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Patient Zero for Untreatable Depression Begins Groundbreaking Psychedelics Therapy

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psychedelics for depression

In a phase 2b clinical trial, Beckley Psytech has started treating the first subject for BPL-003, an intranasal synthetic formulation of the psychedelic chemical 5-MeO-DMT intended for patients with treatment-resistant depression.

 

With FDA clearance for investigational new medication status in February, this groundbreaking research represents the biggest controlled examination into the potential of 5-MeO-DMT, involving 40 locations throughout Australia, Europe, and the US.

 

The trial, employing a randomized, quadruple-masked design, seeks to identify optimal dosages of BPL-003, complemented by psychological support, in 225 individuals grappling with moderate to severe treatment-resistant depression, compared to a placebo group.

 

Efficacy will be gauged using the Montgomery-Asberg Depression Rating Scale at various intervals throughout the trial, with all participants receiving psychological support before, during, and after dosing. An open-label extension is slated for select sites eight weeks post-initial dosing to evaluate sustained effects following a second dose.

 

Anticipated findings from this phase 2b endeavor, projected by late 2024, will augment insights gleaned from the ongoing phase 2a exploration of BPL-003, as highlighted by the company.

 

Cosmo Feilding Mellen, CEO of Beckley Psytech, expressed confidence in the compound, citing promising safety and pharmacokinetic data. He emphasized its capacity to induce brief yet profound subjective experiences correlating with therapeutic benefits, underscoring the company’s eagerness to advance BPL-003 through the clinical development pipeline.

 

Unprecedented Research Scope

 

An important turning point in the field of psychedelic research, especially in the area of mental health therapy, was reached with the start of Beckley Psytech’s phase 2b clinical experiment. The large-scale nature of this experiment highlights an important development in our knowledge of the therapeutic potential of psychedelic substances, with a particular emphasis on 5-MeO-DMT for patients suffering from depression that does not respond to conventional therapy. This experiment, which spans 40 sites throughout Australia, Europe, and the US, is the biggest controlled investigation into the possible effectiveness of 5-MeO-DMT, in contrast to earlier research. This wide outreach guarantees a varied pool of participants and improves the trial’s outcomes dependability and generalizability.

 

A rising awareness among scientists of the need for novel strategies to tackle the widespread problems associated with treatment-resistant depression is reflected in the decision to launch such an extensive research project. Researchers want to increase the number of therapy choices available for those who have not reacted well to traditional medications by investigating the therapeutic benefits of 5-MeO-DMT in a rigorous clinical environment. The trial’s multi-site design also makes it easier for clinicians and researchers in various areas to collaborate, which promotes a group effort to further our understanding of psychedelic-assisted treatment.

 

The size of this phase 2b experiment not only emphasizes the significance of its findings, but also demonstrates Beckley Psytech’s dedication to pushing the limits of psychedelic research. Through strategic alliances and diligent preparation, the firm has proved its commitment to performing high-quality clinical studies that meet rigorous scientific criteria while investigating novel treatment approaches. This innovative method not only aids the area of mental health treatment, but also helps to de-stigmatize psychedelics by demonstrating their ability to treat significant psychiatric illnesses safely and responsibly.

 

The experiment is expected to yield valuable insights that might influence future research, clinical recommendations, and regulatory choices related to the use of psychedelic substances in mental health therapy. This is because the trial is expected to proceed and data will accrue. Psychedelic-assisted therapy is being promoted as a possible therapeutic option for the intricate problems associated with treatment-resistant depression, thanks to the combined efforts of researchers, physicians, and study participants.

 

Trial Design and Objectives

 

BPL-003’s phase 2b clinical trial has been carefully designed to assess the drug’s potential as a therapy for people with depression who are not responding to conventional treatments. The experiment uses a quadruple-masked, randomized design to reduce biases and guarantee the validity and dependability of the results. This methodological rigor bolsters the foundation for well-informed decision-making on developing BPL-003 and increases the legitimacy of the study’s findings.

 

Central to the trial’s objectives is the identification of optimal dosages of BPL-003 that can effectively alleviate symptoms of moderate to severe treatment-resistant depression. By employing a range of doses and comparing them against a placebo group, researchers seek to discern the therapeutic window within which BPL-003 demonstrates the greatest efficacy while minimizing adverse effects. This dose-finding aspect of the trial is crucial for informing subsequent clinical studies and eventual therapeutic use.

 

The experiment incorporates psychological support as an additional therapeutic component in addition to dose optimization. All patients get thorough psychological care before, during, and following medication since it is acknowledged that depression is a complex condition with psychosocial components that may influence treatment outcomes. To promote complete healing and recovery, this holistic approach emphasizes the need to address not only the biology but also the psychological and emotional elements of depression.

 

Furthermore, the trial’s design includes strong metrics for measuring effectiveness, particularly using the Montgomery-Asberg Depression Rating Scale at several points throughout the research. This validated method enables researchers to systematically assess changes in depression symptoms and track the therapeutic benefits of BPL-003 over time. The trial uses standardized evaluation techniques to improve the consistency and comparability of outcomes across multiple research sites, increasing the reliability and generalizability of the findings.

 

Evaluation Methods and Milestones

 

A wide range of evaluation techniques and milestones are included in the phase 2b clinical study to assess BPL-003’s effectiveness in treating depression that is resistant to therapy. The Montgomery-Asberg Depression Rating Scale, a reliable instrument for gauging depression symptoms and treatment response, is a key component of this evaluation. Researchers can systematically monitor changes in participants’ depressed symptoms and evaluate the therapeutic efficacy of BPL-003 in comparison to placebo by giving this scale to participants at different intervals during the experiment.

 

The study underlines the need to provide psychological support to all participants before, during, and after dosing. This integrated approach stresses the need to meet the holistic needs of patients receiving therapy while also recognizing the complex interplay between biological, psychological, and social factors in depression. The study’s purpose is to improve treatment outcomes and participants’ overall well-being by offering comprehensive psychological support, such as counseling and therapeutic sessions, during the experiment.

 

Furthermore, the trial includes an open-label extension phase at select sites, scheduled eight weeks post-initial dosing, to evaluate the sustained effects of BPL-003 following a second dose. This extension phase allows researchers to assess the durability of treatment response and investigate the potential for long-term therapeutic benefits. By extending the observation period beyond the initial dosing phase, the trial aims to provide insights into the maintenance of treatment effects over time and inform recommendations for the optimal dosing regimen of BPL-003 in clinical practice.

 

Bottom Line

 

Beckley Psytech’s phase 2b clinical trial of BPL-003 for treatment-resistant depression marks a significant milestone in psychedelic research. With its expansive scope, rigorous trial design, and emphasis on comprehensive evaluation methods, the study holds promise for advancing our understanding of psychedelic-assisted therapy. As the trial progresses and data accumulates, it is poised to provide valuable insights that could influence future treatment approaches and regulatory decisions in the field of mental health.

 

MUSHROOMS TO END DEPRESSION, READ ON…

MUSHROOMS FOR DEPRESSION

UK STUDY SAYS MUSHROOMS ARE BEST DRUG TO FIGHT DEPRESSION!



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Colorado Could Become a Global Hub for Marijuana Genetics

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Ability to source marijuana genetic material from outside Colorado

Senate Bill 23-271, which went into effect in early 2024, aims to enhance Colorado’s marijuana industry. A key provision allows licensed marijuana cultivators to source “genetic material” from approved entities in other jurisdictions. Genetic material is defined as material used to propagate cannabis plants, including:

  • Immature plants and small plant fragments with ≤0.3% D9 THC on a dry weight basis;
  • Cannabis seeds, which grow into marijuana; and
  • Tissue cultures.

This law significantly expands sourcing options for Colorado cultivators, including opportunities, both domestic and international. Colorado cultivators can now bring in popular OG strains from around the world.

The anticipated marketing frenzy, however, hasn’t fully materialized. The answer lies in the complexity of transporting genetics across state and international lines.

That’s where we come in. With years of experience advising clients on compliant cross-border transportation, we understand the nuances in the law. Below is a high-level overview of the challenges involved. If you or your clients are ready to make an impact in Colorado’s market, please reach out to me or my team— we’d be happy to assist.

Marijuana genetics: are they hemp or marijuana?

This question – the Schrödinger’s Cat of the cannabis industry – is both simple and complex. In short, under federal law, marijuana genetics appear to be hemp. However, they are neither strictly hemp nor marijuana until a state makes that determination. In fact, in some states they may be both marijuana and hemp.

  • “Marihuana” (referred to in this blog post as “marijuana”) is defined in the Controlled Substances Act (“CSA”), as “all parts of the plant Cannabis sativa L., whether growing or not; the seeds thereof; the resin extracted from any part of such plant; and every compound, manufacture, salt, derivative, mixture, or preparation of such plant, its seeds or resin.”
  • Marijuana does not include “hemp” as defined in the Agricultural Improvement Act of 2018 (the “2018 Farm Bill”).
  • Hemp is defined as the plant Cannabis sativa L. and any part of that plant, including the seeds thereof and all derivatives, extracts, cannabinoids, isomers, acids, salts, and salts of isomers, whether growing or not, with a delta-9 THC concentration of not more than 0.3 percent on a dry weight basis.

In January 2022, the DEA issued a letter stating that cannabis seeds and other genetic material with ≤0.3% D9 THC meet the definition of hemp and aren’t controlled substances. Importantly, the DEA further clarified in a December 2022 letter that if the cannabis seed germinates into material exceeding 0.3% THC, then “that material” falls within CSA control. DEA’s use of “that material” rather than specifying the seed used to grow “that material” further supports that DEA, at least for now, does not view marijuana genetics (testing at ≤0.3% THC on a dry weight basis) as marijuana.

While these DEA letters aren’t legally binding, they suggest that marijuana genetics, when testing at ≤0.3% D9 THC, are considered hemp under federal law.

State complexities with marijuana and hemp genetics

Since marijuana genetics are currently treated as hemp under federal law, they can move across U.S. state and international lines. However, the 2018 Farm Bill allows states to impose stricter laws.

Some states, like neighboring Arizona, define marijuana genetics as material that will only grow into hemp. Others, like Arkansas, do not expressly exempt “hemp” form the definition of “marijuana,” creating a situation where the genetics are both hemp and marijuana. And States like Mississippi and Minnesota prohibit the sale of cannabis sativa seeds all together.

Understanding both federal and state laws is critical to ensuring a compliant transfer into Colorado. If the exporting state defines the genetics as hemp and permits exports, cultivators can likely import them into Colorado. If the exporting state does not define marijuana genetics as hemp, then selling or transporting marijuana genetics could lead to criminal violations under a state’s marijuana laws.

International considerations

An international import of marijuana genetics must comply with both state, federal, and international laws. As long as the export meets USDA and Customs requirements, federal law typically won’t pose an issue. However, it’s essential to consider the laws of the exporting country, and importing US state, ensuring that the genetics are classified as hemp by both governments. Otherwise, the transport may not only violate a US state’s laws, but also international law.

Conclusion

Licensed Colorado cultivators seeking unique marijuana strains from outside the state—whether from California, Oregon, or countries like Colombia and Jamaica—must navigate both federal and state laws. Harris Sliwoski has extensive experience helping operators transfer cannabis genetics. With our new Denver office, we are ready to assist Colorado cultivators with global genetics imports. A “Tour de Cannabis” anyone?



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America’s Constitutional Conundrum: Guns and Ganja

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gun rights and medical marijuana

Of Guns and Ganja: America’s Constitutional Conundrum

 

If there’s one thing America is famous for, it’s guns – and lots of ’em! In the land of the free and home of the brave, firearms aren’t just a right, they’re practically a national pastime. With over 400 million firearms floating around a nation of 330 million people, it’s safe to say that guns are as American as apple pie and baseball.

But you know what else Americans love? Drugs. The US remains the world’s largest drug market, with an particularly passionate affair with cannabis. Mary Jane has come a long way since the “Just Say No” propaganda of the D.A.R.E. days. Now, millions of Americans legally light up in their home states, transforming from “criminals” to “consumers” faster than you can say “tax revenue.”

Here’s where things get sticky though. Despite the Biden administration’s vague promises of reform, cannabis remains stubbornly classified as a Schedule I substance at the federal level. This creates a peculiar predicament for freedom-loving Americans who appreciate both their Second Amendment rights and their evening toke.

You see, there’s this obscure interpretation of federal law that says if you consume cannabis – even legally in your state – you’re technically not allowed to own firearms. Let that sink in for a moment: in a country with more guns than people, where cannabis is legally sold in most states, you’re forced to choose between your constitutional right to bear arms and your state-sanctioned right to consume a plant.

As you might imagine, telling Americans they can’t have their guns AND their ganja isn’t exactly going over well. It’s a uniquely American saga that pits state rights against federal law, personal freedom against bureaucratic overreach, and common sense against, well… whatever you’d call this situation.

Let’s dive into this bizarre legal battleground where constitutional rights and cannabis collide.

As America’s cannabis landscape evolves, we’re witnessing a fascinating legal tug-of-war between state sovereignty and federal authority. The latest battleground? The constitutional rights of cannabis consumers to bear arms.

In a groundbreaking decision, the U.S. Court of Appeals for the Fifth Circuit recently reaffirmed that banning occasional marijuana users from owning firearms is unconstitutional. The case, known as U.S. v. Daniels, centers around a man who was sentenced to four years in prison after police found trace amounts of cannabis and firearms during a routine traffic stop. Talk about wrong place, wrong time!

The federal government, particularly under the Biden administration, has been performing some impressive mental gymnastics to justify their position. Their argument? Cannabis users with guns “endanger public safety,” “pose a greater risk of suicide,” and are more likely to commit crimes “to fund their drug habit.” They’ve even argued that cannabis consumers are “unlikely to store their weapons properly.” I guess they never met my ex-military uncle who meticulously organizes his gun safe while enjoying his evening edible.

But here’s where it gets really interesting. The Department of Justice claims the restriction is perfectly constitutional because it aligns with the nation’s history of disarming “dangerous” individuals. They’re essentially putting cannabis users in the same category as folks with domestic violence restraining orders. As someone who’s spent considerable time around both cannabis users and domestic abusers (professionally, of course), I can tell you there’s a slight difference in temperament.

The courts, however, aren’t buying it. As the Fifth Circuit pointed out, the government failed to prove that Daniels was “presently or even regularly intoxicated at the time of arrest.” They noted that even if the government had proven frequent intoxication, they offered “no Founding-era law or practice of disarming ordinary citizens ‘even if their intoxication was routine.'”

The ruling doesn’t completely invalidate the federal statute (known as § 922(g)(3)), but it does expose its shaky constitutional foundation. As the court stated, “This is not a windfall for defendants charged under § 922(g)(3),” but rather a recognition that the government’s enforcement approach is fundamentally flawed.

Meanwhile, the National Rifle Association (NRA) – not exactly known for their progressive stance on substances – acknowledges the absurdity of the situation. They point out that “marijuana use is no longer limited to the domain of indigenous religious customs or youth-oriented counterculture and now includes a wide variety of people who use it for medicinal or recreational reasons.” When even the NRA is suggesting your gun control measure might be a bit extreme, you know something’s amiss.

The result of all this legal wrangling? A patchwork of confusion where state-legal cannabis users must choose between their Second Amendment rights and their medicine or recreational preference. It’s a prime example of how federal prohibition creates more problems than it solves, forcing otherwise law-abiding citizens to become unwitting criminals simply for exercising multiple legal rights simultaneously.

Welcome to America, folks, where you can have your guns or your ganja, but apparently not both – at least until the courts finish sorting out this constitutional cannabis conundrum.

Let me be blunt – we’re caught in a classic American political pretzel. The Biden administration dangles the carrot of rescheduling cannabis to Schedule III, making vague promises that sound good on the campaign trail but do little to address the fundamental issues plaguing cannabis consumers, including their right to bear arms.

While some celebrate these baby steps toward reform, I’ve been around this block enough times to know that rescheduling is like putting a Band-Aid on a bullet wound. It might stop some bleeding, but it doesn’t address the underlying trauma. The gun rights issue is just one of many complications that arise from cannabis’s continued inclusion in the Controlled Substances Act (CSA).

Here’s the uncomfortable truth: there’s only one real solution, and it runs straight through the halls of Congress. The same body that created this mess with the CSA in 1971 is the only one with the power to truly fix it. Congress needs to completely remove cannabis from the CSA – not reschedule it, not modify its status, but fully deschedule it.

Think about it. Rescheduling to Schedule III would still leave cannabis in a weird legal limbo. Sure, it might make research easier and give Big Pharma more room to play, but what about the millions of Americans who use cannabis medicinally or recreationally in their state-legal markets? They’d still be federal criminals, still banned from purchasing firearms, still caught in the crossfire between state and federal law.

The only path forward is complete removal from the CSA, coupled with a federal framework that respects state markets while establishing basic national standards. This would resolve the gun rights issue overnight – no more choosing between your Second Amendment rights and your medicine or recreational preference.

Would I love to see Congress completely overhaul the CSA? Absolutely. The entire scheduling system is based on outdated science and political theater rather than actual harm reduction principles. But let’s be realistic – that’s about as likely as finding bipartisan agreement on… well, anything these days.

Instead, we need to focus on what’s achievable: complete cannabis descheduling. This isn’t just about guns and ganja – it’s about fixing a broken system that’s created countless legal paradoxes and unnecessary criminal penalties. It’s about acknowledging that the emperor has no clothes, that cannabis prohibition has failed, and that it’s time to move forward with a sensible federal policy.

Until Congress acts, we’ll continue to see these legal battles play out in courts across the country, watching judges try to reconcile constitutional rights with outdated federal drug laws. It’s a waste of judicial resources, taxpayer money, and most importantly, it’s a waste of Americans’ time and freedom.

The solution is clear. The only question is: how many more Americans need to get caught in this legal crossfire before Congress finally does its job?

 

Inspiration:

https://www.marijuanamoment.net/federal-court-reaffirms-that-ban-

on-gun-ownership-for-people-who-occasionally-use-marijuana-is-unconstitutional/

https://www.marijuanamoment.net/nra-says-federal-ban-on-

marijuana-amid-state-level-legalization-has-created-confusing-legal-landscape-for-gun-owners/

 

CANNABIS AND GUN RIGHTS, READ ON…

CANNABIS USERS GUNS RIGHT

WHY CAN’T MMJ PATIENTS OWN GUNS, AGAIN? READ THIS!



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MLK Day 2025: Cannabis and Civil Rights

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It’s MLK Day once again.

I’ve been writing an MLK Day post on this blog for eight consecutive years. The theme of my posts is that cannabis is a civil rights issue, and that Dr. King would have advocated for ending prohibition based on that fact.

Each year, I have demonstrated with facts (upon facts upon facts) that the War on Drugs continues in insidious ways. In, 2023, which is the most recent year that FBI data is available, law enforcement officials made over 200,000 arrests for marijuana-related convictions. Those 200,000 arrests constitute roughly 25% of all drug-related arrests.

Sadly, arrests of black people constituted 29% of all drug arrests in 2023, although only 13.6% of Americans are black.

Heading into MLK Day weekend, President Biden announced that he is commuting the sentences of nearly 2,500 people convicted of non-violent drug offenses. The focus was predominantly on individuals “who received lengthy sentences based on discredited distinctions between crack and powder cocaine…”, as opposed to cannabis-related crimes. According to the Last Prisoner Project, “the total number of those incarcerated for cannabis who received commutations is not knows, but nine LPP constituents will be free.”

For all that Biden promised as to cannabis, it’s the least we could have asked. Under the new Trump administration, attention will quickly return to the frustrating marijuana rescheduling process. If cannabis ends up on Schedule III, criminal penalties for traffickers may soften, but make no mistake: possessing and distributing cannabis will still be a federal crime.

At the state level, where most arrest occur, progress has slowed in the last few years. Out here where I live in Oregon, with our 800 cannabis stores, it’s astonishing to think of 200,000 annual cannabis arrests– most for simple possession, no less.

There is a lot of work to do. Here are a short list of organizations if you’d like to get involved:

For prior posts in this series:



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