cannabis with lower THC levels (around 4%), which early research suggests might slightly reduce pain, improving pain scores by about 30% compared to a placebo. Alternatively, participants may receive cannabis with higher THC levels (around 10%), which has more evidence supporting its effectiveness for relieving chronic pain in adults. Cannabis-based medicines, in fact, may reduce pain by 30% or more for various conditions. Both low and high THC cannabis show promise in managing pain, although stronger cannabis has more consistent evidence supporting its effectiveness. ^{6 7 8 9 10}

Who Is on the Research Team?

Ziva D Cooper, PhD

Principal Investigator

University of California, Los Angeles

Are You a Good Fit for This Trial?

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Active Cannabis
• Placebo Cannabis

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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]

Medical cannabis and cannabinoids are increasingly recognized for their efficacy in managing chronic pain, with various preparations available that differ in their THC:CBD ratios.

Despite the popularity of the 'entourage effect' theory, systematic studies have not supported the idea that other cannabis plant constituents enhance pain treatment, and there is a lack of well-conducted comparisons between different cannabis products.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Role of Cannabis, Cannabidiol and Other Cannabinoids in Chronic Pain. The Perspective of Physicians. Köstenberger, M., Nahler, G., Jones, TM., 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]

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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12472909/

Cannabinoids in Chronic Pain: Clinical Outcomes, Adverse ... Cannabinoids can provide modest but measurable relief in chronic pain, although variability in study design continues to limit interpretation.

2. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK425767/

Therapeutic Effects of Cannabis and Cannabinoids - NCBI - NIH CONCLUSION 4-1 There is substantial evidence that cannabis is an effective treatment for chronic pain in adults. Go to: CANCER. Cancer is a broad term used to ...

3. jamanetwork.com jamanetwork.com/journals/jama/fullarticle/2338251

Cannabinoids for Medical Use: A Systematic Review and ... Odds indicate 30% or greater improvement in pain with cannabinoid compared with placebo, stratified according to cannabinoid. The square data markers indicate ...

4. jcannabisresearch.biomedcentral.com jcannabisresearch.biomedcentral.com/articles/10.1186/s42238-023-00207-7

The holistic effects of medical cannabis compared to opioids ... MC and opioids were perceived to be equally efficacious in reducing pain intensity, but MC additionally positively affected broader pain-related factors.

5. bmj.com bmj.com/content/382/bmj-2022-072348

Balancing risks and benefits of cannabis use: umbrella ... For chronic pain, cannabis based medicines or cannabinoids reduced pain by 30% (0.59 (0.37 to 0.93), GRADE=high), across different conditions (n ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12317335/

The Efficacy and Safety of Use of Cannabis and Cannabinoid ... (1.29% THC )7.13% reduction in pain compared to the placebo, and the (3.53% THC) treatment shows an approximate 0.35% reduction in pain compared ...

7. medicine.yale.edu medicine.yale.edu/news-article/not-your-grandmothers-marijuana-rising-thc-concentrations-in-cannabis-can-pose-devastating-health-risks/

Marijuana: Rising THC Concentrations in Cannabis Can Pose ... Marijuana: Rising THC Concentrations in Cannabis Can Pose Health Risks · Brain changes and other cannabis side effects need more study, say Yale ...

8. sciencedirect.com sciencedirect.com/science/article/pii/S1526590015008378

Cannabis for the Management of Pain: Assessment ... Medical cannabis used for chronic pain over one year appears to have a reasonable safety profile. •. The detailed listing of adverse events to medical ...

9. goodrx.com goodrx.com/health-topic/cannabis/treatment-marijuana-for-pain?srsltid=AfmBOoqIkjKUC1ZOQXFFliKSq4zlMYjwJFhmkY7EL--VlzQTAWBP9VNj

Using Cannabis for Pain Relief Since cannabis isn't an FDA-approved medication, there's not a set dosage for chronic pain. Experts recommend starting with 10 mg per day of a high-CBD ...

10. mdpi.com mdpi.com/2035-8377/17/9/141

Cannabinoids in Chronic Pain: Clinical Outcomes, Adverse ... Inhaled cannabis containing 6% THC and 11% CBD relieved pain in 67.2% of patients and eliminated pain completely in 34.5% within two hours, significantly ...