Cannabis-based Product Research Articles

Comparison of Cannabis-Based Medicinal Product Formulations for Fibromyalgia: A Cohort Study

This cohort study aims to assess the outcomes of fibromyalgia patients enrolled in the UK Medical Cannabis Registry prescribed a homogenous selection of cannabis-based medicinal products (CBMPs). A cohort study of fibromyalgia patients treated with oils (Adven®, Curaleaf International, UK), dried flower (Adven®, Curaleaf International, UK) or both CBMPs was performed. Primary outcomes were changes from baseline at 1, 3, 6 and 12 months in validated patient-reported outcome measures. Secondary outcomes included descriptive analysis of adverse events. One hundred and forty-eight participants were treated with oils (n = 77; 52.03%), dried flower (n = 14; 9.46%) or both (n = 57; 38.51%). Improvements in the generalized anxiety disorder-7 questionnaire, single-item sleep quality scale, fibromyalgia symptom severity score and EQ-5D-5L Index values were observed at each follow up period compared to baseline (p < 0.050). Thirty-six (24.32%) patients experienced 648 adverse events. Improvements were observed across all primary outcomes with no differences observed across different formulations of CBMPs. Adverse events were reported by one-quarter of participants and were more likely to reported by cannabis naïve patients. This present work through focusing on a homogeneous group of CBMPs can help inform randomized controlled trials after observing signals of improvement associated with a specific cultivar of CBMPs.

Feasibility of a cannabidiol-dominant cannabis-based medicinal product for the treatment of long COVID symptoms: A single-arm open-label feasibility trial.

To conduct a single-arm open-label feasibility trial of the safety and tolerability of a full-spectrum cannabidiol (CBD)-dominant cannabis-based medicinal product for treating the symptoms of long COVID. The treatment phase ran for a total of 21 weeks, followed by ~3weeks without the study drug. Participants received up to 3mL of MediCabilis 5% CBD Oil (50 mg CBD/mL, <2mg δ-9-tetrahydrocannabinol/mL) per day orally. Monthly patient-reported outcome measures of common symptoms and daily self-report of symptoms were collected via a smartphone app. Key measures of heart rate, activity, sleep and oxygen saturation were assessed using wearable technology. Twelve (1 male, 11 female) individuals diagnosed with long COVID were recruited into the trial. All participants adhered to the treatment protocol for the duration of the study and there were no serious adverse events. Response rates for the research assessments were high with over 90% completion of patient-reported outcome measures and daily self-report. The study drug was safe and well-tolerated, demonstrating feasibility of CBD-dominant cannabis-based medicinal products in individuals diagnosed with long COVID. However, there were limitations in research design related to recruitment strategy demonstrating a lack of feasibility in the approach implemented in this study. Future work with larger samples and incorporating a control group are required to test the efficacy of this treatment.

Clinical Research Evidence Supporting Administration and Dosing Recommendations of Medicinal Cannabis as Analgesic in Cancer Patients

The analgesic potential of Cannabis sativa L.-based medicinal cannabis products for treatment of cancer associated chronic pains has gained increased interest in recent years. To ensure a controlled distribution of these products and investigate their therapeutic potential, several countries have established so-called pilot trials. Many doctors, however, are hesitant to prescribe medicinal cannabis primarily due to lack of research evidence regarding the products' efficacy, safety and thus questionable dosing guidelines. This review aims to elucidate clinical research supporting administration of medicinal cannabis in cancer patients for analgesic purposes. The cannabinoids' effects on the endocannabinoid system (ECS) and its implication in pain regulation is included to illustrate the complexity related to this research field. Published clinical studies on medicinal cannabis primarily consist of observational studies and only one pilot randomized controlled trial (RCT), where more RCTs exist on the cannabis-based product, Sativex® (GW Pharma Ltd., Cambridge, UK). The studies indicate analgesic potential, however non-significantly, for most patients and with acceptable safety profile. Summarizing, high-quality RCTs are scarce in this research field, and the limitations of the observational studies complicates interpretation of clinical outcomes. Despite discrepancy among the studies, they do show indications for administration and dosing regimens providing analgesic effects for some cancer patients.

Automated Detection of Cannabis-Induced Alteration in Cardiac Autonomic Regulation of the Indian Paddy-Field Workers Using Empirical Mode Decomposition, Discrete Wavelet Transform and Wavelet Packet Decomposition Techniques with HRV Signals

Early detection of the dysfunction of the cardiac autonomic regulation (CAR) may help in reducing cannabis-related cardiovascular morbidities. The current study examined the occurrence of changes in the CAR activity that is associated with the consumption of bhang, a cannabis-based product. For this purpose, the heart rate variability (HRV) signals of 200 Indian male volunteers, who were categorized into cannabis consumers and non-consumers, were decomposed by Empirical Mode Decomposition (EMD), Discrete Wavelet transform (DWT), and Wavelet Packet Decomposition (WPD) at different levels. The entropy-based parameters were computed from all the decomposed signals. The statistical significance of the parameters was examined using the Mann–Whitney test and t-test. The results revealed a significant variation in the HRV signals among the two groups. Herein, we proposed the development of machine learning (ML) models for the automatic classification of cannabis consumers and non-consumers. The selection of suitable input parameters for the ML models was performed by employing weight-based parameter ranking and dimension reduction methods. The performance indices of the ML models were compared. The results recommended the Naïve Bayes (NB) model developed from WPD processing (level 8, db02 mother wavelet) of the HRV signals as the most suitable ML model for automatic identification of cannabis users.

The Reshaping of the E-Cigarette Retail Environment: Its Evolution and Public Health Concerns.

E-cigarette use represents a public health controversy in the US and globally. Despite the potential of e-cigarettes to support cigarette cessation, their use increases health risks and risk for addiction, particularly in young people. Various federal, state, and local laws have impacted tobacco retail in general and e-cigarettes in particular. In the US, 2019–2020 federal laws increased in the minimum legal sales age for tobacco to 21 and banned flavored cartridge-based e-cigarettes. Many states and localities were early adopters of Tobacco 21 and implemented more comprehensive flavor restrictions than the federal ban. Meanwhile, cannabis retail is increasingly being legalized in the US—while cannabis-based product regulation has notable gaps at the federal, state, and local levels. These regulatory complexities have impacted specialized retailers selling e-cigarettes, including “vape shops” that exclusively sell e-cigarettes, “smoke shops” that sell e-cigarettes and other tobacco (and potentially CBD/THC and other un- or under-regulated products), and online retail. This commentary outlines public health concerns related to: (1) youth access; (2) consumer exposure to a broader range of tobacco products and marketing in retail settings where they may seek products to aid in cigarette cessation (i.e., such broad product exposure could hinder cessation attempts); (3) consumer exposure to un-/under-regulated products (e.g., delta-8-THC, kratom); and (4) federal, state, and local regulations being undermined by consumer access to prohibited products online and via the mail. These concerns underscore the need for ongoing surveillance of how retailers and consumers respond to regulations.

Prevalence, symptom management, and reporting of cannabis use among invasive cancer patients.

e24114 Background: Interest in the use of cannabis-based products, including marijuana (products containing ≥0.3% tetrahydrocannabinol [THC]) and cannabidiol (CBD; containing &lt; 0.3% THC) for cancer symptom management, is increasing. Preliminary studies suggest that marijuana and CBD products are effective in alleviating common cancer- or treatment-related symptoms. Few studies have reported on the magnitude of cannabis use among cancer patients, but data remain limited to states with legalized non-medical (i.e., recreational) use. Further, none have assessed the prevalence of CBD use in cancer patients. The reasons for cannabis-based product use and patient attitudes towards discussing use with their physicians are not well understood. Methods: We report preliminary results from an ongoing anonymous cross-sectional study of cannabis use among patients attending 8 clinics at the Ohio State University Comprehensive Cancer Center. Eligible patients were diagnosed with invasive cancer and treated in the past 12 months. Between July 2021 and January 2022, 771 patients were contacted and 639 (82.9%) agreed to participate. Participants answered a validated, extensive cannabis-focused questionnaire and were remunerated with a gift card. We report here frequencies and prevalence proportions of cannabis-based product use, and cannabis-related behaviors and attitudes on reporting use with cancer providers. Missing values were included in the denominator of prevalence calculations, thereby making estimates conservative. Results: Participants were equally distributed by sex, White (86.4%), and resided within Ohio (90.3%). Among 433 patients who reported age, the median was 47 years (IQR 38-53). The prevalence of current cannabis-based product use was 15.2% (97/639), with overall prevalence of 6.9% for exclusive marijuana use, 1.7% exclusive CBD use, and 5.2% poly-use. Among current users, patients primarily reported inhaling or ingesting cannabis products; fewer reported topical or other applications. The top 5 reported reasons for cannabis use were to treat stress, improve sleep, reduce pain, improve appetite, and to treat depression. Among current users, 66% reported that their cancer care team was aware of their cannabis use, 17.5% reported none of their healthcare providers were aware, and 15.4% reported a medical professional unaffiliated with their cancer care was aware. A large proportion (86.6%) felt comfortable discussing cannabis with their treating physician. Conclusions: Our results indicate current cannabis-based product use for symptom relief among a sizeable minority of adults with cancer in a state where only medicinal marijuana is legalized. Further research is needed to characterize provider perspectives and communication about reported cannabis use among their patients.

An assessment of solvent residue contaminants related to cannabis-based products in the South African market

Organic solvents are used for manufacturing herbal medicines and can be detected as residues of such processing in the final products. It is important for the safety of consumers to control these solvent residues. South African cannabis-based product samples were analysed for solvent residue contaminants as classified by the United States Pharmacopeia (USP), chapter 467. The origin of these samples ranged anywhere from crude extract, product development samples, and market ready final products. Samples were submitted to a contract laboratory over a period of 2 years from 2019 to 2021. To date, no data of this kind exist in South Africa specifically relating to cannabis-based medicinal, recreational, or complementary products. A total of 279 samples were analysed in duplicate by full evaporation headspace gas-chromatography mass-spectrometry and the results are reported in an anonymised format. The results showed an alarming 37% sample solvent residue failure rate with respect to adherence to USP 467 specification. It is important to ensure regulation is enforced to control product quality. The South African public need to be educated about the risks associated with cannabis-based products.

The effect of next day responsibilities and an adaptive purchase task on cannabis demand

BackgroundThe marijuana purchase task (MPT) is a commonly used behavioral economic measure of relative cannabis value (i.e. demand) that presents specific methodological concerns due to non-standardized measurement, variability in modality of use, and evolving legalization policies. Refinement of the task is critical to improve task ecological validity and accurate measurement of cannabis demand. The present study examined the construct validity of an adaptive MPT that allowed for participant selection of their preferred cannabis-based product and unit of measurement and the effect of next-day responsibilities on demand. MethodsParticipants reporting at least monthly cannabis use (N = 186, 40.3 % women, Mage = 33.59) were recruited via Amazon Mechanical Turk and completed the original MPT and our adaptive form with 2 next-day responsibilities scenarios (no responsibilities vs. morning job interview) for each MPT. Cannabis use motives, problems, and risk for cannabis use disorder were also assessed. ResultsCannabis demand was sensitive to next-day responsibility, with higher hypothetical consumption observed in the no responsibilities condition. Responsibility-related decreases in Omax (F(1,185) = 4.83, p = .029, η2p = .03) were significantly greater on the adaptive MPT than the original MPT. Demand indices derived from the adaptive MPT were significantly correlated with cannabis problems (rbreakpoint = .19, rPmax = 0.18, relasticity=-0.18) and motives (rrange=-.32−.25), and demand metrics from the original MPT. ConclusionsResults provide preliminary support for the construct validity of an adaptive MPT and suggest that early-morning work responsibilities may reduce cannabis demand. Continued research is needed to further refine this task and determine implications for cannabis use disorder intervention and prevention approaches.

Community nurses' support for patients with fibromyalgia who use cannabis to manage pain.

Supporting patients to manage chronic pain conditions, such as fibromyalgia (FM), remains a challenge for community nurses. Research suggests that despite the absence of a licensed cannabis-based product for medicinal use (CBPM) available for people with FM in the UK, there is an appetite for FM patients to use cannabis for pain management. Nurses have expressed anxieties when balancing tensions between helping patients and working within medical guidelines, as well as a need for further education about patient cannabis use. This article provides community nurses with insight into how cannabis use affects the pain experience for people living with FM. Despite potential harms, cannabis is perceived by users to have a positive impact on the lived experience of pain, and it may be preferred to prescribed opioid medication. This understanding can help to inform empathic practice and recommendations are made for reducing the risks of cannabis use to patient health.

Experiences, patient interactions and knowledge regarding the use of cannabis as a medicine in a cohort of New Zealand doctors in an oncology setting

Purpose of StudyTo explore the experiences, patient interactions and knowledge regarding the use of cannabis as a medicine in New Zealand doctors in an oncology setting.Study DesignAn observational cross-sectional survey...

Medicinal cannabis in Thailand: 1-year experience after legalization.

Medicinal cannabis in Thailand: 1-year experience after legalization.

Analysis of heart rate variability to understand the effect of cannabis consumption on Indian male paddy-field workers

The consumption of cannabis-based products is increasing worldwide day-by-day because of their euphoric effects. Numerous studies have reported the incidence of cardiovascular diseases and even mortality in people consuming cannabis. However, not much attention has been paid to understand the cannabis-induced alteration in the autonomic nervous system (ANS) activity, which can help in the early diagnosis of cardiovascular diseases. The current study investigated the alteration in the ANS activity of 200 Indian male volunteers due to the consumption of bhang (a cannabis-based product) using heart rate variability (HRV) analysis. The results suggested a reduction in the variability of the heart rate, increased sympathetic dominance, and a corresponding reduction in the parasympathetic activity in the bhang consuming population, which may lead to various cardiovascular diseases. These inferences can act as evidence for counseling people to stop consuming cannabis. The study further proposes a machine learning model for automated identification of the bhang consuming population. The HRV parameters were subjected to weight-based feature ranking and dimension reduction methods to select suitable inputs for the machine learning models. After comparing the performances of the Naïve Bayes (NB), Generalized Linear Model (GLM), Linear Regression (LR), Fast Large Margin (FLM), Deep Learning (DL), Decision Tree (DT), Random Forest (RF), Gradient Boosted Tree (GBT), and Support Vector Machine (SVM), a GBT model was finally chosen as the best model.

Cannabinoids, Pain, and Opioid Use Reduction: The Importance of Distilling and Disseminating Existing Data.

The high prevalence of chronic pain conditions combined with an over-reliance on opioid prescriptions has resulted in an opioid epidemic and a desperate need for solutions. There is some debate about whether cannabis might play a role in addressing chronic pain conditions as well as the opioid epidemic. Recent surveys suggest that a large number of people are using cannabis as a treatment for pain and to reduce use of opioids, and cannabis-derived products demonstrate at least modest efficacy in the treatment of pain in randomized controlled trials. In addition, surveillance studies from countries that have approved the use of Sativex, which is a cannabis-based product, have demonstrated that a combination of Δ9-tetrahydrocannabinol and cannabidiol has low potential for harm, is well tolerated, and is helpful to patients. Given the number of people in the United States who are already using cannabis to manage pain and opioid use in state-regulated markets, it is imperative to conduct additional research in these areas, and to disseminate information on how to minimize harm and maximize any benefits of using cannabinoids to mitigate pain and reduce opioid use. The purpose of this article is to call attention to the fact that cannabis is being used in the management of chronic pain. Thus, this article also provides a set of guidelines on how to approach using cannabis to treat pain.

Cannabis-based product use in a multiple sclerosis cohort.

ObjectiveThe objective of this study was to characterize the use of cannabis-based products (CBPs) by multiple sclerosis (MS) patients who attend the University of British Columbia Hospital (UBCH) MS clinic.MethodsAll patients attending the UBCH MS clinic from January to March 2018 were invited to participate in an anonymous survey that included: patient demographics (sex, age and employment status), self-reported MS-specific data (subtype, disease duration, previous and current disease modifying therapies, symptomatic medications) and CBP use (formulation, frequency, perceived benefits/side-effects). A second cohort of retrospective patient data (CBP use, sex, age, disease subtype and Expanded Disability Status Scale) was extracted from the UBCH MS clinic electronic medical record (EMR).ResultsOf 600 surveys distributed, 188 were returned with completed CBP usage. CBP use was daily for 19% (n = 37), weekly for 6% (n = 11), monthly for 4% (n = 7), rarely for 21% (n = 39) and 50% (n = 94) never used. Of the CBP users (daily, weekly and monthly), CBP use included: oral (n = 43/55), smoked/vaporized (n = 42/55), topical (n = 14/55) and mucosal (n = 5/55). EMR data was available for 561 MS patients where cannabis use/non-use was documented. CBP users represented 19% (107/561).ConclusionsCBP use is common based on volunteer reporting, with approximately one out of four patients who attend the UBCH MS clinic using CBPs.

A Survey of Cannabis-Based Product Use in Multiple Sclerosis Patients at the University of British Columbia Hospital (P5.2-092)

A Survey of Cannabis-Based Product Use in Multiple Sclerosis Patients at the University of British Columbia Hospital (P5.2-092)

Irish general practitioner attitudes toward decriminalisation and medical use of cannabis: results from a national survey

BackgroundGovernmental debate in Ireland on the de facto decriminalisation of cannabis and legalisation for medical use is ongoing. A cannabis-based medicinal product (Sativex®) has recently been granted market authorisation in Ireland. This unique study aimed to investigate Irish general practitioner (GP) attitudes toward decriminalisation of cannabis and assess levels of support for use of cannabis for therapeutic purposes (CTP).MethodsGeneral practitioners in the Irish College of General Practitioner (ICGP) database were invited to complete an online survey. Anonymous data yielded descriptive statistics (frequencies, percentages) to summarise participant demographic information and agreement with attitudinal statements. Chi-square tests and multi-nominal logistic regression were included.ResultsThe response rate was 15% (n = 565) which is similar to other Irish national GP attitudinal surveys. Over half of Irish GPs did not support the decriminalisation of cannabis (56.8%). In terms of gender, a significantly higher proportion of males compared with females (40.6 vs. 15%; p < 0.0001) agreed or strongly agreed with this drug policy approach. A higher percentage of GPs with advanced addiction specialist training (level 2) agreed/strongly agreed that cannabis should be decriminalised (54.1 vs. 31.5%; p = 0.021). Over 80% of both genders supported the view that cannabis use has a significant effect on patients’ mental health and increases the risk of schizophrenia (77.3%). Over half of Irish GPs supported the legalisation of cannabis for medical use (58.6%). A higher percentage of those who were level 1-trained (trained in addiction treatment but not to an advanced level) agreed/strongly agreed cannabis should be legalised for medical use (p = 0.003). Over 60% agreed that cannabis can have a role in palliative care, pain management and treatment of multiple sclerosis (MS). In the regression response predicator analysis, females were 66.2% less likely to agree that cannabis should be decriminalised, 42.5% less likely to agree that cannabis should be legalised for medical use and 59.8 and 37.6% less likely to agree that cannabis has a role in palliative care and in the treatment of multiple sclerosis (respectively) than males.ConclusionsThe majority of Irish GPs do not support the present Irish governmental drug policy of decriminalisation of cannabis but do support the legalisation of cannabis for therapeutic purposes. Male GPs and those with higher levels of addiction training are more likely to support a more liberal drug policy approach to cannabis for personal use. A clear majority of GPs expressed significant concerns regarding both the mental and physical health risks of cannabis use. Ongoing research into the health and other effects of drug policy changes on cannabis use is required.

Cannabinoids for paediatric epilepsy: Weeding out the issues.

Cannabinoids for paediatric epilepsy: Weeding out the issues.

The Role of Cannabis and Cannabinoids in Diabetes

This paper reviews the role of cannabis in diabetes. Cannabis is by far the most commonly used illicit drug in Britain, though its use may be declining. There are an estimated 50,000–100,000 people with diabetes using cannabis, with an unknown number using the drug for self-medication. The evidence of the effects of cannabis on diabetes is complex, ranging from anecdotal reports of benefits and harms to experimental research on cannabinoids. The endocannabinoid system appears to have a role in the regulation of body weight and food intake, and the development of hyperglycaemia, insulin resistance and dyslipidaemia. In experimental models, the main psychoactive constituent of herbal cannabis, Δ9-tetrahydrocannabinol, has been shown to interfere with both the action of insulin and its release. The paper also considers the effects of cannabis on complications of diabetes. Experimental work has suggested a mechanism to reduce neuropathy but the only double-blind clinical trial to date of a cannabis-based drug found no difference in the ability of the cannabis-based product to relieve neuropathic pain when compared with placebo. In conclusion, new insights into the role of cannabis and cannabinoids in diabetes are emerging from this developing field of research.

Randomized Placebo-Controlled Double-Blind Clinical Trial of Cannabis-Based Medicinal Product (Sativex) in Painful Diabetic Neuropathy

OBJECTIVETo assess the efficacy of Sativex, a cannabis-based medicinal extract, as adjuvant treatment in painful diabetic peripheral neuropathy (DPN).RESEARCH DESIGN AND METHODSIn this randomized controlled trial, 30 subjects with painful DPN received daily Sativex or placebo. The primary outcome measure was change in mean daily pain scores, and secondary outcome measures included quality-of-life assessments.RESULTSThere was significant improvement in pain scores in both groups, but mean change between groups was not significant. There were no significant differences in secondary outcome measures. Patients with depression had significantly greater baseline pain scores that improved regardless of intervention.CONCLUSIONSThis first-ever trial assessing the efficacy of cannabis has shown it to be no more efficacious than placebo in painful DPN. Depression was a major confounder and may have important implications for future trials on painful DPN.