Don't miss our October issue focused on pediatric cancer.

Cannabis Patient Care October 2022

On this month’s episode, we are joined by Dr. John MacKay, Co-founder of Synergistic Technology Associates. 

Ep 11: Cannabis Formulations: A Deep Dive on Processing with Dr. John MacKay

Check out our July/August issue focused on autoimmune diseases

Cannabis Patient Care July/August

Check out our March/April issue focused on chronic pain

Cannabis Patient Care March/April

Recently King’s College London announced the start of the world’s largest independent cannabis use research study called Cannabis & Me (1). King’s College, located in London, England, is a research college with “£273m annual research income and ranked 6th in the world for research ‘power’ (2021 Research Excellence Framework)” (2). The Cannabis & Me study was allocated more than £2.5 million of funding by the Medical Research Council (1).

The Cannabis & Me study reportedly aims to understand the wider impact of cannabis use on the physical and mental health of cannabis users (3). “It also aims to identify environmental and biological factors, which can explain the different effects people experience when using cannabis, and in particular, identify those users more likely to experience mental health and social issues,” as was stated in the survey provided to potential participants (3). The study will use a combination of DNA genetic and epigenetic testing, psychological and cognitive analysis, and virtual reality to understand how a user’s biological makeup is affected by cannabis use. It also intends to identify the environmental and biological factors that are most likely to cause mental health and social problems in cannabis users (3).

The study will be headed by Medical Research Council Senior Clinical Fellow Dr. Marta Di Forti. “Cannabis is consumed daily by many recreationally but also for medicinal reasons,” said Dr. Di Forti (1). “But in the UK, the prescription of medicinal cannabis remains rare. Our study aims to provide data and tools that can make physicians in the UK [United Kingdom] and across the world more confident, where appropriate, in prescribing cannabis safely.”

The study is looking for 6000 participants between the ages of 18-45 who are living in the London area and who currently use cannabis, have used it less than three times, or have never used it before. The 40-minute survey will be conducted in two parts: a survey and face-to-face interviews (3).

The full details of the survey can be found here: 

https://kings.onlinesurveys.ac.uk/cannabisme

https://www.kcl.ac.uk/news/kings-college-london-spearheads-the-largest-ever-independent-study-into-cannabis-use

Articles

The Cannabis & Me research study will reportedly study the effects of cannabis on the human brain, particularly in terms of a user’s prior psychological conditions. 

King’s College London Launches Largest-Ever Independent Study on the Impact of Cannabis Use

Recently, the nation’s first cannabis-trained nurse guidance service, Leaf411, announced the resumption of their affordability program for patients in need of cannabis products (1). Leaf411 was founded in 2019 with a mission to provide education and directional support to the general public about the safe and effective use of cannabis (1). Their affordability program connects participating patients with free or low-cost cannabis products donated from business partners.

“We recently accepted a very generous donation of product from Elixinol, a long-time vetted Leaf411 member,” Katherine Golden, CEO of Leaf411, said in a press release (1). “It could not have come at a better time because we have seen such a large increase in need from the Leaf411 community. We are receiving more requests for affordable medicine than ever in the history of the organization.”

Enrollment in the program reportedly quadrupled in recent weeks to a current total of 600 participants.

The typical donation process involves dispensaries or manufacturers, who are vetted Leaf411 business members, providing donations when their products are nearing their expiration date. The products enter Leaf411’s Affordability Program, which then assigns a program participant to the donated product that is then picked up at a participating dispensary or shipped directly if it is a hemp product. Products are distributed on a first come, first served basis, which means a patient’s preferred product might not be readily available. Leaf411 is reportedly working to grow its partnerships to continue to gain access to more products and connect them with patients.

“Affordable access to medical cannabis can often be critical for many patients who are undergoing financial hardship,” Golden continued (1). “This program helps to fill in the gaps to safe, affordable access while organizations like 

 work to find policy solutions to ensure that no patient is without safe access.”

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

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

To learn more about the program, visit the 

https://www.globenewswire.com/news-release/2022/11/07/2549500/0/en/Leaf411-Resumes-Affordability-Program-as-Economic-Conditions-Create-More-Patients-in-Need.html

Due to inflation and rising costs of living, Leaf411 resumed its affordability program to address the needs of patients seeking medical cannabis.

Cannabis Guidance Service, Leaf411, Resumes its Affordability Program for Patients in Need

PQE Group, an international life sciences consulting company, announced the establishment of the world’s first start-up to support pharmaceutical companies in medical cannabis development in a recent press release (1). The start-up, called Glocal Quality Cannabis (GQC) will reportedly provide services including engineering, GxP quality compliance, regulatory affairs, medical-scientific advisory, clinical studies, and a GQC academy. According to their website (2), “PQE Group is a woman-owned, ISO 9001-certified technology solutions and compliance consulting services company for the life sciences industry, providing global capabilities deliverable throughout the entire product quality life cycle.”

In their press release (1), Gilda D'Incerti, PQE Group CEO and Founder and President of GQC, explained that this project represents an important challenge for her, adding that she strongly believes in the therapeutical power of cannabis. “I wanted to support the field of research as well as the development and dissemination of medical cannabis through the creation of this new start-up,” said D'Incerti. “I personally, and with great care, researched the professionals who make up the new GQC team: chemists, pharmacists, physicians, and biologists who take care of the supply chain at three hundred and sixty degrees.”

QGC will address the market’s struggles with fragmented legislation by applying “the highest international standards locally to always guarantee efficacy, safety, and quality to the end patient” (1).

"I believe that medical cannabis should be treated the same as any other pharmaceutical product,” Riccardo Salvagnini, GQC VP Executive, said during the start-up's launch ceremony (1). “Our vision is to support the development of new therapies through effective management of data quality by accelerating the registration of cannabis products and reducing the timing of the supply chain to be faster for the patients. Therefore, we want to provide effective technological solutions to medical cannabis products to accelerate our go-to-market strategy through a local approach but with a global mindset.”

https://www.businesswire.com/news/home/20221024005107/en/GQC-Is-Born-the-First-Start-up-Federated-by-PQE-Group-to-Support-Medical-Cannabis

International company PQE Group announced in late October their first ever start-up to provide support for medical cannabis.

New International Start-Up Established to Support Pharmaceutical Companies in Medical Cannabis Development

(1), a study sponsored and co-published by Gb Sciences Inc. has reportedly “identified and validated cannabinoid ratio-controlled, Minimum Essential Mixtures (MEM) for the treatment of Parkinson's disease symptoms.” Gb Sciences Inc., is a plant-inspired, biopharmaceutical research and development company that creates patented, disease-targeted formulations of plant-inspired therapeutic mixtures for the prescription drug market (2).

“Our drug discovery process has identified promising ratio-controlled mixtures of cannabis-inspired compounds for the treatment of Parkinson's disease, which have proven effective at reducing Parkinsonian motor symptoms in an animal model of the disease," said Dr. Andrea Small-Howard, President, Chief Science Officer, and Director of Gb Sciences in a press release (2). Dr. Small-Howard presented this study and others at Canna Pharma 2022 in San Diego, California earlier this month in a talk titled “Identification of Minimum Essential Therapeutic Mixtures from Cannabis Plant Extracts by Screening in Cell and Animal Models.”

According to the press release (2), the company-sponsored study was conducted with discovery research using cell models of Parkinson's disease performed at Chaminade University (Honolulu, Hawai'i), and the MEM refinement and validation research was performed in a zebrafish model of Parkinson's disease at the National Research Council of Canada (NRC). The study is titled "Identification of minimum essential therapeutic mixtures from Cannabis plant extracts by screening in cell and animal models of Parkinson's disease

 and was co-authored by Andrea Small-Howard and her collaborators Michael G. Morash, Jessica Nixon, and Lee Ellis from the National Research Council of Canada; Lori M.N. Shimoda and Helen Turner from Chaminade University of Honolulu; and Alexander J. Stokes from the University of Hawai'i at Manoa (Manoa, Hawai'i).

“The sequentially reductionist process implemented in this multi-site study preserves some of the entourage-like effects of whole plant extracts while achieving ‘relative’ simplicity within MEM that is a requirement for obtaining the manufacturing and quality control advantages of single-ingredient drugs,” the press release stated (2). “Gb Sciences' Parkinson's therapeutics are currently being tested in a rodent model of Parkinson's disease and these Parkinson's MEM have been formulated as oral dissolving tablets in preparation for human clinical trials. They are preparing for the final rounds of toxicology and pharmacology testing required for filing an Investigational New Drug (IND) Application with the US Food and Drug Administration.”

For more coverage of Canna Pharma 2022, please click here: 

https://www.cannabissciencetech.com/view/highlights-from-canna-pharma-2022-driving-cannabis-science-and-therapeutics-forward

https://www.frontiersin.org/articles/10.3389/fphar.2022.907579/full

https://www.globenewswire.com/en/news-release/2022/10/10/2530872/0/en/Gb-Sciences-Co-Publishes-Study-Demonstrating-Efficacy-of-Its-Proprietary-Cannabinoid-Mixtures-for-the-Treatment-of-Parkinson-s-Disease.html

Research sponsored by biopharmaceutical drug development company Gb Sciences Inc. identified and validated mixtures of cannabis-inspired compounds for the treatment of Parkinson's disease.

A New Study Demonstrates the Efficacy of Cannabinoid Mixtures for the Treatment of Parkinson's Disease

In San Diego, California, presenters, attendees, and others in the cannabis industry gathered from October 12-13, 2022 at 

 to share current strategies and knowledge to move cannabis science and medicine forward. The two-day conference featured nearly two dozen presentations, poster presentations, and opportunities for networking, including a post-conference mixer. Here we present highlights from each presentation at the event.

A half day pre-conference workshop led by Charlotte Peyton on October 11th, an independent consultant from EAS Consulting Group, instructed attendees on an overview of good manufacturing practices (GMP) in the cannabis industry, including expectations and compliance requirements to help employees stay on top of critical quality and safety issues.

Plenary keynote speaker Stephen Goldner, Esq., CEO and Chair of Pure Green Pharmaceuticals, gave an overview of methods to decentralize clinical trials in cannabis medical research. Using a recent proof-of-concept study involving cannabidiol (CBD), Goldner presented a detail-rich explanation of the clinical, scientific, business, and legal approaches to decentralized clinical trials; the challenges and benefits; and how they can become commercial and professional opportunities.

Dr. Ethan Russo, Founder and CEO of CReDO Science, gave an in-depth exploration of two minor yet important cannabinoids in his presentation “Cannabigerol (CBG) and Tetrahydrocannabivarin (THCV): Sources of Novel Cannabis Therapeutics.” Dr. Russo explained the genetics of the two cannabinoids, compared their mechanisms and roles to other cannabinoids’, plus explained the therapeutic potential of CBG for treatment of anxiety, pain, primary cancer treatment and antibiotic-resistant bacterial infections, and the potential of THCV for treating obesity, metabolic syndrome, Type II diabetes mellitus, and drug addiction. He also gave an overview of past and recent studies on these cannabinoids in humans. Following Dr. Russo’s presentation, Hunter Land presented “Active Pharmaceutical Ingredients: Strategic Considerations for Cannabinoid Development,” in which he explained the benefits of synthetic and biosynthetic production of cannabinoids versus extraction and explored their development as medicines.

Medical topics were covered in several more presentations as well. Marilyn Barrett, PhD, gave an in-depth explanation of the proof-of-concept study that Stephen Goldner had mentioned in his talk. In “Diabetic Neuropathic Pain Decreased Upon Coadministration of CBD and PEA,” Dr. Barrett explained how cannabis-derived medicine can be an opportunity for both patients and the pharmaceutical industry. She explained the details of the randomized, double-blind, placebo-controlled trial, including the patient selection process, dosing, endpoints, and treatment period, then analyzed the results. In “Case Studies: Identification of Minimum Essential Therapeutic Mixtures from Cannabis Plant Extracts by Screening in Cell and Animal Models,” Andrea Small-Howard, PhD, explained the rationale behind patients using essential compounds rather than whole plant extracts. Dr. Small-Howard gave an explanation of three case studies using cannabis components to examine the potential for treatment of conditions such as Parkinson’s disease, chronic pain, and inflammation. For a global perspective, S. Zev Barnett explained in his presentation, “Hemp Derived Medicine: The Need for Fast Global Adoption,” how cannabis could improve healthcare in the US, using examples and personal stories. He also gave an overview of a large trial study of CBD and its implications for further study.

Chairperson Monica Taing from Holistic Industries moderated a panel discussion and audience Q&A on industry regulation and practice. The three panelists were Lori Dodson, Maryland Medical Cannabis Commission, Heather Krug, Colorado Department of Public Health and Environment, and Susan Audino, PhD. The panel answered questions from the audience on topics such as how to ensure laboratory competency, laboratory shopping, vape testing requirements, delta 8 regulations, and what federal oversight on state regulations could look like. Dr. Audino also gave a separate, in-depth presentation titled “The Triangulation (Or Strangulation) Consuming Cannabis-Testing Laboratories” which explained the issues currently restricting cannabis laboratories.

In a spotlight on technology, two presentations covered improving bioavailability and formulation challenges. In her presentation titled “Overcoming Formulation Challenges of Cannabinoids,” Inayet Dumanli-Ellis, PhD, explained methods of drug delivery modalities and covered topics such as the development of oral THC and CBD self-emulsifying formulations and improving the stability of cannabinoids in lipid vehicles. In “Emerging Formulation Technologies for Pharmaceutical Applications of Cannabinoids,” Andreas Papas, PhD, explained the role of formulation technologies on solubility, stability and enhanced absorption, and bioavailability of cannabinoids, plus examples of commercial applications in product formats.

Two presentations explored the legal interests in the cannabis industry nationally and globally. Scheril Murray Powell, Esq. gave a talk titled “Managing Consumer Protections while Growing a Robust Inclusive Cannabis Space,” in which she elaborated on the need for industry standards to protect consumers and the JUSTÜS Foundation’s work in assisting legacy cannabis companies with integration. Dale Hunt, Esq. presented “Navigating IP Opportunities and Risk in Cannabis – What Everyone in the R&D Business Should Know,” and explained what companies can and cannot do with patents and why.

Several presentations covered the cannabis industry in Canada. Presenting virtually were Andrew Waye, PhD, and Sophie-Anne Lamour, PhD, both from Health Canada. Dr. Waye presented “An Overview of Chemical and Microbial Contaminant Requirements for Cannabis Products in Canada,” and explained supply chain regulation, quality control, and integration with existing frameworks. Expanding on these topics, Dr. Lamour presented “A Risk-based Framework to Facilitate Non-therapeutic Research on Cannabis in Humans in Canada,” in which she explained current regulations and the benefits to the proposed framework changes. Karolina Urban, PhD, presented “Advancing the Potential Use and Efficacy of Cannabinoid-based Medicine,” which explained what factors contribute to the current mixed results of cannabinoid-based medicine and what research is being done. Presentations and audience questions included comparisons to the United States’ cannabis industry.

Other presentations covered various topics such as the importance of cleaning procedures for all cannabis equipment as explained by Michael Moussourakis in his presentation “Critical Cleaning: the Key to Quality and Safety;” an argument for choosing mass spectrometry over ultraviolet (UV) detection presented by Anthony Macherone, PhD, in his talk “Why Are We Using Non-Selective UV Detectors for Regulatory Cannabinoid Profiling and Agency Testing?”; an explanation of the various benefits of cannabis tissue culture as presented by Hope Jones in “Tissue Culture Techniques;” and an explanation of the FDA’s “Cannabis and Cannabis-Derived Compounds: Quality Considerations for Clinical Research” draft guidance as presented by Nandu Sarma, PhD, in his talk “Quality Considerations for Cannabis Clinical Research.”

The 2022 Canna Pharma Conference was held October 12-13 in San Diego, California.

Highlights from Canna Pharma 2022: Driving Cannabis Science and Therapeutics Forward

Meg is the Group Editorial Director for Cannabis Patient Care and Cannabis Science and Technology magazines at MJH Life Sciences.

President Biden announced three steps as part of enacting this plan. “First, I am announcing a pardon of all prior Federal offenses of simple possession of marijuana. I have directed the Attorney General to develop an administrative process for the issuance of certificates of pardon to eligible individuals,” said President Biden (1). “There are thousands of people who have prior Federal convictions for marijuana possession, who may be denied employment, housing, or educational opportunities as a result. My action will help relieve the collateral consequences arising from these convictions.”

President Biden’s second step is to call on all US Governors to offer the same pardons for state-level offences regarding marijuana possession.

“Third, I am asking the Secretary of Health and Human Services and the Attorney General to initiate the administrative process to review expeditiously how marijuana is scheduled under federal law,” said the President. “Federal law currently classifies marijuana in Schedule I of the Controlled Substances Act, the classification meant for the most dangerous substances. This is the same schedule as for heroin and LSD, and even higher than the classification of fentanyl and methamphetamine – the drugs that are driving our overdose epidemic.”

This monumental announcement has been a long time coming for many cannabis activists and advocates. As stated in an article from 

 (2), it’s not clear how long this review process could take, but the call to review is a big first step.

https://www.whitehouse.gov/briefing-room/statements-releases/2022/10/06/statement-from-president-biden-on-marijuana-reform/

https://www.marijuanamoment.net/biden-announces-mass-marijuana-pardons-and-calls-for-cannabis-scheduling-review/

In a statement released from the White House on October 6, 2022, President Joe Biden announced plans to pardon Federal convictions for simple possession of marijuana and issued a call to review the scheduling of cannabis (1).

US President Joe Biden Announces Cannabis Possession Pardons at the Federal Level and Calls for a Schedule Review

Here, Dr. Dustin Sulak discusses how his patients, who have sometimes failed to respond to traditional treatments, see symptom improvement and other positive results after being treated with cannabis and psychedelics such as ketamine.

View the video for more of the discussion.

In this video interview, Dr. Dustin Sulak of Healer.com and Integr8 Health shares the most surprising results and quality of treatment response he sees when treating his patients with medical cannabis and psychedelics.

Cannabis Science Conference East 2022: Dr. Dustin Sulak Shares Surprising Results when Treating Patients with Cannabis and Psychedelics

In early September, the Cannabis Center of Excellence (CCOE), Undoo, LLC, and Patriots Helping Vets launched a new national research project for US military veterans. According to the press release (1), “the Undoo® Veterans Study will be conducted in tandem with the CCOE iCount for Veterans - Veterans Cannabis Access Program (VCAP).” The CCOE’s iCount for Veterans program connects veterans to cannabis products to participate in research and educational programs (1). The study will include 500 qualifying veterans and will study the effects of three Undoo® products (1).

Undoo, LLC develops products that address some of the after-effects of cannabis consumption (1). Patriots Helping Vets is providing support for the research study. Their mission is to provide US service veterans the materials, support, and education to start their own gardens (2). The goal of the CCOE, a 501c(3) non-profit, is to bring together citizens, medical patients, academics, researchers, community members, healthcare professionals, and policy makers to drive change in access, best practices, and social justice in cannabis industry (3).

According to the CCOE press release (1), “veterans will receive Undoo® products as a part of their participation in ongoing CCOE studies and report on their effectiveness for the intended outcomes.” The three products are Undoo® Rescue softgels intended to lessen the effects of tetrahydrocannabinol (THC) consumption, Undoo® Refresh softgels for lingering haziness and mental fog from cannabis consumption, and Undoo® Reset for restoring THC tolerance (1). “Veterans can share their experiences, voice, and opinions to drive changes in the cannabis industry,” the CCOE further stated (1).

This study is approved by the University of Massachusetts Dartmouth Institutional Review Board (1).

For more information on the research project or to register, please visit: 

https://www.cannacenterofexcellence.org/offers/b82wt2hw/checkout

https://www.cannacenterofexcellence.org/undoo

On September 7th, 2022, the Cannabis Center of Excellence (CCOE), Undoo, LLC, and Patriots Helping Vets launched a new national research project for US military veterans to study the efficacy of three products that address the after-effects of cannabis usage.

New Research Project for Veterans Launched to Study the Efficacy of Products Addressing After-Effects of Cannabis Consumption

Here, Dr. Dustin Sulak explains how the attitudes of healthcare professionals have changed over the years and how he has responded. He also notes a positive outcome he has seen recently when training clinicians on medical cannabis.

In this video interview, Dr. Dustin Sulak of Healer.com and Integr8 Health shares the biggest challenge he encounters when educating other healthcare professionals on medical cannabis, both in the past and today.

Cannabis Science Conference East 2022: Dr. Dustin Sulak Discusses Healthcare Professionals and Medical Cannabis Education

Can you tell us more about your background areas of study and how you got involved in cannabis studies?

 I have a broad academic background, my training ranges from evolutionary biology to very applied community research. Some of my research is very theoretical, using evolutionary biology to understand human psychology and behavior. At the other end of the spectrum, it's very applied: I’m trying to understand health patterns in communities and ways to improve them. As part of the latter research, I attend and present in public health conferences, and other venues where people are working in health and healthcare.

Public health conferences would feature presentations on cannabis, but all the presentations were from the framework of the Prohibition Era. It was all about abstinence-based programs, getting people to quit if they're using cannabis, all the possible harmful effects, which is a valid area of study, but also the so-called gateway drug fallacy: basically, if people are using cannabis, that's going to lead them into harder drug use. So, after seeing presentation after presentation repeating these themes, I would talk to the presenters and I would say, “Okay, now California and other states have legalized access to cannabis for people who want to use it for medical purposes. So, what's the public health framework for that?” And there really weren't any answers. I mean, people were stunned. It was sort of like deer in the headlights. If they said anything, they would say, “well, we don't think that's a good idea,” or “that's too risky.” After a while, it occurred to me that public health is really not prepared for this change.

A lot of the changes in the cannabis landscape were driven by ballot initiatives and grassroots legislation. But, transitioning from a world where cannabis is an illicit substance, and you're just thinking about it in a criminal model, to the medicalization of cannabis, there's so many things that you want to know. Just imagine all the things that it takes to bring a pharmaceutical drug to market. All these different phases of clinical trials. You have to test for dosage, safety, risks, and so forth. Unfortunately, because it was just prohibited for so long this research hadn't been done.

So, it's sort of like public health is standing on the train tracks and there's this freight train of legalized cannabis coming down the tracks and it's just going to get run over because millions and millions, in fact, now the majority of people in the United States, have legal access to cannabis, both for medical and even recreational use. They don't even need a medical card.

There's a lot of research and education that needs to come along with that for us to fulfill the proper mission of public health. And that's really to keep people healthy and to maximize the health benefits, and to minimize the costs, risks, and harms of any kind of medication or substance that people are using. And at the time, a decade ago, the kind of research that would support that was few and far between. So, like George Washington getting called into action, somebody has to do this work and I guess it's us. It wasn't really an area that we had trained in, there was no training available at the time. So my partner and I started research collaborations investigating naturalistic cannabis use and how people were using it to treat all sorts of different health or medical conditions: what they knew about it, what they didn't know, what harm reduction techniques they were using. I'm pleased to say that now there's a boom in cannabis research just like there is in the cannabis industry. It’s a very different landscape than it was 10 years ago, but there are still many, many questions to be answered.

So, 10 years ago when you started this research, what kind of challenges did you face? Was it hard to get people to be honest in the kind of questions you were asking them, or even just to get the research approved?

 I don't think that people were as concerned, because we had a little bit of an outside the box thinking in terms of our initial studies. One of the challenges when we're thinking about this is, well, how are we going to survey people who are using cannabis, which at the time was technically illegal. How are you going to advertise for a study or gather people or get them to respond even to an online survey?

Fortunately, being at the University of Michigan in Ann Arbor, the people come to us because there's an annual event called Hash Bash that started originally as a protest when John Sinclair, who's a musician, poet, and activist was arrested for giving away, not selling, but giving away two joints to an undercover agent. This happened in the early 1970s. At the time, cannabis use was really prevalent—I don't think the police were really even arresting people for it so much then. But Sinclair was a troublemaker for the powers that be. He was an activist and they wanted to get rid of him, so this is how they were going to do it. Because at the time, the laws in Michigan were still very strict. So technically, he committed this crime that they could sentence him to 10 years in jail, so they did and then there was a big protest about it.

In fact, John Lennon and Yoko Ono came as well as many other musicians, and they filled up the Crisler Center arena, which is where they play hockey and basketball at the University of Michigan. There was this big protest, but coincidentally, a federal judge also reviewed the case and said, “Now this is ridiculous, you can't sentence someone to 10 years in prison for having two joints.” So, he threw the case out and then technically there were no anti-cannabis laws on the books in the state of Michigan. There was this legal opening and people threw a celebration that became the first Hash Bash when technically it was not illegal because the law of criminalizing it had been thrown out. Of course, the Michigan legislature quickly responded and recriminalized it. But this started a tradition where thousands and thousands of cannabis enthusiasts come to Ann Arbor and have a rally and celebration right in the heart of campus, right on what we call “The Diag,” which is like the quad in front of the big, beautiful library. You have guest speakers and there's thousands of people.

Well, we thought this was the perfect opportunity to do a survey there, having a lot of experience in the survey world. In fact, when I was training, I even interned as a door-to-door survey researcher in Chicago on a National Institute on Drug Abuse (NIDA) drug use study. So that gave me some real practical lessons in the best practices for conducting a survey like this. We actually had a team of students and at the time—we were still really concerned about this. It was the first time that we had done this or anyone had ever thought about doing something like this. It was a team of faculty and graduate students; we thought graduate students would be more mature and better able to handle anything that would happen than undergraduates. It went really smoothly and we went out there and we had colorful displays and people wore costumes to be more relatable to the potential participants.

It was a great success. We were able to collect, I believe, more than 300 surveys and thus document naturalistic cannabis use and how people were using it and what their concerns were. Then after that, I thought, I can't believe that nobody else had thought about this before because it really was a great opportunity. You really had to know how to do it appropriately. Long story short, we couldn't come in there with a typical psychological survey instrument that takes 30 to 45 minutes to complete and such. We knew that we only had a short amount of time to get to get people's input.

We continued to do that every year and then our studies were eventually published. Then when we made it into the news, we were contacted by a local dispensary in Ann Arbor, whose staff at the time had a very idealistic vision for what they wanted their dispensary to be. They really did want to follow best practices and be informed by research and be good for consumers. Not just a profit-making business, but something that really did have the best interests of their clients in mind. So, I partnered with them and then through them met other researchers who had a similar mind set and were surprisingly also at the University of Michigan, but miles away in a different part of campus.

We’ve continued to collaborate since. So, it's nice that there's a growing research community at the University of Michigan, looking at cannabis and taking it seriously. Well, what does it mean to take it seriously? If we were to take the medical use of cannabis seriously, what would that look like and how should we do it?

What made you decide to work as the principal investigator with the Releaf app in your current study related to chronic pain?

 There are a lot of different components to that. One is pain, which is one of the main conditions that people use medical cannabis to treat. We found that in our studies, and other people have found it in their studies as well, pain is consistently one of the most common conditions that that people are treating.

The National Academies of Science, Engineering, and Medicine, basically, the United States’ official scientific body and authority, issued a 

 a few years ago, a literature review on cannabis to really determine the state of the field and the state of evidence, especially regarding risks and benefits (1). They concluded that cannabis was effective at treating chronic pain. It’s very promising and at the same time, very general, because there's a lot of details in there that we'd want to know beyond just that simple fact. So that really encourages more research.

There's also the technical element of the Releaf app as a data collection platform. It can conduct what we call ecological momentary assessments (EMA), which ping people at specific times of the day, or even random times if the study wants that, to fill out a brief survey on their phone. So, it's a mechanism for data collection, or platform for data collection. The larger picture is that this sort of cross-sector collaboration enables the kind of research that needs to be done that would be difficult to do otherwise, because right now, cannabis is still illegal at the federal level. It's still a Schedule I substance. So, if we were to do a study where we wanted to give cannabis products to people and then assess their efficacy for treating chronic pain or anything else, we'd have to get a Schedule I license from the Food and Drug Administration (FDA). Those are incredibly difficult to do. There are some people that do it, but it's a very difficult, cumbersome, and lengthy process of setting up such a study.

By collaborating, we can investigate naturalistic cannabis use, or basically people who are self-medicating. We can survey them and ask them about their experiences, and if they're doing it systematically, it's fairly equivalent to a clinical trial. If there are standards and procedures that are followed and it’s putting the components together in a way that makes this kind of work feasible, or much more feasible, given the current restrictions. So, it’s pretty ideal.

Another reason why this kind of partnership is ideal is because, you have both industry—people who are working in this field—and academics working together. There’s often very different perspectives that they bring to the table, but one aspect that academics bring is independence. In other words, we can use solid science and follow the data. We’re not so much tied to what the results of a particular study are. Not necessarily the partners we’re working with now, but certainly some people in industry would feel pressure to have positive results. Some might even fudge or fake data to show those positive results even if they’re not there. But if you have academics who are outside and independent and the outcome of this study really isn’t going to affect my career, it’s nice to have that independence where you can objectively assess the data and say these are the results.

I think that builds trust, especially in an area like this that’s sort of sensitive. I think that’s one big component of value that this kind of partnership brings to the table. I actually consulted in other industries where there was some internal evaluation staff and they’re basically cherry-picking evaluation results because they want it to show that their program worked. I said to them, “listen, here are the results, this is the way I wrote it up, and I wrote it up in a way to try to be clear and informative, and don’t change it. Don’t edit it.” They really struggled with that and I think that's one reason why I'm not working with them any longer, because I wouldn't let them bend the data to their interests.

These are results, and honestly, you really do want to be informed by honest, accurate information for someone who has a dispassionate interest. We really want to seek the truth. Ideally, that's what academics do.

Can you tell us more about the chronic pain study and how it was designed? What types of pain you're looking at?

 We're looking at individuals who have different types of chronic pain conditions such as fibromyalgia, rheumatoid arthritis, and osteoarthritis of the knee or hip. To make a long story short, these conditions have somewhat different mechanisms biologically, maybe even psychologically. So, it's interesting to study them together and to see how effective cannabis is at relieving pain because they might operate with somewhat different mechanisms in the body. Also, we are studying how different types of chemical compositions of cannabis could be more or less effective at treating each one of those.

That's important because cannabis is very complex in terms of all the different compounds in it. It's not like alcohol. Alcohol is just one substance, ethyl alcohol and we have a pretty good understanding of its effects. But with cannabis, there's hundreds of different cannabinoids, as well as terpenes and other components that people are now investigating, things like the entourage effect. Is there any truth to this notion that there's a synergistic effect between all these different compounds? That's a good question.

Many people know about tetrahydrocannabinol (THC), and cannabidiol (CBD). These are probably the two most well-known cannabinoids, but there are hundreds more that we know very little about. Imagine if you went to a pharmacy and they gave you a bunch of different looking pills in unlabeled bottles and said, “just take these pills until you feel better.” It's not very systematic. That's the picture with cannabis right now.

There's a lot of research going on, but we really do need to answer these questions. What are all the different effects of all these cannabinoids separately and how do they work together? What are the appropriate dosages? Is there individual variation in what the appropriate dosage is?

There are all these questions that you really want to answer to maximize the effectiveness beyond just the statement that cannabis is effective for treating chronic pain. That's just the start. That’s really our call to action to see how we really can maximize the benefits and minimize the cost, risks, and harms for people who are using cannabis to treat chronic pain conditions.

How do people enroll? Is it still ongoing or has the study ended?

Enrollment is currently open. Interested individuals can learn more about this study and enroll by visiting 

What do you hope to learn from the chronic pain study, and when do you plan on having results published?

 There are two major components to this: 1. The different cannabinoid compositions and how effective those are; and 2. The different types of pain. We might even see an interaction where there are certain types of pain that certain compositions are more effective for. Then other compositions are more effective for other types of pain. Those are some of the basic questions that we're looking to answer. The data collection was launched in August 2022. We're hoping to complete data collection in late fall 2022. Then we'll be working on our data analysis and writing up reports, and then we will submit at least one manuscript to a peer-reviewed journal. That again puts our research through another process of scientific scrutiny, where independent researchers and scholars will look at our study to see if there are limitations? Can we justify the conclusions that we're presenting? We think we have a solid study and given the National Academies’ determination and other evidence that we've seen from the field, we're expecting to see interesting results. We're looking forward to writing up that manuscript and submitting it, and then it will go through a peer review process to see how trustworthy this information is.

Sometimes that does take months because you will likely have to revise your manuscript sometimes more than once. But hopefully we'll have an article out by the middle of next year. Then certainly anyone, anyone who participated in the study, can contact us and we'll share the results with them.

You also conducted a study in 2019 to find out how knowledgeable a sample of cannabis consumers were in regard to the effective levels of THC and CBD and dosing. Why was it important to gather and study this kind of information and what were the outcomes?

This really gets at some of the major issues regarding the gap between the medicinal use of cannabis and what you would expect best practices to be. As well as the gap with mainstream medicine. We found that most of our participants use cannabis every day and the vast majority, 85%, use cannabis to treat a health or medical condition. That's significant. People might consider recreational use something different. Maybe they wouldn't take it as seriously. But if people are using it medically, using it to treat a health or medical condition, you really want to know what the best practices are, especially regarding something like dosage.

However, people's knowledge about cannabis was mostly from their own experiences. Maybe about a fifth of them got information from a medical cannabis caregiver or dispensary, the place where they were getting their cannabis from. That would be expected, but fewer get any from their primary healthcare provider. That’s less than one-fifth. That's really striking and remarkable. In fact, many of them said that their primary health care provider didn't even know that they were using cannabis to treat their health or medical condition. For us, that raises serious issues, if there's a disconnect between their medicinal cannabis use and the healthcare system.

Maybe people aren't revealing it because they're concerned about the legality in their state or maybe they have employment concerns like, “what if my job finds out that I'm using cannabis?” It's a very real issue as to why people might not be disclosing to their primary healthcare provider. At the same time, that does create additional issues or concerns. One of these concerns is that to what extent do people really know what they're doing. So, we asked, “What do you think an effective dose of THC is? What do you think an effective dose of CBD is?”

There are also some questions to be answered. For example, are there different dosages for different conditions? That's something that hopefully, we'll find out in our research and future research. But as of now, there are a number of different bodies that have defined dosages for THC and CBD. For THC, that's typically, 5 milligrams or 10 milligrams. For research purposes, 5 milligrams has been defined as the standard unit. California, other states, and other areas have defined 10 milligrams of THC as a standard dose. So, if you're buying an edible, they'll say, okay, here's a chocolate bar, and it has 10 pieces. Each of them has 10 milligrams, so it's 10 doses. It's really good to inform people about how much you need to take. But the majority of our participants had no idea what an effective dose of THC was. Even those who did gave estimates that averaged 91 milligrams. That's about nine times what the guidelines would recommend. Honestly, this is one of the legitimate concerns you have with cannabis. People might overconsume an edible because they don't know how much to take. They might see one cookie or one brownie and just eat the whole thing and then literally might end up in the hospital because they're having a panic attack.

That's something that people really need to be educated on—and the same with CBD. There's less research into dosages of CBD, but still the majority in our 2019 study had no idea what the dosages were and said that the appropriate amount would be 177 milligrams. So again, that's several times what you would typically find, say, in a gummy or a capsule that has maybe 25 milligrams of CBD.

There were also estimates for how much THC and CBD would be in strains of cannabis flower, basically, the raw bud that people might smoke or vape. Their estimates were way higher than in reality. They thought that the average THC content in cannabis flower was 52% and that's far beyond what even the highest THC strains have right now. This is the same for CBD. Long story short, they grossly overestimate how much THC is necessary, how much CBD is necessary. That's a concern and something that we really should address with education and more research.

What has surprised you most from your research with cannabis?

: I think those findings show how far we are from where we need to be. Imagine an ideal system where cannabis is treated seriously as a medicine and is fully integrated with people's medical treatment. All those different aspects we would need to have, including patient education.

It’s apparent to us from our research that we're still pretty far away. Honestly, I think the Schedule I status is probably still a major barrier for this to be fully realized for legal concerns, constraints on research, and other aspects. So hopefully, that will shift in the future, especially now that a majority of the American population, as I said, have legal access to not just medical, but recreational cannabis.

Where do you recommend people go to find information on similar studies, current or past studies, and research on cannabis usage?

Google Scholar is a great tool. You can search Google Scholar and you can now find thousands of articles on cannabis. They may be difficult to digest, but that could be a good start. The National Academies Report is also available online. You can download a PDF, especially the summary of findings, which is free to download. Go to the National Academies of Science, Engineering, and Medicine and look for their most recent report on cannabis. Hopefully more and more trusted sources will get into cannabis education.

We actually did have a previous study on internet content on cannabis because that was actually the second most prevalent source of information that people had beyond their own individual experiences. Where do you get information? From the internet, everyone searches the internet. And we found that the information on the internet was very mixed in terms of the quality and value of its content. It’s concerning. So, we do really want to have more trusted information sources and ways that we could digest the primary literature for non-researchers.

People really have a good understanding of what these studies mean. Academic fields take years, sometimes decades, to master. It might be too high of an expectation to say, go to Google Scholar and just read a bunch of articles there, because there's going to be a lot of technical language. I think that would be a worthy effort for someone to really try to summarize that and translate it translate it for people who are non-researchers.

Psychedelics have been coming up a lot for us in our two publications as the next big area of research. Do you have any plans to conduct studies similar to what you've done with cannabis on psilocybin or psychedelics in general?

our first manuscript has been published on naturalistic psychedelic use

 (2). A very similar paradigm to see just how people are using it, and sure enough, they are using it to treat health and medical conditions, although it's different from cannabis in the sense that cannabis is something that people take on an ongoing basis to treat anxiety, pain, or sleep issues.

Psychedelics are something that people could have a lot of change with in just one or a few sessions. Those are also predominantly for things that are related to mental health, but also for all sorts of existential issues, for cancer patients or other people who are facing the prospect of mortality, a fear of death. For existential issues like that as well as post-traumatic stress disorder or depression. There's a lot of people who have treatment-resistant depression. All the medications on the market today just aren't working for like a third of people who are clinically depressed.

That's one of the reasons why there's so much interest in psychedelics being the next big thing. We're just getting into this in the sense that we now have a few studies going on. Hopefully, in the future, we'll be able to conduct a similar study to this one with psychedelics.

The medicalization of psychedelics is happening 10 times as fast as the medicalization of cannabis, especially interest from industry and investors. I think that a lot of that rapid change has been driven more so from the top-down rather than the bottom-up grassroots efforts of cannabis advocates.

It’s going to be an interesting research future and it is really nice that we can conduct this kind of research now, studying naturalistic use with surveys, but also the fact that more and more people are paying attention to it and that we can conduct the study with the approval of the Institutional Review Board at the university. Those are those are very promising signs.

 Well, there's so much more that needs to be done to answer questions with cannabis. There's all sorts of other cannabinoids. We've also looked into Delta-8 THC, so we have some studies on that. That is a product that really surged in popularity in areas where Delta-9 THC was prohibited or restricted.

Delta-9 THC is the primary component of cannabis that gives people the high feeling. The regulation in terms of the legality of hemp or cannabis is defined based on Delta-9 THC. Delta-8 is an isomer, so it's chemically similar to Delta-9 THC, but it doesn't bind as strongly to the endogenous cannabinoid CB1 receptor in your brain. So, people will say maybe it's about half as strong or so. It has a slightly weaker effect, but it was being widely sold and utilized. At the same time, local and state governments were cracking down on it because we don't know anything about this. What is this? Following the experiences people had with the so called spice, which is any kind of substance sprayed onto some plant matter that people are buying from a gas station and smoking. And, there's a lot of issues with that. I mean, that's one of the challenges.

Well, if you criminalize cannabis, then people are going to try to find a substitute for it, sometimes with really, really awful results. So, people are maybe being very cautious, maybe overly cautious thinking, “we don’t know enough about this Delta-8 THC, so let’s just stop it.” Ironically, that's happening in states that are medicalizing and legalizing Delta-9 THC cannabis—they’re suppressing Delta-8 cannabis. So, we did a study of Delta-8 cannabis use. Based on people's self-reports, it seems to have maybe an even more desirable profile of effects than Delta-9 cannabis. It’s the inverse of what you'd expect of the legal trends. Again, that's self-report, so it's based on people's experiences and what they said to us and we have no reason to doubt that they're being honest. It would be great to do a nice double-blind trial with Delta-8 and Delta-9 cannabis so we can really confirm that.

That's one possibility. There are many others. Eventually we hope to do similar types of studies with various psychedelics. We're seeing very rapid change and hopefully very rapid progress in these areas that have really been suppressed and repressed for decades.

If you’re interested in learning more about Dr. Kruger’s current study with Releaf or participating, please visit 

https://nap.nationalacademies.org/catalog/24625/the-health-effects-of-cannabis-and-cannabinoids-the-current-state

https://www.tandfonline.com/doi/abs/10.1080/02791072.2022.2108356?journalCode=ujpd20

One of the recurring challenges in the medical cannabis space is the difficulty in conducting research because of the plant’s Schedule I status. Although there are some researchers diving in with special licenses to conduct clinical studies, there are others that are looking at real-world users to supply data. For instance, Dr. Daniel J. Kruger is a Research Investigator with the Population Study Center at the University of Michigan and Principal Investigator on a study being conducted with the Releaf app. Here, Dr. Kruger shares his interest and background in these types of surveys and his plans for the current study with Releaf on chronic pain.

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