Cannabis for Pain
Recruiting in Palo Alto (17 mi)
+1 other location
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase < 1
Recruiting
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
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.
12345Is 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.
56789How 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.
210111213Eligibility 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.
+14 more
Exclusion Criteria
You are afraid of being in small, enclosed spaces.
MRI contraindications
Prisoner
+8 more
Trial 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
Participant Groups
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.
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Active THCExperimental Treatment1 Intervention
Participants will be administered 400mg of vaporized cannabis (5.1%) before pain testing and fMRI.
Group II: Placebo THCPlacebo Group1 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
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
University of California, San DiegoSan Diego, CA
Altman Clinical and Translational Research InstituteLa Jolla, CA
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Who Is Running the Clinical Trial?
University of California, San DiegoLead Sponsor
References
Perceived Efficacy, Reduced Prescription Drug Use, and Minimal Side Effects of Cannabis in Patients with Chronic Orthopedic Pain. [2023]Introduction: Although cannabis is widely used for the treatment of chronic pain, most research relies on patient self-report and few studies have objectively quantified its efficacy and side effects. Extant inventories for measuring cannabis use were not designed to capture the medically relevant features of cannabis use, but rather were designed to detect problematic use or cannabis use disorder. Thus, we sought to capture the medically relevant features of cannabis use in a population of patients with orthopedic pain and pair these data with objective measures of pain and prescription drug use. Materials and Methods: In this prospective observational study, orthopedic pain patients were enrolled in Pennsylvania's medical cannabis program by their treating pain management physician, received cannabis education from their physician at the time of certification, and purchased products from state-licensed cannabis retailers. Results: Medical cannabis use was associated with clinical improvements in pain, function, and quality of life with reductions in prescription drug use; 73% either ceased or decreased opioid consumption and 31% discontinued benzodiazepines. Importantly, 52% of patients did not experience intoxication as a side effect of cannabis therapy. Significant clinical benefits of cannabis occurred within 3 months of initiating cannabis therapy and plateaued at the subsequent follow-ups. Conclusions: This work provides a direct relationship between the initiation of cannabis therapy and objectively fewer opioid and benzodiazepine prescriptions. Our work also identifies specific subpopulations of patients for whom cannabis may be most efficacious in reducing opioid consumption, and it highlights the importance of both physician involvement and patient self-titration in symptom management with cannabis.
Medicinal cannabis products for the treatment of acute pain. [2023]For thousands of years, medicinal cannabis has been used for pain treatment, but its use for pain management is still controversial. Meta-analysis of the literature has shown contrasting results on the addition of cannabinoids to opioids compared with placebo/other active agents to reduce pain. Clinical studies are mainly focused on medicinal cannabis use in chronic pain management, for which the analgesic effect has been proven in many studies. This review focuses on the potential use of medical cannabis for acute pain management in preclinical studies, studies on healthy subjects and the few pioneering studies in the clinical setting.
Are cannabinoids an effective and safe treatment option in the management of pain? A qualitative systematic review. [2022]To establish whether cannabis is an effective and safe treatment option in the management of pain.
Cannabis and Pain: A Clinical Review. [2023]Introduction: Cannabis has been used for medical purposes across the world for centuries. As states and countries implement medical and recreational cannabis policies, increasing numbers of people are using cannabis pharmacotherapy for pain. There is a theoretical rationale for cannabis' efficacy for pain management, although the subjective pain relief from cannabis may not match objective measurements of analgesia. As more patients turn to cannabis for pain relief, there is a need for additional scientific evidence to evaluate this increase. Materials and Methods: Research for this review was performed in the PubMed/National Library of Medicine database. Discussion: Preclinical studies demonstrate a narrow therapeutic window for cannabis as pharmacotherapy for pain; the body of clinical evidence for this indication is not as extensive. A recent meta-analysis of clinical trials of cannabis and cannabinoids for pain found modest evidence supporting the use of cannabinoid pharmacotherapy for pain. Recent epidemiological studies have provided initial evidence for a possible reduction in opioid pharmacotherapy for pain as a result of increased implementation of medical cannabis regimens. Conclusion: With increased use of medical cannabis as pharmacotherapy for pain comes a need for comprehensive risk-benefit discussions that take into account cannabis' significant possible side effects. As cannabis use increases in the context of medical and recreational cannabis policies, additional research to support or refute the current evidence base is essential to attempt to answer the questions that so many healthcare professionals and patients are asking.
The Quebec Cannabis Registry: Investigating the Safety and Effectiveness of Medical Cannabis. [2023]Objective: To investigate the safety and effectiveness of medical cannabis (MC) in the real-world clinical practice setting. Design: A 4-year prospective noncomparative registry of adult patients who initiated MC for a variety of indications. This paper reports on patients followed for up to 12 months, with interim visits at 3, 6, and 9 months after enrollment. Setting: Public or private outpatient clinics certified to authorize MC in the province of Quebec, Canada. Participants: Overall, 2991 adult (age ≥18 years) patients (mean age 51 years; 50.2% women) were enrolled between May 2015 and October 2018, with the last follow-up ending in May 2019. Interventions/Exposures: Cannabis products (dried, oil, or other) purchased from a Canadian licensed cannabis producer as authorized by physicians. Main Outcome Measures: The primary outcomes were self-reported pain severity, interference and relief (Brief Pain Inventory [BPI]), symptoms using the Revised Edmonton Symptom Assessment System (ESAS-r) and health-related quality of life dimensions (EQ-5D-5L) at baseline and each follow-up visit. The secondary outcomes were self-reported adverse events (AEs) and characteristics of cannabis treatment. Results: All patient-reported outcomes (BPI, ESAS-r, and EQ-5D-5L) showed a statistically significant improvement at 3 months (all p<0.01), which was maintained or further improved (for pain interference, tiredness, and well-being) over the remainder of the 12-month follow-up. Results also revealed clinically significant improvements in pain interference and tiredness, anxiety, and well-being from baseline. There were 79 AE reports (77 patients), 16 met the regulatory definition of seriousness, in which only 8 AEs were certainly or probably related to MC. Conclusions: MC directed by physicians appears to be safe and effective within 3 months of initiation for a variety of medical indications.
A Scoping Review on Clinical Trials of Pain Reduction With Cannabis Administration in Adults. [2020]Indications of cannabis use are numerous although the indication to relief pain remains a major research interest and clinical application. Studies investigating the effect of herbal cannabis and cannabis-based medicine on neuropathic, non-neuropathic pain, acute pain and experimentally induced pain were reviewed. A search was performed in PubMed and Cochrane library for articles published in English between January 1, 2000 and May 8, 2020. The search terms used were related to cannabis and pain in adults. We identified 34 studies, of which 30 were randomized controlled clinical trials (RCTs). Varying effects were identified from the RCTs, and as expected more promising effects from non-RCTs. Cannabis-based medications were found most effective as an adjuvant therapy in refractory multiple sclerosis, and weak evidence was found to support the treatment of cancer pain especially in advanced stages. Chronic rheumatic pain showed promising results. Adverse events of cannabis-based treatment were found to be more frequent with tetrahydrocannabinol herbal strains compared to other cannabis-derived products.
Adverse Impact of Cannabis on Human Health. [2023]Cannabis, the most commonly used recreational drug, is illicit in many areas of the world. With increasing decriminalization and legalization, cannabis use is increasing in the United States and other countries. The adverse effects of cannabis are unclear because its status as a Schedule 1 drug in the United States restricts research. Despite a paucity of data, cannabis is commonly perceived as a benign or even beneficial drug. However, recent studies show that cannabis has adverse cardiovascular and pulmonary effects and is linked with malignancy. Moreover, case reports have shown an association between cannabis use and neuropsychiatric disorders. With growing availability, cannabis misuse by minors has led to increasing incidences of overdose and toxicity. Though difficult to detect, cannabis intoxication may be linked to impaired driving and motor vehicle accidents. Overall, cannabis use is on the rise, and adverse effects are becoming apparent in clinical data sets. Expected final online publication date for the Annual Review of Medicine, Volume 75 is January 2024. Please see http://www.annualreviews.org/page/journal/pubdates for revised estimates.
Cannabis for the Management of Pain: Assessment of Safety Study (COMPASS). [2022]Cannabis is widely used as a self-management strategy by patients with a wide range of symptoms and diseases including chronic non-cancer pain. The safety of cannabis use for medical purposes has not been systematically evaluated. We conducted a prospective cohort study to describe safety issues among individuals with chronic non-cancer pain. A standardized herbal cannabis product (12.5% tetrahydrocannabinol) was dispensed to eligible individuals for a 1-year period; controls were individuals with chronic pain from the same clinics who were not cannabis users. The primary outcome consisted of serious adverse events and non-serious adverse events. Secondary safety outcomes included pulmonary and neurocognitive function and standard hematology, biochemistry, renal, liver, and endocrine function. Secondary efficacy parameters included pain and other symptoms, mood, and quality of life. Two hundred and fifteen individuals with chronic pain were recruited to the cannabis group (141 current users and 58 ex-users) and 216 controls (chronic pain but no current cannabis use) from 7 clinics across Canada. The median daily cannabis dose was 2.5 g/d. There was no difference in risk of serious adverse events (adjusted incidence rate ratio = 1.08, 95% confidence interval = .57-2.04) between groups. Medical cannabis users were at increased risk of non-serious adverse events (adjusted incidence rate ratio = 1.73, 95% confidence interval = 1.41-2.13); most were mild to moderate. There were no differences in secondary safety assessments. Quality-controlled herbal cannabis, when used by patients with experience of cannabis use as part of a monitored treatment program over 1 year, appears to have a reasonable safety profile. Longer-term monitoring for functional outcomes is needed.
Efficacy, tolerability and safety of cannabis-based medicines for chronic pain management - An overview of systematic reviews. [2022]Medicinal cannabis has already entered mainstream medicine in some countries. This systematic review (SR) aimed at evaluating the efficacy, acceptability and safety of cannabis-based medicines for chronic pain management. Qualitative systematic review of SRs of randomized controlled trials with cannabis-based medicines for chronic pain management. The Cochrane databases of SRs, Database of Abstracts of Reviews of Effects and PubMed were searched for SR published in the period January 2009 to January 2017. Assessment of the methodological quality of SR was performed by the AMSTAR checklist. Out of 748 papers identified, 10 SRs met the inclusion criteria. The methodological quality was high in four and moderate in six SRs. There were inconsistent findings of four SRs on the efficacy of cannabis-based medicines in neuropathic pain and of one SR for painful spasms in multiple sclerosis. There were consistent results that there was insufficient evidence of any cannabis-based medicine for pain management in patients with rheumatic diseases (three SRs) and in cancer pain (two SRs). Cannabis-based medicines undoubtedly enrich the possibilities of drug treatment of chronic pain conditions. It remains the responsibility of the health care community to continue to pursue rigorous study of cannabis-based medicines to provide evidence that meets the standard of 21st century clinical care.
[Cannabis and cannabinoids for the treatment of acute and chronic pain]. [2022]Since the Act on the medical use of cannabis, at which cannabis-based medicines and cannabinoids became law, there has been an exponential increase in prescriptions for the acquisition of cannabis for medical purposes. The aim of this leading article is to compile and assess the currently available relevant clinical evidence for the use of cannabis and cannabinoids for treatment of acute and chronic pain. Based on the systematic literature review "Cannabis-Potential and risks (CAPRIS)" commissioned by the German Federal Ministry of Health and the recently published recommendations of the European Pain Federation EFIC, this article aims to give an orientation aid for the decision-making process in the clinical routine.
Preliminary evaluation of the efficacy, safety, and costs associated with the treatment of chronic pain with medical cannabis. [2022]Medical cannabis (MC) is commonly claimed to be an effective treatment for chronic or refractory pain. With interest in MC in the United States growing, as evidenced by the 29 states and 3 US districts that now have public MC programs, the need for clinical evidence supporting this claim has never been greater.
Pills to Pot: Observational Analyses of Cannabis Substitution Among Medical Cannabis Users With Chronic Pain. [2020]Chronic pain is common, costly, and challenging to treat. Many individuals with chronic pain have turned to cannabis as an alternative form of pain management. We report results from an ongoing, online survey of medical cannabis users with chronic pain nationwide about how cannabis affects pain management, health, and pain medication use. We also examined whether and how these parameters were affected by concomitant recreational use, and duration of use (novice:
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]There is an increasing interest in the medical use of cannabis, particularly in the treatment of chronic pain.