Tell the FDA What’s on Your Mind

By Zoe Sigman On June 05, 2019

The FDA is asking for input on how to regulate CBD and cannabis. Project CBD gave oral comments at last week’s public hearing, and we plan on submitting written comments and supporting documents to their public docket. You should, too.

You have until July 2 to share your thoughts on the best path forward. The FDA’s ask is a big one, and it concerns more than just CBD (the full prompt is attached below). Whatever regulation is coming will shape not only CBD regulation, but that of cannabis and cannabinoids more generally.

In their announcement, the FDA clearly states that they’re looking for information about 1) health and safety risks; 2) manufacturing and product quality; and 3) marketing/labeling/sales. Each category is broken into specific queries, all aimed at seeking input on how they should regulate cannabis and cannabis-derived products.

The FDA is faced with the challenge of crafting regulation in a way they’ve never done before. Both THC (Marinol, Syndros, Nabilone) and CBD (Epidiolex) have been approved by the FDA for the treatment of specific diseases. This means that the FDA has, until this point, regulated single-molecule cannabinoids just like any other pharmaceutical. Now the FDA is tasked with regulating those same compounds for general consumption as food supplements and nutraceuticals. But the FDA is not generally in the business of approving the same plant compound both as a prescription medication and an over-the-counter food supplement – there is little precedent to draw upon.

Given the enormous public interest in cannabis and the huge demand for CBD products, the FDA says they’re willing to listen. So, tell them your story. Write about how CBD has helped (or not helped) you and your family (including your dog!). If you’ve researched how cannabis and CBD can impact a particular medical condition, share the data with the FDA. If you are involved in manufacturing hemp or cannabis products, tell the FDA how that’s working in your state.

DO:

  • Read the entire prompt that the FDA has provided. The FDA is looking for specific information about a broad range of topics related to cannabis. It was apparent that some of the people who spoke at the public hearing hadn’t taken into account the information the FDA already has. The FDA knows about Epidiolex, the pharmaceutical version of CBD. They approved it as a drug and are aware of the high-dose hepatotoxicity data from clinical trials.
  • Submit data and studies to support the information in your comments. Be specific. If you know of a study that backs up your experience with managing a specific condition, cite it and provide the article. One of the FDA’s most frequent requests at the recent public hearing was for more data to support claims.
  • If possible, include dosage amounts (in milligrams of cannabinoids) when sharing stories about how cannabis or CBD has helped you or those you care for.
  • Read the FAQs.
  • Submit your comments by 11:59 PM EST on July 2, 2019.

DO NOT:

  • Do not try to address the entire FDA prompt. Address the areas that directly apply to your experience or body of expertise.
  • Don’t use profanity or casual, lingo-laden language. You’re speaking to government officials, after all. The more formal, specific, and detailed, the better. Personal stories are wonderful, but make sure to support your story with specific dosages so that the FDA has some data to work with.
  • Do not make up data. If there isn’t data to support your experience, state that plainly and encourage the FDA to facilitate crucial research in that area.

Zoe Sigman is Project CBD’s Program Director.


Copyright, Project CBD. May not be reprinted without permission.

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Americans Spent as Much on Cannabis as Taco Bell Last Year

It’s official: The Crunchwrap is losing ground to the blunt wrap.

With the opening of more and more state-legal markets, cannabis sales are quickly catching up with that of more established products, brands, and services. New data compiled by Marijuana Business Daily shows that Americans spent an estimated $10.4 billion on cannabis last year–about as much as they dropped at the country’s sixth-largest fast food chain, Taco Bell.

Just two years ago, cannabis sales in the US stood at about $6.7 billion.

That $10.4 billion in sales, which combines medical and adult-use markets, was nearly $2 billion more than in 2017. It was also nearly three times the $3.6 billion that Americans spent on e-cigarettes in 2018.

As the industry continues to expand–Illinois is poised to become the 11th state to legalize adult-use cannabis, and Texas just OK’d a massive expansion to its medical marijuana program–it seems only a matter of time until cannabis eclipses other sectors of the American economy. Already there are more legal cannabis-industry employees in the US than there are steelworkers.

Explosive Growth

A number of interconnected factors fueled the industry’s growth in 2018. Perhaps most notably, regulated adult-use sales began in California, making it the largest legal market in the country–perhaps the world. Meanwhile, Utah and Oklahoma opened their doors to medical cannabis, and the latter already has more registered patients than New York state.

As Leafly reported earlier this year, the cannabis industry added 64,000 jobs in 2018 alone, bringing the total number of legal cannabis workers up to nearly a quarter million. On the finance side, investors poured in nearly $10 billion.

“The gradual legalization around the world of a plant which humans have been happily consuming for millennia is creating one of the largest industry-growth phenomena in history,” said Tom Adams, the managing director and principal analyst at BDS Analytics. He’s not exaggerating: Just two years ago, cannabis sales in the US stood at about $6.7 billion.

Goldfish Crackers Today, NFL Tomorrow

The MJBiz analysis made a few other striking comparisons to help contextualize what $10 billion in sales looks like. For instance, it’s about 10 times the roughly $900 million that Americans forked out for Goldfish crackers. It’s just a sliver of the $72.2 billion spent on wine. And it’s more than twice what Americans paid to play the popular video game Fortnite.

Some of the most interesting data points in the report highlight the industries that cannabis is likely to surpass next. The NFL generated $15 billion in 2018, for example. Cannabis is almost guaranteed to blow past that figure in the next few years.

Online food deliveries, meanwhile, added up to $17 billion in 2018. Whether cannabis will pull ahead there remains to be seen–in part because more legal cannabis may in fact lead to more online food deliveries…

Whether cannabis will ever surpass the king of fast food, McDonalds ($36 billion), pizza ($46 billion) or alcohol ($254 billion!) remains to be seen. But no matter how the numbers play out, they tell us that when legal cannabis becomes available, people want it. A lot.

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Congressional Report Raises Questions About Whether Marijuana Impairs Driving

Concerns expressed by lawmakers that marijuana legalization will make the roads more dangerous might not be totally founded, a congressional research body said in a recent report. In fact, the experts tasked by the House and Senate with looking into the issue found that evidence about cannabis’s ability to impair driving is currently inconclusive.

While law enforcement has well-established tools to identify impaired driving from alcohol, developing technology to do the same for cannabis has proved difficult. Not only is the technology lacking, but questions remain as to how THC affects driving skills in the first place and what levels of THC should be considered safe.

“Although laboratory studies have shown that marijuana consumption can affect a person’s response times and motor performance, studies of the impact of marijuana consumption on a driver’s risk of being involved in a crash have produced conflicting results, with some studies finding little or no increased risk of a crash from marijuana usage,” the Congressional Research Service (CRS) wrote.

What’s more, “studies have been unable to consistently correlate levels of marijuana consumption, or THC in a person’s body, and levels of impairment.”

Both advocates and opponents of marijuana reform strongly support finding a resolution to the impaired driving detection issue. But experts aren’t so confident that researchers will be able to develop something akin to an alcohol breathalyzer, as the most promising attempts have only been able to determine whether a person has smoked within recent hours.

What’s striking about the report from Congress’s official research arm is that it repeatedly states it’s not clear that cannabis consumption is associated with an increased risk of traffic accidents. In general, the issue has been treated as something of a given in congressional hearings, with some lawmakers arguing that loosening federal cannabis laws would lead to a spike in traffic deaths.

That argument was echoed in a separate House Appropriations Committee report that was released on Monday. A section of the document described ongoing concerns about drugged driving “due to the increase in States legalizing marijuana use” and designated funds to help law enforcement identify impaired driving from cannabis.

The CRS report, which was published last month, signals that the problem isn’t quite as cut and dry as lawmakers might think.

Researchers have found on several occasions that traffic fatalities do not increase after a state legalizes marijuana.

Of course, that doesn’t change the fact that both opponents and supporters of legalization generally caution against driving under the influence.

“Cannabis inhalation in a dose-response manner may influence certain aspects of psychomotor performance, particularly in those who are more naive to its effect,” Paul Armentano, deputy director of NORML, told Marijuana Moment. “But this influence is typically short-lived and is far less acute than the psychomotor effects associate with alcohol.”

“By contrast, THC’s unique absorption profile and prolonged detection window in blood makes it so that–unlike as is the case with alcohol–the detection of THC in blood is not necessarily indicative of either recency of use or behavioral impairment,” he said.

The congressional report discusses the limitations of technology in detecting active impairment from cannabis and details previous studies on traffic trends in states that have reformed their cannabis laws. It also lays out legislative options for Congress to “aid policymaking around the issue of marijuana and impairment.”

As it stands, states have generally enforced impaired driving laws through one of two processes. Some states “require that the state prove that a driver’s impairment was caused by the substance or behavior at issue” while others have per se laws asserting that “a driver is automatically guilty of driving while impaired if specified levels of a potentially impairing substance are found in his or her body.”

But it’s significantly easier to prove impairment for alcohol however you cut it, the report explains.

“Detecting impairment due to use of marijuana is more difficult. The body metabolizes marijuana differently from alcohol,” the authors wrote. “The level of THC (the psychoactive ingredient of marijuana) in the body drops quickly within an hour after usage, yet traces of THC (nonpsychoactive metabolites) can still be found in the body weeks after usage of marijuana.”

Further there is “as yet no scientifically demonstrated correlation between levels of THC and degrees of impairment of driver performance, and epidemiological studies disagree as to whether marijuana use by a driver results in increased crash risk.”

Detecting impairment from cannabis is additionally complicated by another extraneous circumstance: variation in THC potency. The THC concentration conundrum is exacerbated by the fact that the only source of federal, research-grade cannabis “is considered by some researchers to be low quality,” the report stated, referring to studies showing that the government’s marijuana supply does not chemically reflect what’s available in state-legal commercial markets.

CRS also looked at the “inconsistent” results of studies examining the effects of cannabis use on traffic incidents. While some have indicated that consumption poses an increased risk on the road, the report argues that some may be conflating correlation and causation.

“Relatively few epidemiological studies of marijuana usage and crash risk have been conducted, and the few that have been conducted have generally found low or no increased risk of crashes from marijuana use,” CRS wrote.

After going through several other related issues, CRS laid out a couple of choices for Congress when it comes to dealing with the impaired driving issue. Those options include “continued research into whether a quantitative standard can be established that correlates the level of THC in a person’s body and the level of impairment” and compiling “better data on the prevalence of marijuana use by drivers, especially among drivers involved in crashes and drivers arrested for impaired driving.”

One of the last elements the report specifically focused on was federally mandated drug testing for individuals in “safety sensitive” jobs in the transportation sector. Interestingly, CRS seemed to suggest that, given the issues they outlined with respect to difficulties identifying active impairment from THC, the government should reevaluate whether suspensions for testing positive should be permanent.

“CRS could not identify any data on how many safety-sensitive transportation employees have lost their jobs as a result of positive tests for marijuana use,” the report states. “Considering the length of time that marijuana is detectable in the body after usage, and the uncertainty about the impairing effect of marijuana on driving performance, Congress and other federal policymakers may elect to reexamine the rationale for testing all safety-sensitive transportation workers for marijuana usage.”

“Alternatively, Congress and federal policymakers may opt to maintain the status quo until more research results become available,” the report advised.

Armentano, of NORML, said that legislators should be way of enacting policies focused on levels of THC or metabolites in drivers.

“As more states consider amending their cannabis consumption laws, lawmakers would best served to avoid amending traffic safety laws in a manner that relies solely on the presence of THC or its metabolites as determinants of driving impairment,” he said. “Otherwise, the imposition of traffic safety laws may inadvertently become a criminal mechanism for law enforcement and prosecutors to punish those who have engage in legally protected behavior and who have not posed any actionable traffic safety threat.”

Marijuana Legalization Not Linked To Increased Traffic Deaths, Study Finds

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Five Fallacies About Hemp

Praise be to all things hemp! Faithful friend of humanity since before the written word, a versatile source of food, fiber, fuel, and pharmacy, a plant with a patriotic pedigree prized by America’s Founding Fathers.

After languishing for eight decades in the wilderness of marijuana prohibition, hemp is making a big comeback thanks in no small part to cannabidiol (CBD), the mischievous, nonintoxicating cannabis compound that has upended the drug war establishment.

There’s no denying that CBD has catalyzed the rebirth of the U.S. hemp industry. In response to overwhelming public demand for CBD, Congress passed the groundbreaking 2018 Farm Bill, which legalized (or, more accurately, re-legalized) the cultivation of hemp on domestic soil. Many American farmers are jumping on the CBD bandwagon, imagining a bright future of Colossal Big Dollars now that hemp is once again a legitimate cash crop. But along with the rush of enthusiasm for CBD as an economic opportunity, a number of fallacies about industrial hemp have taken root.

Fallacy #1 – The Farm Bill legalized CBD commerce.

Not quite. The 2018 Farm Bill defined as hemp as cannabis with no more than 0.3 percent tetrahydrocannabinol and legalized its cultivation in the United States. The Farm Bill also removed various derivatives of hemp, including CBD, from the purview of the Drug Enforcement Administration (DEA) and the Controlled Substances Act.

So now farmers can grow and sell hemp, but the Food and Drug Administration (FDA) views CBD strictly as a pharmaceutical. And because it had already approved CBD as a prescription drug (Epidiolex) for treating two kinds of pediatric seizure disorders, the FDA asserts that it is illegal to sell hemp-derived CBD as a dietary supplement or over-the-counter drug.

Several states have followed the FDA’s lead and explicitly banned CBD-infused edibles and beverages, though there has been little effort to enforce this policy. The recent decision by Visa, the world’s largest credit card company, to stop processing CBD-related payments underscores the uncertain legal status of CBD.

The DEA, meanwhile, retains jurisdiction over CBD extracted from “marijuana” (cannabis with more than 0.3 percent THC), which is still prohibited under federal law. Rooted in reefer madness racism and enforced disproportionately against ethnic minorities, marijuana prohibition is akin to the Confederate statue still standing, a sign of ongoing social injustice. By carving out a legal loophole only for hemp, the Farm Bill perpetuates this shameful scandal.

The Farm Bill – which a cynic might refer to as the ‘Keep Marijuana Illegal Bill’ – is seriously flawed. It solves some problems, while creating others. Like a patch designed to correct defective software, the Farm Bill attempts to fix the unfixable. In this case, the defective software is the Controlled Substances Act, an odious edifice built upon a mountain of lies. Consequently, the legal status of CBD commerce remains mired in contradiction.

Fallacy #2 – The definition of hemp as distinct from marijuana is based on sound science.

The molecular structure of CBD is the same irrespective of its botanical source, but CBD extracted from a hemp plant is no longer a controlled substance while CBD extracted from marijuana is federally illegal. CBD is currently both a Schedule One drug, a category reserved for dangerous drugs with no medical value, and a Schedule Five pharmaceutical, the safest designation possible for a controlled therapeutic substance.

There is no logical basis for distinguishing between hemp with 0.3 percent THC and cannabis with 0.4 percent THC, as stipulated according to federal law. The ‘0.3 percent THC or less’ definition for hemp is a political distinction without a scientific foundation.

Where did the 0.3 percent THC qualifier come from? It stems from a 1976 taxonomic report by Canadian plant scientists Ernest Small and Arthur Cronquist, who never meant for 0.3 percent THC to function as a legal demarcation between hemp and other forms of cannabis. But that’s what has happened.

To cut to the chase, the 0.3 percent THC legal limit for hemp is an arbitrary, impractical, irrational relic of reefer madness. Although it lacks scientific validity, it has become the cornerstone of cannabis prohibition, a discredited, anachronistic policy that impedes medical discovery and patient access to effective therapeutic options, including herbal formulations with various mixtures of CBD and THC, both of which have important remedial properties, especially when combined.

Fallacy #3 -The federal government conspired with big business to make hemp illegal.

Why did hemp become illegal in the first place? The notion of an anti-hemp conspiracy involving corporate and government collusion has become Holy Writ among some cannabis proponents. The operative assumption is that anything made from trees or petroleum could also be made from hemp. Thus, DuPont, a manufacturer of plastics, supposedly sought to eliminate hemp because it was a natural competitor to the emergent plastics industry.

This theory also posits that the Hearst newspaper chain railed against “marihuana” because Hearst wanted to vanquish a paper business rival. But the Hearst syndicate always needed more paper for newsprint and, if anything, it would have been in Hearst’s interest to grow lots of hemp as a source for making paper.

There’s no smoking gun, let alone much evidence, showing that Federal Bureau of Narcotics chief Harry Anslinger was acting at the behest of DuPont or press baron William Randolph Hearst when America’s top narc launched the “reefer madness” crusade to outlaw marijuana in the 1930s.

When it comes to conspiracies – and, yes, they’re everywhere to the point of banality – better to look first for the lowest common denominator, the mundane explanation, to see what’s plausible. Screaming headlines and scare stories sell newspapers. Hearst’s anti-marihuana hyperbole was racist and opportunistic to the core. Ditto for Anslinger, whose entire government department was on the chopping block during the Great Depression.

Anslinger had sufficient motive and means to demonize marihuana, “the evil weed,” in order to preserve and expand his bureaucratic fiefdom. Reefer madness, a racist propaganda campaign, was his way of avoiding budget cuts and inflating his self-importance. He had a key ally in Hearst, an outspoken supporter of fascism and anti-Mexican ethnic cleansing.

Hearst and Anslinger were the main engines behind marihuana prohibition, a policy that some speculate was implemented to benefit the business interests of DuPont, a major client of Mellon Bank. Ex-Treasury Secretary Andrew Mellon was Anslinger’s former boss and his uncle by marriage. All these associations are intriguing and suggestive. But covert corporate machinations in this case probably account for much less than endemic racism, boardroom bigotry, and bureaucratic self-interest.

Fallacy #4 – Industrial hemp doesn’t need pesticides and therefore it’s not necessary to regulate or restrict the use of pesticides on hemp.

Hemp is a hardy, adaptable botanical that feasts on sunlight and thrives in various climates. It acts as a “bio-remediator” that can remove heavy metals and other toxins from a polluted landscape. But this eco-friendly, soil-rejuvenating plant is not immune to mold or pest infestation.

Hemp and psychoactive cannabis (marijuana) have innate defense mechanisms that protect against predators and disease. The sticky gooey resin that is concentrated on the leaves and flower tops of psychoactive cannabis contains a treasure trove of medicinal and aromatic compounds – including cannabidiol (CBD) and tetrahydrocannabinol (THC) – and some of these compounds have antifungal, antibacterial, and insecticidal properties. The stickiness of cannabis resin adds another defensive layer by trapping bugs.

But sometimes the plant’s innate defense capabilities aren’t sufficient to save a crop, as many cannabis farmers have learned from bitter experience. Industrial hemp grown for fiber or seed oil are low-resin plants compared to high-resin drug plants. Resin-deficient industrial hemp is more vulnerable to mold and pests – and is therefore more likely to require pesticides and fungicides – than high-resin cannabis.

Fallacy #5- Industrial hemp is a good source for extracting CBD oil.

The CBD molecule is exactly the same whether extracted from industrial hemp or other forms of cannabis. But the quality of the CBD products made from industrial hemp that’s grown for fiber or seed protein is typically inferior to the products made from CBD-rich “drug” plants that are grown specifically for medicinal oil extraction.

CBD is the most common cannabinoid present in industrial hemp, but the CBD levels top out at about 3.5% by dry weight – much less than the remarkable varieties of CBD-rich cannabs flower grown for medicine that can reach as high as 20% CBD by dry weight. Because industrial hemp produces relatively small amounts of CBD, a huge amount of hemp biomass is necessary to produce a significant quantity of CBD oil.

Such a large amount of plant material means there’s a greater likelihood that toxic contaminants will be concentrated in the CBD oil extracted from industrial hemp, which will suck up and absorb any pesticides or heavy metals present in the soil through a process known as “bioaccumulation.” This is excellent for cleaning up a toxic waste site, but not so good for medicinal oil extraction and production. Industrial hemp and its extracts usually aren’t subject to stringent (state-level) regulations governing pesticide and solvent residues, and these contaminants end up in CBD products manufactured by unscrupulous producers.

It’s noteworthy that the phrasing of the 2018 Farm Bill refers to “hemp” rather than “industrial hemp.” The decision to drop the word “industrial” from legislative parlance is a reflection of the primacy of CBD in the brave new world of legal hemp. Industrial hemp cultivated for fiber and seed isn’t CBD-rich. But new high-resin cannabis cultivars are becoming available that have been bred specifically to produce copious quantities of CBD with less than 0.3 percent THC, thereby satisfying the federal government’s absurd legal criteria for hemp.

Martin A. Lee is Project CBD’s cofounder and Director, and Zoe Sigman is Project CBD’s Program Director.


Copyright, Project CBD. May not be reprinted without permission.


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CBD Might Help You Cut Back On Drinking Alcohol And Reduce Its Damaging Effects, Study Says

CBD, the widely available cannabinoid touted for various health benefits, may have the potential to help people with serious alcohol issues, according to a new review of current scientific evidence.

Not only does cannabidiol appear to “facilitate drinking reduction,” the paper’s authors write, but research also shows the compound “may provide idiosyncratic protection to the liver and brain, which could reduce the development and impact of alcohol-related liver disease and alcohol-related brain injury.”

The review, which is awaiting publication in the journal Frontiers in Pharmacology, offers a comprehensive look at how promising the data is so far regarding the effectiveness of CBD on alcohol use disorders (AUD). The authors, however, also call for human clinical trials, of which none have been published to date, to “pave the way for testing new harm reduction approaches in AUD.”

Researchers in France and Belgium reviewed 26 previous studies published between 1974 and June 2018 that explored the effects of CBD on animal subjects dosed with ethanol. They found several studies that showed CBD can reduce alcohol consumption. In one, for example, researchers discovered that mice administered CBD were less motivated to work (in this case, push a lever) for access to a liquid solution that included 8 percent of ethanol.

“Experimental studies converge to find that CBD reduces the overall level of alcohol drinking in animal models of AUD by reducing ethanol intake, motivation for ethanol, relapse, and by decreasing anxiety and impulsivity.”

Other studies found that mice regularly dosed with the non-intoxicating marijuana compound were also less likely to relapse after they’d been weaned off alcohol, even when they were stressed.

Because of its impact on various aspects of the disease (including “intake, motivation, relapse, anxiety and impulsivity”), CBD “could have a significant action on drinking levels in human subjects with AUD” the review’s authors write. They add, however, that it would be useful to have data using binge-drinking models and models that focus on long-term exposure to alcohol.

The review also highlighted evidence showing CBD could affect alcohol-related liver inflammation. In one study, researchers found that the livers of mice that’d been given the compound prior to being force-fed alcohol every 12 hours for five days were less damaged than those of mice not exposed to CBD.

“CBD seems to have valuable therapeutic properties for ethanol-induced liver damage, through multiple mechanisms,” including the reduction of oxidative stress, inflammation control, and the death of certain cells responsible for large amounts of scar tissue, the authors write.

Finally, CBD may also offer added protection to specific areas in the brain susceptible to alcohol-related damage. In one study, the brains of rats who’d binged on alcohol and given CBD were found to have lost “significantly” fewer brain cells in the hippocampus and entorhinal cortex. In those rats, CBD acted as a “neuroprotective antioxidant,” the review states. In another experiment, CBD also appeared to restore the neurological and cognitive functions of rats in acute liver failure.

“CBD has been found to reduce alcohol-related brain damage, preventing neuronal loss by its antioxidant and immunomodulatory properties.”

The authors suggest these overall benefits of CBD regarding problematic alcohol use may be due to the “complex” way the cannabinoid interacts with CB2 receptors, which are located throughout the body.

Currently, the review states, the pharmaceuticals available to help people with AUD stop drinking are “insufficiently effective at a population level, and new therapeutic prospects are needed. Moreover, no drug for reducing alcohol-related harms, either on the brain or the liver, has ever been studied.”

Plus, the authors conclude, “CBD could have many more positive effects in subjects with AUD, including antiepileptic, cardioprotective, anxiolytic, or analgesic ones. Human studies are thus crucially needed to explore the many prospects of CBD in AUD and related conditions.”

Meanwhile, there’s still time to submit public comments to the U.S. Food and Drug Administration on how the federal government should regulate CBD products, including supplements and foods. So far, hundreds of people have submitted information. The public comment period ends July 2.

FDA Is Taking Public Comments On CBD. Here’s How To Make Your Voice Heard

Photo by Kimzy Nanney.

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CBD Can Help Curb Heroin Cravings, New Study Finds

The record-breaking climb in US overdose deaths–which now outnumber peak annual deaths from car crashes, guns, and HIV–has led some to second-guess cannabis legalization. But a new study suggests cannabinoids may actually help people wean themselves off deadly drugs.

“CBD holds significant promise for treating individuals with heroin use disorder.”

Yasmin Hurd, director, Addiction Institute at Mount Sinai

The study, by researchers at New York’s Mount Sinai Hospital, looked at 42 individuals with problem heroin use disorder who abstained from heroin during the program. Researchers found that individuals who were given CBD experienced significantly reduced heroin cravings–both immediately and in the longer term.

The study was published Tuesday in the American Journal of Psychiatry.

“Our findings indicate that CBD holds significant promise for treating individuals with heroin use disorder,” Yasmin Hurd, lead author of the study and director of the Addiction Institute at Mount Sinai, said in a statement.

We’ve known for a while now that the availability of medical cannabis is associated with lower opioid prescription and overdose death rates. What’s been less clear is whether cannabinoids can reliably help individuals disrupt problem drug use.

Participants in the Mount Sinai experiment were given either CBD or a placebo and then presented with three-minute videos featuring either “neutral cues”–including relaxing nature scenes–or “drug-related cues,” such as intravenous drug use, syringes, or packets of powder that resembled heroin. The CBD dosages were quite large–either 400 mg or 800 mg of CBD–and taken daily as an oral solution for three consecutive days.

As participants watched the videos, researchers measured opioids cravings, anxiety, and other health indicators, such as heart rate, blood pressure, respiratory rate, skin temperature, and blood oxygen levels. The measurements were taken at three video sessions conducted at various times: immediately after administering CBD or the placebo, 24 hours later, and a week after the final dose. The results were remarkable:

The study team found that CBD, in contrast to placebo, significantly reduced both the craving and anxiety induced by drug cues compared with neutral cues in the acute term. CBD also showed significant protracted effects on these measures seven days after the final short-term exposure. In addition, CBD reduced the drug cue-induced physiological measures of heart rate and salivary cortisol levels. There were no significant effects on cognition, and there were no serious adverse events. The capacity of CBD to reduce craving and anxiety one week after the final administration mirrors the results of the original preclinical animal study, suggesting that the effects of CBD are long-lasting, even when the cannabinoid would not be expected to be present in the body.

This isn’t the first time Hurd and her team have explored CBD’s impacts on heroin use. But previous studies focused on animals–finding that their heroin cravings could be reduced with CBD–and Hurd was eager to expand research involving humans.

“To address the critical need for new treatment options for the millions of people and families who are being devastated by this epidemic, we initiated a study to assess the potential of a non-intoxicating cannabinoid on craving and anxiety in heroin-addicted individuals,” Hurd said. “A successful non-opioid medication would add significantly to the existing addiction medication toolbox to help reduce the growing death toll, enormous health care costs, and treatment limitations imposed by stringent government regulations amid this persistent opioid epidemic.”

The study’s findings, the hospital said, suggest a role for CBD “in helping to break the cycle of addiction.”

“The specific effects of CBD on cue-induced drug craving and anxiety are particularly important in the development of addiction therapeutics,” Hurd explained, “because environmental cues are one of the strongest triggers for relapse and continued drug use.”

While the initial study is relatively small, it’s likely to fuel continued research into the use of cannabinoids and opioids. Already Hurd’s research team is working on two follow-up studies aimed at putting a dent in the overdose epidemic. One explores the mechanisms of how CBD affects the brain, while the second looks at unique medical cannabis formulations that Mount Sinai said “are likely to become a significant part of the medical arsenal available to address the opioid epidemic.”

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Meet Geraniol, the Sweet Cannabis Terpene With a Citrus Aroma

All the nuances and characteristics in the flavor profile of a cannabis strain come from the terpenes within it. From commonly found compounds like myrcene to rarely seen players like phellandrene, each terpene in cannabis plays a distinct role in creating a unique aromatic fingerprint of a strain.

Some terpenes play a larger role in the foundational character of a strain, while others add accents and complexity. Cannabis strains with fruity and floral aromatic profiles may owe their uniquely sweet scents in part to a lesser-known terpene called geraniol.

Although not prevalent in a lot of cannabis, geraniol is known for its delicate rose and floral profile, providing a sweetness to strains like Agent Orange and Black Cherry Soda. It also has a host of potential medical uses including pain reduction, and anti-inflammatory and antifungal benefits.

Geraniol’s Unique Profile

This terpene’s name may sound familiar because it’s derived from the geranium plant, the herb known for its citrus scent and insect-repelling properties. However, geraniol’s somewhat peculiar aroma brings in more subtle notes of rose and fruits, playing a softer role than the strong citrus smells of citronella oil that are found in geraniums.

Geraniol can also be found in:

  • Rose oil
  • Lemongrass
  • Lemons
  • Peaches
  • Grapefruits
  • Oranges
  • Carrots
  • Coriander
  • Blueberries
  • Blackberries

Perhaps the strangest synthesis of geraniol is within honey bees, who produce it in their scent glands as both a marker for nectar-bearing fruits and as a territorial mechanism to thwart off potentially dangerous colonies from creating a hive or taking over a pollination site.

The subtlety of geraniol’s rose and floral notes, which are accentuated by slight citrus tones, make this terpene a major player in the fragrance industry. Geraniol can be found as an additive to a plethora of perfumes, colognes, lotions, detergents, candles, as well as many other household products.

You can even find this terpene used as a food additive, especially in pastries and desserts.

Cannabis Strains Containing Geraniol

Although this secondary terpene can be found in negligible quantities across a wide variety of strains, higher concentrations of geraniol have been found in the following strains:

The Potential Medical Benefits of Geraniol

Geraniol has been at the center of a handful of studies and demonstrates therapeutic potential. Its pharmacological potential as an antioxidant and anti-inflammatory were brought to light in this 2015 review.

Geraniol was also found to be an effective antifungal and antibacterial when put up against 18 varieties of bacteria and 12 varieties of fungi in another study.

Essential oils with geraniol have also been found to have potential tumor-reduction properties in cancer cells, and may even be able to inhibit the growth of colon cancer cells.

Animal studies, primarily on hamsters and rats, have shown the potential of geraniol to manage diabetes and hyperglycemia, as well as to help mitigate the symptoms of atherosclerosis, a condition that causes the formation of plaque in the arteries.

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Female Forward: Periods, Hormones and THC

Hormones are powerful chemicals that are constantly fluctuating and influencing the ways in which our bodies respond to our environments. Sex hormones, and in particular those produced in the ovaries, have been shown to play prominent roles in regulating cognitive and behavioural functioning of cisgender women.*

There are two studies that examine the relationship between cannabis and the menstrual cycle, both of which were done in the 1980s. Neither study satisfies the ‘gold standard’ of scientific inquiry: a randomized double-blind placebo study, large sample groups and few limiting and/or confounding factors.

The first study was on self-reported cannabis use during the menstrual cycle. The sample size was small with only 28 women included. Further, the nature of the study design did not account for the different ways in which women consume cannabis.

The second study was at least randomized and double-blind, but still does not reflect modern cannabis use: the potency of THC used was 1.8% and the sample size was, again, small. Currently, the average percentage of THC per strain is 7-10% and some strains can go as high as 25%!

The study found that there were no significant relationships between THC and sex hormones in women. However, based on the potency of THC used, take these results with a grain of salt.

Instead, let’s examine the specific effects THC has shown to have on ovarian hormones and vice versa.

Like Hormones, Tolerance Can Fluctuate

Women generally have higher tolerances for THC compared to men, for a few reasons.

Consider the chemical properties of THC. It is lipophilic, meaning that when it crosses paths with fat cells, it will attach itself to them. You may have heard that THC can stay in your system for weeks to months beyond abstinence–this is why.

For evolutionary purposes, women have higher fat percentages than men, resulting in higher amounts of THC going to fat cells rather than the bloodstream when ingested by women versus men. The result? Not as much THC circulates to get to your brain for that ‘high’ effect to take hold.

Another reason women have a higher tolerance to THC is ovarian hormones. However, which ovarian hormone we are talking about matters. The amount of tolerance you experience depends on which phase of your menstrual cycle you’re in.

The Estrogen (Estrus) Phase

A menstrual cycle is typically 28 days long. The two weeks is called the estrus phase, or how I like to call it, the ‘sexy’ phase: it builds up until you release your egg and ovulate. Those two blissful weeks where acne and pimples lay to rest and B.O. remains a non-issue is evolutionarily, on purpose.

During this phase your ovaries are producing estrogen, the ‘come hither’ hormone– it’s meant to find you a mate, among other things. It heightens your sexual prowess, which includes your sensitivity. Greater awareness generally indicates an animal-like ‘on the hunt’ state.

Studies using rat models have shown that during the estrus phase, females were more sensitive to THC compared to the diestrus phase, the last two weeks of your cycle. Studies conducted on humans examining the effects of caffeine, alcohol, and stimulants found similar results: during the estrus phase, women felt they were more sensitive to the effects of these substances.

During the diestrus phase (ie. after ovulation), sensitivity to cannabis decreases, along with everything else. Progesterone becomes your ovaries’ best friend and you are left feeling cranky, tired, and agitated when these levels are high.

The Progesterone (Diestrus) Phase

The dynamics between THC and female sex hormones can vary. So far, estrogen and THC seem to have a cordial relationship where they build each other up–but what about progesterone?

Poor progesterone, nobody likes them. No surprise there: it’s the major culprit for PMS.

High progesterone levels are correlated with mood swings, tender/sore breasts, fatigue and acne, among others.

Luckily, studies conducted on rhesus monkeys (at least we’re in the primate category!) show that THC reduced the amount of progesterone produced in the diestrus phase. This was not a direct inhibition, which means it ‘modulated’ the production of progesterone–a safer version than simply arresting its production directly.

It’s no wonder that many women are turning to cannabis products during PMS and menses: it helps to level out the effects of progesterone and satisfy a physiological need for cannabinoids.

What I mean by ‘physiological need’ is that studies have shown that CB1 receptor increases in the hypothalamus during the diestrus phase. This means that your body is in demand for cannabinoids–whether you are producing them yourself or ingesting them through cannabis.

Additional studies are needed on the subject of female sex hormones and cannabis. Hormones are highly complex: there are layers to which they affect cognitive functioning (short-term and long-term), physiological changes (CB-1 receptor fluctuation), and their role in the female reproductive system.

However, some things are beginning to be clear. The estrus phase can cause a heightened state of awareness, which tends towards greater sensitivity towards mind-altering substances. The diestrus phase produces progesterone and increases CB1 receptors in the hypothalamus–both of these changes can be helped by a spoonful of THC in the diet.

That being said, consume in moderation and consult your physician if you experience severe symptoms associated with PMS.

*This article uses the terms women, females, men, and males in reference to biological sex.

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