Poll States 28% of Americans Have Tried At Least One Psychedelic Substance

The poll asked 1,000 adults to answer questions online between July 22-25, which revealed that 28% of Americans have used at least one of the seven psychedelic drugs included in the questionnaire. In order of most used to least used, the list of substances included LSD (14% of participants), psilocybin (13%), MDMA (9%), ketamine (6%), DMT (6%), and salvia (5%).

The poll notes that psychedelic acceptance is increasing, and more legislation is being proposed. “Recent shifts, both in policy and public opinion, suggest the tide in the United States may be turning toward increasingly favoring psychedelic drugs,” YouGov states. “In the past few years, a number of cities across the U.S., such as Oakland, California, have decriminalized psilocybin, also known as psychedelic mushrooms. This November, Coloradans will vote on whether to legalize the drug state-wide, and by January 2023, Oregon is expected to begin allowing its use for mental-health treatment in supervised settings.”

According to the poll, 42% percent of those who have tried psychedelics at least once have a family income of $100,000 or more, while only 34% have an income of $50,000 to $100,000, and 23% reported having an income of $50,000 or less. Forty-two percent also said they had earned a postgraduate degree, with 26% having graduated with an undergraduate degree, and 24% who have a high school degree or less.

In terms of age, 39% of participants who have tried psychedelics range between 30-44 years old, whereas 35% range between 18-29 years of age, and only 14% were over 65. Thirty-four percent of participants who have tried a substance identified as men, while 22% identified as women.

Regionally, the pattern of acceptance follows areas that have enacted psychedelics-related legislation. Thirty-seven percent of participants who have tried substances live in the western United States, with 34% in the Northeast, 23% in the South (other regions were not specified). Those who have experimented with psychedelics often live in cities (36%), compared to those who live in suburbs (26%), and rural areas (19%).

Other categories of definition explored people from different religions, those who live in other regions of the country, age, and other identifiers such as “very conservative,” “conservative” or “liberal.” The poll data shows that those who are liberal, which is defined by the 52% of participants, said that they have tried at least one psychedelic drug.

However, many of the participants still showed opposition to decriminalizing of some of these substances. Forty-four percent oppose decriminalization of psilocybin, 53% oppose decriminalizing LSD, and 53% oppose MDMA decriminalization. Overall, those who have tried one of these substances are more likely to agree that it should be decriminalized. “And while support for legalizing psychedelic drugs is relatively low among Americans overall, it’s much higher among people who have personal experiences with the substances—especially in the case of people who have used mushrooms.”

Those who have tried these substances also expressed support for medical initiatives that promote psychedelics as a medical treatment. “Recently proposed bipartisan amendments to the annual National Defense Authorization Act, suggested by Reps. Dan Crenshaw and Alexandria Ocasio-Cortez, relax federal restrictions on research into psychedelic-assisted post-traumatic stress disorder (PTSD) treatment for veterans,” YouGov wrote. When participants were asked about their support of research such as that initiative, 54% said they supported it and 18% said they were opposed. Sixty-three percent of those who hold a college degree supported research efforts for at least one psychedelic drug, but 49% of those without a college degree also support research. Sixty percent of participants who aligned as Democrat said they were more likely to favor psychedelic research, versus 54% of Independents and 45% of Republicans.

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Bipartisan Senate Bill Would Give ‘Right to Try’ Protection to Psilocybin and MDMA

Democratic Senator Cory Booker of New Jersey and Senator Rand Paul, a Republican from Kentucky, introduced bipartisan legislation on Wednesday to extend federal Right to Try protection to the psychedelic drugs psilocybin and MDMA. Under the bill, titled the Right to Try Clarification Act, restrictions of the federal Controlled Substances Act would not apply to Schedule I Drugs for which a Phase 1 clinical trial has been completed. The new provisions would apply to doctors and patients with life-threatening medical conditions using Schedule 1 controlled substances under the federal Right to Try Act.

“As a physician, I know how important Right to Try is for patients facing a life-threatening condition,” Paul said in a statement about the legislation from Booker’s office. “Unfortunately, the federal bureaucracy continues to block patients seeking to use Schedule I drugs under Right to Try. I’m proud to lead this bipartisan legislation with Sen. Booker that will get government out of the way and give doctors more resources to help patients.”

The Right to Try Act allows patients who have been diagnosed with life-threatening diseases or conditions for which traditional therapies have not been effective to use certain treatments that have not yet been approved by the U.S. Food and Drug Administration. In most cases, a drug is eligible for Right to Try use after a Phase 1 clinical trial has been completed for that drug but before the drug is approved or licensed by the FDA for any use. Under the provisions of the Right to Try law, states have the option to permit or prohibit Right to Try use under state law.

The senators noted that two drugs, MDMA and psilocybin, show promise as treatment for a variety of mental health conditions, including depression, anxiety, and PTSD. The success and safety of the drugs exhibited in Phase 1 and Phase 2 clinical trials has been so encouraging that the FDA has classified both substances as “breakthrough therapies,” indicating that they show a substantial improvement over currently approved therapies.

“Recent studies suggest that MDMA and psilocybin could represent an enormous advancement in mental health and psychopharmacology,” said Booker. “Unfortunately, many eligible patients who urgently need care do not currently have access to these promising therapies. This legislation will put the patient first and help ensure access to life-changing and life-saving drugs.”

Companion Measure To Be Introduced in the House

A bipartisan duo of members of the House of Representatives who support federal cannabis policy have already signed on to support Booker and Paul’s bill and will introduce companion legislation in the House. Democratic Representative Earl Blumenauer of Oregon, who has long supported reforming the nation’s cannabis laws, and Representative Nancy Mace, a first-term Republican who introduced a bill to legalize cannabis last year, expressed their support for the change to Right to Try legislation.

“Oregon has a long legacy of ensuring that end-of-life patients have access to the full spectrum of treatment options to alleviate their condition and improve their quality of life. Patients and doctors deserve to discuss treatments—including psilocybin—that researchers find provide immediate and sustained relief from pain, anxiety, and depression for people battling terminal illness,” Blumenauer said. “Federal restrictions have obstructed access to end-of-life care for too long, this legislation will change that and ensure that all patients have the Right to Try. I appreciate Senator Booker’s leadership, it is timely and important.”

“Advances in science and technology are often made when we think outside the box and try new things,” said Mace. “This legislation gives patients the power to choose alternative options like psilocybin or MDMA when facing a life-threatening condition. We know these chemicals have the potential to save lives, and today is an important step forward in medical progress. I want to thank Senators Booker and Paul for their bipartisan work to bring these exciting new options into the mainstream medical world.”

The Right to Try Clarification Act was introduced in the Senate only one day before Booker, Senate Majority Leader Chuck Schumer of New York and Democratic Senator Ron Wyden of Oregon introduced a long-anticipated bill to legalize cannabis at the federal level. Shane Pennington, an attorney with the law firm Vicente Sederberg, said that he is “happy to see Congress paying attention to psychedelics issues, particularly those that affect the veteran community. Vets shouldn’t have to go to other countries to access therapies that evidence has shown to be safe and likely effective.”

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How ‘How to Change Your Mind’ Will Change Your Mind About Psychedelics

Netflix has no shortage of documentaries about psychedelics. In 2016’s The Last Shaman, a severely depressed actor ventures into the Amazon rainforest in the hope that a cup of ayahuasca can keep his suicidal thoughts at bay. Ram Dass, Going Home (2017) follows the last days of the eponymous psychologist, who was once ousted from Harvard for using drugs in his research. In Have a Good Trip (2020), A$AP Rocky, Anthony Bourdain, and other celebrities—both dead and living—share the stories behind their wildest psychedelic trips.

To these entries the streamer recently added How to Change Your Mind. Based on a 2018 book of the same name by the journalist and New York Times best-selling author Michael Pollan, this docuseries follows Pollan as he researches (and uses) 4 different psychedelic drugs: LSD, psilocybin, MDMA, and mescaline. Unsurprisingly, the series quickly became a huge hit, trending in the streaming service’s top 10 ever since its release on July 12.

How to Change Your Mind is a captivating watch, even if you’re not remotely interested in psychedelics. This is largely thanks to Pollan, who is not only a likable host but a talented writer. Pollan began his career reporting on the relationship between people and plants, focusing mostly on the food industry. His beat eventually led him from ordinary plants to mind-altering plants, starting with insidious examples like coffee and tea and ending with full-blown psychedelics.

In the opening scenes of the first episode, Pollan refers to himself as a “late bloomer.” Born shortly after the infamous Summer of Love, his understanding of psychedelics was limited to the terrifying and exaggerated stories he’d been told by agents of the U.S. government. Later in life, journalism taught him to think for himself. Viewers now find Pollan, approaching his 70s, sitting cross legged in a field while a ceremonial leader shoots concentrated doses of tobacco up his nostrils. The journalist, quivering and groaning as though his body has been set on fire, tries his best to remain composed; he knows his trip is only just beginning, and the worst (or best) has yet to come.

The first episode of How to Change Your Mind is dedicated to the “first” psychedelic: LSD. Lysergic acid diethylamide, Pollan explains, was first synthesized in 1938 by Albert Hofmann. Hofmann, a Swiss chemist under the employment of pharmaceutical giant Sandoz, unknowingly synthesized the psychedelic while breaking down ergot, a fungus that commonly grows on rye. Hofmann suspects the substance must have accidentally entered his bloodstream through his fingertips, causing him to undergo the first acid trip in European history. The initially terrifying but ultimately pleasant experience motivated Hofmann to experiment further, ingesting quantities of LSD that would intimidate even the most seasoned psychonauts.

Unsure what to do with the new substance and curious about its pharmaceutical potential, Sandoz started an open research and development program, shipping LSD to any chemist, neurologist, and psychoanalyst interested in running experiments. These experiments continued into the sixties, until the U.S. government interfered. Detecting a link between the eye-opening drug and conscientious objection to the Vietnam War, Washington declared LSD a schedule 1 narcotic. Other countries including Switzerland followed suit, and all research was shut down.

Mainstream media, which previously covered LSD with unbridled enthusiasm, now presented the drug as a dangerous and addictive substance. News coverage focused exclusively on “bad trips,” presenting them as the only kind of outcome one can expect from LSD. Crying teenagers are unable to distinguish between reality and hallucination. Their panic attacks are so severe they have to be restrained by police or medical personnel. Though LSD is non-lethal and non-toxic, there is indeed a slight danger to it. For people prone to mental illness, warns Pollan, dropping acid might trigger their first psychotic break.

That’s not to say LSD is a shortcut to schizophrenia. For the majority of psychonauts, the drug causes a myriad of exciting, pleasant sensations. They say the only way to understand a trip is to experience one for yourself, but Pollan and the people he interviews actually do a pretty good job describing what they see and feel. Hofmann recalls that the Swiss landscape morphed into “kaleidoscopic” shapes and that acoustic perceptions were translated into visual ones. (How to Change Your Mind uses some cool CGI to show what this might look like). The Canadian psychiatrist Humphrey Osmond initially took LSD to better understand his psychotic patients, only to realize that acid trips were more mystical than maddening. Everything around him, the psychiatrist explains, acquired a profound sense of beauty and intrigue, so much so that he could spend all day contemplating something as unremarkable as a flower. Pollan agrees, adding that LSD makes you look at the world as though you are seeing it for the first time, the way you did when you were a child.

Indeed, many find that taking LSD puts them back in touch with lost or suppressed memories. One young man participating in a modern-day clinical trial in Zurich says he remembered being inside his mother’s womb where, the umbilical cord tightly wrapped around his little neck, he was forced to decide whether to survive or give up. This predicament, though strange, is hardly unique; from war veterans to sexual assault survivors, people say psychedelics allow them to confront—and, crucially—move past their traumatic experiences, healing themselves in ways that conventional psychiatry and medication cannot.

It is interesting that individuals from all walks of life use the same basic language to describe the emotional significance of their trips. They say LSD makes them feel “connected” to the world around them. Starstruck by the beauty and awe described by Osmond, they suddenly realize that they are but one small part of a much larger organism. This realization leads them to the conclusion that if they hurt someone else, or hurt nature, they are also hurting themselves—a train of thought which may explain why love plays such a central role in the psychedelic movement, and why so many young Americans ended up refusing to participate in the Vietnam War.

It is only in retrospect that we recognize the influence psychedelics have had on society. Bill Wilson, the co-founder of Alcoholics Anonymous, did not quit drinking until he was given a dose of LSD. According to Wilson, the drug changed his perspective on addiction and awakened his capacity to himself. To this day AA remains a deeply spiritual organization, and that spirit can be traced back directly to psychedelics.

Psychedelics also gave us the personal computer. Steve Jobs, founder of Apple, famously referred to a college LSD trip as “one of the most important things in my life.” Like other entrepreneurs and artists who came of age during the Summer of Love, Jobs used drugs to unwind and open his mind to new creative possibilities. Pollan says it’s no coincidence that Jobs and other future tech titans took a liking to LSD, as both psychedelics and digital technology are all about dissolving boundaries and connecting people that would have otherwise been separated by space and time. Times haven’t changed that much either. If life on Wall Street continues to be defined by its normalization of cocaine use, Silicon Valley is still a place where employees can release their inner psychonaut without fear of being sacked by straight-laced superiors.

Today, research into LSD and other kinds of psychedelics is gradually resuming. Between the War on Drugs being unmasked as the witch hunt that it was, and the legalization of other previously persecuted substances like cannabis, researchers are once again able to legally handle their test subjects. How to Change Your Mind spotlights a number of contemporary studies, several of which are happening in Switzerland: the very country where Hofmann discovered LSD all those years ago. One team is looking at whether or not psychedelics could improve the mental state of terminally ill cancer patients. Another is finding out, once and for all, which areas of the brain are stimulated when an acid trip kicks in (one of these, spoiler alert, is the area of the brain that regulates our sense of self).

Once you finish the first episode of Pollan’s documentary, chances are you’ll stick around for the other three. Though they are all qualified as psychedelics, each substance influences the brain in different ways. Whereas LSD toys with our sense perception, its cousin MDMA straight up fills our heads with serotonin. The popular party drug does not cause us to see outlandish visuals, but feel an unprecedented amount of love. While LSD allows you to look at the world from a different perspective, MDMA enables you to see and accept yourself for who you are—yet another fascinating prospect for medical researchers. As for psilocybin and mescaline, you’ll simply have to watch How to Change Your Mind for yourself.

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Veterans Affairs Researchers Embrace Psychedelics for Military Vets

According to The New York Times, the last time that Veterans Affairs (VA) explored psychedelics as a medical treatment was in 1963. This was around the same time that the Central Intelligence Agency and U.S. Army was testing LSD as a way to “mind-control” enemies. Many decades later, these four researchers are bridging the gap between veteran mental health and psychedelic-assisted therapy. These studies are being conducted by VA clinicians, and the results could lead the way to more studies in the future.

Dr. Shannon Remick, is conducting a study with 10 veterans in a VA clinic in Loma Linda, California. She became one of the first doctors since the 1960s to be allowed to use psychedelics as a treatment in that clinic, which is overseeing the progress of combat veterans suffering from post-traumatic stress disorder (PTSD). Each volunteer will experience three sessions using MDMA as a way to explore their condition, and begin each session with calming activities (such as breathing exercises or poem readings). Sessions are led by the patient, but assisted through the process with the help of a therapist who mainly listens, rather than directs.

“We are alongside and with the patient as they are exploring a kind of excavation site,” Dr. Remick said. “Ultimately, it’s not for us to point and say, ‘Hey, look at that,’ because what I’m seeing may not be the same from their angle.”

Dr. Rachel Yehuda actually delayed her retirement to dedicate herself to psychedelic-assisted therapy. She sought out permission to help PTSD sufferers with MDMA, and began the study earlier this year in January. Her study is examining the effects of MDMA on PTSD patients, specifically to determine whether two or three sessions are more beneficial overall.

Yehuda herself participated in an MDMA trip in 2019 for therapist training. “It made me really understand what it is you’re supposed to be doing in psychotherapy,” Dr. Yehuda said. “I’ve never quite understood what it means to have a breakthrough.” She also noted the importance of doing such a process with “the right therapists.”

Dr. Leslie Morland has over two decades worth of experience with PTSD therapies, and is also exploring how MDMA could help veterans after they return home from duty—specifically as a way to make couples therapy more successful. Her clinical study is expected to begin at the end of 2022, and will study eight participants and their respective partners in San Diego.

“A lot of our military learn to emotionally disconnect in order to be effective in combat,” Dr. Morland said. “And then we’re bringing them back and saying: Now we need you to open up with our talk therapy.” With the help of MDMA, Morland hopes to see an increase in bonding and empathy in her patients. “How do they work together to really sustain the improvements that have been achieved in therapy?”

Finally, Dr. Christopher Stauffer has previously explored the effectiveness of psilocybin as a way to combat substance abuse. One of his studies will review how psilocybin can assist 30 veterans who are addicted to methamphetamine. Half of them will receive conventional therapy plus two psilocybin therapies, and the other half will only receive conventional therapy.

Another study led by Stauffer will review how MDMA can help group therapy sessions for veterans. “[MDMA is] brand-new to a lot of people and yet it’s been around longer than most of our psychiatric medications have been around,” Dr. Stauffer said. “But it feels like we’re approaching it this time with a lot more knowledge and a lot of more rigorous research practices that didn’t really exist back in the ’50s and ’60s.”

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Canadian Firm Seeks Approval to Manufacture MDMA and Other Psychedelics

A Canadian company that produces functional mushroom formulations for health and wellness has submitted a request to federal regulators that would allow it to manufacture MDMA and other synthetic psychedelic drugs. If the request made to Canada Health by Optimi Health seeking an amendment to its Controlled Substances Dealer’s license is approved, the company plans to manufacture MDMA, LSD, Mescaline, GHB and other psychedelics at its production facility in Princeton, British Columbia.

Optimi Health Corporation is a Canadian firm that produces psilocybin and other functional formulations at its two plants in British Columbia following the European Union’s standards for good manufacturing practices (EU-GMP). Operating under a vertically integrated business model, the company is engaged in the cultivation, extraction, processing, and distribution of functional and psychedelic mushroom products at its two facilities in Princeton, which cover a combined total of 20,000 square feet.

The company noted that with its major capital expenditures now completed, Optimi Health plans to expand its product offerings to include a wide variety of synthetic psychedelic compounds, leveraging its state-of-the-art cultivation facility and analytical lab in the process. The move aligns with the company’s transition to commercialization through standardized psychedelic drug research, testing, and product development via approved clinical trials and exemption-based applications.

Growing Market for Psychedelics

Optimi Health noted that ongoing large-scale studies including Phase III clinical trials into MDMA sponsored by the Multidisciplinary Association for Psychedelic Studies (MAPS) and a move to decriminalize drugs in British Columbia have led to an increased demand for psychedelics.

“Since our inception, Optimi has received a steadily increasing volume of inquiries related to the production of synthetic psychedelics from stakeholders within the sector, made all the more timely by recent developments,” Optimi Health chief science officer Justin Kirkland said in a statement from the company. “Our analytical laboratories were purpose-built to enable us to act as an EU-GMP compliant drug manufacturer for these interests, without in any way detracting from our primary goal of cultivating natural psilocybin.”

Optimi CEO Bill Ciprick said that the company’s EU-GMP compliant operational footprint and production capacity is unmatched in North America, adding that it would likely take new entrants into the psychedelics sector years and millions of dollars to meet Optimi’s scale and clinical efficiency.

“We have a strong idea of our position in the market and how the amendment fits with our strategic priorities,” said Ciprick. “We are filing this amendment following conversations with researchers and drug developers which have led to a high volume of requests for GMP-compliant synthetic psychedelics. The positive reports from trauma sufferers, including veterans groups, for whom substances such as MDMA might make a difference, mean that safe, scalable supply is going to be more crucial than ever to the success of psychedelic medicine.”

“As we continue with our planned year of commercialization, Optimi views the capacity to produce and distribute these substances as integral to our overall positioning and revenue generation within the sector’s supply chain,” Ciprick added.

The psychedelic drugs included in the Optimi request to Canadian regulators are N,N-Dimethyltryptamine (“DMT”); 3,4,5-trimethoxyphenethylamine (“Mescaline”); 2-(2-chlorophenyl)-2- (methylamino)cyclohexanone (“Ketamine”); Lysergic Acid Diethylamide (“LSD”); 1-(1-phenylcyclohexyl)piperidine (“Phencyclidine”); 4-Hydroxybutanoic Acid (“GHB”);  4,9–dihydro–7–methoxy–1–methyl–3H–pyrido(3,4–b)indole (“Harmaline”); 4,9–dihydro–1–methyl–3H–pyrido(3,4–b)indol–7–ol (“Harmalol”); Salvia Divinorum, Salvinorin A; and, 4-Bromo-2,5-Dimethoxybenzeneethanamine (“2C-B”).

British Columbia to Decriminalize Drugs

Last month, the Canadian federal government announced that it had approved a request from British Columbia to decriminalize possession of street drugs including heroin, fentanyl, cocaine, and methamphetamine for three years.

“Eliminating criminal penalties for those carrying small amounts of illicit drugs for personal use will reduce stigma and harm and provide another tool for British Columbia to end the overdose crisis,” federal Minister of Mental Health and Addictions Carolyn Bennett said in a statement quoted by Reuters.

Late last year, provincial officials requested an exemption from enforcing the federal Controlled Drugs and Substances Act to test the impact decriminalization will have on British Columbia’s ongoing epidemic of overdose deaths. Under the plan, personal possession of up to a cumulative total of 2.5 grams of opioids, cocaine, methamphetamine, and MDMA will not result in an arrest, citation, or confiscation of the drugs. The limited drug decriminalization plan does not apply at airports, schools, and to members of the Canadian military, however.

“This is not legalization,” Bennett told reporters at a news conference in Vancouver. “We have not taken this decision lightly.”

Under the plan, possession of larger amounts of the drugs and the sale or trafficking will remain against the law. The limited decriminalization test program will begin on January 31, 2023, and continue until January 31, 2026.

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Is Pierre Poilievre Wrong about Drug Decriminalization?

Is Conservative Party leadership hopeful Pierre Poilievre wrong about drug decriminalization? On May 31, 2022, he tweeted, “Decriminalizing deadly drug use is the opposite of compassionate. Those struggling with addiction need treatment & recovery. Drug dealers need strong policing & tough sentences.” Ben Perrin, UBC law professor and author of Overdose: Heartbreak and Hope in Canada’s […]

The post Is Pierre Poilievre Wrong about Drug Decriminalization? appeared first on Cannabis News, Lifestyle – Headlines, Videos & Cooking.

B.C. Decriminalizes Drugs… But Why?

A federal exemption has allowed British Columbia (B.C.) to decriminalize drugs. Adults in British Columbia will be able to possess small amounts of substances. Things like opioids, cocaine, methamphetamine, and MDMA. Because drug prohibition is Ottawa’s responsibility, there had to be an exemption for British Columbia. B.C. is the first and only province to receive […]

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Connecticut Lawmakers Advance Psychedelics Therapy Bill

A Connecticut legislative panel last week gave its approval to a bill to study the potential of the psychedelic drugs psilocybin and ketamine as treatments for serious mental health conditions. The measure, HB 5396, which would earmark $3 million for psychedelic-assisted therapy research, was approved by the Connecticut General Assembly’s joint Public Health Committee on Friday.

The bill does not legalize the therapeutic use of psychedelic drugs in Connecticut. Instead, the legislation would create a pilot program with the state Department of Mental Health and Addiction Services to provide qualified patients with the funding necessary to receive MDMA-assisted or psilocybin-assisted therapy. The program would be implemented as part of an expanded access program approved by the U.S. Food and Drug Administration.

“The pilot program ends when the federal [Drug Enforcement Agency] approves MDMA and psilocybin for medical use,” said Rep. Jonathan Steinberg, the committee’s co-chair. “We should say ‘When and if,’ but we’re presuming ‘when.’”

The proposal also establishes an advisory panel to be appointed by the governor and legislative leaders to draft regulations in anticipation of an expected change in federal policy regarding the therapeutic use of psychedelic drugs. The bill directs the board to make recommendations on the “design and development of the regulations and infrastructure necessary to safely allow for therapeutic access to psychedelic-assisted therapy upon the legalization of MDMA, psilocybin and any other psychedelic compounds,” according to the text of the bill.

Lawmakers heard testimony at a hearing held by the Public Health Committee last week. Martin Steele, a retired Marine Corps lieutenant general and the founder of psychedelic therapy advocacy group Reason for Hope, told lawmakers that it is time to end the “misguided stigma” associated with the drugs.

“While we still have much to learn, psychedelic medicine, when used safely, responsibly, and in the right setting, may be our best hope to combat the suicide and opioid crises burdening our nation,” Steele said.

The Therapeutic Potential of Psychedelics

Research into psychedelics including psilocybin, MDMA and ketamine has shown that the drugs have potential therapeutic benefits, particularly for serious mental health conditions such as depression, addiction and anxiety. A study published in the peer-reviewed journal JAMA Psychiatry in 2020 found that psilocybin-assisted psychotherapy was an effective and quick-acting treatment for a group of 24 participants with major depressive disorder. Separate research published in 2016 determined that psilocybin treatment produced substantial and sustained decreases in depression and anxiety in patients with life-threatening cancer. Rep. William Petit, a lawmaker who used to work as a practicing physician, said the legislation is supported by the research.

“PCP and other compounds have been fabulously successful in a small number of people with severe PTSD and other severe mental illnesses that have been refractory to other therapies,” Petit said. “It certainly needs to be explored.”

HB 5396 also establishes funding for psychedelic treatment centers by providing “grants to qualified applicants to provide MDMA-assisted or psilocybin-assisted therapy to qualified patients under the pilot program.” Qualified patients would include military veterans, health care workers, retired first responders and patients from “historically underserved communit[ies], and who [have] a serious or life-threatening mental or behavioral health disorder and without access to effective mental or behavioral health medication.”

Not all testimony at last week’s hearing was in favor of the bill. In a joint memo to legislators, the state commissioners of consumer protection, mental health and addiction services, and public health provided written testimony citing a report from a legislative panel. The working group reported that the potential of psychedelic drugs is promising, but federal action on the issue was expected no sooner than 2025.

“The sister state agencies that collaborated on the report are concerned that HB 5396 is much more expansive than the report findings,” the commissioners wrote. “The bill contains premature provisions related to a complex psilocybin program that state agencies are not resourced to implement.”

When asked about the concerns expressed by the commissioners, Steinberg said that the state is “treading new ground here.” He noted that lawmakers would soon meet with mental health and addiction services officials to address their concerns.

“This is, in some ways, a bold bill,” Steinberg said. “We’re really trying to move it forward in a consequential way.”

Steinberg also expressed frustration at the slow pace of federal action on psychedelic-assisted therapy.

“Sometimes we have to struggle with the feds,”  he said. “Sometimes we just wish they’d get out of our way but that doesn’t happen very often.”

Connecticut Rep. Michelle Cook said she welcomed the input of the state agencies. But she also expressed determination to guide the legislation to passage with or without the support of the commissioners.

“If this is something that they feel they can’t get behind, then we need to figure out another mechanism,” Cook said. “But doing nothing, I think, would be criminal in this regard.”

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‘Breakthrough Therapy’: How the FDA is Pushing for Legal Psychedelics

The psychedelics boom is underway, that’s for sure, and its moving full steam ahead. Perhaps pushed on by the success of the cannabis industry, which has been lighting the way, psychedelics have much more quickly come into the spotlight and gained acceptance. While they are still mainly federally illegal, recent breakthrough therapy designations given by the FDA indicate that at least one government body is pushing for legal psychedelics.

The FDA might not have explicitly stated it, but its breakthrough therapy designations given to companies studying psilocybin and MDMA make a pretty big statement, and it seems the FDA wants legal psychedelic medications. We cover everything important in the growing field of psychedelics, so subscribe to The Cannadelics Newsletter for more stories like this, and to stay on top of the big news items coming out of the industry.


What is a breakthrough therapy?

The FDA – Food & Drug Administration, is the US federal agency that governs and regulates all medicines that can be marketed and sold in the US. The FDA sits under the Department of Health and Human Services, and is responsible for more than drugs, also regulating the food industry, tobacco products, dietary supplements, over-the-counter medications, biopharmaceuticals, blood transfusions, vaccines, medical devices, electromagnetic radiation emitting products, animal food, veterinary products, and cosmetics.

In order to get a medication approved, a compound must go through different rounds of testing through clinical trials. After it has passed this part, a company must submit a new drug application to the FDA, and then the FDA decides whether the medicine should be approved or not. The FDA is the sole body to do this, so if it does not approve, a medication cannot legally be sold.

When a drug is in the testing phase, the company that created it and is having it go through trials, can submit it to the FDA for a ‘breakthrough therapy’ designation. This goes for whether the drug is specifically illegal according to the Controlled Substances list, or not. The term ‘breakthrough therapy’ is defined this way by the FDA, as a:

“…drug that treats a serious or life-threatening condition and preliminary clinical evidence indicates that the drug may demonstrate substantial improvement on a clinically significant endpoint(s) over available therapies.”

What is this designation meant to do? According to the FDA, the “Breakthrough therapy designation is intended to expedite the development and review of drugs for serious or life-threatening conditions.” Let’s say a new drug is going through testing that could be used in place of chemotherapy, and which shows promise as a better option in preliminary testing for treating cancer. Then the company that made the drug can apply for a ‘breakthrough therapy’ designation to quicken its product to market, with the hope that this could in turn save lives.

So the point of it is essentially to speed things up. If the FDA gives this designation, it wants to get the drug through trials, and get it on pharmacy shelves. This, of course, becomes all the more interesting when the drugs in question are Schedule I drugs, deemed by the federal government to be dangerous, and with no medical value. Having said that, we all know the government can get it wrong, as it also has cannabis in Schedule I.

How does the breakthrough therapy designation apply to psychedelics?

The FDA has now officially given out three breakthrough therapy designations to three different companies studying either psilocybin or MDMA. All of which has occurred within the last few years. Which companies got it? And what are they studying?

One company to get such a designation is Compass Pathways which received the designation in 2018 for research into psilocybin for use with treatment resistant major depression. The following year, the company Usona Institute also applied for, and received, this designation for its research into psilocybin for treatment resistant depression.

It doesn’t stop at psilocybin though. In fact, before Compass or Usona got their designations, a 2017 breakthrough therapy title was given to the organization MAPS (Multidisciplinary Association for Psychedelic Studies) for its research into MDMA for PTSD. And in this case, the FDA went a step further than simply giving it the title to speed things along.

MDMA

When it came time for MAPS’ phase III trials, they were designed with help by the FDA. The two organizations came up with a ‘Special Protocol Assessment’ to ensure that trial outcomes would be in line with regulation. So not only has the FDA basically said it’s cool with these drugs being studied for use as medications, but it actually helped one of the companies to make sure that should the study results be positive, that there will be no issue with them breaking regulation. Maybe it’s just me, but this seems to outwardly imply that the FDA wants the drugs approved.

Are all psychedelics illegal?

The recent moves by the FDA to give breakthrough therapy designations to psilocybin and MDMA, is just another part of a general trajectory when it comes to psychedelics. Back in 2019, the FDA very quietly (as in, under cover of night quietly) legalized a form of ketamine for use with treatment-resistant depression, called esketamine. This is odd when you consider just how much of a debate exists with legalizing cannabis, or when it comes to the legalization of pretty much any drug. Why was this done without discussion, or the public being aware at all?

The US government isn’t big on explaining its moves, but it seems the most probable reason for this change, was related to the quickly expanding gray market ketamine industry which relies on off-label prescribing. As ketamine is Schedule III, this is possible within general regulation, but makes for a market that is untaxed by the federal government, at least beyond standard taxing. Think about how many taxes are applied to the cannabis industry. It would be silly to think a psychedelics industry wouldn’t have the same, so ketamine proposes an issue to the US government.

If this burgeoning market was the reason for the esketamine legalization, the government failed on a couple levels. For one, it requires a regular antidepressant to be taken as well, and that defeats the purpose of using esketamine for treatment, while also making it more likely to have drug interactions. And second, it was only cleared for treatment resistant depression despite the large amount of evidence for it to be used for pain. This is odd considering the current opioid epidemic, and the ability for ketamine to not only deal with pain issues, but also possibly with the addictions that have grown around opioids. In fact, the US government has made no mention of using esketamine in this way at all, while 75,000+ people die a year from opioid overdoses.

Apart from esketamine, there’s another psychedelic that has been legal for quite some time: DXM – dextromethorphan. DXM is a dissociative psychedelic which is in the morphinan class, and not only has it been legal since 1958, but despite its known abuse, it’s been an over-the-counter drug the whole time. And one that can be accessed by anyone of any age. DXM can be found in tons of cold medicine products, and the US government has actually turned down initiatives to make it a prescription medication, though some states like California and Oregon have made their own regulation to stop the sale of DXM to minors.

State’s rights and psychedelics

Everything I just went through relates to federal guidelines, but there’s a caveat here, and it’s the same reason we have legal cannabis in 18 states: whatever isn’t covered explicitly by the constitution, falls under ‘states’ rights’, which are also ‘personal rights’. Because of this, psychedelics are not illegal everywhere.

magic mushrooms

Several locations throughout the US have instituted decriminalization measures, including: Denver, Colorado; Oakland, Santa Cruz, and Arcata in California; Ann Arbor, Washtenaw County, and Detroit, Michigan; Washington, DC; Somerville, Cambridge, Northampton, and Easthampton in Massachusetts; and Seattle, Washington.

Not only that, but as of the 2020 elections, the entire state of Oregon decriminalized psychedelics, while legalizing them for medical use. Three more states are looking to up the ante with full state recreational legalization policies: California, Michigan, and Washington. Though they propose different measures in their respective bills, in all cases legalizations would be made for the recreational use of at least some psychedelics, generally in the form of entheogenic plants (plants with psychedelic compounds).

Conclusion

Right now psychedelics are on the cusp of a major growth spurt, aided in part by breakthrough therapy designations from the FDA, the momentum of the cannabis industry, and the lightening mood of the population toward these two drug classes. I tend to think, when there’s this much of a rally, it can be expected that change is coming. So even if the three current states don’t get their bills through this time, something will pass soon enough. The one thing for sure is, psychedelics are coming.

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DisclaimerHi, I’m a researcher and writer. I’m not a doctor, lawyer, or businessperson. All information in my articles is sourced and referenced, and all opinions stated are mine. I am not giving anyone advice, and though I am more than happy to discuss topics, should someone have a further question or concern, they should seek guidance from a relevant professional.

The post ‘Breakthrough Therapy’: How the FDA is Pushing for Legal Psychedelics appeared first on CBD Testers.

What Would a Psychedelics legalization Look Like?

Unless you’re living under a rock, you should have heard the word that psychedelics are becoming the new medical darling, with the idea of a legalization on its way. What does this mean though? Will we all be tripping on acid, or going to ayahuasca ceremonies, or playing around with magic mushrooms? Well, its possible, but maybe not right away. There are some realities to a psychedelics legalization, and some things to understand.

Is a psychedelics legalization on the way? Could be, but maybe not how you think. The US government is edging closer to the idea of allowing medical use, while different states are floating policies for recreational use. Stay tuned to life to find out what happens next! For more articles like this one, remember to subscribe to the Psychedelics Weekly Newsletteryour #1 source for everything related to this rapidly growing industry.


Are psychedelics legal now?

When it comes to many things in the US, there is a federal truth and a local truth. This goes for both cannabis and psychedelics as well. Cannabis has been federally illegal since the Marihuana Tax Act of 1937, with more stringent laws added to create a complete illegalization by 1970. However, if you’re really not living under that rock, you also know that there are huge legal cannabis markets in the US, but only in certain places, and each individual place with its own individual market.

That’s because America has States rights, which are actually ‘personal rights’, or anything that isn’t established by the US constitution, and which therefore can be argued in the Supreme Court. These rights enable laws to be made that run counter to US federal law, and cannabis is a prime example. 18 states now have legal, regulated recreational industries, or are on their way to. The number should be 19, but South Dakota had its publicly voted on measure taken away by its government. Nearly 40 have comprehensive medical programs, while even many of the remaining states have at least a minimal allowance for something cannabis related.

Psychedelics on the other hand were illegalized much more recently, though some of them only came about more recently. While entheogenic plants (which constitute natural psychedelics) have been used for millennia, synthetic psychedelics like LSD and ketamine were only invented within the last century. Psychedelics first became illegal in the US through the Staggers-Dodd Act of 1968 – though this only applied to mushrooms and LSD.

psychedelics

In 1970 the Comprehensive Drug Abuse Prevention and Control Act was passed which put massive restrictions on pharmaceutical industries, which though not bad in terms of oversite, were the beginning of the current drug scheduling model which works to rule out many compounds, with much bias.

The UN, for its part, put nearly all psychedelic compounds in Schedule I of the Convention On Psychotropic Substances in 1971, making them illegal worldwide. And to add onto all this, the US signed into legislation the Comprehensive Crime Control Act in 1984, which allowed the government to immediately ban any drug it pleased so long as it claimed the drug was dangerous first. The law was used to illegalize MDMA the following year. This, even despite a judge’s decision to put it in Schedule III instead and allow it for medical use.

Having said all this, Oregon decided not to care about it in 2020, allowing residents to vote on the matter of legalizing psychedelic compounds for medical use (Measure 109), and decriminalizing the recreational use of the drugs (along with many other drug classes) with Measure 110. These went through making Oregon the first state to set such policies. But not the first to do something. Denver, Colorado was the first on this front, decriminalizing magic mushrooms in 2019. Since that time, it has been joined by Oakland, Santa Cruz, and Arcata, California; Ann Arbor, Washtenaw County, and Detroit, Michigan; Washington, DC; Somerville, Cambridge, Northampton, and Easthampton, Massachusetts; and Seattle, Washington.

So, what does a psychedelics legalization mean?

The main thing to expect in terms of a psychedelics legalization federally, is for a medical legalization of specific compounds. In fact, this can already be seen with the legalization of esketamine, though chances are this legalization was spurred on by the non-government-sanctioned, yet not-illegal ketamine clinic industry which has been growing rapidly in the last several years.

Esketamine, a close relative of ketamine, was quietly legalized in 2019 as a way to attempt to divert from this existent ketamine industry. Ketamine is legal as an anesthetic, but can be prescribed for ‘off-label’ use legally, allowing it to be used for pain management and psychological issues at these clinics, but outside of specific regulation or taxation for the treatments. More well-known psychedelics MDMA and psilocybin (of magic mushrooms) are on the docket as well. How do we know this? Because the FDA was willing to grant breakthrough therapy designations to three different companies studying these drugs.

Compass Pathways and Usona Institute both received this designation for their studies into psilocybin, while MAPS received it for its study into MDMA. Not only did MAPS win this designation, but it also planned Phase III of its trials in conjunction with the FDA to ensure that results meet regulation. Out of all of this, I’m not sure that another move more clearly signifies the intent to legalize, than for a federal body to actively promote a compound to the point of ensuring a study on it will be able to meet all regulation, even before seeing results.

medical psychedelics

If you’re wondering what this designation of ‘breakthrough therapy’ actually means, according to the FDA, “A breakthrough therapy designation is for a drug that treats a serious or life-threatening condition and preliminary clinical evidence indicates that the drug may demonstrate substantial improvement on a clinically significant endpoint(s) over available therapies.”

Will the US federal government go for a recreational psychedelics legalization? Though I would certainly never say never, I don’t see that happening any time soon, though its quite possible that the US government will find itself in the same place it is with cannabis, having state after state adopt policies that conflict directly with it.

In the case of cannabis, its gotten to such a fever pitch, that the federal government looks weaker and weaker with every new legalization. So much so that the federal government is doing a complete turnaround, and even before getting to a medical legalization, its already floating two different legalization bills. One is called a decriminalization, but as it sets up tax measures, it sounds like more of a legalization in decriminalization clothing.

Will psychedelics ever be legalized?

Sure, as stated, the federal government might get there at some point if more and more states go against it. And its likely to happen faster than with cannabis, as cannabis set the stage so well. But even if the federal government drags its heels, it’s already being taken up by individual locations within states, as well as state governments introducing policies for the entire state. So far, these have been strictly decriminalization measures, with the exception of Oregon, which legalized medical use.

However, two other states are looking to take it up a notch. Both California and Michigan introduced legislation for full-state legalization policies for psychedelics. In California, this is being done through the California Psilocybin Legalization Initiative, which may make it onto the ballot for 2022 as a referendum for public voting. The bill would specifically “legalize psilocybin, including psilocybin mushrooms, truffles, sclerotia, and mycelium, in California.” This would cover the “cultivation, manufacture, processing, distribution, transportation, possession, storage, consumption, and retail sale of psilocybin mushrooms.”

Michigan, for its part, introduced Senate Bill 631 in September of last year, which would legalize plant-derived psychedelics for use (including communal), cultivation, possession, delivery, and production. This would not include sales, however, as this would remain illegal, with a caveat that a fee could be charged for “counseling, spiritual guidance, or a related service that is provided in conjunction with the use of an entheogenic plant or fungus under the guidance and supervision of an individual providing the service.”

entheogens

Psychedelics haven’t been fully legalized anywhere yet like cannabis has, but it looks to be in the works. When trends like these start, they don’t generally just stop. So even if these bills both get stifled, the next round will likely produce a winner. And that means that if this is indicative of a new trend, that we can expect to see state-wide legalizations for recreational use of psychedelics within the next couple years. Add onto this the FDA’s interest in psilocybin and MDMA, and the US government’s desire to tax anything it can, and it looks like a medical legalization can be expected on a federal level whenever those drugs are ready to be sold.

Conclusion

What will a psychedelics legalization look like? Probably a lot like with cannabis. Individual governments will set up policies, and eventually the federal government will cave and start to offer its own legislation. Much like with cannabis as well, the government will fight itself to legalize the compounds medically, knowing its smear campaigns can’t work forever, and that eventually it will have to take a 180º turn.

In both cases – cannabis and psychedelics – these compounds do not go from fully illegal to fully legal with no parameters at all. The cannabis industries of today are highly overregulated, so even in a legal place, the guidelines for legality are extensive, with tons of pitfalls. Smokers in legal locations must beware of blood THC levels as a new DUI possibility, the inability to smoke in public places, and the appearance of alcohol in places that cannabis is still not allowed, among many other regulations.

Hello readers, thanks for joining us! You’ve made it to CBDtesters.co, the internet’s one-stop-shop for the most relevant and important cannabis and psychedelics-related news going on world-wide. Drop by whenever possible to stay aware of the constantly-morphing landscape of cannabis and medical psychedelics, and check out the The Psychedelics Weekly Newsletter, so you’re always on top of everything going on.

DisclaimerHi, I’m a researcher and writer. I’m not a doctor, lawyer, or businessperson. All information in my articles is sourced and referenced, and all opinions stated are mine. I am not giving anyone advice, and though I am more than happy to discuss topics, should someone have a further question or concern, they should seek guidance from a relevant professional.

The post What Would a Psychedelics legalization Look Like? appeared first on CBD Testers.