The Treatments

Recent research shows that psychedelic medicines may have great potential in treating PTSD, depression, addiction, and other conditions.

An estimated 6.8 percent of Americans will have PTSD at some point in their lives.
Approximately 870,000 U.S. veterans receive disability payments for PTSD from the U.S. Department of Veterans Affairs, costing an estimated $17 billion a year.

Initial results of MDMA-assisted psychotherapy showed that two-thirds of patients no longer qualified for a PTSD diagnosis 12 months after treatment.

These promising initial results suggest that MDMA-assisted therapy could help millions of Americans.

Affects over 300 million people worldwide.
Especially impacts the estimated 5 million people in the U.S. who have treatment-resistant depression.
Is the leading cause of disability in the U.S., costing society $210 billion a year.

In clinical trials, initial results of psilocybin intervention in depressed patients with a life-threatening terminal diagnosis showed a reduction of symptoms in 80 percent of study participants.

If these same results extend even partially to the general population, this treatment has the potential to help millions of people worldwide.

How does psychedelic-assisted therapy work?

Psychedelic treatments such as MDMA and psilocybin can help reset processes and patterns of thinking that are often the root of mental health issues.

Other drugs, like antidepressant and anti-anxiety medications, suppress symptoms. In contrast, MDMA and psilocybin appear to change the way a patient processes memory and information in order to treat the actual disease, not just the symptoms.

MDMA

In the U.S., Europe, and Israel, clinical trials have been conducted using MDMA-assisted psychotherapy to treat PTSD in veterans, sexual abuse survivors, and people with other traumas. The treatment has received Breakthrough Therapy designation from the U.S. FDA, and Phase 3 trials began in the U.S. in 2018 and concluded in 2023. If MDMA’s new drug application submission to the FDA is successful, it could result in the first-ever regulatory approval of a Schedule I psychedelic compound.

Here’s how the MDMA trials work:

Patients who suffer from treatment-resistant PTSD receive three day-long sessions of MDMA-assisted psychotherapy, with sustained interactions with their therapist, and a series of non-drug psychotherapy sessions for preparation and integration.
During the psychotherapy sessions, patients discuss the traumatic incident in a controlled and secure setting.
PTSD is marked by often debilitating anxiety and fear triggered by reminders of the traumatic event. Current treatment of PTSD involves medicating the symptoms or revisiting the trauma through therapy, but many people have repressed memories of the event or are re-traumatized when trying to talk about it.
MDMA reduces fear and promotes empathy and trust. As part of psychotherapy, MDMA makes it possible to internally process the trauma and to talk about it from a place of safety, leading to release and reframing that lessens or eliminates PTSD symptoms.

Psilocybin

Johns Hopkins and NYU have completed trials of psilocybin to relieve psychological distress in patients with a life-threatening cancer diagnosis.

Here’s how the trials work:

Cancer patients have initial sessions with the lead guide to set expectations and build rapport and trust, as well as follow up counseling sessions to integrate the psilocybin experience.
During the psilocybin administration session, patients receive a dose of psilocybin or a placebo in a comfortable, living-room-like setting with two guides present.
High-dose psilocybin can create a mystical or spiritual experience for many patients, leading them to feel more connected to themselves and with a new perspective on mortality, leading to a dramatic decrease in symptoms of depression.

Because of encouraging results in early academic research with end-of-life depression, Usona Institute and Compass Pathways have begun work toward conducting clinical trials to study Major Depressive Disorder in the general population at sites in Europe and across the U.S. At the same time, researchers associated with Heffter Research Institute are exploring psilocybin as a treatment for addiction and other disorders.