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Connecticut Cites FDA Program to Launch Psychedelic Therapy Pilot

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Connecticut Cites FDA Program to Launch Psychedelic Therapy Pilot

After receiving bipartisan support from representatives of the Connecticut state legislature, Governor Ned Lamont signed a tax bill that includes a pilot program that will provide psychedelic-assisted therapy, using MDMA and psilocybin, to qualifying veterans, retired first-responders, and frontline workers such as police and firefighters. Originally drafted as the House Bill 5396, the program is designed to give access to psychedelic medicines to a population deprived of options for mental health treatments, ahead of FDA approval. 

The bil​​l is the first in the nation to provide access to these substances, which are illegal federally, by citing the FDA’s Expanded Access Program. According to the FDA website, the EAP offers a “potential pathway” to patients with a serious disease or condition “to gain access to an investigational medical product… for treatment outside of clinical trials when no comparable or satisfactory alternative therapy options are available.” 

With the rare benefit of bipartisan support, this bill was approved by a vote of 95 to 52. “We even received bipartisan co-sponsorship” beamed Jesse MacLachlan, a former Connecticut state representative and the current State Policy and Advocacy Coordinator for Reason for Hope, which advocated for the new program. 

He noted that the bill enables Connecticut to “move quickly into an anticipatory position to consider and adopt federal guidance on best practices for all infrastructure considerations around psychedelic therapy, from the training and credentialing of their therapists, to patient care and drug diversion. I think [using the Expanded Access Program] is going to be a really important piece of language that will help states save time and provide a lot of clarity to conservative voices.”

Brett Waters, executive director and co-founder of Reason for Hope, says that by citing the EAP, the Connecticut program “is not legalizing anything. It’s taking advantage of an existing program that’s typically underutilized because of the high cost to patients and the high volume of paperwork it requires of medical practitioners.”

The Connecticut program is taking an innovative approach to the EAP, Waters explains. “We’re trying to incentivize clinics to actually provide the treatment by sharing the administrative costs, and following an established protocol that lets them collect and submit usable data on their patients. This way, we can really learn a lot about these drugs and also provide access to people before FDA approval, as well as being able to provide the funding for patients to get the treatment that wouldn’t be covered by insurance.” 

He feels hopeful that patients participating in the Connecticut program will be able to sit for treatment by early 2023. 

As legislation and ballot initiatives enabling psychedelic-assisted therapy are adopted in states and cities across the country, Rep. Michelle Cook, who sponsored the HB5396 bill, feels that utilizing the EAP offers a route for more moderate states to embrace these programs. “If you look at Oregon, they’re a little bit more progressive. That’s why I think that where we started was a little bit more conservative, to get people comfortable and recognize this stuff does work.” 

The bill establishes a nine-person body, the Connecticut Psychedelic Therapy Advisory Board, which will be composed of experts in the fields of psychedelic research, psychedelic-assisted therapy, public health, access to mental and behavioral health care in underserved communities, veteran mental and behavioral health care, harm reduction, and sacramental use of psychedelic substances. Advisory board members will be appointed by majority and minority leadership in the state House of Representatives, the office of the governor, and the commissioners of several state agencies that supervise various aspects of public health and safety.

The next step will be for the board to formulate how therapists will receive the necessary training and certifications to administer these drugs, and the pipeline patients can use to apply for treatment. It is too early to speculate on the specifics of the program, including the size of dosages and the number of sessions, according to Rep. Cook.

“I think that’s still a little premature for the conversation. We know what might have worked in other places, but that’s more underground,” she says. “It’s frustrating, but at the same time you don’t want to construct something hastily and have it go wrong. If we’re going to set up a program that is state-of-the-art and truly out-of-the box to help folks that we know that haven’t been cared for properly up to now, I want to make sure that we do it right. We can’t afford to make any errors.”

This board will determine the per-patient program cost, and advise the state on future expansion, including whether other substances, such as ketamine, should be added to the program. In addition, the board will advise the state on how to respond to changes in federal policy on psychedelics. The bill calls for ending the program following federal deregulation of these substances. 

The program intends to include a fund designated to offset the out of pocket cost of receiving these therapies with state funds. But the bill did not provide funding for the initiative, which will have to wait until the next state biennium budget meeting in 2023, when most new programs are reviewed to receive funding. 

Dr. Stephen Xenakis, a Reason for Hope board member, suggested that the cost per-patient could be as high as $40,000. “There are a great many things left to be set up,” he qualified. “We now have to let the professionals do their work, and we must set up these clinical programs in a way that is as near to how treatment will be administered in the real world.” 

Dr. Lynnette Averill, another Reason for Hope board member, was part of the workgroup that crafted the bill language. She notes that, unlike the research and clinical trials to date, which filter out people who suffer from more than one condition, the Connecticut program “will be much more focused on real world implementation.” This approach will enable the program to collect “fairly robust outcomes data relative to clinical trials, which often are very exclusionary and often have these pristine patients who only have PTSD, and don’t have significant mental health comorbidities, and no significant medical comorbidities.”

A controlled research environment effectively eliminates many factors that a mental health service has to be ready to handle. Averill explains, “They’re not these patients who have tried 15 different interventions and done ECT and have done ketamine and so on. A challenge that we often run into with clinical trials is that once they get rolled out into the real world, sometimes wildly complex patients with really chronic histories of stress and trauma and various comorbidities, don’t work well. We should never be surprised that they don’t work well because we never tried them in those sorts of patients.” 

The program’s passage augurs well for the therapeutic pathway model, says Dr. Stephen Xenakis, retired US Army Brigadier General and a licensed psychiatrist in the state. In public testimony in support of HB 5396 in March, Xenakis, who also works with Reason for Hope, implored lawmakers to support the program. “Our current treatments and therapy help about half of the patients – in the best hands of experienced and dedicated practitioners. We need to find new and better ways to provide more effective treatments, especially for those often labeled as ‘treatment-resistant,’ who are not benefitting from standard care.”

Reflecting on the potential of psychedelic-assisted therapies, Averill captures why they are attracting support from across the political spectrum. People benefiting from these therapies, she says, “are talking about such robust improvements; feeling like they actually not only can tolerate their lives, but enjoy them. They’re connecting with their family, they’re finding meaning and purpose, and they’re feeling more spiritual. These kinds of things are magical. And I know, as a scientist, I’m not supposed to say things are magical, because how do you measure magic?”

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