VA Leaning in on Molly, Mushrooms as Psychedelics Show Promise for Treating Post-Traumatic Stress Disorder

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In this photo made with a long exposure, a man is silhouetted against lights reflected in the waters off Cape Neddick in Maine.
In this photo made with a long exposure, a man is silhouetted against lights reflected in the waters off Cape Neddick in Maine on Dec. 11, 2017. A study published Thursday, Sept. 14, 2023, in the journal Nature Medicine has found that the psychedelic drug MDMA, combined with talk therapy, can reduce PTSD symptoms. (Robert F. Bukaty/AP File Photo)

For eight years, Marine and Army veteran Jonathan Lubecky suffered flashbacks and nightmares, got rip-roaring drunk to quell his troubled mind, took 42 pills a day to address various medical conditions, and attempted suicide multiple times.

An emergency visit to the Department of Veterans Affairs hospital in Charleston, South Carolina, in 2014 changed his life, not because he was able to get treatment -- no inpatient psychiatric beds were available that day – but because an intern slipped him a note.

It said, "Google MDMA/PTSD."

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The intern knew that in Charleston, a researcher for the Multidisciplinary Association for Psychedelic Studies, or MAPS, was conducting a safety trial on the use of MDMA -- 3,4-methylenedioxymethamphetamine, also known as ecstasy or molly -- for treatment-resistant post-traumatic stress disorder.

Nine years later, having enrolled in the study and received three MDMA-assisted therapy sessions, Lubecky has no thoughts of suicide. He has founded his own company, traveled to Ukraine three times for humanitarian work, and lived through several personal traumas without recurrence of his PTSD.

MDMA and the psychotherapy he underwent while using the drug have led him to where he is today.

"I'm now PTSD-free longer than I had it," said Lubecky during the VA's inaugural New Horizons in Health podcast. "It's like doing therapy while being hugged by everyone who loves you with a basketful of puppies licking your face."

Since 2011, MAPS has studied the potential of MDMA to put PTSD in remission, most recently releasing the results of Phase 3 clinical trials in the journal Nature that confirmed its safety and efficacy in patients with PTSD.

With those promising results and the organization preparing to file a new drug application with the Food and Drug Administration later this year, the VA is exploring ways to expand research into psychedelic drugs like MDMA and psilocybin -- the active drug in psychedelic mushrooms -- to treat PTSD, depression, substance use disorder and more across the veteran population.

The VA is restricted from conducting large-scale studies of these medications because MDMA and psilocybin are illegal in most states and at the federal level, where they are listed as Schedule 1 drugs by the Drug Enforcement Agency.

But according to VA Under Secretary for Health Dr. Shereef Elnahal, department researchers have received waivers to support ongoing studies and have conducted research funded with private donations rather than federal money.

VA scientists are interested in exploring the protocols for psychedelics-assisted therapy and how the department can support the research nationwide, as well as build the infrastructure needed for larger clinical trials, according to Elnahal.

"If and when this becomes available," Elnahal said during the New Horizons podcast, "VA will be able to scale it, I think, better than any other health care system because of our focus particularly on veterans."

The VA is invested in novel approaches to treat mental health conditions in former service members because such conditions can be debilitating or even life-threatening. Studies show that PTSD, either alone or when diagnosed with other mental health conditions, is associated with suicide.

Data released last year showed 6,146 veterans took their own lives in 2020, 342 fewer deaths than 2019 and 650 fewer deaths than in 2018. Data for 2021 is expected in the coming weeks.

According to the VA, of the 6 million veterans enrolled in VA health care in 2021, 10% of male veterans and 19% of female veterans were diagnosed with PTSD.

Standard treatments for PTSD include cognitive processing therapy, prolonged exposure therapy, and eye movement desensitization and reprocessing, along with drug therapies such as Zoloft and Paxil.

Lubecky said he tried most standard therapies but, while they may be effective for other veterans, they didn't work for him. MDMA, which increases the release of neurotransmitters responsible for feelings of positivity, energy and alertness, combined with therapy proved to be effective, although he admitted that the sessions were a challenge.

"It's not the MDMA that fixed you. It's the therapist working with you putting in the hard work," Lubecky said during the podcast. "The medicine just puts the mind, body and spirit in the place it needs to be so the problem can be fixed."

According to the results of the most recent Stage 3 clinical trial, nearly 87% of the patients who received MDMA-assisted therapy showed significant improvement in their PTSD symptoms more than four months after treatment.

By the study's end, 71% no longer met the diagnostic criteria for having PTSD.

Two participants who received MDMA reported having serious thoughts of suicide, although no one involved in the study -- neither the MDMA or placebo group -- attempted suicide.

MDMA is not without its risks. It is linked to high blood pressure, seizures and kidney failure, and its use can cause negative aftereffects such as irritability, depression, anxiety and memory issues, according to the National Institute on Drug Abuse.

Lubecky and VA officials expressed concern that the buzz over its success as a PTSD treatment as well as new research on psilocybin as a potential therapy for PTSD and major depressive disorder will encourage veterans who can't enroll in a clinical trial to self-medicate.

Given the risk of a negative reaction and potential contamination of black market medications with substances like fentanyl, VA officials warn veterans to steer clear.

"When you are using recreationally, you are finding something on the street. You don't know what you are taking and what's in that pill. That's a risk that I hope that will cause people some pause," said Dr. Ilse Wiechers, deputy executive director of the VA's Office of Mental Health and Suicide Prevention, during the podcast.

With MAPS wrapping up more than 12 years of research on MDMA as a treatment for combat-related PTSD, the organization plans to seek approval of the therapy from the FDA in 2024. The agency granted a "breakthrough therapy" status to the treatment in 2017.

The Drug Enforcement Agency also will need to weigh in, removing it from the list of illicit controlled substances.

To date, the DEA has been reluctant to alter that list, known as Schedule 1, to include declassifying medical cannabis, which remains illegal under federal law but is now allowed either for medical or recreational use in 38 states.

Legislation currently under consideration by Congress includes amendments that would require the Department of Defense and VA to study the use of marijuana to treat PTSD, depression and chronic pain in service members and veterans.

The legislation, part of the House version of the National Defense Authorization Act, also would require the Pentagon to conduct clinical trials on the MDMA and psilocybin for PTSD, traumatic brain injury and chronic traumatic encephalopathy.

The amendments were introduced by Rep. Nancy Mace, R-S.C., and Rep. Morgan Luttrell, R-Texas, a former Navy SEAL.

Lubecky said he would like more veterans to be able to access MDMA therapy, and he has

become a proponent, establishing an advocacy firm focusing on psychedelic research.

"I don't know the date of the first night I didn't have nightmares. I know the first night I remember I didn't have nightmares. I don't remember the first day I didn't think about suicide, but I remember the day I realized I didn't and that was an amazing day," Lubecky said during the podcast.

-- Patricia Kime can be reached at Patricia.Kime@Military.com

Related: 'You Can Forgive Yourself:' Molly Helps Vets with PTSD, New Study Says

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