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.

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New Study Dives Deep Into The Benefits Of Medical Marijuana For Patients’ Mental Health

Cannabis Is A Healing Tool In More Ways Than One

As of today, 38 states plus the District of Columbia and three territories have legalized marijuana for medical purposes.

There’s a reason why the movement to legalize weed for therapeutic use only continues to grow: that’s because it simply works. Depending on the state, the most common conditions that cannabis has accepted medical uses for includes seizures, nausea, chronic pain, glaucoma, cancer, multiple sclerosis, muscle spasms, and others to name a few. But even without a medical marijuana card, thousands of people are already enjoying the powerful therapeutic properties that cannabis has for a number of ailments.

That said, using cannabis for a physical ailment also has other positive effects – particularly on patients’ mental health.

There is a strong link, after all, between chronic illnesses and poor mental health. The diagnosis of a physical disease will directly impact and challenge your emotions or state of mind, which is why it’s so common to suffer from severe depression, anxiety, and bouts of anger or sadness. It’s only natural: it seems like you’re going into a downward spiral of emotions, having to figure out treatment, prognosis, and how to live the rest of your life.

But medicating with cannabis may not only help your physical ailment; it can greatly help you regain sanity, too.

According to a recent study out of Cambridge in the United Kingdom conducted by researchers from Switzerland’s University of Basel, patients with chronic health problems most especially chronic pain experience significant improvements in their mental health after medical marijuana has been legalized. The researchers assessed feedback from 7.9 million participants of an online survey conducted from 1993 through 2018.

The participants were grouped into various categories based on their cannabis consumption, including individuals who were “highly likely to abstain from using marijuana, to use marijuana as a recreational drug, or to use it for medical reasons” to identify the impact of medical marijuana legalization on mental health. The investigators also considered the use of marijuana for chronic pain. They measured the participants’ mental health by polling participants to grade their state based on the number of days they experienced mental health issues.

The findings, which were published in Health Economics, Policy, and Law, revealed: “Eased access to marijuana through medical marijuana laws reduce the reported number of days with poor mental health for individuals who consume marijuana for medical purposes and for those individuals who likely suffer from frequent pain.”

They also found that medical marijuana legalization didn’t impact the youth and recreational consumers. “Overall, our results show that medical cannabis legalization in the USA benefits the people it is intended for without harming other groups,” according to Professor Alois Stutzer. He also summarized that there a clear association between mental wellness and liberalization.

The findings of a similar study was released in 2023; it was conducted by researchers at the University of Sydney. They polled over 2,300 patients who were prescribed cannabis in the form of CBD and THC in a carrier oil from November 2020 through December 2021. The participants’ ages ranged from 18 to 97, and almost 2/3 of them were female.

The participants were asked to measure their quality of life relating to their overall health, pain, sleep, depression and anxiety before they began therapy with marijuana. They were polled again after 2 weeks of therapy, a routine that continued monthly for 3 months.

“Within the first three months of medicinal cannabis therapy, participants reported improvements in their health-related quality of life, fatigue, and health conditions associated with anxiety, depression, and pain,” explained Margaret-Ann Tait, a senior research officer to SWNS.

Additionally, the researchers reported that the patients experienced significant benefits when it came to their fatigue, pain, and quality of life.

The struggles with mental health are even more intense for cancer patients. However, medical marijuana use has been shown to help reduce depression, anxiety, and fatigue in patients diagnosed with cancer. A single-center, case-matched study conducted on 74 patients who were recently diagnosed with head and neck cancers found that cannabis users, compared to non users, reported less pain, better well-being, less fatigue, depression, and anxiety.

Head and neck cancers, in particular, can significantly impact one’s mental health given that it affects one’s swallowing mechanisms, facial structures, and speech. “These very much impact people’s social interactions and sense of self-worth,” said Dr. Zhang.

Conclusion

Medical marijuana has numerous therapeutic applications for patients suffering from a wide array of disease. Its anti-inflammatory, anti-emetic, anxiolytic, and anti-epileptic effects have been studied, and found to be extremely beneficial for those who are healing from disease. Cannabis makes life more bearable while helping to treat pain at its source, which is a major help for patients who simply want to make it, day by day.

At this day and age, we unfortunately still don’t have the standardized formulations of THC or CBD to help with conditions. However, doctors who are knowledgeable with medical marijuana can help. If you or a loved one are struggling with chronic disease and want to explore using marijuana as adjunct treatment, reach out to a medical professional who can help. There is hope on the other end of the line when cannabis is involved!

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The Death of the Lazy Stoner Stereotype

https://neurosciencenews.com/attention-cannabis-psychology-25994/

https://www.reddit.com/r/psychology/comments/1cdsuhj/cannabis_users_stay_motivated_lazy_stoner_myth/

For decades, the stereotype of the “lazy stoner” has been deeply ingrained in our collective unconscious, thanks to years of prohibitionist programming. This image of the unmotivated, unproductive cannabis user has become a pervasive cultural trope, perpetuated by media portrayals and anti-drug campaigns.

However, this bias not only unfairly discriminates against the countless hardworking and diligent individuals who choose to consume cannabis, but it also fails to stand up to scientific scrutiny.

A groundbreaking new study challenges the notion that chronic cannabis users are inherently lazy and unproductive.

The research, conducted by the University of Toronto and published in the journal Social Psychological and Personality Science, surveyed 260 frequent cannabis users to investigate the effects of cannabis use on their daily lives. The findings paint a far more nuanced picture of the relationship between cannabis consumption and motivation, emotional well-being, and self-regulation.

The study’s most striking revelation is that chronic cannabis users exhibit the same level of willingness to exert effort on tasks while under the influence as they do when sober. This finding directly contradicts the popular belief that cannabis use invariably leads to a loss of motivation and productivity.

Furthermore, the research found no evidence of a “weed hangover” effect, debunking the idea that cannabis users experience a decline in emotional or motivational function the day after consumption.

While the study did observe some changes in behavior among participants while they were high, such as increased impulsivity and decreased orderliness, these effects did not translate into a lack of hard work, responsibility, or focus.

In fact, the researchers found that cannabis use was associated with enhanced positive emotions like awe and gratitude, although very heavy users experienced more negative emotions both while high and while sober.

As we delve deeper into this study and its implications, it becomes clear that the lazy stoner stereotype is not only outdated but also fundamentally flawed.

By shedding light on the misconceptions surrounding cannabis use, we can begin to dismantle the stigma that has long plagued responsible, productive cannabis consumers.

The University of Toronto study, led by Professor Michael Inzlicht from the Department of Psychology, provides compelling evidence that challenges the lazy stoner stereotype. By surveying 260 chronic cannabis users, defined as those who consume cannabis at least three times a week or more, the researchers gained valuable insights into the effects of cannabis use on motivation, emotion, and self-regulation.

One of the most significant findings of the study relates to motivation. As Inzlicht explains, “We found that’s not the case — their behaviors might change a bit in the moment while they’re high, but our evidence shows they are not lazy or lacking motivation at all.”

The researchers assessed participants’ willingness to exert effort in completing a task while high and found that they were just as motivated and willing to invest effort as when they were sober. This finding directly contradicts the notion that cannabis use inevitably leads to a decrease in motivation and productivity.

The study also delved into the emotional and self-regulatory effects of cannabis use. While the researchers observed that being high led to lower levels of self-regulation, characterized by increased impulsivity and decreased orderliness, they emphasized that these changes did not translate into a lack of hard work, responsibility, or focus. As Inzlicht states, “These things can detract someone from getting stuff done, but we didn’t find it made them less hard-working, responsible or able to focus.”

Furthermore, the study revealed that chronic cannabis users experienced a boost in positive emotions, such as awe and gratitude, and a reduction in some negative emotions, like fear and anxiety, while high. However, it is important to note that very heavy users, those on the higher end of chronic use, experienced more negative emotions both while high and while sober.

The data from this study illustrates that the myth of the lazy stoner is just that—a myth. While cannabis use may indeed have a relaxing effect, it does not necessarily lead to a loss of motivation or productivity. In fact, when an individual is passionate about a particular project or activity, cannabis can be used to enhance the process, especially when tackling stressful and challenging tasks.

It is essential to recognize that the relationship between cannabis use and productivity is not black and white. As Inzlicht points out, “Our data suggests that you can be hard-working, motivated and a chronic cannabis user at the same time.” This nuanced perspective challenges the simplistic and stigmatizing view of cannabis users as unmotivated and unproductive.

By shedding light on the actual experiences of chronic cannabis users, this study contributes to a more balanced and evidence-based understanding of the effects of cannabis on daily life. It encourages us to question our preconceived notions and to approach the topic of cannabis use with a more open and objective mindset, recognizing that responsible cannabis consumption and productivity are not mutually exclusive.

As we’ve seen, the University of Toronto study challenges the long-held stereotype of the lazy, unmotivated stoner. This research is just one example of how science continues to debunk the myths and misconceptions perpetuated by cannabis prohibition. Time and time again, we are confronted with the reality that many of the alleged harms associated with cannabis use are not grounded in fact, but rather in the feelings and biases of prohibitionists.

The lazy stoner trope is a prime example of a fabrication that has been used to stigmatize and marginalize cannabis users for decades. However, as this study demonstrates, chronic cannabis users are just as capable of being motivated, hard-working, and productive as their non-using counterparts. In fact, many cannabis enthusiasts find that incorporating the plant into their lives enhances their ability to stay active, focused, and engaged in their passions.

Contrary to popular belief, most stoners enjoy being active and engaging in a wide range of activities. From hitting the gym to tackling household chores, cannabis can be a helpful tool for staying motivated and focused on the task at hand. As one participant in the study noted, “I find that a little bit of cannabis helps me get into a flow state when I’m working on a project I’m passionate about. It helps me stay creative and motivated, even when the work is challenging.”

This sentiment is echoed by countless cannabis users who have found ways to integrate the plant into their lives in a responsible and productive manner. Whether it’s using cannabis to enhance their workout routine, to spark creativity in their artistic pursuits, or simply to unwind after a long day, these individuals are living proof that the lazy stoner stereotype is a myth.

So, to all the productive stoners out there, we want to hear from you. How do you incorporate cannabis into your life in a way that supports your goals and aspirations? What activities do you enjoy while under the influence? By sharing our stories and experiences, we can continue to challenge the stigma surrounding cannabis use and paint a more accurate picture of the diverse and dynamic community of cannabis enthusiasts.

In the end, the sticky bottom line is this: cannabis use does not define a person’s character, motivation, or productivity. It is time to move beyond the outdated stereotypes and embrace a more nuanced, evidence-based understanding of the role that cannabis can play in our lives. With science on our side, we can continue to dismantle the myths of prohibition and advocate for a more just and equitable approach to cannabis policy.

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