Randomized, Double Blind Clinical Trial to Study the Effect of Cannabidiol (CBD) 133mg + Cannabigerol (CBG) 66mg + Tetrahydrocannabinol (THC) 4mg a Day as Adjunctive Therapy in the Treatment of Chronic Migraine - CAMTREA TRIAL

To evaluate the effect of the cannabidiol (CBD) + cannabigerol (CBG) + tetrahydrocannabinol (THC) up to 133/66/4mg daily versus placebo as adjuvant treatment in chronic migraine (CM) patients under preventive treatment at a stable dose for at least 3 months who present at least 5 headaches day a month. CM patients of both sexes, between 25 and 65 years old, who have not had CBD and/or THC as a migraine treatment. Patients may be having migraine preventive treatment such as propranolol, atenolol, topiramate, valproic acid/sodium valproate, levetiracetam, gabapentin, lamotrigine, pre-gabaline, flunarizine, amitriptyline, nortriptyline, clomipramine, candesartan, galcanezumab, erenumab, fremanezumab, botulinum toxin type A. Acute treatment will follow patients doctor's prescription. Exclusion criteria: active liver disease or elevated liver transaminases> 3 times than the normal values, pregnancy, fertile age women without contraceptive treatment or who intend to get pregnant, patients without migraine preventive treatment or that changed the preventive treatment less than 3 months from the study start, substance abuse or addiction, use of medical cannabis or products with CBD or THC in the last 30 days or during study period, history of allergy or adverse reactions with the use of CBD or related products, substance users of liver enzymes inducers such as rifampicin, ketoconazole, theophylline, carbamazepine, phenytoin, phenobarbital and St. John's wort, clobazam, macrolides, verapamil, fluoxetine, amiodarone and tacrolimus. Patients on vitamin K anticoagulant medicines, as warfarin.
Randomization using a computacional system will stratify participants in each group by gender (F/M), age (25-34/35-44/45-54/55-65yo), headache days presented in the baseline month (5-10/11-15/16-20/21-25/26-30), overuse medication (yes or no). After randomization patients will be divided into two groups of 55 participants, who will receive CBD + CBG + THC up to a maximum daily dose of 133/66/4 mg or placebo for 12 weeks (V0 screening, V1 allocation, V4 final visit).
The main outcome is the reduction in frequency of headache days per 4 weeks between V1 and V4 compared to placebo. Secondary outcomes will be a reduction in duration and intensity of migraine attacks, amount of painkillers used and percentage of patients with a reduction greater than 50% on migraine days, 50% reduction in the other variables as MIDAS scores, HIT-6 scores, Beck's Anxiety and Depression Scales, Epworth Sleepiness Scales, and the scores at The Severity of Dependence Scale used as an indicator of overuse medication in this sample.
Clinical data will be registered on a personalized headache diary developed to this study using MyCap, from RedCap System, as an APP for daily entries using smartphones, androids or IOS system.
The clinical and laboratory data obtained in this study will comply with the objectives elaborated in the evaluation of the primary and secondary endpoints, the proposal of which is to publish the data regardless of the results obtained.

Start Date18 Oct 2022

Sponsor / Collaborator

Hospital Israelita Albert Einstein

100 Clinical Results associated with Cannabigerol

100 Translational Medicine associated with Cannabigerol

100 Patents (Medical) associated with Cannabigerol

397

Literatures (Medical) associated with Cannabigerol

01 Dec 2024·European Journal of Pharmaceutical Sciences

A new cannabigerol derivative, LE-127/2, induces autophagy mediated cell death in human cutaneous melanoma cells

Article

Author: Király, József ; Szabó, Erzsébet ; Herczegh, Pál ; Tósaki, Ágnes ; Vass, Virág ; Szabó, Zsuzsanna ; Bereczki, Ilona ; Lőrincz, Eszter Boglárka ; Remenyik, Éva ; Tánczos, Bence ; Tósaki, Árpád

Despite the targeted- and immunotherapies used in the past decade, survival rate among patients with metastatic melanoma remains low, therefore, melanoma is responsible for the majority of skin cancer-related deaths. The ongoing investigation of natural antitumor agents, the nonpsychoactive cannabinoid, cannabigerol (CBG) found in Cannabis sativa is emerging as a promising candidate. CBG offers a potential therapeutic role in the treatment of melanoma demonstrating cell growth inhibition in some tumors. Its low water solubility and bioavailability hinder the potential effectiveness. To address these challenges, a modified CBG, namely LE-127/2 was synthesized by Mannich-type reaction. The aim was to investigate the effect of this novel compound on cell proliferation as well as the mechanism of cell death with a particular focus on autophagy and apoptosis. Human cutan melanoma cell lines, WM35, A2058 and WM3000 were utilized for the present study. Cell proliferation of the cells after the treatment with LE-127/2, parent CBG or vemurafenib was assessed by Cell Titer Blue Assay. Cells were treated with a 1.25-80 µM of the above-mentioned compounds, and it was found that at 20 μM of all drugs showed a comparable effective inhibition of cell proliferation, however, vemurafenib and CBG proved to be more effective than LE-127/2. In addition, clonogenic cell survival assays were performed to examine the inhibitory effect of LE-127/2 on the colony formation ability of melanoma cell lines. Cells treated with 20 µM of LE-127/2 for 14 days showed about a 50% suppression of clonogenic cell survival. LE-127/2 exerted the most intensive inhibition on A2058 cell colonies. Furthermore, notably, LDH cytotoxicity assay performed on HaCaT cell line, proved LE-127/2 to be cytotoxic only at higher concentration, such as 80 μM, while the parent CBG was cytotoxic at concentration as low as 5 μM, suggesting that the new CBG derivative as a drug candidate may be applied in human pharmacotherapy without causing a substantial damage in intact epidermal cells. Analysis of protein expression revealed the impact of LE-127/2 on the expression of basic proteins (LC-3, Beclin-1 and p62) involved in the process of autophagy in the three different melanoma cell lines studied. Elevated expression of these proteins was detected as a result of LE-127/2 (20 µM) treatment. LE-127/2 also induced the expression of some proteins involved in apoptosis, and it is particularly noteworthy the increased level of cleaved PARP. Based on the results obtained, it can be concluded that LE-127/2 induced autophagy could lead to the inhibition of cell proliferation and death in melanoma cells.

01 Dec 2024·Pharmacology Biochemistry and Behavior

Orally administered Cannabigerol (CBG) in rats: Cannabimimetic actions, anxiety-like behavior, and inflammation-induced pain

Article

Author: Moore, Catherine F ; Jenkins, Bryan W ; Hausker, Alma ; Kuang, Robbie Y ; Weerts, Elise M

Cannabigerol (CBG) is a phytocannabinoid found in cannabis that is promoted for medical use and other health benefits, but current empirical data on the behavioral effects of CBG are lacking. The purpose of this study was to evaluate the effects of a wide dose range of orally administered CBG on outcomes related to its potential cannabimimetic effects (cannabinoid tetrad), as well as effects on anxiety-like behavior, inflammation and related pain hypersensitivity. In a series of experiments, male and female Sprague Dawley rats received oral CBG (per os [p.o.]) or vehicle prior to testing of effects on 1) the cannabinoid tetrad (30-600 mg/kg, p.o.): assessments of locomotor activity, body temperature, antinociception (tail flick test), and catalepsy (bar test); 2) acoustic startle response (ASR) test of anxiety-like behavior (30-300 mg/kg, p.o.); 3) carrageenan-induced inflammation (paw edema), hyperalgesia (Hargreaves test), and allodynia (von Frey test) tests (10-60 mg/kg, p.o.). Positive control groups were administered THC (0-30 mg/kg, p.o.) for the cannabinoid tetrad assay, the benzodiazepine lorazepam (0-3 mg/kg, intraperitoneal [i.p.]) for the ASR test, or the opioid analgesic morphine (0-10 mg/kg, i.p.) for the carrageenan-induced inflammation and pain hypersensitivity tests. CBG did not produce cannabimimetic actions in the tetrad, but increased locomotor activity at the highest doses (300-600 mg/kg). THC produced typical dose-related cannabimimetic effects. CBG did not produce anxiolytic effects in the ASR test, while groups pretreated with lorazepam showed reductions in ASR. Finally, pretreatment with CBG prior to an intraplantar injection of carrageenan did not prevent the induction of an acute inflammatory state (i.e., increased paw edema and associated hyperalgesia and allodynia). In contrast, morphine alleviated hyperalgesia and allodynia induced by intraplantar carrageenan but did not affect the development of paw edema. In sum, these data do not support the use of oral CBG for anxiety or inflammatory pain.

01 Oct 2024·Archives of Toxicology

Genotoxicity of selected cannabinoids in human lymphoblastoid TK6 cells

Article

Author: Kolar, Nicol ; Bankoglu, Ezgi Eyluel ; Stopper, Helga

AbstractNatural non-psychoactive cannabinoids such as cannabigerol (CBG), cannabidiol (CBD), cannabichromene (CBC), cannabidivarin (CBDV), and cannabinol (CBN) are increasingly consumed as constituents of dietary products because of the health benefits claims. Cannabinoids may reduce certain types of pain, nausea, and anxiety. Anti-inflammatory and even anti-carcinogenic properties have been discussed. However, there are insufficient data available regarding their potential (geno-)toxic effects. Therefore, we tested CBG, CBD, CBC, CBDV, and CBN for their genotoxic potential and effects on mitosis and cell cycle in human lymphoblastoid TK6 cells. The selected cannabinoids (except CBDV) induced increased micronuclei formation, which was reduced with the addition of a metabolic activation system (S9 mix). CBDV induced micronuclei only after metabolic activation. Mitotic disturbances were observed with all tested cannabinoids, while G1 phase accumulation of cells was observed for CBG, CBD and CBDV. The genotoxic effects occurred at about 1000-fold higher concentrations than are reported as blood levels from human consumption. However, the results clearly indicate a need for further research into the genotoxic effects of cannabinoids. The mechanism of the mitotic disturbance, the shape of the dose–response curves and the possible effects of mixtures of cannabinoids are aspects which need clarification.

News (Medical) associated with Cannabigerol

26 Oct 2023

·www.sciencedaily.com

CBD and CBG may promote bone fracture healing, manage pain

Cannabidiol (CBD) and cannabigerol (CBG) might someday help bone fracture patients manage their pain, according to a new study. In a study in mice, the researchers unexpectedly found that the cannabinoids also promoted fracture healing. Cannabidiol (CBD) and cannabigerol (CBG) might someday help bone fracture patients manage their pain, according to a Penn State study. In a study in mice, the researchers unexpectedly found that the cannabinoids also promoted fracture healing. The results were published in the Journal of Bone and Mineral Research. Scientists estimate that more than 178 million people suffer from bone fracture injuries annually around the globe. According to corresponding author Reyad Elbarbary, associate professor of orthopaedics and rehabilitation at Penn State College of Medicine, current methods for managing pain, often nonsteroidal anti-inflammatory drugs (NSAIDS) like aspirin, are not optimal. "NSAIDS may help patients manage pain, but they also reduce inflammation, which is a crucial first step in fracture healing," Elbarbary said. "An alternative for pain management is needed that does not prevent inflammation from occurring." Elbarbary and his team's primary goal was to measure CBD and CBG's separate abilities to alleviate pain in mice. The team, in what they called the first study to analyze cannabinoids in the context of fracture healing and pain management, found that the cannabinoids were comparable to the NSAIDS in their ability to manage pain. But they said they were also surprised to find that CBD and CBG helped with the fracture healing process. With immunofluorescence microscopy, microcomputer tomography imaging and biomechanical testing, the researchers studied the fracture healing process -- everything from bone density and bone strength to the expression of genes that are necessary for the progression of fracture healing. In the early phase of treatment, the cannabinoids were associated with an increase in the abundance of periosteal bone progenitors, which later develop into specialized bone cells that help bone tissue form. During the later phase of healing, CBD and CBG accelerated the process by which the body absorbs minerals to strengthen newly formed bone. "Both treatments led to higher bone volume fraction and mineral density than with NSAID treatments, which leads to a functional and healthy newly formed bone," Elbarbary said. "We still have a lot to learn about the biological mechanisms behind what we observed." According to Elbarbary, future research will focus on defining the cellular and molecular processes behind the cannabinoids' role in early and late stages of fracture healing, as well as developing a clinical formulation for use in adult fracture patients. While CBD is already approved by the Federal Drug Administration to treat seizures in children, finding a formulation, or dose, that is suitable for adults in the context of bone fractures will be a critical next step, Elbarbary said. "There is already robust safety information gathered on CBD," Elbarbary explained. "CBG is more investigational at this stage. It's more likely that CBD would be repurposed for treating fractures once a formulation is found and its efficacy for treatment in the context of bone fractures is determined." Deepak Kumar Khajuria, Vengadeshprabhu Karuppagounder, Irena Nowak, Diana Sepulveda, Gregory Lewis, Christopher Norbury, Wesley Raup Konsavage, Kent Vrana and Fadia Kamal of Penn State College of Medicine also contributed to this research. The authors declare no conflicts of interest. The National Institutes of Health and PA Options for Wellness supported this research.

08 Jun 2023

·www.prnewswire.com

BioWellnessX Expands Delta-9 Inventory with Two Powerful THCp Gummies

BURBANK, Calif., June 8, 2023 /PRNewswire/ -- BioWellnessX, a pillar in the alternative health and wellness community, has expanded their Delta-9 THC line with two ultra-potent THCp gummies. These organic gummies are crafted with the newly discovered cannabinoid THCp to provide extra-strength relief for a variety of painful conditions and symptoms. "We couldn't be more excited to announce the addition of our Delta-9X and Delta-9Z Zen Gummies," said a BioWellnessX representative. "Each new THCp gummy is formulated with 53mg of total cannabinoids, including 3mg of ultra-potent THCp. With the potential to be up to 33x as potent as traditional THC, our THCp gummies can bring real alternative medicinal options to those who are suffering the most." Like the rest of their cannabis line, BioWellnessX is committed to creating the cleanest, health-centric THCp gummies: free from harmful pesticides, synthetic chemicals, and other artificial additives. For a Sativa-like experience, the company's Delta-9X Gummies include 3mg of THCp plus 25mg of cannabigerol (CBG) and 25mg Delta-9 THC. CBG's unique cognitive benefits provide a stimulating and uplifting experience in combination with Delta-9 THC and THCp. For those suffering from moderate to severe sleep disorders, the company offers Delta-9Z gummies. These include 3mg of THCp, 25mg of Delta-9 THC, and 25mg of CBN - a naturally sedative minor cannabinoid. The three cannabinoids work together to promote improved sleep quality and duration. Here's a closer look at BioWellnessX's new THCp gummies: THCp Gummies (Delta-9X with CBG): 25mg Premium Delta-9 THC, 25mg CBG, 3mg THCp 1 Count, 4 Count, 15 Count Options in Exotic Delight Flavor THCp Gummies (Delta-9Z with CBN): 25mg Premium Delta-9 THC, 25mg CBN, 3mg THCp 1 Count, 4 Count, and 15 Count Options in Sunset Zen Flavor To learn more about their THCp Gummies, Click Here. "Our mission is to bring the latest health and wellness products to the public. THCp offers a more powerful option to those who want to experience all the mental and physical effects of natural cannabinoids," said the BioWellnessX representative. "We believe our new THCp gummy formulas, with the unrivaled quality of our ingredients, will be able to help finally offer relief to individuals across the country." BioWellnessX's organic THCp gummies are now available online. To learn more about the product and THCp's unique benefits, visit . Interested in wholesale options? Explore our bulk and wholesale options HERE. About BioWellnessX Thanks to the groundbreaking Farm Bill passed in 2018, what started as a simple CBD line grew into an industry leader in full-spectrum cannabinoids – each crafted with the same care and attention to detail as our very first CBD product. Our core mission is to help everyone suffering from chronic discomfort to find safe, clean, legal, and natural relief without worrying about adverse side effects. Not only do we want to make these products more accessible to anyone that needs them, but we also want to educate the public on the benefits of cannabinoids and get rid of the stigma behind the name. BioWellnessX Inc Customer Service Phone +1747-236-6616 Customer Service Email [email protected] BURBANK, CA 91506 SOURCE BioWellnesssX Inc

30 May 2023

·www.businesswire.com

KND Labs Named 2023 NASC MVP Supplier of the Year

LAKEWOOD, Colo.--( BUSINESS WIRE )--KND Labs is pleased to announce the company has been named National Animal Supplement Council’s (NASC) MVP Supplier of the Year in 2023 — KND Labs’ second consecutive year receiving this recognition . MVP Supplier of the Year is awarded by the NASC Board of Directors each year during the organization’s annual member conference as a way to showcase the supplier most beneficial to its members in the last year. The award is presented based on a series of performance metrics including delivery of excellence in products and services; continuing industry education through webinars and presentations; and support and service to individual companies. “KND Labs is thrilled and honored by this continued recognition as the premier supplier of CBD ingredients for pet products,” said KND Labs President Nich Wilson. “As the authority in animal supplements, this award from NASC underscores KND Labs’ commitment to our pet industry partners and our goal of being the most compliant certified supplier of bulk hemp-derived ingredients.” The award comes on the heels of the groundbreaking release of a study conducted by NASC on the tolerability of CBD in dogs. Pet brands and veterinarians alike continue to promote the use of CBD oil in products for dogs, cats and other animals based on their endocannabinoid systems. The study, which has been submitted for peer review, shows the tolerability of broad spectrum cannabidiol (CBD), broad spectrum CBD with cannabigerol (CBG) and broad-spectrum CBD with cannabidiolic acid (CBDA) in healthy male and female dogs when given a daily dose for 90 consecutive days. “Part of what makes this study unique is the data from support from the NASC’s Adverse Event Reporting System (NAERS™) which is the most advanced system of post market surveillance in the world,” said Bill Bookout, President of NASC, in announcing the study result. “Through this system, NASC members enter their products, ingredients, and administration recommendations into the NAERS database along with the number of units in each container provided to customers. These collective data are processed by algorithms in the system and Adverse Events, both serious and non-serious, can be compared and analyzed per million administrations.” The discovery further supports the use of therapeutic CBD in healthy dogs, which often is used in response to animals with seizures, anxiety, pain, skin issues, and other physical and neurological issues. “Partnering with a trustworthy CBD supply chain partner is critical for producers of pet supplements and other pet industry products,” said KND Labs Manager of Sales, Courtlandt Pennell. “Having now earned the NASC MVP supplier award for two years running, KND Labs has shown time and again our commitment to compliance and quality for our partners in the pet industry and across all the industries we serve.” In addition to its NASC supplier status, KND Labs is also NSF, cGMP 111 and 117, euGMP Effci ISO 9001, Kosher-certified and is certified as an API (Active Pharmaceutical Ingredients) manufacturer for the pharmaceutical industry and for OTC applications. About KND Labs KND Labs is a leading manufacturer of hemp-derived ingredients, extracting quality bulk ingredients for brands and manufacturers of both human and pet products. Focused on certification and compliance in the CBD market, KND is a preferred NASC supplier, EFFCI eGMP, 21 CFR PART 117 cGMP, 21 CFR Part 111 cGMP, ISO 9001:2105 certified, API certified, NSF certified, USDA Organic certified and Kosher certified. KND is also an active member of the European Industrial Hemp Association (EIHA) and an FDA Drug Establishment. With two state-of-the-art facilities in Lakewood, Colo. and Arvada, Colo., KND Labs produces hemp-derived cannabinoids such as CBD, CBG, and other hemp-derived cannabinoids in powdered isolate form, distillate oil form and liquid or powder water-soluble form. Learn more at kndlabs.com .

100 Deals associated with Cannabigerol

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Indication	Highest Phase	Country/Location	Organization	Date
Rheumatoid Arthritis	Preclinical	CZ	First Faculty of Medicine, Charles University in Prague	05 Jun 2024
Gastrointestinal Neoplasms	Discovery	IL	CNBX Pharmaceuticals, Inc.	09 Jan 2020

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