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States Are Embracing Psychedelics, Paving the Way for FDA Approval

Over the course of the past year, several states across the US have taken legal action to expand access to psychedelic-assisted therapies for some citizens. Many of these efforts have been catalyzed by veterans who have personally benefited from psychedelic-assisted therapies.

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Updated July 5, 2022

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Marcus Capone served as a Navy SEAL for thirteen years. He had survived seven combat deployments to both Iraq and Afghanistan. He was an elite soldier, someone who could be relied upon to remain calm and composed even in the most dire of circumstances. 

But nothing in his years of service could have prepared him for the private war that he was to fight upon his retirement from the military in 2013. 

Once charismatic and relaxed, he became withdrawn, gloomy, erratic. His mood eventually took a toll on his relationship with his wife, Amber. “It was a very, very difficult set of years where we exhausted everything available to us through military and VA medicine,” she would recall years later. “Mostly that consisted of pharmaceuticals [and] talk therapy.” There were a few treatments which provided Marcus with some relief—including sauna, chiropractic, and transcranial magnetic stimulation (TMS)—but none of those were covered by the Capones’ insurance at the time. “It seemed like everything that did work wasn’t covered, and what was covered only made things worse” she says. At one point, Marcus was taking as many as ten separate prescription medications at once. The pills would temporarily take the edge off, but the dark clouds always came rolling back in.

man wearing army uniform
Image courtesy of Amber Capone

In 2017, after a relationship that had lasted more than twenty years, Amber decided to leave. “It just wasn’t working,” she says. “I felt that Marcus was close to giving up. Suicide felt imminent. Our marriage seemed beyond repair. It had become clear that our current state was unsustainable and a major shift was necessary… I didn’t know if that meant death, divorce, or finding a miracle, but our life was on a collision course and we needed something serious.”

A single, recurring thought kept stopping her in her tracks: If I leave, will I know that I had tried everything?

Mainstream psychiatry had failed them. But there was one other potential path to healing, a path which led not to a VA hospital, but to Mexico—and which involved not another long list of pills, but two substances with strange and unfamiliar names: 5-MeO-DMT and ibogaine (both of which are illegal in the US, but unregulated in Mexico). After hearing the story of a close friend (another vet) who had also been suffering from symptoms of PTSD and had found great relief from psychedelic-assisted therapy, Amber finally asked Marcus if it would be something that he’d be willing to try—a last resort to save himself and their marriage. It took some time, but he finally agreed. 

Read: Ibogaine and Iboga: Traditional Use, Conservation, and Ethical Considerations

Down in Mexico, with a physician by his side, Marcus would be given ibogaine—an African root and a potent psychedelic. Marcus would later describe that first experience as “dark and heavy,” but that he also “felt immediate relief once the experience was finished…[like] taking off a rucksack with a thousand pounds inside.” 

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Amber, who hadn’t made the trip to Mexico, didn’t know exactly what she was expecting in the aftermath of Marcus’ sessions. But she didn’t expect that her husband would return a completely changed man. “It felt like he was the same person I had met prior to the military,” she said. “Once Marcus found psychedelic therapy, it stopped the bleeding. The storm quieted for the first time in almost 20 years.” 

The Capones knew that they had found a source of healing that, unlike those on offer from the VA, provided lasting relief. 

They immediately got to work making it accessible to as many veterans as possible.

spinning circle

Over the course of the past year, several states across the US have taken legal action to expand access to psychedelic-assisted therapies for some citizens. Many of these efforts have been catalyzed by veterans who have personally benefited from psychedelic-assisted therapies.

Last year, Marcus and Amber Capone—together with their nonprofit, Veterans Exploring Treatment Solutions (VETS)—played a prominent role in the passing of Texas’ House Bill 1802, which aims to make psychedelic-assisted therapies available to Texas veterans with PTSD. (The Capones split their time between Dallas, Texas and Coranado, California.) The bill, introduced in February 2021 and enacted without the signature of Governor Greg Abbott in June 2021, mandates that the Department of State Health Services—in collaboration with the Baylor College of Medicine (BCM) and hospitals for military veterans—“shall conduct a study to evaluate the therapeutic efficacy of alternative therapies, including the use of 3,4-methylenedioxymethamphetamine (MDMA), psilocybin, and ketamine, in the treatment of veterans who suffer from post-traumatic stress disorder.” It also requires the physicians conducting these trials—led by Dr. Lynnette Averill, a clinical research psychologist and Associate Professor at BCM—to submit quarterly reports on their progress. These will be followed by a complete, final written report of the team’s findings, which will have to be submitted no later than December 01 of this year.

The Texas bill was bolstered by the results of a groundbreaking phase three clinical trial, conducted by the Multidisciplinary Association for Psychedelic Studies (MAPS), that had been recently published in the prestigious journal Nature Medicine. The trial investigated the therapeutic effects of MDMA-assisted therapy for individuals with chronic PTSD and found that “67 percent of participants who received three MDMA-assisted therapy sessions no longer qualified for a PTSD diagnosis and 88 percent experienced a clinically meaningful reduction in symptoms.”

Though no clinical trials to date have investigated the effects of psilocybin—or any of the other “classic psychedelics”—for the treatment of PTSD specifically, researchers have been able to demonstrate its therapeutic potential for a range of other serious psychological disorders, including end-of-life anxiety, depression, and some forms of addiction (which, arguably may also be related to, rooted in, or comorbid with trauma). One now-famous study conducted by a team from the Johns Hopkins University School of Medicine and published in the Journal of Psychopharmacology in 2016 administered psilocybin to dozens of “cancer patients with life-threatening diagnoses and symptoms of depression and/or anxiety.” After two sessions, the vast majority of participants showed a decrease in their symptoms. Even more impressively, those changes were largely sustained after six months, “with about 80 percent of participants continuing to show clinically significant decreases in depressed mood and anxiety.” The Hopkins researchers concluded that psilocybin-assisted therapy can lead to “increases in quality of life, life meaning, and optimism, and decreases in death anxiety.”

In addition to the scientific evidence, the success of the Texas bill—which received strong bipartisan support and passed both the state House and Senate in a landslide—can also be attributed in part to none other than former Texas Governor and U.S. Secretary of Energy Rick Perry. Despite being a conservative, Perry’s outspoken and energetic support of the bill helped to push it forward while also capturing the attention of other right-leaning lawmakers in Texas who might otherwise blanch at any bill containing the word “psychedelic”. 

man speaking at press conference
Rick Perry speaking at a press conference for HB1802. Marcus and Amber Capone can be seen standing behind him. | Image courtesy of Amber Capone

Perry himself has even acknowledged the irony of his support for HB1802: “I’m a great example of a fairly conservative elected official who is against drugs in any form or fashion,” he admitted during a press conference last year, when the bill was still in its earliest stages. “This compound of psilocybin, in a clinical trial environment, with the right medical oversight, the right diagnosis, the right dosing… and then the right follow-up… can save lives.” He was speaking mainly about veterans—the intended beneficiaries of HB1802—but he also mentioned others who could potentially benefit from psychedelic-assisted therapies, such as athletes with traumatic brain injuries or victims of sexual assault. “The idea that we have in our hands a way to positively affect their future is a powerful thing,” he said.  

Read: Trauma is the New Buzzword, but Does Everyone Really Have It?

Testimony from veterans, including Marcus Capone, also helped to win the hearts and minds of Texas lawmakers. In April 2021, at a Committee on Public Health hearing, Marcus stood at the podium and told his story: “I can say unequivocally that psychedelic-assisted therapy changed my life forever, and [it’s] why I’m standing here today, speaking with you,” he said. “I’ve seen it save the lives of countless friends, teammates, colleagues, and acquaintances… I’ve seen it work for veterans with recent suicide attempts who are now living productive and thriving lives.” He then fell into a long pause, fighting back tears. He took a single deep breath before regaining his composure. 

When Marcus finished his testimony, Amber took his place at the podium. “What I saw after one weekend on plant-based therapy was the reemergence of who I met before he was a SEAL, before there was a war,” she told the commissioners. 

Just over a month after the Capones’ testimonies, the bill would pass the House—134 in favor, nine against. Dr. Averill’s team is currently finalizing the protocols for the study and acquiring various approvals from government agencies. She hopes to begin recruiting participants in the fall of this year.  

Marcus and Amber Capone speaking on stage
Marcus and Amber Capone | Image courtesy of Amber Capone
spinning circle

A similar push to expand access to psychedelic-assisted therapies has also been underway in Pennsylvania. In October 2021, the Public Health Benefits of Psilocybin Act was introduced into the Pennsylvania General Assembly, aimed at enabling “approved investigators” within the state to begin clinical trials using naturally grown psilocybin as a potential treatment for ten specific disorders: PTSD, depression, anxiety, suicidality, bipolar disorder, migraines, chronic pain, traumatic brain injury, eating disorders, and substance use disorders.

Like its counterpart in Texas, the Pennsylvania bill initially received widespread support from both sides of the political aisle. Unlike the Texas bill, it has not yet passed. After being tabled late last year, a  modified version was reintroduced in March 2022, only to have its momentum falter again when the House Health Committee’s chairwoman withdrew her support from the bill, claiming—apparently without evidence—that one of her constituents had died from an overdose involving psilocybin-containing mushrooms. (There have not been any recorded instances of fatal overdoses caused by any of the classic psychedelics, such as psilocybin and LSD.)

Undeterred, the team behind the bill — led by Reason for Hope, a nonprofit devoted to the legalization of psychedelic research — adjusted its course: They’ll now attempt to open the door to psychedelic research in Pennsylvania through the FDA’s expanded access program, a pathway that can give patients with serious and life-threatening conditions access to experimental drugs “for treatment outside of clinical trials when no comparable or satisfactory alternative therapy options are available.” (The expanded access program is also sometimes referred to as “compassionate use.”)

They’ll be following in the footsteps of lawmakers in Connecticut, who approved a bill in March allowing for the creation of “a Psychedelic-Assisted Therapy Pilot Program to provide funding for qualified patients to receive MDMA or psilocybin-assisted therapy” via the expanded access program. The Connecticut bill explicitly states that the “pilot program will end once MDMA and psilocybin are approved by the federal DEA for medical use.” (If MAPS founder Rick Doblin is to be believed, FDA approval for MDMA could happen as soon as next year, with psilocybin trailing not far behind.) The Pennsylvania team is now partnering with a number of veteran-led groups, including VETS, and mental health advocacy organizations to push similar efforts in Pennsylvania, Florida, and New York. 

The Pennsylvania team is also working on a separate initiative to jumpstart research within the state into naturally-grown psilocybin-containing mushrooms, which they envision potentially becoming a more affordable alternative to synthetic psilocybin in the future. Some hope that effort will be made easier by the fact that the state has a proud history as a producer of fungi. (Kennett Square, a small town just outside of Philadelphia, is known as “the mushroom capital of the world.”) The team recently gathered at the Pennsylvania State Capitol building to discuss their next steps; they were joined in support by State Representatives Tracy Pennycuick and Greg Rothman, both of whom are veterans. 

A handful of other states have also been joining the fray. Maryland, for example, recently passed a bill allowing for the creation of a fund to provide access to psychedelics for veterans suffering from PTSD. Lawmakers in Georgia formed a committee earlier this year to investigate psilocybin as a potential treatment for PTSD in veterans. Initiatives to decriminalize or expand access to psychedelic medicines for some citizens have also been underway in New York, Washington, Utah, Missouri, Oklahoma, Oregon, Colorado, Virginia, California, New Hampshire, Rhode Island, and Hawaii. 

spinning circle

Many of those state-sponsored initiatives have been set into motion during a moment of crisis for the veteran community.

According to the Department of Veteran Affairs (VA), as much as 20 percent of all veterans returning home from Afghanistan will suffer from symptoms of PTSD. It’s currently estimated that roughly twenty-two veterans commit suicide every day in the United States—almost one every hour. 

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The past couple of years have also arguably taken a particularly heavy toll on veterans. In addition to the isolation and fear that we’ve all had to endure during the pandemic, many veterans have struggled to come to terms with the grim milestone of the twentieth anniversary of the U.S. invasion of Afghanistan—while simultaneously watching in disbelief as the U.S. military hastily withdrew from the country, allowing the enemy to fill the power vacuum left in its wake. 

At the same time, mainstream psychiatry has become increasingly aware of its inability to effectively treat PTSD among veterans. SSRIs and talk therapy—the field’s traditional frontline defenses against PTSD—have, to be sure, saved countless lives. But as many psychiatrists will readily admit, those are rather blunt instruments given the scope and complexity of the problem. “[With] SSRIs, the intent is to dull the symptoms,” said Dr. Lynnette Averill, the Baylor psychologist who will be leading the clinical research in Texas. “Hopefully they can resolve the symptoms, but in so few cases do they really do much other than take the top off.” Talk therapy can lead to significant breakthroughs, but as Dr. Averill explains, its efficacy also depends largely on the amount of work that a patient is willing to put in outside the therapist’s office. “No matter how great the therapy or your therapist is, none of this happens in a vacuum,” she says. “You still are going home to the same life.” 

This, Dr. Averill believes, is where psychedelics can come into play: “We often do a very good job at teaching people not to die… the thing that we do not do as well in medicine and mental health care is really teaching people how to live… [Psychedelics] work so much more rapidly and so much more robustly than any of our traditionally available interventions… they seem to open the space or provide a foundation for people to really build the life that they want to be living.” 

spinning circle

Though the myriad state-led efforts that are currently underway represent significant progress in the effort to end the prohibition on psychedelics, they are mere steps on the long road ahead. 

Jesse Gould, a former Army Ranger who participated in a week-long ayahuasca retreat in Peru to treat his PTSD after returning home from Afghanistan, points out that the potential impact of state-sponsored initiatives are limited by the fact that they’re embedded within a larger, federal healthcare system which, many would argue, is deeply flawed. “If we just push psilocybin [and] MDMA through a system that’s already broken, you’re still gonna have big issues,” Gould says. “Lower-served communities are still not going to have access to this. Those who couldn’t afford a therapist are still not going to be able to afford a therapist, especially the bigger cost that’s going to come with longer experiences like MDMA [and] psilocybin. We’re not building this baseline infrastructure.”

In 2017, Gould founded the Heroic Hearts Project, a nonprofit which connects veterans with psychedelic-assisted therapies. The organization has already worked with close to 200 veterans, and there are nearly 1,000 more currently on the waiting list. (It’s also one of the veteran-led groups backing Reason for Hope’s efforts.)

The Heroic Hearts Project also functions as a kind of support group for veterans—which, Gould argues, is a crucial part of the healing process that has yet to be built into the mainstream model for the treatment of PTSD. “We focus on mental health [as we would]  any [other] sort of sickness,” he says. “When you feel bad, you go to the doctor, they prescribe you something. Hopefully that makes you feel better. If not, you check back in…[but] mental health is a continuous sort of thing, especially for people with serious sorts of issues. It cannot just be, ‘Okay, I see this therapist every month, and then I’m going to be good to go for the next month.’ That’s not how it works. You have ebbs and flows. And so yes, you do need that baseline support from the therapist, but we also need communities around this to support it. And we just don’t have that.”

In other words: The merging of psychedelic-assisted therapy with the national healthcare system is going to take a while. That said, many within the veteran and medical communities are optimistic about the pace of change. Even though it could be years until the federal government decides to support intensive psychedelic research, there’s a pervasive sense among many in this community of a domino effect at play: As the chorus of support grows more deafening, and as partisan divides continue to crumble, states may continue to take the example of their neighbors by introducing new bills aimed at the decriminalization of psychedelic research. 

“We will continue pushing state by state for policies—outside the federal regulatory scheme if we have to—to pressure the federal government to make the change that’s needed. If that’s what has to be done, that’s what we’ll do,” says Brett Waters, an attorney and the founder of Reason for Hope. “The veteran lobbyists…are literally going into the meetings themselves and telling their story, legislator by legislator, state by state. That is how this is getting done. And if that’s where you can get the meetings and affect change and put pressure on the federal government to catch up, then that’s the route that we’ll take.”

DoubleBlind Magazine does not encourage or condone any illegal activities, including but not limited to the use of illegal substances. We do not provide mental health, clinical, or medical services. We are not a substitute for medical, psychological, or psychiatric diagnosis, treatment, or advice. If you are in a crisis or if you or any other person may be in danger or experiencing a mental health emergency, immediately call 911 or your local emergency resources. If you are considering suicide, please call 988 to connect with the National Suicide Prevention Lifeline.

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