The House Rules Committee recently cleared two cannabis and psychedelic-related amendments on Sept. 23 to be discussed on the floor. Days later on Sept. 27, the House approved the two amendments—Amendment No. 48 and Amendment No. 137—to be included in H.R. 4365, or the Department of Defense Appropriations Act, 2024.

Amendment No. 48, supported by Texas Reps. Dan Crenshaw and Morgan Luttrell, would provide $15 million Department of Defense funding for psychedelic medical clinical trials. Through a voice vote, it passed with 240 in favor and 191 opposed.

The second amendment, Amendment No. 137, was sponsored by only Crenshaw and would ask the Defense Health Agency (DHA) to submit a congressional report on how to provide options for active-duty service members who suffer from Traumatic Brain Injury (TBI) and PTSD. It would also allow them to participate in clinical trials through the Department of Veteran Affairs to study psychedelics.

Luttrell spoke ahead of the vote on Amendment No. 48, explaining how he “personally attest[s] to the benefits in treating post-traumatic stress, traumatic brain injury and chronic traumatic encephalopathy through the use of psychedelic substances.”

Luttrell served as a SEAL for 14 years, and endured through a nearly fatal helicopter crash that left him with a broken back and a TBI. In June, Luttrell spoke openly about using ibogaine and 5-MeO-DMT as treatment for his injuries at a press event at the capitol with the introduction of a federal grant bill for psychedelic research. “If you find yourself in a place that you were lost, and no other modalities have worked, this could possibly be that tool,” Luttrell said. “And I can honestly stand in front of all of you and the American public and say I was reborn. This changed my life. It saved my marriage. It is one of the greatest things that ever happened to me.”

At the most recent hearing, Luttrell explained why the amendment should be passed. “There’s a stigma that exists within the [House] that I believe stems from a lack of education experience around the clinical use of plant-based, or psychedelic, medications,” Luttrell said. “I understand that when many of my colleagues hear the word ‘psychedelics,’ they think of mushrooms and so on. This isn’t what we are talking about today.”

“Unfortunately, the stigma has led to the slow or no adoption of medical procedures that may have saved countless lives, and our service members, veterans and first responders,” Luttrell continued. “It is our duty to explore all options when the lives of our nation’s most precious resources our sons, our daughters, our mothers, our fathers, brothers and sisters are at stake.”

Rep. Betty McCollum spoke to oppose Amendment No. 48, claiming that the DHA can’t realistically implement these measures because of current “clearances, legal hurdles, and logistics,” and “reluctantly” denied support. 

Crenshaw later spoke to congress for Amendment No. 137 in defense of psychedelic clinical trials, describing it as an important step forward. “…there’s no reason that we should not be looking into the benefits of this research for our men and women that are already currently serving our country actively,” Crenshaw explained. “This is not about legalization. This is not about recreational use. It’s about honoring our promise to our military families and confronting the high incidence of suicide in the military and veteran community.”

“We should be listening to the stories. They have come up on Capitol Hill multiple times,” Crenshaw added. “For the members who say, ‘Well, we need to learn more. We don’t know enough’—well then why would you get in the way of more research?” he asked. “We shouldn’t make them come up here and spill their guts anymore. We should listen to them and we should act on it.”

The SAFER Banking Act was passed in the Senate Banking Committee on the same day that these amendments were approved in the House. Seven previous iterations of the bill (formerly called the “SAFE” Banking Act”) have progressed to varying levels of congress before, the most recent of which was in December 2022 was it was left out of the Defense Spending Bill.

Many legislators support passing the SAFER Banking Act to protect both financial institutions and cannabis businesses. A joint statement from senators Jeff Merkley, Steve Daines, Kyrsten Sinema, Cynthia Lummis, and Majority Leader Chuck Schumer collectively spoke in favor of the bill and its necessity. “This legislation will help make our communities and small businesses safer by giving legal cannabis businesses access to traditional financial institutions, including bank accounts and small business loans,” the joint statement said. “It also prevents federal bank regulators from ordering a bank or credit union to close an account based on reputational risk.”

On Sept. 28, Schumer spoke about the next steps for the SAFER Banking Act. “The next step is to bring SAFER Banking to the floor for a vote, which I will do soon,” he said. “I worked long and hard for years to get us to this point, and now the Senate is one step—one crucial step—closer to helping cannabis businesses operate more efficiently, more safely and more transparently in the states that allow cannabis to be sold.”

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The United States Food and Drug Administration, aka the FDA, issued the first-ever guidance for clinical studies on psychedelics, according to a news release issued Friday. They filed the 14-page document shortly after Congress introduced bipartisan legislation led by Texas Republican Representative Dan Crenshaw, directing the issuance of clinical trial guidelines.

They aimed the guidance specifically towards classical psychedelics, which include psilocybin, LSD, mescaline, and DMT, the psychoactive ingredient in ayahuasca, in addition to entactogens or empathogens such as MDMA. This means that it does not cover other drugs used therapeutically embraced by the psychedelic community, such as ketamine, which is technically a dissociative anesthetic that has hallucinogenic effects.

While the FDA guidance is new, research on the benefits of psychedelics is not. Applied Clinical Trials reports that there are currently 163 Phase I, II, or III studies on clinicaltrials.gov involving psychedelics. For instance, in January, MAPS Public Benefit Corporation, a biopharmaceutical company dedicated to psychedelic treatment, announced its Phase 3 clinical trial on MDMA-assisted therapy for post-traumatic stress disorder (PTSD) produced promising results.

“The Phase 3 confirmatory results support the development of MDMA-assisted therapy as a potentially new breakthrough therapy to treat individuals with PTSD—a patient population that is often left to suffer for years,” said Amy Emerson, chief executive officer of MAPS Public Benefit Corporation. MAPS plans to submit the new drug application to the FDA in the third quarter of 2023.

Like MAPS’ study on MDMA, psychedelic research to date has primarily been backed by private sponsors. Many of these may want nothing to do with the Feds and their infamously regressive views on psychedelics. The FDA approval process is expensive and riddled with red tape. Many companies may prefer to follow state guidelines and leave psychedelics, such as psilocybin, which researchers currently study for OCD, and alcohol use disorder, nestled in the safety of libertarian-esque gray areas. (Oregon and Colorado are the only states to decriminalize the supervised use of psychedelics). 

For example, let’s look at ketamine, which, as noted, is not technically a psychedelic. While Esketamine, or S-ketamine, the S enantiomer of ketamine, is FDA-approved as a nasal spray, many ketamine clinics and psychiatrists prefer to prescribe patients actual ketamine, off-label, because it’s not only more affordable but may work better than the version the FDA approved, which was only changed to S-ketamine in the first place so Johnson & Johnson could patent it under the brand name Spravato. 

However, if a substance earns FDA approval, it is easier to market and sell and could reach more consumers who trust that it’s met the FDA decision that the benefits outweigh the risk. For instance, Tryp Therapeutics is currently seeking FDA approval for psilocybin-assisted therapy to help those with irritable bowel syndrome (IBS).

While such studies show that psychedelics hold great therapeutic potential, as anyone with personal experience using psilocybin, MDMA, or other psychedelics can attest, the FDA asserts that they must address the challenges associated with designing clinical studies to evaluate the safety and effectiveness of psychedelics.

“Psychedelic drugs show initial promise as potential treatments for mood, anxiety and substance use disorders. However, these are still investigational products. Sponsors evaluating the therapeutic potential of these drugs should consider their unique characteristics when designing clinical studies,” said Tiffany Farchione, M.D., director of the Division of Psychiatry at CDER.1, Applied Clinical Trials reports. 

The guidance addresses the psychoactive and hallucinogenic effects of psychedelics, the potential for abuse, and the importance of conscientious safety measures. It includes considerations for the importance of characterizing dose-response and the durability of any treatments. The draft also tackles potential drug interactions for patients on antidepressants or mood stabilizers such as lithium. 

Additionally, for any Schedule I controlled psychedelics, the FDA states that the research must comply with applicable Drug Enforcement Administration (DEA) regulatory requirements. 

It also tackles the role of psychotherapy within a psychedelic treatment, what folks in the community often describe as integration, or the therapeutic process of a patient going through therapy with a professional to integrate their experience into everyday life, ensuring that it’s not just a one-time trip, but an ongoing treatment plan. 

If anyone has thoughts on the draft guidance, the FDA accepts public comments for 60 days. 

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Legislation proposed in Arizona would provide millions of dollars in grant funding to expand research into psilocybin––the primary psychoactive component in magic mushrooms––as a potential treatment for certain mental health conditions.

The bill, introduced by a Republican lawmaker and backed by Democrats, “would put $30 million in grants over three years toward clinical trials using whole-mushroom psilocybin to treat mental health conditions like depression and PTSD,” the Arizona Mirror reports. 

The outlet reports that one of the bill’s biggest backers is Dr. Sue Sisely, an internal medicine physician who believes that psilocybin treatment could be a boon for ailing military veterans. 

“It’s curbed their suicidality, it’s put their PTSD into remission, it’s even mitigated their pain syndromes,” Sisely said of patients she has seen benefit from psilocybin, as quoted by the Arizona Mirror. “It’s shown evidence of promoting neurogenesis (the growth and development of nerve tissue). There’s all kinds of great things that are being uncovered, but they’re not in controlled trials—they’re anecdotes from veterans and other trauma sufferers.” 

According to the Mirror, “so far the only controlled trials on psilocybin to treat medical conditions have used a synthetic, one-molecule version of the substance, which is vastly different from a whole mushroom, which contains hundreds of compounds.”

“These agricultural products are very complex, and that is what people are reporting benefit from,” Sisley told the Arizona Mirror. “Nobody in the world has access to synthetic psilocybin unless you’re in one of these big pharma trials.” 

In the last decade, psilocybin has gone from the fringes to the mainstream, as researchers and policymakers have grown more amenable to mushrooms as an effective treatment for a variety of different disorders. 

It has also become the next frontier for drug legalization advocates, as states like Arizona consider measures that would expand its usage. 

To the north of the Grand Canyon State, advocates in Utah have launched a campaign to push legislators to legalize psilocybin for clinical and academic purposes.

“Numerous robust studies have shown that psilocybin therapy is beneficial in reducing treatment-resistant depression, anxiety, addiction, trauma, obsessive-compulsive disorder, and other mental health disorders. It is more effective than synthetic pharmaceuticals by a large margin. Psilocybin has also shown effectiveness in easing fear and anxiety in people with terminal cancer. For instance, a groundbreaking study performed by John Hopkins Medicine found that psilocybin reported better moods and greater mental health after participating in a single clinical dose,” Utah Mushroom Therapy, the group behind the campaign, says in a statement.

The group is looking to gin up public support for the treatment after the state’s Republican governor, Spencer Cox, signed a bill last year establishing a task force that will study psilocybin as a mental health treatment.

Utah Mushroom Therapy says that, in the wake of the task force, “legalizing and decriminalizing Psilocybin in Utah is now very likely but still needs public support.”

“The use of mushrooms has been documented in 15 indigenous groups in America and various religious communities in Utah. This petition supports those groups who wish to use psilocybin safely, sincerely, and as a necessary part of their religion. The use of psilocybin does not contradict other Utah cultures and is protected by the first amendment as well as the Religious Freedom Restoration Act. This petition is to advocate Utah law to protect the religious rights of Utahns,” the group says. 

“Psilocybin is a natural, non-toxic substance. Despite this, it is currently a Schedule I substance. Scientists have demonstrated it has profound medicinal value and believe serotonergic hallucinogens assist cognitive processes and should be decriminalized. Psychedelics can change perception and mood, help people soften their perspective and outlook, and process events that may otherwise lead to substance abuse, trauma, and criminal behavior,” it continues.

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Could a fentanyl vaccine potentially save thousands of lives? A recent animal study published in the journal Pharmaceutics indicates that a fentanyl vaccine was able to block the drug from entering the brain of rats—thus making it a worthy candidate for human studies and eventually something available to the public that can save lives.

Researchers administered rats with three doses of the vaccine or immunization at three-week intervals, and another group of rats received a placebo. To determine if the drug was working, they tested the immunized rats’ pain responses by heating up their tails for up to 10 seconds and seeing how long they took to pull away.

The vaccination significantly reduced entry of fentanyl into the brain and anti-fentanyl antibodies targeted fentanyl with no cross-reactions to other opioids. 

“We believe these findings could have a significant impact on a very serious problem plaguing society for years—opioid misuse,” study lead author Colin Haile told University of Houston (UH) news. “Our vaccine is able to generate anti-fentanyl antibodies that bind to the consumed fentanyl and prevent it from entering the brain, allowing it to be eliminated out of the body via the kidneys. Thus, the individual will not feel the euphoric effects and can ‘get back on the wagon’ to sobriety.” 

Haile is a research associate professor of psychology at UH and the Texas Institute for Measurement, Evaluation and Statistics (TIMES), and a founding member of the UH Drug Discovery Institute.  

“The anti-fentanyl antibodies were specific to fentanyl and a fentanyl derivative and did not cross-react with other opioids, such as morphine. That means a vaccinated person would still be able to be treated for pain relief with other opioids,” said Haile. 

Meanwhile, over 150 people die every day of overdose from synthetic opioids including fentanyl, which is 50 times stronger than heroin and 100 times stronger than morphine. Just 2 milligrams of fentanyl, or the size of two grains of rice, can be fatal depending on the size of the person.  

“These preclinical results demonstrate efficacy in neutralizing [fentanyl]’s effects and warrant further development as a potential therapeutic for OUD and overdose in humans,” researchers wrote in the study. “We expect minimal side effects in clinical trials because the two components of our formulation (CRM and dmLT) are already in other vaccines on the market or have been tested in multiple human clinical trials and shown to be safe and effective. Further, the effective dose of dmLT used in human clinical trials is comparable to the dose used in the present study. Since low vaccine concentrations elicit adequate anti-[fentanyl] antibody levels, we expect there to be no adverse events when this vaccine is tested in humans.”

The vaccine did not lead to any adverse side effects in the immunized rats that were observed. 

Researchers plan to begin manufacturing a clinical-grade vaccine in the coming months with clinical trials on humans planned soon.  

Efforts are being made to abate the deadly toll fentanyl plays on America. The U.S. Drug Enforcement Administration (DEA) announced the results of a widespread drug operation last September, with data spanning May to September, resulting in over 10 million fentanyl pills and what they say is 36 million lethal doses of the drug.

The DEA says that fentanyl is the deadliest drug threat facing this nation. “In 2021, a record number of Americans—107,622—died from a drug poisoning or overdose,” the DEA release reads. “Sixty-six percent of those deaths can be attributed to synthetic opioids such as fentanyl.”

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