Study to Evaluate the Safety, Tolerability and Efficacy of Cannabidiol (CBD) as a Steroid-sparing Therapy in Chronic Spontaneous Urticaria (CSU) Patients Each patient will commence the study with CBD is a plant-based compound, and allergies to plants are a real thing. But can you actually be allergic to CBD oil? Is it CBD or other hemp compounds that can trigger an allergic reaction? Can CBD Oil Be Used To Treat Hives? Today, cannabidiol (CBD) is an increasingly popular ingredient in skincare products, found in everything from beauty creams to salves for inflammatory skin
Study to Evaluate the Safety, Tolerability and Efficacy of Cannabidiol (CBD) as a Steroid-sparing Therapy in Chronic Spontaneous Urticaria (CSU) Patients
Each patient will commence the study with a one month run-in period in which he/she will be administered individual patient Standard of Care :anti-histamines and steroids as needed plus placebo (olive oil).
After the run-in period, doses of CBD will be incresed during the first six weeks of the study.
At the conclusion of the six weeks CBD dose escalation segment of the study, if the 300 mg CBD dose level is deemed safe for two weeks with standard of care doses of anti-histamines, patients will continue receiving 300 mg CBD with Anti-histamines as needed for an additional follow-up period of three month.
Each patient will serve as his/her own control.
|Condition or disease||Intervention/treatment||Phase|
|Chronic Spontaneous Urticaria||Drug: CBD||Phase 2|
Each patient will commence the study with a one month run-in period in which he/she will be administered individual patient Standard of Care :anti-histamines and steroids as needed plus placebo (olive oil).
At the end of the one month run-in period, all trial subjects will continue on individual Standard of Care plus increasing doses of CBD during the first six weeks of the study. Dosage of CBD will start at 25 mg twice daily and will be increased once every 14 days, if no side effects are observed, to 50 mg twice a day, 100 mg twice a day and finally to 150 mg twice a day CBD respectively. Treatment will be given with food.
At the conclusion of the six weeks CBD dose escalation segment of the study, if the 300 mg CBD dose level is deemed safe for two weeks with standard of care doses of anti-histamines, patients will continue receiving 300 mg CBD with Anti-histamines as needed for an additional follow-up period of three months. In the case of flare, the patient will be treated with higher dose of Anti-histamines and Steroides if needed in addition to CBD. Once the flare has been brought under control, then another attempt will be made to discontinue the steroids and continue treating with CBD + Anti-histamines only. Each patient will serve as his/her own control.
Laboratory studies will be carried out at the beginning of the study (baseline), and then on a monthly basis until the end of the study.
Adverse events will be continuously assessed throughout the study
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||each patient will commence the study with a one month run-in period in which he/she will be administered individual with placebo (olive oil). At the end of the one month run-in period, all trial subjects will receive CBD|
|Masking:||None (Open Label)|
|Official Title:||A Phase 2a Placebo-controlled, Open-label, Single Center Study to Evaluate the Safety, Tolerability and Efficacy of Cannabidiol (CBD) as a Steroid-sparing Therapy in Chronic Spontaneous Urticaria (CSU) Patients|
|Actual Study Start Date :||February 1, 2020|
|Estimated Primary Completion Date :||December 30, 2020|
|Estimated Study Completion Date :||December 30, 2020|
At the end of the one month run-in period, all trial subjects will continue on individual Standard of case plus increasing doses of CBD during the first six weeks of the study. Dosage of CBD will start at 25 mg twice a day and will be increased once every 14 days, if no side effects are observed, to 50 mg twice a day, 100 mg twice a day and finally to 150 mg twice a day CBD respectively. Treatment will be given with food. If the 300 mg CBD dose level is deemed safe for two weeks patients will continue receiving 300 mg CBD +for an additional follow-up period of three months
Adverse Event reporting of up to 300 mg CBD/day [ Time Frame: 6 month ]
measured by Adverse Events significance of the difference in percent of subjects experienced any Adverse events, drug-related Adverse events and Serious Adverse events between the study groups
Total steroid dose needed to control flares during CBD administration period per patient versus the total steroid dose administered during the one month placebo run-in period
Total number of days of flares/month experienced per patient during CBD administration versus the total number of days of flares experienced during the one month placebo run-in period
change in anti histamine use reporting [ Time Frame: 6 month ]
via UAS7, SF36, VAS, Cognitive QoL questionnaire, HDAS at baseline before initiation of CBD administration and at each clinical visit
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- Patients with active CSU for at least 4 months which was treated with anti-histamines as well as at least one course of steroids (ex. Prednisone)
- Age ≥18 years
- Patients will undergo an ECG and QT parameters will be measured for further analysis.
- Female subjects who are postmenopausal (absence of menses for ≥ 2 years confirmed by a follicle stimulating hormone test), or who are surgically sterilized may be enrolled. Similarly, women of childbearing potential who had a negative pregnancy test at screening, who are willing to use two medically acceptable methods of contraception for the duration of the study as well as for at least three months after cessation of CBD treatment and who are willing to undergo pregnancy testing according to the study protocol may be enrolled.
- Female subjects who are not breast-feeding and who have no intention to breast-feed during the term of the trial and for at least three months after cessation of CBD treatment may be enrolled.
- Subject able to provide written informed consent
- Viral Hepatitis (HAV, HBV, HCV)
- Serious psychiatric or psychological disorders
- Other chronic dermatological conditions under active treatment
- Active consumption of illicit drugs including cannabis or derivatives for at least three months prior to the study
- Patients with significant cardiac, respiratory or active malignance disease (except Basel Cell Carcinoma) comorbidities.
- Any uncontrolled infection at time of registration
- Renal comorbidity: eGFR < 30 mL/min/1.73m2 (note: CKD Grade 4 is defined as eGFR 15-29 mL/min/1.73 m2)
- Patient who is taking immunomodulatory medications for other indication
- Women of child-bearing potential who intend to become pregnant or who are pregnant or breastfeeding
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04439955
CBD Allergies: Can You Have Allergic Reaction to CBD Oil (Itching & Rash)?
Allergies are adverse reactions of the immune system that are not triggered in healthy people. Symptoms of allergies include sniffling, watery eyes, itching, or asthma.
According to official statistics, allergies are the No. 6 cause of chronic illnesses in the United States. Hay fever affects roughly 19.9 adults, as reported in 2017 by the Centers for Disease Control and Prevention.
CBD is a phytochemical. In other words, it comes from plants — specifically, from cannabis plants.
Given this, it’s natural to wonder whether CBD oil, a product that contains over 400 phytochemicals aside from CBD, can trigger allergies.
Though there’s not much research regarding allergic reactions to CBD oil, the cannabis plant itself has been linked to allergies.
Today, we’ll elaborate on potential allergies to CBD oil, why they happen, what researchers are saying, and whether you can still use CBD if the full-spectrum oil causes you to experience the aforementioned pesky symptoms.
Allergies in the United States in Numbers
Over 50% of the U.S. population has allergies to at least one thing. Hay fever — allergic rhinitis — is the most common allergy, affecting between 10 and 30% of all American adults, and may affect up to 40% of children.
While there’s no cure for allergies, they can be effectively managed with proper nutrition, supplementation, and a healthy lifestyle. Of course, avoiding triggers is also a good strategy.
Some allergies are more severe than others and may require a complex treatment
Below we break down the mechanism of allergies.
A Brief Overview of Allergies and How They Work
Allergies are a common health problem. They manifest in itching, sneezing, a runny nose, droopy eyes, and sometimes difficulty breathing.
But what is the root of allergies? Where do they start?
The answer is: A compromised immune system.
The immune system controls allergic reactions. A properly functioning immune system can tell the difference between harmful and safe compounds to eliminate potential dangers. However, when it goes out of whack, it starts to identify benign substances as potential dangers — creating antibodies to attack these “irritants.”
In fact, the body releases antibodies every time a person is exposed to the allergen.
Histamine is the antibody with plant allergies like hay fever. The antihistamine medications work to prevent antibodies from causing damage to the immune system. Common antihistamine drugs include Claritin, which is available over the counter. CBD allergies fall into the category of plant allergies.
Food allergies are more difficult to treat. The immune system becomes aggressive against proteins in the food, triggering serious symptoms like anaphylaxis.
Anaphylaxis can be fatal if left without immediate help. Sufferers usually carry special pens with epinephrine to treat an allergic reaction once it begins.
In a 2009 study published in Immunobiology, the authors suggested that cannabinoids such as CBD and THC could take part in immunosuppressive processes (1). This means that they may block the reactions of the immune system against the triggers.
Does it mean you could use CBD oil for allergies directly as well as for preventative measures?
Not exactly, but we’ll get to that later on.
Some people are worried that CBD might cause allergies. Is this claim backed by any scientific evidence, or is it just a rumor?
Can You Be Allergic to CBD?
An allergy to cannabis is a real thing. By the same token, a person might be allergic to CBD. Inhaling, eating, or touching cannabis plants can cause allergic reactions due to contact with pollen. When you inhale that pollen, you may suffer from hay fever.
In a 2018 study, the research team found that people with allergies to mold, dust mites, cat dander, and plants, have a higher risk of developing an allergy to cannabis (2). However, this is the only study regarding this subject as of today. More research is needed to establish a clear link between cannabis and allergic reactions.
Since it’s possible to be allergic to cannabis if you’re allergic to pollen or mold, contaminants in CBD products should be the main concern for you.
When it comes to cannabinoids, things look quite similar. A 1971 study found that THC could produce an allergic reaction (3). CBD and THC have similar chemical structures, meaning that CBD also has the potential to trigger an allergy. However, it’s important to note that the side effects of CBD are different from allergic reactions. The study also didn’t focus specifically on CBD.
Common Allergic Reactions to CBD Oil
A CBD allergy can show up in a variety of ways. Two people may have completely different symptoms, so it can be tricky to distinguish between a CBD allergy from the mild side effects of CBD.
Potential adverse reactions to CBD include dizziness, dry mouth, lethargy, nausea, and diarrhea. These are not the symptoms of an allergy to CBD. Moreover, they are nearly nonexistent in normal doses.
CBD oil allergies have the following effects:
- Dry, Itchy, or Red Eyes: Although this side effect is associated with taking THC due to its ability to dilate blood vessels in the eyes, some users might experience this after taking CBD oil. If you have this kind of reaction, or your eyes are watering, it might be the symptom of a CBD allergy.
- Breathing Difficulty: If you have difficulty breathing, seek immediate medical attention. With CBD products, this side effect may stem from poor-quality products that contain dangerous additives or mold.
- Skin Irritations: when you use CBD topically, you may notice a rash or hives as the manifestation of your allergy to CBD. However, this could also be triggered by one of the many other ingredients in creams and gels, so make sure to read the list of ingredients carefully.
- Migraines: While some CBD users may experience a slight headache at higher doses, migraines are a severe symptom that can indicate an allergy to some of the compounds in CBD oil.
People who are allergic to CBD oil are advised to try CBD isolate instead of full-spectrum products. Full-spectrum CBD oils are made using the whole plant, so they contain cannabinoids, terpenes, flavonoids, essential oils, proteins, vitamins, trace minerals, and plant wax. As a result, there’s a higher risk of experiencing an allergic reaction.
It’s a good idea to try a few different CBD products with various spectra to determine which form of CBD works without triggering allergies. You should also check with a doctor to seek medical advice about what to do when the symptoms kick in.
Research on CBD Oil & Allergies
- Researchers from the Duke University School of Medicine found that about 20% of the 100 people they tested experienced allergic reactions to linalool, while 8% were allergic to limonene (4). These two molecules are commonly found in cannabis extracts such as CBD oil.
- In a letter entitled “Marijuana and stoned fruit,” written by doctors from the University of California, San Diego, and published in the Annals of Allergy, Asthma, and Immunology, a 24-year-old male marijuana daily user had an anaphylactic reaction after eating yogurt with hemp seeds (5).
- A 2013 study from the Internal Archives of Allergy and Immunology examined 21 patients with food allergies for reactivity to cannabis lipid transfer proteins (LTP), which are alleged allergens (6). Twelve subjects were allergic to cannabis, and all 12 had more severe symptoms of food allergy than those who weren’t allergic to cannabis.
Can CBD Oil Help with Allergies?
1While research supporting the idea that CBD could alleviate allergies and their symptoms are limited, there are some studies regarding its general effects on inflammation, which is one of the body’s triggers of an allergic reaction.
In a 2011 research report published in the journal Free Radical Biology and Medicine, the authors investigated the potential impact of CBD on various inflammatory conditions (7). George W. Booz, a professor in the department of pharmacology and toxicology at the University of Mississippi Medical Center, suggested in the report:
“Inflammation and oxidative stress are intimately involved in the genesis of many human diseases. Unraveling that relationship therapeutically has proven challenging, in part because inflammation and oxidative stress feed off each other. However, CBD would seem to be a promising starting point for further drug development given its antioxidant (although relatively modest) and anti-inflammatory actions on immune cells.”
According to the research team, there is no clinical evidence CBD oil could alleviate allergies, so while we have some laboratory studies suggesting anti-inflammatory effects exist, we need more longitudinal research to draw definitive conclusions.
Final Thoughts on CBD Allergies
If you want to minimize the risk of experiencing an allergic reaction to CBD, it’s best to purchase from a reputable brand that sells high-quality products. A lot of allergies caused by CBD oils appear to stem from unwanted substances such as contaminants, solvents, or plant residue. Always make sure to check for third-party lab reports when browsing different CBD products. It might be worth spending some extra time to ensure you get a decent product.
Right now, research on CBD allergies is in the early stage. As the number of CBD users grows, so will the data about potential allergic reactions. An allergy to CBD is extremely rare, but people with pre-existing allergies or other health conditions should take particular caution.
Can CBD Oil Be Used To Treat Hives?
Today, cannabidiol (CBD) is an increasingly popular ingredient in skincare products, found in everything from beauty creams to salves for inflammatory skin conditions. A cursory Google search will reveal CBD-infused products touted as effective treatments for rashes, bug bites, dry skin, acne, and hives. As anyone who has ever dealt with these itchy red welts knows, hives can be a miserable experience, and the quest for relief can be urgent — but research on the efficacy of CBD in treating hives and similar conditions is in its infancy and new knowledge is being gained every day. Keep reading to learn more about CBD and hives from Massachusetts medical marijuana doctor Jordan Tishler.
Benefits of CBD for Skin Inflammation
CBD can benefit a wide variety of medical conditions. The evidence that CBD benefits for hives and other skin conditions hinges on its general anti-inflammatory properties. However, as noted in a thorough overview of CBD’s growing ubiquity in beauty and skincare products by Self magazine, this evidence is largely limited to lab and animal studies.
One especially popular study from the Journal of Dermatological Science in 2007 found that when isolated CBD was applied to human skin cells in the lab, it inhibited the overproduction of skin cells that drives the common skin condition psoriasis. It’s important to make a distinction here between long-term diseases like psoriasis, which may show an inflammatory response due to an underlying problem, versus skin conditions that are acute reactions some outside stimulus — as is often the case with hives, bug bites, and rashes. In other words, evidence that CBD has therapeutic potential for psoriasis is not necessarily evidence for its potential in treating hives.
CBD Oil and Topical Pain Relief
One of the best-established medical uses of marijuana is in the management of pain. However, it is not reasonable to infer that CBD necessarily has these same properties. In one study from the European Journal of Pain using rats showed that topical CBD was able to reduce pain and inflammation from arthritis in the animals. This study, however, used very high doses that would necessitate covering a human from head to toe if the CBD were to be applied topically.
Another wrinkle in the CBD use story is the fact that in all studies, human or mouse, when benefit has been shown, it has always been a very high dose. The dose has consistently been shown to be 10-20mg per kilogram of body weight. Obviously, this is not a problem with tiny mice, but in humans this means 700-1400mg per day, or a whopping $50-100 per day. This is clearly not affordable for most people.
Worse, we know that tiny doses, such as you’d get from the products available at the gas station or even at most dispensaries, do nothing. People claiming “miraculous” benefit are simply getting placebo effect.
Circling back to hives, it’s possible that these pain-relieving effects of CBD may help with the discomfort of hives, but it seems unlikely in light of the data we have at present.
Is There Potential for CBD to Treat Hives?
The bottom line is: no notable studies have been performed addressing the effect of CBD, taken orally or topically, on hives. Any products currently claiming to treat hives (and most other skin problems, for that matter) using CBD is really just marketing to people’s hopes. As a recent article in the journal Clinics in Dermatology put it: CBD has become a “trendy” additive to skincare products, but “data are limited regarding its efficacy and safety.”
Contact a Medical Marijuana Healthcare Professional About Treating Your Skin Condition
With so much still unknown about the benefits of CBD, a specialist in medical marijuana and its derivatives is your best source of information on its potential for helping manage hives and other inflammatory skin conditions. Boston medical marijuana doctor Jordan Tishler is a Harvard Medical School cannabis expert and stands ready to help you determine if marijuana may be the right medication for you. To learn more, contact the team at InhaleMD by calling (617) 477-8886 today.