On this month’s episode, we are joined by James Schwartz, BSN, LNC CEO of Cascade High Organics

 Ep 13: Psychedelic Science: Understanding Emerging Research and Potential Therapeutic Applications

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, provided thorough coverage of the FDA press release from Thursday, January 26th.

Click here to see the full article on this important update: 

https://www.nutritionaloutlook.com/view/fda-concludes-that-cbd-needs-its-own-regulatory-pathway-separate-from-dietary-supplements-and-food

Articles

A statement released on Thursday, January 26, 2023 from Dr. Janet Woodcock, the principal deputy commissioner of the Food and Drug Administration (FDA), announced that the FDA will work with Congress in formulating regulatory oversight to balance risk and access for products in the cannabidiol (CBD) market.

Food and Drug Administration to Work with Congress on Creating Regulatory Framework for the Cannabidiol Market

The number of accidental ingestions of cannabis products by children has increased sharply in the past several years, according to a report released in early January 2023 from the American Academy of Pediatrics (1). The report, published in the journal 

, looked at data from the National Poison Data System from 2017 to 2021 on exposure to edible cannabis products in children younger than six years old (2).

“In 2017, 207 cases of accidental marijuana ingestion were reported. In 2021, there were 3,054, an increase by more than 1,000%,” read an article covering the study (1). Furthermore, when comparing 2017–2019 to 2020–2021 there was also an increase in intensive care unit (ICU) and non-ICU hospital admission as well an increase in major and moderate effects of cannabis ingestion (1).

“It is important for providers to be aware of this in their practice and it presents an important opportunity for education and prevention,” concluded the report (2). According to state and nationwide census data, the number of Americans with access to legal recreational cannabis rose from 68.9 million in 2017 to 134.4 million in 2021 (1).

Other recent news articles have also highlighted young children and cannabis ingestion. For example, calls to the Mississippi state medical center rose from two in 2019 to 36 in 2022, almost half were concerning children ages 0 to 12 (3). "It’s hard to overdose on marijuana, but some of these gummies contain very large doses and some kids are eating a whole lot of them," said Jenna Davis, the managing director of the Mississippi Poison Control Center. The center also warned that calls will continue to rise as more dispensaries open across the state.

Davis also said that symptoms of overdoses can include central nervous system depression, rapid heartbeat, vomiting, confusion, difficulty walking and drowsiness, and in extreme situations, respiratory distress and seizures (3).

Last year, a woman in Virginia was charged after her four-year-old son died two days after eating tetrahydrocannabinol (THC) gummies. Investigators allege the woman did not seek medical help fast enough and an autopsy revealed extremely high levels of THC in the boy’s body. The lack of childproof packaging, resemblance to candy, and unregulated amounts of THC contributes greatly to the danger posed to children, the article said (4).

Earlier this month, a woman in Arizona had her name removed from the state’s child abuse registry after the Arizona Court of Appeals found her cannabis use did not amount to child neglect—she had a medical cannabis card prescribed by a doctor (5,6). In 2019, she used cannabis to combat morning sickness symptoms and was added to the registry after her newborn tested positive for cannabis. “This is of national import," the woman’s lawyer said (5). “No other states have won a court ruling as clear as that handed up by the Arizona Court of Appeals.”

https://www.theguardian.com/society/2023/jan/05/children-edible-marijuana-cannabis-use

https://publications.aap.org/pediatrics/article/doi/10.1542/peds.2022-057761/190427/Pediatric-Edible-Cannabis-Exposures-and-Acute?autologincheck=redirected

https://abcnews.go.com/Health/reports-children-poisoned-marijuana-edibles-spike-mississippi/story?id=96532247

https://www.nbcnews.com/news/crime-courts/virginia-mother-charged-murder-4-year-old-son-dies-eating-thc-gummies-rcna53449

https://www.usatoday.com/story/news/nation/2023/01/12/medical-marijuana-pregnancy-not-child-abuse-arizona/11038203002/

https://www.usatoday.com/story/news/politics/arizona/2022/04/01/medical-marijuana-use-while-pregnant-not-neglect-if-under-doctors-care-arizona-court-rules/7053073001/

As access to edible cannabis increases for adults across the United States, children are also becoming more exposed as well.

Child Welfare Concerns Increasing across the Country over Ingestion of Cannabis

, researchers conducted a web-based international survey with 541 participants who self-reported a diagnosis of bipolar disorder (BP) and had used psilocybin to achieve a “full psychedelic trip” (1). In addition to multiple choice questions, the survey also offered the option for respondents to answer an open-ended question and leave comments about their experiences with psilocybin.

“Before we run clinical trials to investigate the effectiveness of psilocybin for people with bipolar disorder, we need to know whether it’s safe for them to use, as some medications which have a similar neurobiological mechanism of action can trigger manic episodes,” said study author Emma Morton, a Canadian Institutes of Health Research Banting Postdoctoral Fellow at the University of British Columbia (2). “That’s why we turned to community members to ask about their experiences.”

Responses to survey questions indicated mixed experiences to psilocybin (2). On average, participants rated the harmfulness of their experience as 1.6 out of 5, and the helpfulness as a 4. However, a third of respondents reported new or increasing manic symptoms, difficulty sleeping, and anxiety. Use of emergency medical services occurred for 18 participants and was considered rare in this study.

“Respondents (even those who experienced adverse effects) indicated that psilocybin use was more helpful than harmful,” read part of the results (2). “Quantitative findings elaborated on perceived benefits, as well as the potential for psilocybin trips to contain both positively and negatively received elements.”

Following the Phase I study, interviews with 15 of the respondents were conducted to further understand their psilocybin use to determine the cause of negative outcomes. “We learned that contextual factors like dose, setting, use of other substances, or pre-existing sleep problems, may have had a role in whether people experienced positive or negative outcomes,” Morton explained. “This finding emphasizes how important it will be to conduct additional research under controlled conditions to be more confident about the potential risks and benefits of psilocybin use for bipolar disorder.”

“Our findings demonstrate both benefits and risks of psilocybin use in this population,” read part of the conclusion (3). “Carefully designed clinical trials focused on safety and preliminary efficacy are warranted.”

https://journals.sagepub.com/doi/full/10.1177/02698811221131997

https://www.psypost.org/2023/01/scientists-are-beginning-to-unravel-the-effects-of-psilocybin-mushrooms-on-bipolar-disorder-65142

https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0279073

Results from recently published survey studies on the effect of psilocybin and bipolar disorder offered support for the design of future clinical trials.

Psilocybin and Bipolar Disorder: Careful Clinical Studies are Warranted, Survey Study Suggests

is currently offering a continuing medical education (CME) article for 1 credit. According to their website, the goal of this activity is to evaluate evidence-based behavioral treatments, medications, and management strategies for cannabis use disorder. This accredited continuing education (CE) activity is intended for psychiatrists, psychologists, primary care physicians, physician assistants, nurse practitioners, and other health care professionals seeking to improve the care of patients with mental health disorders.

https://www.psychiatrictimes.com/view/current-treatments-for-cannabis-use-disorder

This 1 CME credit article evaluates evidence-based behavioral treatments, medications, and management strategies for cannabis use disorder.

Continuing Medical Education (CME) Article from Psychiatric Times: Current Treatments for Cannabis Use Disorder

Cannabigerol (CBG) may have therapeutic potential when treating nonalcoholic fatty liver disease (NAFLD), concluded a study published by researchers at the Universities of Utah and Northern Colorado (1). The study, published in 

 in the Special Issue "Liver Disease, Lifestyle and Cardiovascular Risk,” analyzed the effects of CBG on hepatic steatosis, fibrosis, and inflammation connected to NAFLD (1). Scientists analyzed the livers of mice after being separated into groups, fed specific diets, then given either low or high doses of CBG.

“Overall, our results suggest that the low dose of CBG treatment has a higher potential for alleviating liver damage due to methionine/choline-deficient (MCD)-induced non-alcoholic steatohepatitis (NASH) symptoms, compared to high dose of CBG, which caused elevated liver damage,” read part of the study’s results section (2). “In conclusion, this study provides initial findings and a foundation for future studies on the efficacy of CBG on NASH.”

CBG is called “The Mother Cannabinoid” because all other cannabinoids derive from it. CBG also has potential anti-inflammatory effects similar to other cannabinoids and is non-psychotropic (1,2).

https://www.msn.com/en-us/health/medical/cbg-the-mother-cannabinoid-may-hold-key-to-treating-nonalcoholic-fatty-liver-disease-symptoms/ar-AA16ECLO?ocid=mailsignout&pc=U591&cvid=a851c3b444aa4691b7fbfb6ef82bca6a

A study published in January 2023 examined the effects of high and low doses of cannabigerol (CBG) on mice liver.

Cannabigerol May Help in Treating Nonalcoholic Fatty Liver Disease, New Study Suggests

According to a recent press release, Leaf411 sought to raise awareness about concerns they are hearing from patients across the country around the ability to afford medical cannabis. Last November, Leaf411 resumed their Affordability Program, which connects participating patients with free or low-cost donated cannabis products (1). Now the nation’s first no- or low-cost cannabis nurse guidance call service worries economic downturns in 2023 will increase the struggle for low-income patients to afford their medicine.

“Our recently relaunched Affordability Program has seen a huge increase in demand with 500 new applicants in the last 60 days and we are unable to meet many patient requests due to a lack of available products,” said Katherine Golden, CEO of Leaf411, in a press release (2)

“We expect that demand for these services will continue to rise in 2023 as the economy struggles.”

According to the press release, costs of utilizing cannabis as medicine can include fees for obtaining a medical card and consultations with a cannabis clinician in addition to the cost of the medicine itself (2). Leaf411 says the fee for their scheduled guidance calls are a suggested $25 donation, and only 17% of callers are able to afford that (2).

“Unlike patients who benefit from insurance or other assistance programs to help pay for prescription pharmaceuticals, cannabis patients have almost no such resources—and those programs that exist are increasingly underfunded,” Golden continued (2). “The industry has spent a great deal of energy and time educating the public about cannabis medicine, but we are far behind in supporting the programs and services that support education and greater access. The economic challenges of the coming year will unfortunately expose just how vulnerable these patients are and why industry assistance programs need stronger support.”

Patients interested in participating in the Leaf411 Affordability Program can complete an application 

Cannabis businesses interested in donating products to the program should contact Leaf411 at 

To learn more about the program, visit the 

https://www.cannapatientcare.com/view/cannabis-guidance-service-leaf411-resumes-its-affordability-program-for-patients-in-need

https://www.globenewswire.com/news-release/2022/12/15/2574907/0/en/2023-Outlook-Economic-Downturn-Will-Magnify-Challenges-of-Low-income-Cannabis-Patients.html

In late 2022, Leaf411, a cannabis-trained nurse guidance service, announced that they resumed their affordability program for patients struggling to pay for their medicine. In a recent update, Leaf411 outlined their continued response to requests for assistance they are receiving from across the country.

Leaf411 Renews Appeal to Help Patients Across the Country Afford Medical Cannabis

A peer-reviewed, longitudinal study recently published in the journal 

 suggested that people who live in states where cannabis was legal experienced lower rates of alcohol use disorder (AUD) compared to those who lived in states where cannabis was illegal (1). The study, funded by grants from the National Institutes of Health, involved 240 pairs of twins (one twin living in a state with legalized cannabis, and the other twin in a state where cannabis was illegal) and sought to quantify the impact of recreational cannabis on substance use, day-to-day functioning, and whether vulnerable people are more susceptible to potential negative effects than others (1).

The “Results” section of the paper stated (2): “In the co-twin control design accounting for earlier cannabis frequency and alcohol use disorder symptoms respectively, the twin living in a recreational state used cannabis on average more often, and had fewer AUD symptoms than their co-twin living in a non-recreational state. Cannabis legalization was associated with no other adverse outcome in the co-twin design, including cannabis use disorder. No risk factor significantly interacted with legalization status to predict any outcome.”

“Recreational legalization was associated with increased cannabis use and decreased AUD symptoms, but was not associated with other maladaptations” (2), the authors of the study concluded. “Moreover, vulnerabilities to cannabis use were not exacerbated by the legal cannabis environment.”

The authors did acknowledge that not all outcomes typically associated with cannabis use were evaluated and that a broadly characterized sample population was used (1). In its conclusion, the study suggested that further research could investigate causal links between cannabis consumption and outcomes (2). “Prevention and intervention efforts may be best implemented by continuing to target established risk factors rather than focusing on availability,” they also concluded (1).

https://www.marijuanamoment.net/people-living-in-states-with-legal-marijuana-have-lower-rates-of-alcohol-use-disorder-federally-funded-twin-study-finds/

https://www.cambridge.org/core/journals/psychological-medicine/article/abs/recreational-cannabis-legalization-has-had-limited-effects-on-a-wide-range-of-adult-psychiatric-and-psychosocial-outcomes/D4AB5EB78D588473A054877E05D45F16

The study, which began before states started legalizing cannabis, published its results on the impact of a legal cannabis environment on cannabis use and alcohol use disorder.

Twin Study Assesses Alcohol Use Disorder in States with and without Legal Cannabis

In early January, Texas Tech University Health Sciences Center (TTUHSC) announced that researcher and associate professor Josee Guindon, DVM, PhD, had been chosen to receive the international William A. Devane Young Investigator Award from the International Cannabinoid Research Society (ICRS). Dr. Guindon will receive the award at the ICRS’s 33rd Annual International Cannabinoid Research Society Symposium June 24–29, 2023 in Toronto, Canada.

“It's quite a diverse field that has been booming extensively and a lot of National Institute of Health (NIH) funding is put toward cannabinoids because of its legalization across many states now,” said Dr. Guindon (1). “Basically, it’s medicinal versus recreational that are the main focus, but a lot of studies now are trying to improve our understanding about the physiological effects of cannabinoids across different disciplines.”

According to TTUHSC’s announcement, three of Dr. Guindon’s most recent peer-reviewed publications demonstrated the role of sex hormones and cannabinoids in pain, in modulating breast and ovarian cancer tumor growth, and how cannabinoids influence ovarian tumor growth (1).

https://dailydose.ttuhsc.edu/2023/january/guindon-award-cannabinoid-research.aspx

Josee Guindon, DVM, PhD of Texas Tech University Health Sciences Center, was named as the recipient for this award, which recognizes dedication, perseverance, and skill in studying and researching the endocannabinoid system.

International Cannabinoid Research Society (ICRS) Announces Recipient of 2023 William A. Devane Young Investigator Award

James Sinnott, a sheep farmer in Ireland who grew and distributed cannabis, was charged last month with three counts of possession of cannabis and avoided a two-year jail sentence (1).

“I have helped hundreds of people over the years,” Sinnott told reporters (1). “We helped people with Crohn’s disease, MS, cancer, people with brain tumors. And, over 10 years, I never made one penny out of it.”

Sinnott claims he sold the oil at cost price or gave it away for free to customers who could not afford it.

According to the website for the Garda (the Irish police): “It is an offence to cultivate, import, export, produce, supply and possess cannabis except in accordance with a Ministerial Licence,” (2). “Policy to date has not permitted the cultivation of cannabis for medical purposes and no licences have been issued for this activity.”

Sinnott said he became involved in growing and distributing cannabis more than a decade ago, after his father developed three forms of cancer. When their original supply of cannabis oil became unavailable, Sinnott started producing it himself. He said they used every part of the plant to make the oil, including the roots. He also distributed some of the plants to his customers and instructed them on how to make the oil themselves.

“I have the height of respect for the judge and guards,” Sinnott said. “They’re applying the law as is stands in the best way that they can. But that’s why the law needs to be changed. Cannabis oil should be supplied to the people in this country like it is in other jurisdictions without seriously ill people having to go through hell to get it. Even if it doesn’t work for everyone, and I’m not saying it does, at least give people the chance to try it for themselves.”

While the judge believed Sinnott’s choice to break the law to help ill patients was misguided, he did acknowledge that he made no profit from it and imposed a suspended two-year jail term on the condition of good behavior (1).

“To me, when I was in court, facing five to seven years, it meant nothing to me compared to all the years we have given back to people while we were doing this,” said Sinnott. With his conviction and the publicity, he can no longer make the oil and worries that his customers will turn to “con artists” who could be selling overpriced or false products (1).

For more resources on cannabis laws in Ireland please see: 

https://cannigma.com/regulation/ireland-marijuana-laws/

https://www.sundayworld.com/crime/irish-crime/farmer-who-avoided-jail-for-growing-cannabis-plants-says-he-has-helped-hundreds-of-people/972381696.html

https://www.garda.ie/en/crime/drugs/is-cannabis-legal-.html

A farmer in Ireland who was arrested for growing and selling cannabis from his farm received a suspended sentence. Currently, cannabis is illegal in Ireland, except within a limited medical program.

Irish Farmer Avoids Jail Time for Producing Cannabis for Seriously Ill Customers

Journal of the American Medical Association 

 this month shows that people with chronic pain are using cannabis as a replacement for prescription pain medications. The cross-sectional study was conducted from March–April 2022 using data from 1724 adults with chronic pain living in 36 states, plus Washington D.C., that had medical cannabis programs (1). The study received funding by National Institute on Drug Abuse (NIDA) (1).

The “Results” section of the paper stated (1): “More than half of adults who used cannabis to manage their chronic pain reported that use of cannabis led them to decrease use of prescription opioid, prescription non-opioid, and over-the-counter pain medications, and less than one percent reported that use of cannabis increased their use of these medications.”

The authors also went on to state that (1) “the high degree of substitution of cannabis with both opioid and non-opioid treatment emphasizes the importance of research to clarify the effectiveness and potential adverse consequences of cannabis. Our results suggest that state cannabis laws have enabled access to cannabis as an analgesic treatment despite knowledge gaps in use as a medical treatment for pain.”

“It is no wonder that those with legal access to it are substituting cannabis in lieu of other, potentially less effective and more harmful substances,” said NORML Deputy Director Paul Armentano (2). “As legal access continues to expand, one would expect the cannabis substitution effect to grow even more pronounced in the future.”

Among the other results (1), 38.7% reported that their use of cannabis led to decreased use of physical therapy, while 5.9% reported it led to increased use; 19.1% reported it led to decreased use of meditation, while 23.7% reported it led to increased use; and 26.0% reported it led to decreased used of cognitive behavioral therapy, while 17.1% reported it led to increased use. Fewer than half of respondents reported that cannabis use changed their use of nonpharmacologic pain treatments.

https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2800119

https://www.marijuanamoment.net/pain-patients-are-switching-to-medical-marijuana-instead-of-opioids-american-medical-association-study-shows/

In results from a recent study, respondents reported that cannabis use led them to decrease their use of pharmacological treatments, including opioids.

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