Momentum is growing around the therapeutic use of psychedelic drugs in what is called psychedelic-assisted therapy or PAT.
Psychedelic drugs being researched for this type of therapy include psilocybin (found in some mushrooms) and other natural and synthetic substances that are not currently approved by the U.S. Food and Drug Administration (FDA) for legal use in medical or recreational settings.
That could change.
In April of 2026, President Donald J. Trump issued an executive order to "accelerate innovative research models and appropriate drug approvals to increase access to psychedelic drugs" in therapy that might help treat serious mental health conditions.
That announcement came amid continued comments by U.S. Secretary of Health and Human Services Robert F. Kennedy, Jr., suggesting he supports the use of psychedelic drugs like psilocybin and ibogaine (from a plant native to Central Africa) in supervised clinical settings to treat mental health issues and addiction.
Since then, the FDA has said it wants to review studies around psilocybin and another psychedelic called methylone (which is a synthetic drug related to MDMA, also known as ecstasy) as treatments for depression and post-traumatic stress disorder (PTSD). The FDA is also inviting submissions related to early-phase clinical trials of ibogaine.
But while PAT can now be accessed legally in the U.S. through a few select ways, the research around the use of psychedelics in therapy is still considered inconclusive. There are also inherent risks to psychedelics.
Here are some basic answers to common questions about PAT.
What are psychedelics?
According to the American Brain Foundation, psychedelics are hallucinogenic drugs that affect a person’s mental state and can temporarily change their perceptions, sensory experiences, mood, and thought processes.
Classic psychedelics include:
- LSD (lysergic acid diethylamide)
- Psilocybin and Psilocin (“magic mushrooms”)
- DMT (Dimethyltryptamine)
- Mescaline (found in cacti-like peyote)
MDMA is synthetic and not considered a classic psychedelic. Ibogaine is also not considered a classic psychedelic because it works a little differently, but it, MDMA and other classic psychedelics are all “Schedule 1” controlled substances.
Schedule 1 classification means the U.S. Drug Enforcement Agency (DEA) classifies them as having:
- Potential for abuse
- No currently accepted medical use in treatment in the U.S.
- No acceptable safety criteria for use under medical supervision
What exactly is PAT?
PAT involves taking psychedelics under structured and supportive therapeutic supervision by certified personnel to address or reduce symptoms of a range of mental health conditions.
These conditions generally include anxiety, depression, PTSD, existential distress in patients facing life-threatening diseases (such as cancer) and addiction.
PAT usually consists of three distinct phases, supported by a trained and licensed facilitator, often a psychologist or another trained clinician or overseer.
These three phases typically are:
- Preparation: Goals, expectations, and safety planning are discussed and explored.
- Dosing day: A carefully monitored session that lasts most the day, typically five to eight hours and may include so-called non-directive scripts, accompanying music, and eye masks.
- Integration: Reflection and meaning-making following up care.
To help realize the full benefits of PAT, these phases usually consist of multiple sessions and are carefully monitored and overseen by a trained and licensed facilitator.
Where is PAT legal?
As of the end of October 2026, no psychedelic drug treatment is FDA-approved. That does not mean there are no legal pathways to treatment.
Currently, you can get PAT in the U.S. by participating in a clinical trial (found on sites like clinicaltrials.gov) or through state-regulated markets in Oregon and Colorado.
Oregon allows people 21 and older to use psilocybin in a supervised and licensed setting with licensed facilitators. The initiative is overseen by the Oregon Psilocybin Services Program. Through that program, people access treatment for depression, anxiety, PTSD, end-of-life distress, addiction, or personal growth and spiritual exploration. But the state of Oregon doesn’t ask for, or limit, the reason. Residency isn’t required.
Colorado, meanwhile, has decriminalized the personal use of some natural psychedelics and allows facilitators at licensed healing centers and micro-healing centers to administer psilocybin to adults, as well as the closely related psilocin.
Many other state legislatures have introduced or are actively reviewing bills to establish legal frameworks for psychedelic-assisted therapies, including California, New York, Illinois, Massachusetts, New Jersey, and others.
How has PAT grown?
While PAT is right now getting a lot of attention, the use of psychedelics dates back thousands of years to indigenous peoples who used the substances in spiritual, healing, and communal rituals.
In the U.S., awareness around psychedelics grew significantly during the 1960s when psychologist and countercultural icon Timothy Leary advocated for the therapeutic use of psychedelic drugs like LSD and psilocybin.
But not until some 50 years later did the concept of psychedelic medicine begin to enter more mainstream medical discussion with the publication of two landmark clinical studies: a 2016 Johns Hopkins study on psilocybin for cancer-related distress, and a trial of MDMA-assisted therapy for PTSD published by the Multidisciplinary Association for Psychedelic Studies (MAPS).
The Johns Hopkins study suggested that high-dose psilocybin produced large decreases in clinician-rated and self-rated measures of depressed mood and anxiety, along with increases in quality of life, life meaning, and optimism, and decreases in death anxiety.
What is research around specific psychedelics suggesting?
Research around PAT is growing. Among current major areas of study are:
1. Psilocybin-assisted therapy for:
- Major depressive disorder (MDD)
- Treatment-resistant depression (TRD)
- PTSD
- Substance use disorders
- Cancer-related existential distress
2. MDMA-assisted therapy for PTSD, especially in veterans, as noted by the US Department of Veterans Affairs
Geisel School of Medicine at Dartmouth (Geisel) Professor of Psychiatry Paula P. Schnurr, PhD, is among many scientists supporting research efforts in this area.
Schnurr was among the authors of a March 2026 review of the state of science around MDMA-assisted psychotherapy for the treatment of PTSD. The review noted increased interest in the use of PAT to better meet the needs of patients who do not prefer or respond to traditional evidence-based treatments. It also said that MDMA–assisted psychotherapy has shown promising outcomes in recent randomized controlled trials, with high response and remission rates. However, the review also noted that the FDA declined to approve the therapy in August 2024 due to insufficient evidence.
“Considerable heat, and a great deal of passion, have been generated around this issue: Some people are strong advocates, whereas others are strong skeptics,” Schnurr observed in this May 7, 2025 edited transcript from the 2024 Annual Meeting of the International Society for Traumatic Stress Studies.
“If we try to look through the cloud, however, there is a signal here worthy of investigation,” she continued. “This is an important area of study because even though we have great treatments for PTSD, we have hit a wall—we do not get enough people well enough.”
3. Ibogaine to treat opioid dependence and other conditions
Likewise, studies are suggesting that ibogaine-based therapy may be helpful in the treatment of opioid dependence.
There is also some preliminary evidence, though still inconclusive, that ibogaine-based treatment may help treat PTSD, anxiety, depression, and traumatic brain injury (TB) in veterans, but more research needs to be done here, too.
Why is research so far considered inconclusive?
As Dartmouth Health’s Amber E. Barnato, MD, MPH, MS, points out, one of the issues facing PAT is that the research behind it has clear limitations.
Barnato is a physician-scientist trained in public health and preventive medicine, health policy research, and hospice and palliative medicine who recently completed training and certification as a PAT facilitator.
As a clinician who specializes in palliative medicine at Dartmouth Health Medical Center (DHMC), Barnato is interested in how PAT could change the paradigm of medical practice by offering new pathways for treating mental health conditions and existential distress associated with life-threatening illness.
But she also cautions that while studies on PAT may be promising, they have mostly come from small samples of people who may, on average, be healthier than the general population.
In addition, study participants usually know whether they received the active drug because it’s hard, if not near impossible, to replicate a psychedelic drug’s effects with a placebo.
Additionally, getting patients to participate in clinical trials has its challenges. People who are taking certain medicines that may interact with psychedelics—such as fluoxetine, sertraline, citalopram and other selective serotonin reuptake inhibitors (SSRIs)—are expected to wean off those prescriptions prior to receiving PAT.
Further, for those who are very depressed or in existential crisis, not qualifying for a study or being randomized to the placebo arm can be devastating.
What are the risks of psychedelics?
There are inherent risks to psychedelics. These include but are not limited to:
- Cardiovascular strain, which can pose risks for those with underlying heart conditions
- Adverse drug interactions, particularly with SSRIs, monoamine oxidase inhibitors (MAOIs), or lithium, and so participants need to go off them first.
- Gastrointestinal issues, like nausea, vomiting, and stomach cramps.
- Psychosis or mania trigger, especially if you have a personal or family history of schizophrenia, bipolar disorder, or psychotic disorder.
- Severe anxiety and panic or a so-called "Bad Trip" that might include intense fear, confusion, disorientation, or paranoia, as well as emotional distress. That is one of the many reasons PAT requires that the drug be delivered in a soothing environment with structured psychological support.
- Lack of national standardization around clinical safety protocols, certification of medical staff, and testing of substances.
And then there is the lack of consistency and safeguards around getting and receiving that treatment, especially given the absence of federal oversight.
What is the future of PAT?
Momentum continues to grow at both the federal and state levels around the use of PAT to address a range of conditions. But questions remain about its risks, the limitations of the research behind the therapy, and how patients access it.
“I am cautiously optimistic about these treatments, but I worry that our delivery system is woefully unprepared to deliver them,” warns Barnato. “I worry, in particular, that our healthcare system might take a reductionistic approach in the name of ‘efficiency’ that strips out the critical elements of therapeutic alliance, ritual, and healing human connection that characterize PAT.”
Schnurr, while optimistic about the potential of using MDMA-assisted therapy for PTSD, emphasizes that the research needs to be more conclusive before PAT is made widely available.
“We are still in the early stages of understanding the potential of PAT,” she said in her comments at the 2024 Annual Meeting of the International Society for Traumatic Stress Studies. “Any strategy that shows promise for enhancing treatment outcomes is worthy of investigation. Do we need more science? Absolutely, and the science has to be more rigorous, but PAT has the potential to benefit trauma survivors around the world.”
Trump's executive order may have loosened restrictions and allotted funds to research therapy that uses certain designated psychedelics in research and clinical settings to treat mental health conditions. The FDA may also seem committed to accelerating the review of that therapy. But time will tell when—or if—the evidence catches up to the growing optimism about what PAT can do.
