Tag: ptsd

Arizona’s Democratic Governor Vetoes Bill To Legalize Psilocybin Service Centers

The Democratic governor of Arizona has vetoed a bill to legalize psilocybin service centers where people could receive the psychedelic in a medically supervised setting.

Less than a week after lawmakers gave final approval to the legislation, Gov. Katie Hobbs (D) rejected it on Tuesday, arguing that while the psychedelic may hold therapeutic potential, “we do not yet have the evidence needed to support widespread clinical expansion.”

“Arizonans with depression and PTSD deserve access to treatments that may be seen as outside the mainstream, but they should not be the subject of experiments for unproven therapies with a lack of appropriate guardrails,” the governor said in a veto message.

She also said that the bill’s estimated cost is $400,000 per year, which wasn’t accounted for in the budget.

Under the now-vetoed legislation, the Department of Human Services (DHS) would have been authorized to license psilocybin-assisted therapy centers in the state, where trained facilitators could have administered the psychedelic.

The measure would have significantly expanded on Arizona’s existing research-focused psychedelics law that provides $5 million in annual funding to support studies into psilocybin therapy.

Hobbs cited that research funding in her statement, saying the goal is to “ensure that those who seek psilocybin treatment are doing so confidently and safely under proper supervision of qualified professionals with documented and verified research to support the treatment.”

She said that money “will be allowed to continue with this year’s budget,” with a separate funding bill she signed into law on Tuesday protecting those dollars, which are exempt from lapsing appropriations provisions.

The vetoed proposal, meanwhile, would have established an Arizona Psilocybin Advisory Board, comprised of members appointed by the governor and legislative leaders. Representatives of the attorney general’s office and DHS, as well as military veterans, first responders, scientists with experience with psilocybin and physicians would have been among the members.

The board would have been responsible for establishing training criteria for psilocybin service center staff, making recommendations on the implementation of the law, and studying the science and policy developments related to psychedelics.

Sen. T. J. Shope (R), the bill’s sponsor, told The Center Square that the veto is a “disappointing result after months of hard work and the overwhelming bipartisan support this received in both houses of the Legislature this year.”

The senator added that if lawmakers were still in session, he’d be pushing for a vote to override the veto, but he’ll have to “settle for trying again next year.”

Keep reading

Missouri Lawmakers Approve Bill To Legalize Psilocybin Therapy For Veterans

A Missouri House committee has unanimously approved a bill to legalize the medical use of psilocybin by military veterans and fund studies exploring the therapeutic potential of the psychedelic.

The House Veterans Committee passed the legislation from Rep. Aaron McMullen (R) on Tuesday, with amendments to align it with a Senate companion version that moved through a panel in that chamber last week.

The revised bill text of the House measure—which received an initial committee hearing last month—hasn’t been published yet, but the Senate version as recently amended would allow military veterans who are at least 21 and are diagnosed with a qualifying condition such as post-traumatic stress disorder (PTSD) or substance use disorders to legally access laboratory-tested psilocybin.

In order to receive legal protections under the legislation, participants would need to be enrolled, or have sought enrollment, in a study involving the psychedelic.

There are also numerous requirements for patients to provide the state Department of Mental Health (DMH) with information about their diagnosis, the person who would be administering psilocybin and other details on the place and time of the treatment sessions.

Psilocybin could only be administered over a maximum of a one-year period, with the amount of the psychedelic used in that treatment capped at 150 milligrams, though qualifying patients could be also approved to continue for subsequent one-year periods.

Regulators, physicians and state agency officials would all be protected from legal consequences related to activity made lawful under the legislation.

Also, the legislation calls for DMH to provide funding to support research into the therapeutic potential of psilocybin.

Keep reading

FDA Grants Priority Review Of MDMA-Assisted Therapy For PTSD, Psychedelics Drug Development Company Says

The Food and Drug Administration (FDA) has agreed to review MDMA-assisted therapy as a potential treatment option for post-traumatic stress disorder (PTSD), and the application has been granted priority status, according to the psychedelics-focused drug development company that’s leading the effort.

About two months after Lykos Therapeutics (formerly MAPS Public Benefit Corporation) submitted the new drug application (NDA) for MDMA in combination with psychotherapy, FDA granted it priority review last week and has set a target date for determination by August 11, the company announced on Friday.

If the NDA is ultimately approved, the Drug Enforcement Administration (DEA) would then need to reschedule MDMA accordingly. It would become the first psychedelic in history to be approved as a pharmaceutical, to be administered in tandem with talk therapy and other supportive services.

“Securing priority review for our investigational MDMA-assisted therapy is a significant accomplishment and underscores the urgent unmet need for new innovation in the treatment of PTSD,” Lykos CEO Amy Emerson said in a press release. “We remain focused on working with the FDA through the review process and preparing for a controlled launch with an emphasis on quality should this potential treatment be approved.”

Keep reading

Psychedelics Company Raises $100 Million in Push To Legalize Selling MDMA for PTSD

A key player in the competitive pharmaceutical psychedelics industry has raised over $100 million to fund a final push to get government approval to legally sell MDMA in the U.S. to those struggling with post-traumatic stress disorder.  

The nonprofit Multidisciplinary Association for Psychedelic Studies, or MAPS, raised the money in a Series A funding round through a subsidiary previously known as the MAPS Public Benefit Corporation, or MAPS PBC. In a release on Friday announcing the news of the cash infusion, the organization also said it was renaming the public benefit company Lykos Therapeutics.

Lykos is part of a growing number of players in the industry racing to get money as they push to get legal psychedelic drugs to market. Last month, the organization submitted an application to the FDA that included data from a series of clinical trials related to the use of MDMA for PTSD. The federal agency is currently deciding whether to officially review the application, a process that would take months. 

Keep reading

Military Veterans Who Received Psychedelic Ibogaine Treatment Saw ‘Dramatic’ And ‘Life-Changing’ Improvements In PTSD And Depression, Stanford Study Finds

Military combat veterans with traumatic brain injuries (TBI) saw “dramatic” and “life-changing” improvements in their symptoms and cognitive functioning immediately after receiving treatment with the psychedelic ibogaine, new research shows.

Stanford University researchers behind the study, which was published in the journal Nature Medicine last week, followed 30 veterans who were functionally disabled from symptoms of TBI such as post-traumatic stress, depression and anxiety and who had a history of repeated blast or combat exposures.

The team, which collaboration with the foundation VETS, Inc., assessed the veterans before and after they visited a clinic in Mexico to receive ibogaine treatment, and they identified profound changes in the participants’ mental health, with minimal side effects.

Prior to the treatment, the veterans each met the criteria for clinically significant levels of disability. Twenty-three had diagnosable PTSD, 14 had anxiety disorder, 15 had alcohol use disorder and 19 had been suicidal at some point in their lifetimes.

After receiving ibogaine, in addition to magnesium to protect against potential heart-related complications, there was an immediate “remarkable reduction” in symptoms, “with large effect sizes” that sustained over time.

Keep reading

FDA Weighs New Application To Approve MDMA As First-Ever Psychedelic Medicine For PTSD

A psychedelics-focused drug development company is officially asking the Food and Drug Administration (FDA) to review an application to approve MDMA as a prescription medication for the treatment of post-traumatic stress disorder (PTSD).

The MAPS Public Benefit Corporation (MAPS PBC) announced on Tuesday that it submitted the new drug application (NDA) to FDA, requesting an expedited review given that the agency previously designated the psychedelic as a breakthrough therapy.

If the NDA is ultimately approved, the Drug Enforcement Administration (DEA) would then need to reschedule MDMA accordingly. It would become the first psychedelic in history to be approved as a pharmaceutical, to be administered in tandem with psychotherapy and other supportive services.

MAPS PBC, which is a wholly owned subsidiary of the nonprofit Multidisciplinary Association for Psychedelic Studies (MAPS), said it provided FDA with copious scientific data derived from multiple clinical trials that supported the efficacy of MDMA as a therapeutic for moderate and severe PTSD.

“The filing of our NDA is the culmination of more than 30 years of clinical research, advocacy, collaboration and dedication to bring a potential new option to adults living with PTSD, a patient group that has experienced little innovation in decades,” Amy Emerson, CEO of MAPS PBC, said in a press release.

“If approved, MDMA-assisted therapy would be the first psychedelic-assisted therapy, which we hope will drive additional investment into new research in mental health,” she said.

MAPS published the results of a recent Phase 3 trial in the journal Nature in September, finding that MDMA “significantly attenuated PTSD symptomology versus placebo with therapy.”

FDA in 2017 designated MDMA as a “breakthrough therapy” based on previous MAPS-sponsored trials. In total, the organization says findings from 18 of its Phase 2 and Phase 3 trials formed the basis of the NDA submitted to FDA.

Because the agency has already recognized the significant therapeutic potential of the psychedelic, MAPS PBC asked it to grant their application a priority review. FDA has 60 days to decided whether it will accept the NDA and whether it will grant priority status for a six-month review or the standards 10-month review.

Keep reading

We All Have PTSD

Two years ago, reports started appearing that compared the effects of lockdowns with post-traumatic stress disorder. As it turns out, one of the symptoms of PTSD is forgetting what happened. It’s an evolved trait that helps the human mind cope with terrible things. Our brains are good at blocking it out. I will explain the neuroscience behind this in a bit but first an anecdote from this morning.

I was speaking to the director of a childrens’ choir and he was speaking about an age gap in his singers. The lead singer just graduated high school, and the next oldest singer is 14, which creates huge problems for the choral competence. I hesitated to do it but I finally just observed that this 3-year gap fits exactly with the lockdown period, child masking, and Zoom school.

He began to speak about what it was like to train a choir on Zoom and then conduct masked singers outdoors on winter nights. He recalled the attacks and the difficulties, and then his voice trailed off.

“Actually I’ve blocked out that whole period of life from my memory. I won’t think about it anymore. Anyway, I need to circulate a bit here but good seeing you.”

That was that.

It got me curious about the relationship between selective memory and trauma. For a long time now I’ve noticed that when this subject comes up, the response is either to quickly change the subject, which is common, or dig deeper into what seems like a bit of catharsis. Some people have so much to share, so many painful memories, so much shock and abuse to report, that once they start they cannot stop talking.

This one comment from this one choir director got me suspecting that vast numbers of people might be trying to forget it all. This is how the political debates manage to pretend like this never happened, how the major media gets away with never bringing it up, and how people like Fauci still get high speaking fees, and so on. It’s not just that they are no-good liars; too often it’s because people really do want to forget.

This is how the number one most shared trauma of our lives is fading so fast into the national and global consciousness.

It’s a well-known feature of child or spousal abuse. The memories are so terrible and grim that the human mind develops the capacity for pretending like it never happened if only so that life functioning can continue. This is fine but actually the trauma is still there and feeds other forms of pathologies like substance abuse and attachment disorders and so on. The point of therapy is to come to terms with the reality itself in the process of healing.

Keep reading

House And Senate Reach Deal To Require Psychedelics Clinical Trials For Active Duty Military Service Members Under Defense Bill

Bipartisan and bicameral congressional lawmakers have reached an agreement on a large-scale defense bill that contains a House GOP-led section to fund studies into the therapeutic use of psychedelics such as psilocybin and MDMA for military service members.

Following negotiations, lawmakers released the conference report for the 2024 National Defense Authorization Act (NDAA) on Wednesday evening, maintaining psychedelics research provisions championed by Rep. Morgan Luttrell (R-TX) that were attached to the House version over the summer. The report notes, however, that the House negotiators receded on a separate section to create a medical cannabis pilot program for veterans.

The psychedelics provisions that have been adopted would require the Department of Defense (DOD) to establish a process by which service members with post-traumatic stress disorder (PTSD) or traumatic brain injury could participate in clinical trials involving psilocybin, MDMA, ibogaine and 5-MeO-DMT. The list of covered psychedelics was also expanded to broadly include “qualified plant-based alternative therapies.”

DOD would need to facilitate that process within 180 days of enactment. It could partner with eligible federal or state government agencies, as well as academic institutions to carry out the clinical trials, with $10 million in funding.

Keep reading

Health Benefits Provider Will Cover Psilocybin-Assisted Therapy In States Where It’s Legal

A Massachusetts company that bills itself as “the first and only licensed provider of psychedelic health plans” announced on Tuesday that it will cover psilocybin-assisted therapy in states where it’s legal.

“Given the evidence of effectiveness seen in clinical trials in the U.S. and elsewhere, we have decided to give our employers the option of including psilocybin-assisted therapy in their benefit plans,” said Sherry Rais, CEO and co-founder of Enthea, a third-party health insurance benefits administrator. “Oregon and Colorado have already legalized the use of psilocybin, and we expect others to do so next year.”

Enthea announced earlier this year that it would cover ketamine treatment nationwide. The nonprofit previously worked with soap company Dr. Bronner’s last year to offer psychedelic-assisted therapy to workers through their employee health plans.

Enthea said this week that it plans to expand its standards of care to include adult use of psilocybin “in combination with psychotherapeutic support.” The company expects to publish the change to its provider network sometime in the first quarter of next year.

The goal, Enthea said, is to be able to cover psilocybin-assisted treatment by mid-2024.

“We have had our eye on the potential benefits of psilocybin therapy since we founded our company,” Dan Rome, Enthea’s co-founder and chief medical officer, said in a press release. “We are very encouraged by published results as well as what we hear from practicing therapists, and are confident that this brings an important new option for combating mental illness.”

Enthea has said its services will expand further to include therapies with other substances, such as MDMA, “as they are approved.”

The Food and Drug Administration (FDA) designated MDMA as a “breakthrough therapy” in 2017, and the substance is now on track for FDA consideration next year following successful Phase 3 clinical trials published in September in the journal Nature that found that MDMA-facilitated talk therapy reduced symptoms in patients with moderate to severe PTSD.

Keep reading

Bipartisan Wisconsin Lawmakers File Bill To Create Psilocybin Research Pilot Program For Military Veterans With PTSD

As marijuana reform continues to stagnate in the Wisconsin legislature, bipartisan and bicameral lawmakers have come together to introduce a new bill that would create a psilocybin research pilot program in the state.

Sens. Jesse James (R) and Dianne Hesselbein (D), as well as Reps. Nate Gustafson (R) and Clinton Anderson (D), are sponsoring the legislation, which would focus on exploring the therapeutic potential of the psychedelic in the treatment of post-traumatic stress disorder (PTSD) among veterans.

The pilot program would be facilitated through the University of Wisconsin at Madison, which already operates a multidisciplinary psychedelics research division that launched in 2021.

Veterans who are 21 and older with diagnosed treatment-resistant PTSD would be eligible to participate in the program. Psilocybin would need to be provided through existing pathways under the federal Food and Drug Administration (FDA), which has designated the psychedelic as a “breakthrough therapy.”

Keep reading