#81 - Debra Kimless, M.D. & Steve Goldner, J.D.: Cannabis – the latest science on CBD & THC

Nov 25, 2019 Episode Page ↗
Overview

Dr. Debra Kimless (CMO) and Steve Goldner (CEO, Pure Green) explore medicinal cannabis, differentiating THC, CBD, and hemp. They discuss cannabinoid mechanisms, benefits, vaping risks, and their mission to deschedule cannabis for medical access.

At a Glance
17 Insights
2h 11m Duration
17 Topics
8 Concepts

Deep Dive Analysis

Guests' Background and Interest in Medical Cannabis

Historical Use and Legal Scheduling of Cannabis

THC: Mechanism of Action and Intoxicating Effects

CBD: Distinction from THC and Therapeutic Mechanisms

Hemp: Legal Definition, Industrial Uses, and Farm Bill

CBD's Legal Status and Clinical Trial Results

Safety Profile and Toxicity of THC

Marijuana as a Gateway Drug: Evidence and Arguments

Routes of Administration: Smoking, Vaping, and Edibles

Vaping-Related Acute Respiratory Illnesses

THC Tolerance and Therapeutic Index

Consumer Demand for Cannabis: Medical vs. Recreational

Synthetic Cannabinoids and Plant-Derived Compounds

CBD for Sleep: Efficacy and Mechanism

Pure Green's Business Model and Research Funding

Managing Hype and Misinformation in Cannabis Treatment

Future of Cannabis: Legalization and Research Challenges

CB1 and CB2 Receptors

These are docking stations in the brain and peripheral nervous system that cannabinoids like THC activate. CB1 receptors are predominantly found in the brain and peripheral nervous system, while CB2 receptors are mainly located on immune cells peripherally.

Endocannabinoid System

This is the body's naturally occurring system of neurotransmitters and receptors that interacts with cannabinoids. CBD works by indirectly activating this system or by acting on entirely different receptors, contributing to its therapeutic effects without intoxication.

Hemp (Legal Definition)

Legally, hemp is defined as a cannabis cultivar that contains less than 0.3% by weight of THC or THCA, distinguishing it from marijuana which has higher THC concentrations. This legal distinction was formalized by the Farm Bill, allowing for its cultivation and processing.

Decarboxylation

This is a chemical process that requires applying time and temperature to the acid forms of cannabinoids (e.g., THCA, CBDA) to convert them into their active, non-acid forms (THC, CBD). This conversion is necessary for the intoxicating effects of THC and for the full therapeutic potential of many cannabinoids.

Therapeutic Index (Therapeutic Window)

This metric represents the ratio between the lethal dose 50 (LD50) and the effective dose of a drug. For cannabis, the therapeutic index is extremely wide, estimated at 1:20,000 to 1:40,000, indicating a very high safety profile and making it difficult to overdose fatally.

Hyperalgesia

This is a paradoxical phenomenon observed with prolonged opiate use where, instead of continued pain relief, patients experience an enhancement or increase in pain. This effect is not seen with THC, which does not lead to the same kind of tolerance or pain sensitization.

Entourage Effect

This concept describes the synergistic interaction between various compounds found in the cannabis plant, including cannabinoids, terpenes, and flavonoids. It suggests that these compounds work together to produce a greater therapeutic effect than any single compound in isolation.

Investigational New Drug (IND) Exemption

An IND is an exemption from federal law that allows a pharmaceutical company to ship an unapproved drug across state lines for the purpose of conducting clinical trials. It is a critical step in the drug development process, allowing for the collection of safety and efficacy data under FDA oversight.

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How long has cannabis been used medicinally by humans?

Historically, cannabis has been used as a medicine for over 5,000 years, with applications ranging from pain relief to memory support in ancient cultures.

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What is the difference between THC and CBD in terms of how they work in the body?

THC directly binds to CB1 and CB2 receptors, leading to intoxicating effects and other physiological changes, while CBD works indirectly by interacting with the breakdown products of natural endocannabinoids or by acting on entirely different receptors, thus not causing intoxication.

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What is the legal definition of hemp?

Hemp is legally defined as a cannabis cultivar containing less than 0.3% by weight of THC or THCA, distinguishing it from marijuana which has higher THC concentrations.

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What are the primary health risks associated with THC use?

While THC has a very low toxicity potential (no known lethal dose), sensitive individuals may experience anxiety, panic, or rapid heartbeat, and its effects can be influenced by set and setting.

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Is marijuana considered a gateway drug?

No, NIDA (National Institute on Drug Abuse) no longer considers cannabis a gateway drug, and some studies suggest it may even serve as an 'exit drug' to help people move off other addictive substances.

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How does the method of cannabis consumption (smoking, vaping, edibles) affect its impact?

Smoking or vaping provides rapid onset of effects but shorter duration, with potential risks from combustion byproducts or unknown vape additives, while edibles have a delayed onset (60-90 minutes) but longer duration (8-10 hours) due to liver metabolism converting THC into a more intoxicating metabolite.

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Can the body build up a tolerance to THC?

While THC can down-regulate receptors with over-consumption, these receptors can be reset quickly by stopping use for a couple of days, and studies suggest patients often stabilize at a consistent daily dose without needing increasing amounts.

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What is the efficacy of CBD for sleep?

Anecdotal evidence and pharmacovigilance data suggest CBD, particularly in water-soluble forms, can help people fall asleep quickly, experience a good night's sleep, and wake up refreshed without grogginess, likely due to its anti-inflammatory effects and GABA receptor activation.

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Why is it difficult to conduct robust research on cannabis in the United States?

Due to the federal illegality of cannabis, most universities and medical institutions are hesitant to conduct research on the plant or its compounds, fearing jeopardy to their federal funding, despite growing scientific interest.

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How can consumers protect themselves when purchasing cannabis products in states where it is legal?

Consumers should buy from legal dispensaries, ask for a certificate of analysis to verify product contents and safety, and ideally seek guidance from physicians knowledgeable in cannabinoid medicine.

1. Avoid Unregulated Cannabis Purchases

Do not buy cannabis products online or off the street, as there is no guarantee of testing, safety, or purity, similar to not taking candy from strangers.

If you live in a legal state, become a certified patient, consult with a physician, and purchase cannabis products from a legal dispensary to ensure guidance and safety.

3. Request Cannabis Certificate of Analysis

When purchasing cannabis products, always ask for the Certificate of Analysis (COA) to verify testing for safety, potency, and the absence of adulterants.

4. Find Expert Cannabis Clinicians

Seek guidance from expert cannabinoid medicine physicians by consulting the Society of Cannabis Clinicians, which provides a list of doctors by state.

5. Beware Vaping Additives

Exercise caution with vape cartridges, as thinning agents like PG, PEG, or Vitamin E acetate, while generally safe for ingestion, can create harmful byproducts like formaldehyde when heated and inhaled.

6. Avoid Inhalational Cannabis Methods

Avoid inhalational methods of cannabis use, as consistent dosing is difficult to control, making it challenging for physicians to accurately titrate and manage patient treatment.

7. Consider Cannabinoid Microdosing

To achieve therapeutic effects without intoxication, consider microdosing cannabinoids by using very small amounts to activate cellular processes.

8. Leverage Cannabinoid Synergistic Effects

When choosing cannabinoid products, look for formulations that combine isolated cannabinoids with other constituents to capitalize on synergistic effects, potentially allowing for lower doses and fewer side effects.

9. Consider CBD for Improved Sleep

Consider using CBD, potentially in a water-soluble form for better efficacy, to help fall asleep quickly, achieve a good night’s sleep, and wake up refreshed without grogginess.

10. Edibles Metabolite More Intoxicating

Be aware that when ingested, THC is converted into a metabolite in the liver that is even more intoxicating than THC itself, which can lead to a more intense experience than inhalation.

11. Reset THC Tolerance with Pause

If you experience down-regulation of THC receptors from over-consumption, you can quickly reset your tolerance by stopping use for a couple of days.

12. Avoid Cannabis on Developing Brains

Do not use chemical substances like cannabis on a developing brain unless there is a clear medical necessity, due to potential unknown effects.

13. Raw Cannabis Not Intoxicating

Eating the raw cannabis plant will not produce intoxicating effects because its chemical constituents are not in an activated form; it may only cause a bellyache from fiber.

14. Consume Hemp Seeds for Nutrition

Incorporate hemp seeds into your diet as they offer an excellent omega-3 to omega-6 profile and are a wonderful source of protein.

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My mom was dying from a complication from a pharmaceutical drug. And because of that, I started really thinking about what we learned in medical school, how we were trained, and what else could there have been for my mom as an option other than a pharmaceutical.

Debra Kimless

Developing methadone at the beginning of my career was a first bookend. And now developing all these formulations to help people with cannabis is the second bookend on my career.

Steve Goldner

I always say that cannabis is a gateway more towards health than to other drugs.

Debra Kimless

It's not just what the LD50 is, it's how far the LD50 is from the use dose.

Peter Attia

We call it a therapeutic window. I call that a therapeutic garage door.

Debra Kimless

The problem with opiates. Opiates sit on these, their own docking station, and they do down-regulate very quickly, which means that you require more and more for the same effect. And then it does something really strange. It flips. And after a certain amount of opiates, your pain gets enhanced, not decreased. And it's called hyperalgesia.

Debra Kimless

I'm kind of amazed, is there not a comparable group that is advocating for the judicious study of THC and CBD?

Peter Attia

This is a human rights issue. You hit the nail on the head. I mean, that's a huge problem for me as a physician to guide patients, which I do.

Debra Kimless
Over 5,000 years
Historical duration of cannabis use as medicine Used in various cultures for a wide range of disorders.
1930s
Approximate decade when marijuana was scheduled in the US Prior to the Nixon administration's 'war on drugs'.
0.3%
Maximum THC content for legal hemp By weight of THC or THCA compared to the rest of the plant biomass.
16 patients
Participants in Dr. Kimless's CBD pain trial Proof-of-concept study for mild to moderate pain.
5 milligrams
Ultra-low dose of CBD used in trial Water-soluble CBD with curated terpenes in a tablet.
2 weeks
Duration of Dr. Kimless's CBD pain trial Showed statistically significant decrease in pain.
1,500 pounds in 15 minutes
Estimated lethal dose of cannabis for a 75kg man (smoked) According to a 1970s DEA attorney, death would be from carbon monoxide, not cannabis itself.
1:20,000 to 1:40,000
Therapeutic index for cannabis Ratio of lethal dose to effective dose, indicating a very high safety profile.
9%
Estimated addiction rate for cannabis Lower than alcohol and tobacco, based on studies.
750 milligrams
Average daily cannabis consumption in Netherlands study Patients stabilized at this dose without increasing amounts, suggesting low tachyphylaxis.
60 to 90 minutes
Onset time for edible cannabis effects In best-case scenarios, due to digestive process and liver metabolism.
Approximately 8%
Bioavailability of edible cannabis Due to first-pass metabolism in the liver.
8 to 10 hours
Duration of action for edible cannabis effects Longer than inhalational methods.
Over 800
Number of commonly used cannabis strains Constantly increasing due to crossbreeding.
10 milligrams CBD and 1 milligram THC
Optimal CBD/THC cocktail for sleep (Pure Green's experience) Utilizes the entourage effect for enhanced efficacy.
15 seconds
Disintegration time for Pure Green's water-soluble tablets Designed for sublingual administration.
8 to 10 minutes
Onset of medical effects from Pure Green's water-soluble tablets Due to rapid absorption via oral tissues, bypassing first-pass metabolism.
3
Number of INDs filed by Pure Green For different therapeutic indications, including pain in dogs, osteoarthritis pain in humans, and PTSD.
2 to 4 years
Estimated time for FDA fast-track approval A rapid timeline in drug development.
10 years and $1 billion
Average time and cost to develop a new drug From IND to final approval.
Approximately 100
Total employees at Pure Green Across production, sales, and administration.
Approximately 10
Direct research team members at Pure Green Supported by additional consultants.
30 to 40
Consultants working on Pure Green's research projects Contributing to various aspects of the studies.
Over 400
Patients treated free of charge by Dr. Kimless For learning and case studies on cannabinoid medicines.
Approximately 5,500
Number of cannabis plants grown by Pure Green affiliates For in-state processing and product development.
70-80 stores
Michigan dispensaries Pure Green works with For distribution of their products.
30 million to 40 million people
Estimated number of regular cannabis users in the US Highlighting widespread use despite federal status.