Hemp Extracts Research Articles

Are side effects of cannabidiol (CBD) products caused by tetrahydrocannabinol (THC) contamination?

Cannabidiol (CBD)-containing products are widely marketed as over the counter products, mostly as food supplements, to avoid the strict rules of medicinal products. Side-effects reported in anecdotal consumer reports or during clinical studies were first assumed to be due to hydrolytic conversion of CBD to psychotropic Δ 9-tetrahydrocannabinol (Δ 9-THC) in the stomach after oral consumption. However, research of pure CBD solutions stored in simulated gastric juice or subjected to various storage conditions such as heat and light with specific liquid chromatographic/tandem mass spectrometric (LC/MS/MS) and ultra-high pressure liquid chromatographic/quadrupole time-of-flight mass spectrometric (UPLC-QTOF) analyses was unable to confirm THC formation. Another hypothesis for the side-effects of CBD products may be residual Δ 9-THC concentrations in the products as contamination, because most of them are based on crude hemp extracts containing the full spectrum of cannabinoids besides CBD. Analyses of 67 food products of the German market (mostly CBD oils) confirmed this hypothesis: 17 products (25%) contained Δ 9-THC above the lowest observed adverse effects level (2.5 mg/day). Inversely, CBD was present in the products below the no observed adverse effect level. Hence, it may be assumed that the adverse effects of some commercial CBD products are based on a low-dose effect of Δ 9-THC and not due to effects of CBD itself. The safety, efficacy and purity of commercial CBD products is highly questionable, and all of the products in our sample collection showed various non-conformities to European food law such as unsafe Δ 9-THC levels, full-spectrum hemp extracts as non-approved novel food ingredients, non-approved health claims, and deficits in mandatory food labelling requirements. In view of the growing market for such lifestyle products, the effectiveness of the instrument of food business operators' own responsibility for product safety must obviously be challenged.

Microwave-assisted extraction of phenolic compounds from Cannabis sativa L.: optimization and kinetics study

ABSTRACT RSM and ANN were evaluated for prediction of physical and chemical properties of industrial hemp extracts prepared using MAE. The effects of liquid to solid ratio, ethanol content, extraction time, extraction temperature, and microwave power were analyzed. ANN had better prediction performance for both physical and chemical properties. Optimal conditions based on RSM were L/S = 30 mL/g, v/v = 25%, t = 25 min, T = 45°C and P = 600 W. Under those conditions, dynamic of the extraction process was analyzed using six kinetic models and showed that the extraction rate reached constant value after approximately 15 min.

Development of ANN models based on combined UV-vis-NIR spectra for rapid quantification of physical and chemical properties of industrial hemp extracts.

The aim of this study was to develop artificial neural network (ANNs) models for prediction of physical (total dissolved solids, extraction yield) and chemical (total polyphenolic content, antioxidant activity) properties of industrial hemp extracts, prepared by two different extraction methods (solid-liquid extraction and microwave-assisted extraction) based on combined UV-VIS-NIR spectra. Spectral data were gathered for 46 samples per extraction method. The PCA analysis ensured efficient separation of the samples based on the amount of ethanol in extraction solvent using NIR spectra for both conventional and microwave-assisted extraction. Results showed that reliable ANN models (R2 >0.7000) for describing physical, chemical, and simultaneously physical and chemical characteristics can be developed based on combined UV-VIS-NIR spectra of industrial hemp extracts without spectra pre-processing.

Analysis of Cannabidiol, Δ9-Tetrahydrocannabinol, and Their Acids in CBD Oil/Hemp Oil Products

Hemp products are readily available and are aggressively marketed for their health and medicinal benefits. Most consumers of these products are interested because of cannabidiol (CBD), which has taken the natural products industry by storm. The CBD and Δ⁹-tetrahydrocannabinol (Δ⁹-THC) concentrations in these products are often absent, and even where labeled, the accuracy of the label amounts is often questionable. In order to gain a better understanding of the CBD content, fifty hemp products were analyzed by gas chromatography coupled with mass spectrometry (GC-MS) for CBD, Δ⁹-THC, tetrahydrocannabinolic acid (Δ⁹-THCAA), and cannabidiolic acid (CBDA). Δ⁹-THCAA and CBDA are the natural precursors of Δ⁹-THC and CBD in the plant material. Decarboxylation to Δ⁹-THC and CBD is essential to get the total benefit of the neutral cannabinoids. Therefore, analysis for the neutral and acid cannabinoids is important to get a complete picture of the chemical profile of the products. The GC-MS method used for the analysis of these products was developed and validated. A 10-m × 0.18-mm DB-1 (0.4 μ film) column was used for the analysis. The majority of the hemp products were oils, one of the products was hemp butter, one was a concentrated hemp powder capsule, and another was a hemp extract capsule. Most of the products contained less than 0.1% CBD and less than 0.01% Δ⁹-THC. Three products contained 0.1–1% CBD, and 2 products contained 0.1–0.9% Δ⁹-THC. All of the samples appeared to be decarboxylated since the CBDA and Δ⁹-THCAA results were less than 0.001%. The developed method is simple, sensitive, and reproducible for the detection of Δ⁹-THC, Δ⁹-THCAA, CBD, and CBDA in CBD oil/hemp products.

Approach for simultaneous cannabidiol isolation and pesticide removal from hemp extracts with liquid-liquid chromatography

In this work, a computer-aided approach for selecting biphasic solvent systems for simultaneous cannabidiol (CBD) isolation and pesticide removal from hemp extracts with liquid-liquid chromatography (LLC) was investigated. By taking advantage of a fully predictive thermodynamic model (COSMO-RS), a considerable number of ternary solvent systems were screened and potential systems were identified with practically no experimental effort; the partition coefficient of the target component CBD was used as screening parameter. After the experimental validation, three solvent systems were chosen: solvent system I: n-heptane/methanol/water 4/3/1 v/v/v, solvent system II: n-heptane/acetone/water 2/5/1 v/v/v and solvent system III: n-heptane/acetonitrile/water 5/3/2 v/v/v. The 59 pesticides regulated by the state of Oregon in cannabis products were included in the next step with the aim to propose a classification system of the most critical pesticides for obtaining pesticide-free CBD. Based on CBD/pesticide separation factors (αCBD/PEST), four critical levels were defined. Depending on the solvent system, it was shown that 50–70 % of the Oregon-listed pesticides were found to be non-critical (αCBD/PEST > 4), while only 13–22 % were retrieved as highly and medium critical (αCBD/PEST < 2). Using the acquired knowledge, a guideline for the selection of the best solvent system candidate for the simultaneous LLC separation of CBD and removal of Oregon-listed pesticides from hemp extracts was proposed. Following a series of LLC experiments with a pesticide-spiked hemp extract, it was shown that the pesticide classification lists can be used to select the most promising solvent system to achieve the removal of most of the contaminating pesticides.

To CBD or not to CBD?: What pharmacists need to know

To CBD or not to CBD?: What pharmacists need to know

Cannabidiol: From Drug Interaction Potential to Modulation of the Gut Microbiome

Abstract Objectives Cannabidiol (CBD) is the major non-psychotropic phytocannabinoid present in Cannabis sativa. In 2018, Congress designated select C. sativa cultivars as “hemp” removing them from the DEA's list of controlled substances. As a result, CBD-containing hemp extracts and other CBD products are now widely available and heavily marketed, yet their FDA regulatory status is still hotly debated. Further complicating the debate is CBD's vastly under-researched safety profile. Safety concerns yet to be adequately addressed include CBD's drug interaction potential and its effect on the gut microbiome. Methods Using acetaminophen (APAP), the most commonly ingested over-the-counter pain medication, we demonstrated that CBD-rich cannabis extract (CRCE) poses a significant drug interaction risk. Results Mice exposed to both CRCE and APAP developed severe liver injury. This hepatotoxicity, however, was not observed when either CRCE or APAP were administered separately. Importantly, this injury was observed in two different strains of mice with susceptibilities seemingly linked to sex (female) and age (older animals). Furthermore, both beneficial and adverse effects of CRCE on the gut microbiome were observed. Specifically, CRCE exposure increased the relative abundance of the beneficial gut microbe, Akkermansia muciniphila, however, an overall decrease in the relative abundance of all gut bacterial species was noted. This decrease was paralleled by numerous pro-inflammatory responses in the proximal jejunum and colon. Conclusions Taken together, these findings raise significant concerns about the safety of widespread CBD usage and underlines the need for additional well-designed studies into its safety and efficacy. Funding Sources NIGMS 1P20 GM109005.

Effects of Hemp Extract on Markers of Wellness, Stress Resilience, Recovery and Clinical Biomarkers of Safety in Overweight, But Otherwise Healthy Subjects

We determined the effects of a commercially available, GRAS (Generally Recognized As Safe) by independent conclusion, CBD-containing hemp oil extract on stress resilience, perceived recovery, mood, affect, body composition, and clinical safety markers in healthy human subjects.Methods: Using a randomized, placebo-controlled, double-blind design, 65 overweight, but otherwise healthy men and women (35.2 ± 11.4 years, 28.5 ± 3.3 kg/m2) ingested either Hemp Oil Extract [Hemp, 60 mg/d PlusCBDTM Extra Strength Hemp Extract Oil (15 mg hemp-derived CBD)] or a placebo (PLA) every day for six weeks while continuing to follow their normal diet and physical activity patterns. Outcome variables included changes in stress resilience, a 14-item panel of various psychometric parameters, heart-rate variability, plasma chromogranin A, body composition, and general markers of health. Data were analyzed using mixed factorial ANOVA, t-tests with 95% confidence intervals, and effect sizes (ES).Results: HDL cholesterol significantly improved in the Hemp group (p = 0.004; ES = 0.75). No other statistically significant group x time interaction effects were observed. Statistical tendencies for between-group differences were found for ‘I Get Pleasure From Life’ (p = 0.06, ES = 0.48) and ‘Ability to Cope with Stress’ (p = 0.07, ES = 0.46). Sleep quality (Hemp, p = 0.005, ES = 0.54) and sleep quantity (Hemp, p = 0.01, ES = 0.58) exhibited significant within-group changes. All values for hepato-renal function, cardiovascular health, fasting blood lipids, and whole blood cell counts remained within normal clinical limits with no between-group differences over time being identified.Conclusions: Hemp supplementation improved HDL cholesterol, tended to support psychometric measures of perceived sleep, stress response, and perceived life pleasure and was well tolerated with no clinically relevant safety concerns. Registered at clinicaltrials.gov: NCT04294706.

Post Marketing Safety of Plus CBD™ Products, a Full Spectrum Hemp Extract: A 2-Year Experience

The market for products featuring hemp extracts is large and growing larger. However, safety concerns have been raised by medical and regulatory agencies. Post marketing surveillance of full spectrum hemp extract (FSHE) products manufactured and distributed by CV Sciences (CVSI) and traded under the brand PlusCBD™ was conducted over a 2-year period (2018-2019). The safety of these products was assessed by analyzing adverse events reports. From a total of approximately five million product units sold during the 2-year period, 1,429 (0.03%) adverse events (AE) were reported in 1,151 unique customers. Of those, only two were classified as serious AEs. For orally ingested products, the most common types of AEs reported were gastrointestinal (e.g. abdominal discomfort), while for topically applied products, the most reports mentioned dermatological symptoms (e.g. rashes). There has been no evidence of liver toxicity associated with CVSI products. Based on this longitudinal dataset, the products manufactured using CVSI’s proprietary processes are safe and well tolerated at the recommended doses.

Potential Probiotic or Trigger of Gut Inflammation – The Janus-Faced Nature of Cannabidiol-Rich Cannabis Extract

Cannabidiol (CBD) is the major non-psychotropic phytocannabinoid present in Cannabis sativa. In 2018, Congress designated certain C. sativa plant material as “hemp,” thus removing it from the DEA’s list of controlled substances. As a result, CBD-containing hemp extracts and other CBD products are now widely available and heavily marketed, yet their FDA regulatory status is still hotly debated. The goal of this study was to investigate the effects of a cannabidiol-rich cannabis extract (CRCE) on the gut microbiome and associated histomorphological and molecular changes in the mouse gut mucosa. Male C57BL6/J mice were gavaged with either 0, 61.5, 184.5, or 615 mg/kg/bw of CRCE in sesame oil for 2 weeks (Mon–Fri). Substantial CRCE-induced increases in the relative abundance of A. muciniphila, a bacterial species currently accepted as probiotic, was observed in fecal samples at all doses. This was paralleled by decreases in the relative abundance of other gut bacterial species. Coincident with the observed changes in gut ecology were multiple pro-inflammatory responses, including increased expression of cytokines and chemokines—Il1ß, Cxcl1, and Cxcl2 in the colon tissue. Furthermore, dramatic increases in the relative abundance of A. muciniphila significantly decreased expression of Muc2—a gene intimately associated with gut integrity. Taken together, these findings raise concerns about the safety of long-term CBD usage and underline the need for additional well-designed studies into its tolerability and efficacy.

Increased Pulmonary Function Following Administration of a CBD‐Containing Compound NCMB‐1 in Fibrotic Lungs of African Green Monkeys.

The endocannabinoid system is a neuromodulatory system that is conserved among vertebrate species. Cannabidiol (CBD) is a modulator of cannabinoid (CB) receptor action both in the central nervous system and in the periphery. CB receptors are involved in inflammatory responses in peripheral organs, including lung tissue. CBD administration has been shown to reduce airway inflammation and fibrosis in vitro and in experimentally induced rodent models of asthma through modulation of the immune system. However, little is understood regarding the relationship between pulmonary disease and CBD modulation of general CB receptors in vivo. The African Green Monkey (Chlorocebus aethiops sabaeus; AGM) has bronchiolar tissue and tracheal branching remarkably similar to that in human lungs, therefore making it a translational model for the study of CBD treatment on pulmonary fibrosis‐related lung dysfunction. We hypothesize that administration of NCMB‐1, a hemp extract with CBD, will increase the tidal volume, inspiratory flow rate, and respiration rate of animals with previously induced pulmonary fibrosis. Baseline tidal volume, inspiration flow rate, and respiration rate of 16 male AGM with induced lung fibrosis were measured. Animals were divided into a vehicle and 3 treatment groups: 50 μL of undiluted, 5X dilution, and 25X dilution NCMB‐1 administered orally twice daily via banana sections for two weeks. Compared to control (n=4, 206.6 ± 36.4 mL), 5X NCMB‐1 treated animals increased tidal volume (n=4, 484.0 ± 54.6 mL; p&lt;0.05) from baseline at two weeks of treatment. Inspiratory flow rate also increased in 5X treated animals (n=4, 412.0 ± 49.9 mL/s; p&lt;0.05) compared to control (n=4, 212.3 ± 50.7 mL/s) after two weeks of administration. Respiration rates increased from baseline in 1X treated animals (n=4, 33.0 ± 4.5 breaths/min) and 5X treated animals (n=4, 30.8 ± 3.9 breaths/min) compared to control (n=4, 28.5 ± 4.1 breaths/min; p&lt;0.05). Treatment with 25X dilution of NCMB‐1 did not alter pulmonary function at either one or two weeks of treatment compared to vehicle treated animals. Thus, administration of 5X diluted NCMB‐1 to AGM with induced pulmonary fibrosis increased tidal volume, inspiratory flow rate, and respiration rate from compared to vehicle treated AGM. These results indicate CBD as a potential modulator of CB receptors improving pulmonary function and suggest a potential for therapeutic value of CBD in the treatment of restrictive pulmonary disease. Future directions include identification of active CBD compounds within the extract responsible for changes in airway resistance, expression of specific pulmonary genes involved in reduction of inflammation, and immunohistochemistry of CB receptors in the hypothalamus of AGM with induced pulmonary fibrosis. CBD crossing the blood brain barrier in animals treated with NCMB‐1 may cause up or downregulation of CB1 and/or CB2 receptors that could positively impact lung function.Support or Funding InformationFunding provided by Primates Plus, LLC.

Study of the Kinetics of Extraction Process for The Production of Hemp Inflorescences Extracts by Means of Conventional Maceration (CM) and Rapid Solid-Liquid Dynamic Extraction (RSLDE)

In the present work, the kinetics of the extraction process from female inflorescences of Canapa sativa subsp. sativa var. sativa were studied, on the basis of determination of the content of cannabinoids: cannabidiolic acid (CBDA), Δ9-tetrahydrocannabinolic acid (THCA), cannabidiol (CBD) and Δ9-tetrahydrocannabinol (THC), before and after decarboxylation in the oven, in order to evaluate the possible use of the hemp extract obtained in the food sector. Therefore, both conventional maceration (CM) and rapid solid-liquid dynamic extraction (RSLDE), also known as cyclically pressurized extraction (CPE), were carried out, using parts of the plant approximately of the same size. The alcoholic extracts thus obtained were analyzed by high-performance liquid chromatography (HPLC) in order to calculate the percentages of cannabinoids present in the inflorescences and thus be able to evaluate the degree of decarboxylation. Furthermore, the extracts were dried to calculate the percentage of solid material present in it, that was made mainly by cannabinoids. The amount of substance extracted from the inflorescences was about 10% (w/w), for both cases considered. Therefore, the extraction yield was the same in the two cases examined and the final qualities were almost identical. However, the extraction times were significantly different. In fact, the maceration of hemp inflorescences in ethyl alcohol was completed in no less than 24 h, while with the RSLDE the extraction was completed in only 4 h. Finally, for a better understanding of the extraction process with cyclically pressurized extraction, a numerical simulation was carried out which allowed to better evaluate the influence of extractive parameters.

Are side effects of cannabidiol (CBD) products caused by tetrahydrocannabinol (THC) contamination?

Cannabidiol (CBD)-containing products are widely marketed as over the counter products, mostly as food supplements, to avoid the strict rules of medicinal products. Side-effects reported in anecdotal consumer reports or during clinical studies were first assumed to be due to hydrolytic conversion of CBD to psychoactive Δ 9-tetrahydrocannainol (THC). However, research of pure CBD solutions stored in simulated gastric juice or subjected to various storage conditions such as heat and light with specific liquid chromatographic/tandem mass spectrometric (LC/MS/MS) and ultra-high pressure liquid chromatographic/quadrupole time-of-flight mass spectrometric (UPLC-QTOF) analyses was unable to confirm THC formation. Another hypothesis for the side-effects of CBD products may be residual THC concentrations in the products as contamination, because most of them are based on crude hemp extracts containing the full spectrum of cannabinoids besides CBD. Analyses of 28 food products of the German market containing hemp extract as an ingredient (mostly CBD oils) confirmed this hypothesis: 10 products (36%) contained THC above the lowest observed adverse effects level (2.5 mg/day). Inversely, CBD was present in the products below the no observed adverse effect level. Hence, it may be assumed that the adverse effects of some commercial CBD products are based on a low-dose effect of THC and not due to effects of CBD itself. The safety, efficacy and purity of commercial CBD products is highly questionable, and all of the products in our sample collection showed various non-conformities to European food law such as unsafe THC levels, full-spectrum hemp extracts as non-approved novel food ingredients, non-approved health claims, and deficits in mandatory food labelling requirements. In view of the growing market for such lifestyle products, the effectiveness of the instrument of food business operators' own responsibility for product safety must obviously be challenged.

Development of extraction technique and GC/FID method for the analysis of cannabinoids in Cannabis sativa L. spp. santicha (hemp).

Nowadays, the interest in industrial Cannabis sativa L. herb has been increasing in the world. As a result, it is becoming one of the most studied plants due to its multifunctional benefits. To the best of our knowledge, no study has been conducted so far to determine the impact of extraction methods and conditions on the extraction yields of CBD and CBG from the Cannabis sativa L. ssp. Santhica. Therefore, we aimed to investigate a simple and sensitive GC-FID method to determine CBD and CBG in hemp extract. As regards sample preparation, three extraction techniques were compared, including maceration (ME), ultrasound-assisted extraction (UAE) and reflux-heat extraction (RHE), in order to obtain a high recovery of the CBD of interest from the plant material. The GC-FID method developed in this study represents a powerful tool for the extraction and analysis of non-psychoactive cannabinoids from hemp varieties to be used for the preparations of extracts with a high content of bioactive compounds for both pharmaceutical and nutraceutical applications. A simple extraction procedure for CBD and CBG from hemp was also optimized in this work, by using ultrasound assisted extraction method with 96% ethanol, material/solvent ratio 1:10 and extraction time 10 min at room temperature. The overall analytical method was fully validated in agreement with international guidelines. Therefore, proving a powerful and reliable tool for both the selection of hemp varieties with a high content of bioactive compounds and the quality control of its derivatives.

Safety Assessment of a Hemp Extract using Genotoxicity and Oral Repeat-Dose Toxicity Studies in Sprague-Dawley Rats

Cannabinoids are extracted from Cannabis sativa L. and are used for a variety of medicinal purposes. Recently, there has been a focus on the cannabinoid Cannabidiol (CBD) and its potential benefits. This study investigated the safety of a proprietary extract of C. sativa, consisting of 9% hemp extract (of which 6.27% is CBD) and 91% olive oil. The mutagenic potential of the hemp extract was evaluated with the AMES assay inclusive of a hepatic drug metabolizing mix (S9) rich in CYP enzymes. The test article did not elicit evidence of bacterial mutagenicity. GLP compliant 14-day and a 90-day toxicity study were conducted. Olive oil was used as a control. The 90-day study had a 28-day recovery period. Treatments for the 14-day non-recovery range-finding study were 0, 1000, 2000 and 4000 mg test article/kg body weight (bw)/day for 14 days. There was a non-statistically significant (p > 0.05) decrease in body weights for the male and female rats receiving the test article. Hypoactivity, hyperactivity, reduced food consumption and piloerection were observed in the rats receiving 4000 mg test article/kg bw. Histopathology showed an increase in the size of liver cells (hypertrophy) around the central vein (centrilobular) in Groups 3 (3/10) and 4 (5/10) that correlated with increased liver weights. In the 90-day study, 8 groups of rats were dosed with 0, 200, 400 and 800 mg test article/kg bw/day. Groups 5 to 8 had a 28-day recovery. There were no test article-linked changes in clinical observations, physical examinations, Functional Observation Battery, ophthalmology, Motor Activity Assessment, hematology, clinical chemistries and macropathology (all groups). With the exception of the liver and adrenal gland, no test article-linked pathology was observed. For all rats receiving the test article, histopathology showed hypertrophy of liver cells around the central vein. The increase of liver weight is most likely caused by hypertrophy due to up-regulation of the hepatic drug metabolizing enzymes. The hepatocellular hypertrophy was completely reversed in 28 days and was not considered to be an adverse effect. Vacuolization of the adrenal zona fasciculata was observed in the control and 800 mg test article/kg bw groups. The vacuolization of the zona fasciculata was of the same incidence and severity in treatment and control male rats and correlated with an increased in the weights of the adrenal glands. In addition, a statistically significant increase (p<0.05) in adrenal-to-body weight ratios was observed for females receiving 800 mg test article/kg bw. This increase in adrenal-to-body weight ratio did not correlate with any of the pathology findings. The NOAEL for the test article is 800 mg/kg bw/day for female and 400 mg/kg bw/day for male Sprague Dawley rats.

New insights in hemp chemical composition: a comprehensive polar lipidome characterization by combining solid phase enrichment, high-resolution mass spectrometry, and cheminformatics.

The chemical composition of Cannabis sativa L. has been extensively investigated for several years; nevertheless, a detailed lipidome characterization is completely lacking in the literature. To achieve this goal, an extraction and enrichment procedure was developed for the characterization of phospholipids and sulfolipids. Firstly, a study on the solid-liquid extraction was performed, to maximize the recovery of the considered lipids; the best procedure consisted of a simple extraction with a mixture of methanol and chloroform (1:1, v/v). The hemp extracts were analyzed by ultra-high-performance liquid chromatography coupled to high-resolution mass spectrometry and lipids were tentatively identified by Lipostar. To improve the number of identifications, an enrichment method, based on graphitized carbon black solid phase extraction, was evaluated to fractionate phospholipids and sulfolipids into separate eluates. Recovery and matrix effects of the procedure were determined on a mixture of standard lipids, containing representative compounds for each considered lipid class. The optimized method allowed the tentative identification of 189 lipids, including 51 phospholipids and 80 sulfolipids, in the first and second fractions, respectively. The detection of only 6 sulfolipids in the first fraction and 9 phospholipids in the second fraction proved the efficacy of the fractionation method, which also allowed the number of lipid identifications to be increased compared to the same procedure without enrichment, which scored 100 lipids. Finally, a semi-quantitative analysis permitted the hemp polar lipidome to be characterized. The results of this study allow knowledge of the hemp chemical composition to be improved with a detailed description of its phospho- and sulfolipid profiles. Graphical abstract.

Evaluation of the effects of CBD hemp extract on opioid use and quality of life indicators in chronic pain patients: a prospective cohort study

ABSTRACTContext: Chronic pain is highly prevalent in most of the industrialized nations around the world. Despite the documented adverse effects, opioids are widely used for pain management. Cannabinoids, and specifically Cannabidiol, is proposed as an opioid alternative, having comparable efficacy with better safety profile.Objectives: We aim to investigate the impact of full hemp extract cannabidiol (CBD) on opioid use and quality of life indicators among chronic pain patients.Methods: An initial sample of 131 patients was recruited from a private pain management center’s investigative population. Ninety-seven patients completed the 8-week study. The primary inclusion criteria included patients between 30 and 65 years old with chronic pain who have been on opioids for at least 1 year. Data were collected at three different time points: baseline, 4, and 8 weeks. Opioid and other medication use were evaluated via the medication and psychiatric treatment receipt. Improvement was evaluated using four indices: Pain Disability Index (PDI-4); Pittsburgh Sleep Quality Index (PSQI), Pain Intensity and Interference (PEG); and Patient Health Questionnaire (PHQ-4).Results: Over half of chronic pain patients (53%) reduced or eliminated their opioids within 8 weeks after adding CBD-rich hemp extract to their regimens. Almost all CBD users (94%) reported quality of life improvements. The results indicated a significant relationship between CBD and PSQI (p = 0.003), and PEG (p = 0.006). There was a trend toward improvement but no significant relationship between CBD use and PHQ and PDI.Conclusion: CBD could significantly reduce opioid use and improve chronic pain and sleep quality among patients who are currently using opioids for pain management.Key Message: This is a prospective, single-arm cohort study for the potential role of cannabinoids as an alternative for opioids. The results indicate that using the CBD-rich extract enabled our patients to reduce or eliminate opioids with significant improvement in their quality of life indices.

Measurement of antibacterial properties of foil-backed electrospun nanofibers

Current methodologies for evaluation of antibacterial properties of traditional textiles are not applicable to foil-backed, poorly-absorbent electrospun nanofiber materials, since existing test methods require absorbent fabrics. Since electrospun nanofibers are adhered to the foil backing only by electrostatic interactions, methods used to evaluate antibacterial properties of surfaces cannot be used because these protocols cause the nanofibers to lift from the foil backing. Therefore, a novel method for measurement of the antibacterial properties of electrospun metallic foil-backed nanofiber materials was developed. This method indicated that acetate-based nanofibers manufactured to contain 5 to 30 weight percent of cold-pressed hemp seed oil or full-spectrum hemp extract inhibited the growth of Staphylococcus aureus in a dose-dependent manner, from 85.3% (SEM = 2.2) inhibition to 99.3% (SEM = 0.15) inhibition, respectively. This testing method represents an advanced manufacturing prototype procedure for assessment of antibacterial properties of novel electrospun, metallic foil-backed nanofiber materials.

Pipeline for High-Throughput Modeling of Marijuana and Hemp Extracts.

Authentication of Cannabis products is important for assuring the quality of manufacturing, with the increasing consumption and regulation. In this report, a two-stage pipeline was developed for high-throughput screening and chemotyping the spectra from two sets of botanical extracts from the Cannabis genus. The first set contains different marijuana samples with higher concentrations of tetrahydrocannabinol (THC). The other set includes samples from hemp, a variety of Cannabis sativa with the THC concentration below 0.3%. The first stage applies the technique of class modeling to determine whether spectra belong to marijuana or hemp and reject novel spectra that may be neither marijuana nor hemp. An automatic soft independent modeling of class analogy (aSIMCA) that self-optimizes the number of principal components and the decision threshold is utilized in the first pipeline process to achieve excellent efficiency and efficacy. Once these spectra are recognized by aSIMCA as marijuana or hemp, they are then routed to the appropriate classifiers in the second stage for chemotyping the spectra, i.e., identifying these spectra into different chemotypes so that the pharmacological properties and cultivars of the spectra can be recognized. Three multivariate classifiers, a fuzzy rule building expert system (FuRES), super partial least-squares-discriminant analysis (sPLS-DA), and support vector machine tree type entropy (SVMtreeH), are employed for chemotyping. The discriminant ability of the pipeline was evaluated with different spectral data sets of these two groups of botanical samples, including proton nuclear magnetic resonance, mass, and ultraviolet spectra. All evaluations gave good results with accuracies greater than 95%, which demonstrated promising application of the pipeline for automated high-throughput screening and chemotyping marijuana and hemp, as well as other botanical products.

Are side effects of cannabidiol (CBD) products caused by tetrahydrocannabinol (THC) contamination?

Cannabidiol (CBD)-containing products are widely marketed as over the counter products, mostly as food supplements, to avoid the strict rules of medicinal products. Side-effects reported in anecdotal consumer reports or during clinical studies were first assumed to be due to hydrolytic conversion of CBD to psychoactive Δ9-tetrahydrocannainol (THC). However, research of pure CBD solutions stored in simulated gastric juice or subjected to various storage conditions such as heat and light with specific liquid chromatographic/tandem mass spectrometric (LC/MS/MS) and ultra-high pressure liquid chromatographic/quadrupole time-of-flight mass spectrometric (UPLC-QTOF) analyses was unable to confirm THC formation. Another hypothesis for the side-effects of CBD products may be residual THC concentrations in the products as contamination, because most of them are based on crude hemp extracts containing the full spectrum of cannabinoids besides CBD. Analyses of 28 food products of the German market containing hemp extract as an ingredient (mostly CBD oils) confirmed this hypothesis: 10 products (36%) contained THC above the lowest observed adverse effects level (2.5 mg/day). Inversely, CBD was present in the products below the no observed adverse effect level. Hence, it may be assumed that the adverse effects of some commercial CBD products are based on a low-dose effect of THC and not due to effects of CBD itself. The safety, efficacy and purity of commercial CBD products is highly questionable, and all of the products in our sample collection showed various non-conformities to European food law such as unsafe THC levels, full-spectrum hemp extracts as non-approved novel food ingredients, non-approved health claims, and deficits in mandatory food labelling requirements. In view of the growing market for such lifestyle products, the effectiveness of the instrument of food business operators' own responsibility for product safety must obviously be challenged.