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Canada Goes All in on Magic Mushrooms for Severe Depression and PTSD

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Psilocybin, the primary psychoactive compound in “magic mushrooms,” has been associated with recreational drug use and 1960s counterculture. However, recent research over the past two decades has shown that it can potentially treat various mental and behavioral health disorders.

 

Health Canada has approved a comprehensive psilocybin trial on 160 patients, including macro and multi doses, by Apex Labs Ltd. This Canadian biopharmaceutical firm is also advancing at-home psilocybin microdose studies and supporting veteran patients. The trial has been deemed “statistically powered.”

SUMMIT-90

The company’s Phase 2b study, known as SUMMIT-90, is a double-blind, multi-site, placebo-controlled, and in-clinic trial. It evaluates the impact of repeated macrodoses of its synthetic psilocybin APEX-90, coupled with exclusive psychotherapy, on participants diagnosed with severe depression and PTSD.

 

To address gaps in current macrodose studies, a precise dose has been chosen for administration in multiple doses over three months. The entire investigation, including screening, recruitment, treatment, and post-treatment effects measurement, is anticipated to last for a year.

Patient recruitment for the trial is set to begin sometime this quarter. The primary indication for the trial is a severe depression within PTSD, while the secondary indications include chronic pain, anxiety, and standalone PTSD symptoms. The severity of symptoms will be measured through scales that assess changes from baseline.

 

Tyler Powell, co-founder, and CEO of Apex, stated that the approval from the federal agency confirms the urgent requirement for enhanced healthcare alternatives. Dr. Peter Tomlinson, the CMO, further added that the dosing schedule for this trial had been optimized for sustained efficacy, focusing on patients suffering from the most severe form of the disease.

 

Following a successful proof-of-concept clinical study, Apex has optimized its proprietary psychedelic compound for treating mild-to-moderate depression in its ongoing Phase 2b trial, PATHFINDER-52. The trial involves take-home microdoses of psilocybin. Dosing for this trial is expected to commence by mid-2023. Centricity Research will be conducting both SUMMIT-90 and PATHFINDER-52 trials across five sites in Canada.

Apex’s Commercial Path

Greg Rutherford, Apex CCC, revealed to Benzinga the commercial pathway that the company intends to pursue, which involves:

  • Exhibit significantly enhanced clinical and patient outcomes compared to current standards of care in treating standalone depression and anxiety, as well as depression and anxiety with diagnosed PTSD. This enables the eventual approval of a broad and optimal treatment label.

  • Optimize access to their treatment resources by securing regulatory approvals in the U.S., Canada, Australia, and the EU, along with commercial listings and drug reimbursement.

 

Given his extensive background in big pharma, Rutherford anticipates that once enrollment for both clinical trials begins, health industry stakeholders will notice the company. If the endpoints are met, and the outcome data is compelling, these stakeholders will analyze the study results and, if appropriate, initiate further action.

 

According to Rutherford, the pharma industry typically seeks to acquire drug assets after Phase 2b trials. Subsequently, they plan and conduct pivotal clinical Phase 3 trials using their clinical and regulatory infrastructure and commercial expertise. This means they aim to acquire assets offering significant commercial potential at a Phase 2 price.

Benefits of magic mushrooms

The notion that psilocybin has no medical applications is not supported by scientific evidence is not true. While further research is required, strong evidence suggests that psilocybin has therapeutic benefits within the mental health field. Some therapeutic benefits of psilocybin include;

Depression

During a study conducted in 2022, a group of researchers examined the impact of psilocybin on 27 individuals who had suffered from depression for an extended period. The study involved administering two doses of psilocybin to each participant every two weeks between August 2017 and April 2019.

 

The study revealed that the subjects’ depression scores remained low after 1, 3, 6, and 12 months following the treatment. While this is encouraging, the researchers highlighted the need for further investigation to understand the connection between psilocybin and depression fully. Specifically, it is essential to determine if the benefits of the treatment can be sustained beyond 12 months.

Post-traumatic stress disorder (PTSD)

A study on mice showed that low doses of psilocybin effectively conditioned the fear response. This could imply that magic mushrooms can potentially treat PTSD and similar conditions. However, further research on humans is required to confirm this connection.

Furthermore, research indicates that the psychological impact of psilocybin can be uncertain, making it challenging to determine the effectiveness of magic mushrooms as a treatment for PTSD with absolute certainty.

Anxiety

Further research is necessary to determine the efficacy of psilocybin in treating anxiety, but preliminary studies show promising results. In a 2016 study, 51 cancer patients with life-threatening diagnoses were administered either a very low or high dose of psilocybin. The high-dose group experienced a significant increase in life meaning, optimism, and quality of life, as well as a reduction in death anxiety compared to the low-dose group.

Reduction In Substance Misuse

Researchers are investigating whether psilocybin can be effective in helping individuals quit smoking, drinking, or misusing drugs. In a small study, researchers looked at the use of psilocybin as a potential treatment for alcohol dependence and found that it helped to reduce drinking and alcohol cravings. However, further research is needed to determine its efficacy in larger populations.

 

In a pilot study, researchers found a significant improvement in the likelihood of smokers abstaining after 12 months when treated with psilocybin. While there are some reports of psilocybin helping with other forms of substance misuse, more research is needed to determine its effectiveness in reducing cravings and drug use.

Conclusion

The recent approval of a comprehensive psilocybin trial on 160 patients by Apex Labs Ltd. marks a significant milestone in the growing acceptance of psychedelics as potential treatments for mental and behavioral health disorders. With their double-blind, multi-site, placebo-controlled, and in-clinic SUMMIT-90 trial, Apex aims to address gaps in current macrodose studies and evaluate the impact of repeated doses of their synthetic psilocybin coupled with psychotherapy on patients diagnosed with severe depression and PTSD.

 

If successful, the experiment might provide a fresh, improved therapy alternative. There is optimism that these trials will help pave the way for upcoming drug approvals and ultimately expand access to cutting-edge therapy alternatives for those in need as the industry keeps track of Apex’s development.

 

MEDICAL PSILOCYBIN, READ ON…

MUSHROOMS FOR DEPRESSION

MUSHROOMS FOR DEPRESSION TAKES A BIG STEP FORWARD!



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Latest Trump Weed Rumor – Trump Will Federally Deschedule and Decriminalize Cannabis, but Not Legalize It

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trump on marijuana reform

In a recent interview, former New Jersey Governor Chris Christie made headlines by asserting that President-elect Donald Trump will pursue significant reforms in federal policies regarding marijuana and cryptocurrency. As the nation grapples with evolving attitudes toward cannabis and the burgeoning digital currency market, Christie’s predictions have ignited discussions about the potential implications of such changes on both industries. This article delves into Christie’s insights, the current state of marijuana and cryptocurrency regulations, and the broader implications of these anticipated reforms.

 

The Current Landscape of Marijuana Legislation

 

Federal vs. State Laws

Marijuana remains classified as a Schedule I substance under the Controlled Substances Act (CSA), which places it in the same category as heroin and LSD. This classification has created a complex legal landscape where states have moved to legalize cannabis for medical and recreational use, while federal law continues to impose strict prohibitions. As of now, over 30 states have legalized marijuana in some form, leading to a burgeoning industry that generates billions in revenue.

 

Challenges Faced by the Cannabis Industry

 

Despite its legality in many states, the cannabis industry faces significant hurdles due to federal restrictions. These challenges include:

  • Banking Access: Many banks are hesitant to work with cannabis businesses due to fear of federal repercussions, forcing these businesses to operate largely in cash.

  • Taxation Issues: The IRS enforces Section 280E of the tax code, which prohibits businesses engaged in illegal activities from deducting normal business expenses, leading to disproportionately high tax burdens for cannabis companies.

  • Interstate Commerce: The lack of federal legalization prevents cannabis businesses from operating across state lines, limiting their growth potential.

 

Chris Christie’s Perspective on Marijuana Reform

 

Christie, a former presidential candidate known for his tough stance on drugs during his tenure as governor, has evolved his views on marijuana over the years. In his recent statements, he emphasized that Trump is likely to pursue descheduling cannabis, which would remove it from the Schedule I classification. This move would not only provide clarity for businesses operating in legal markets but also open avenues for banking and investment.

 

Christie highlighted that descheduling would allow for a more regulated market where safety standards could be established, thus protecting consumers. He believes that this approach aligns with a growing consensus among Americans who support legalization and recognize the potential benefits of cannabis use for both medical and recreational purposes.

 

The Future of Cryptocurrency Regulation = The Rise of Cryptocurrencies

 

Cryptocurrencies have surged in popularity over the past decade, with Bitcoin leading the charge as the first decentralized digital currency. The market has expanded to include thousands of alternative coins (altcoins), each with unique features and use cases. As cryptocurrencies gain traction among investors and consumers alike, regulatory scrutiny has intensified.

 

Current Regulatory Challenges

 

The cryptocurrency market faces several regulatory challenges that hinder its growth and adoption:

 

  • Lack of Clarity: Regulatory frameworks vary significantly across states and countries, creating confusion for investors and businesses.

  • Fraud and Scams: The rapid growth of cryptocurrencies has led to an increase in fraudulent schemes targeting unsuspecting investors.

  • Consumer Protection: Without clear regulations, consumers are often left vulnerable to risks associated with volatile markets.

 

Christie’s Vision for Crypto Regulation

 

Christie believes that under Trump’s leadership, there will be an effort to find a “sweet spot” for cryptocurrency regulation balancing innovation with consumer protection. He argues that overly stringent regulations could stifle growth in this emerging sector while too little oversight could expose consumers to significant risks.

 

In his view, a balanced regulatory framework would include:

 

1. Clear Definitions: Establishing clear definitions for different types of cryptocurrencies and tokens to differentiate between securities and utility tokens.

2. Consumer Protections: Implementing measures to protect investors from fraud while promoting transparency within the market.

3. Encouraging Innovation: Creating an environment conducive to innovation by allowing startups to thrive without excessive regulatory burdens.

 

Christie’s insights reflect a growing recognition among policymakers that cryptocurrencies are here to stay and that appropriate regulations are necessary to foster growth while safeguarding consumers.

 

Implications of Proposed Reforms

 

Economic Impact

 

The potential reforms proposed by Christie could have far-reaching economic implications:

 

  • Job Creation: Legalizing marijuana at the federal level could lead to significant job creation within the cannabis industry—from cultivation and production to retail sales.

  • Investment Opportunities: Descheduling cannabis would open up investment opportunities for institutional investors who have been hesitant due to federal restrictions.

  • Boosting Local Economies: Legal cannabis markets have proven beneficial for local economies through increased tax revenues and job creation.

 

Similarly, clear regulations around cryptocurrencies could stimulate investment in blockchain technology and related industries, fostering innovation and economic growth.

 

Social Justice Considerations

 

Both marijuana legalization and sensible cryptocurrency regulations have social justice implications:

 

  • Addressing Past Injustices: Legalizing marijuana could help rectify past injustices related to drug enforcement policies that disproportionately affected marginalized communities.

  • Financial Inclusion: Cryptocurrencies offer opportunities for financial inclusion for those underserved by traditional banking systems, particularly in low-income communities.

 

Political Landscape

 

The political landscape surrounding these issues is complex. While there is bipartisan support for marijuana reform among certain lawmakers, challenges remain in overcoming entrenched opposition. Similarly, cryptocurrency regulation has garnered attention from both sides of the aisle but requires collaboration to establish effective frameworks.

 

Conclusion

 

Chris Christie’s predictions about President-elect Donald Trump’s approach to federal marijuana descheduling and cryptocurrency regulation suggest a potential shift in U.S. policy that could significantly reshape both industries. As public opinion evolves on these issues, lawmakers have an opportunity to enact meaningful reforms that promote economic growth while ensuring consumer protection. The anticipated changes could foster a more robust cannabis industry that contributes positively to the economy and addresses social justice concerns, while clear regulatory frameworks for cryptocurrencies could encourage innovation and protect consumers in the digital economy. Stakeholders in both sectors are closely watching these developments, eager to see how potential reforms might impact their futures. While the realization of Christie’s predictions remains uncertain, it’s clear that the conversation around marijuana and cryptocurrency regulation is ongoing and far from settled.

 

TRUMP 2.0 ON CANNABIS REFORM, READ ON…

TRUMP ON MARIJUANA REFORM

TRUMP 2.0 ON FEDERAL CANNABIS REFORM – WHAT DO WE KNOW?

 



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Webinar Replay: Post-Election Cannabis Wrap – Smoke ’em if You’ve Got ’em

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On Thursday, November 7th, Vince Sliwoski, Aaron Pelley and Fred Rocafort held a post election discussion “Post-Election Cannabis Wrap – Smoke ’em if You’ve Got ’em”. Watch the replay!

Key Takeaways from the “Smoke ’em if You’ve Got ’em – 2024 Post Election Cannabis Wrap” Webinar:

  1. Panelists:
    • Vince Sliwoski: Oregon Business lawyer specializing in cannabis and commercial real estate.
    • Aaron Pelley: Experienced in cannabis law since Washington’s legalization in 2012.
    • Fred Rocafort: Trademark attorney working closely with the cannabis team.
  2. Election Results Overview:
    • Most 2024 cannabis ballot measures did not pass.
    • Florida, South Dakota, and North Dakota saw failures.
    • Nebraska became the 39th state to legalize cannabis for medical use when it passed two cannabis initiatives, Initiatives 437 and 438.
  3. Federal and State-Level Developments:
    • Medical use is currently legal in 38 states, and 24 states allow recreational use.
    • Republican support for marijuana legalization is growing.
  4. Federal Policy Implications:
    • Schedule III Rescheduling: The process to move cannabis to Schedule III is ongoing, which could significantly impact the industry.
    • Importance of Federal Appointments: The future of cannabis policy depends heavily on who is appointed to key positions in the administration.
  5. International and Domestic Trade:
    • Schedule III status could ease import/export restrictions on cannabis.
    • Unified control of House, Senate, and presidency might expedite legislative progress.
  6. Economic and Industry Impact:
    • Cannabis stocks experienced volatility post-election, reflecting investor uncertainty.
    • Federal legalization and banking reforms are crucial for industry stability and growth.
  7. Future Outlook:
    • The potential for federal rescheduling remains strong, with hearings scheduled for early 2025.
    • State-level initiatives and regulatory developments will continue to shape the industry.

Watch the replay!



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I Had Just One Puff

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one puff of a joint a drug test

“How Long Does One Puff of Weed Stay in Your System?”… This topic can be difficult to answer since it is dependent on elements such as the size of the hit and what constitutes a “one hit.” If you take a large bong pull then cough, it might linger in your system for 5-7 days. A moderate dose from a joint can last 3-5 days, whereas a few hits from a vaporizer may last 1-3 days.

 

The length of time that marijuana stays in the body varies based on a number of factors, including metabolism, THC levels, frequency of use, and hydration.

 

Delta-9-tetrahydrocannabinol, or THC, is the primary psychoactive component of cannabis. THC and its metabolites, which remain in your body long after the effects have subsided, are detected by drug tests.

 

Since these metabolites are fat-soluble, they cling to bodily fat molecules. They could thus take a while to fully pass through your system, particularly if your body fat percentage is higher.

 

THC is absorbed by tissues and organs (including the brain, heart, and fat) and converted by the liver into chemicals such as 11-hydroxy-THC and carboxy-THC. Cannabis is eliminated in feces at a rate of around 65%, while urine accounts for 20%. The leftover amount might be kept within the body.

 

THC deposited in bodily tissues ultimately re-enters the circulation and is processed by the liver. For frequent users, THC accumulates in fatty tissues quicker than it can be removed, thus it may be detectable in drug tests for days or weeks following consumption.

 

The detection time varies according to the amount and frequency of cannabis usage. Higher dosages and regular usage result in longer detection times.

 

The type of drug test also affects detection windows. Blood and saliva tests typically detect cannabis metabolites for shorter periods, while urine and hair samples can reveal use for weeks or even months. In some cases, hair tests have detected cannabis use over 90 days after consumption.

 

Detection Windows for Various Cannabis Drug Tests

 

Urine Tests

Among all drug tests, urine testing is the most commonly used method for screening for drug use in an individual.

 

Detection times vary, but a 2017 review suggests the following windows for cannabis in urine after last use:

 

– Single-use (e.g., one joint): up to 3 days

– Moderate use (around 4 times a week): 5–7 days

– Chronic use (daily): 10–15 days

– Chronic heavy use (multiple times daily): over 30 days

 

Blood Tests

Blood tests generally detect recent cannabis use, typically within 2–12 hours after consumption. However, in cases of heavy use, cannabis has been detected up to 30 days later. Chronic heavy use can extend the detection period in the bloodstream.

 

Saliva Tests

THC can enter saliva through secondhand cannabis smoke, but THC metabolites are only present if you’ve personally smoked or ingested cannabis.

 

Saliva testing has a short detection window and can sometimes identify cannabis use on the same day. A 2020 review found that THC was detectable in the saliva of frequent users for up to 72 hours after use, and it may remain in saliva longer than in blood following recent use.

 

In areas where cannabis is illegal, saliva testing is often used for roadside screenings.

 

Hair Tests

Hair follicle tests can detect cannabis use for up to 90 days. After use, cannabinoids reach the hair follicles through small blood vessels and from sebum and sweat surrounding the hair.

 

Hair grows at approximately 0.5 inches per month, so a 1.5-inch segment of hair close to the scalp can reveal cannabis use over the past three months.

 

Factors Affecting THC and Metabolite Retention

 

The length of time THC and its metabolites stay in your system depends on various factors. Some, like body mass index (BMI) and metabolic rate, relate to individual body processing, not the drug itself.

 

Other factors are specific to cannabis use, including:

 

– Dosage: How much you consume

– Frequency: How often you use cannabis

– Method of consumption: Smoking, dabbing, edibles, or sublingual

– THC potency: Higher potency can extend detection time

 

Higher doses and more frequent use generally extend THC retention. Cannabis consumed orally may remain in the system slightly longer than smoked cannabis, and stronger cannabis strains, higher in THC, may also stay detectable for a longer period.

 

How Quickly Do the Effects of Cannabis Set In?

 

When smoking cannabis, effects appear almost immediately, while ingested cannabis may take 1–3 hours to peak.

 

The psychoactive component THC produces a “high” with common effects such as:

 

– Altered senses, including perception of time

– Mood changes

– Difficulty with thinking and problem-solving

– Impaired memory

 

Other short-term effects can include:

– Anxiety and confusion

– Decreased coordination

– Dry mouth and eyes

– Nausea or lightheadedness

– Trouble focusing

– Increased appetite

– Rapid heart rate

– Restlessness and sleepiness

 

In rare cases, high doses may lead to hallucinations, delusions, or acute psychosis.

 

Regular cannabis use may have additional mental and physical effects. While research is ongoing, cannabis use may increase the risk of:

 

– Cognitive issues like memory loss

– Cardiovascular problems including heart disease and stroke

– Respiratory illnesses such as bronchitis or lung infections

– Mood disorders like depression and anxiety

 

Cannabis use during pregnancy can negatively impact fetal growth and development.

 

Duration of Effects

Short-term effects generally taper off within 1–3 hours, but for chronic users, some long-term effects may last days, weeks, or even months. Certain effects may even be permanent.

 

Bottom Line

The amount of time that cannabis remains in your system following a single use varies greatly depending on individual characteristics such as body fat, metabolism, frequency of use, and mode of intake. Frequent users may maintain traces of THC for weeks, whereas infrequent users may test positive for as little as a few days. Hair tests can disclose usage for up to 90 days, while blood and saliva tests identify more recent use. Urine tests are the most popular and have varying detection durations. The duration that THC and its metabolites are detectable will ultimately depend on a number of factors, including dose, strength, and individual body chemistry.

 

PEE IN A CUP COMING UP, READ ON..

how long does weed stay in your urine

HOW LONG DOES WEED STAY IN YOUR URINE FOR A DRUG TEST?



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