Can I access psychedelic therapy in Massachusetts?
The mental health treatment landscape is evolving as researchers explore psychedelic substances for conditions like depression and PTSD. While these treatments show promise, only one has received FDA approval and is available in Massachusetts. Here's what you need to know.
The Only FDA-Approved Option: Esketamine (Spravato)
Esketamine nasal spray (Spravato) is currently the only psychedelic-related therapy approved by the U.S. Food and Drug Administration. The FDA first approved Spravato on March 5, 2019, for treatment-resistant depression alongside an oral antidepressant. In August 2020, approval expanded to include adults with major depressive disorder experiencing acute suicidal ideation. Most recently, in January 2025, the FDA approved Spravato as a standalone monotherapy for adults who haven't responded to at least two oral antidepressants.
Esketamine is derived from ketamine, an anesthetic the FDA first approved in 1970. Unlike traditional antidepressants targeting serotonin, esketamine works through glutamate, the brain's most abundant excitatory neurotransmitter. However, according to FDA labeling, the exact antidepressant mechanism remains unknown.
Due to risks including sedation, dissociation, and potential for misuse, Spravato is a Schedule III controlled substance. The FDA requires administration only under medical supervision in certified healthcare settings through a Risk Evaluation and Mitigation Strategy (REMS) program.
We offer esketamine therapy at our clinic! Reach out today to learn more.
What's Being Researched: Psilocybin, MDMA, and LSD
According to the National Institute on Drug Abuse (NIDA), researchers are studying several psychedelic substances for therapeutic potential.
Psilocybin for Depression
Psilocybin, the compound in "magic mushrooms," has received significant research attention. The FDA granted breakthrough therapy designation to psilocybin for treatment-resistant depression in 2018 and major depressive disorder in 2019, expediting research and review.
NIDA reports multiple studies investigating psilocybin's effectiveness for depression and anxiety. Phase 3 clinical trials—the large-scale studies required for FDA approval—are currently underway. Compass Pathways and Usona Institute both have ongoing Phase 3 trials evaluating psilocybin for depression. Early evidence suggests psilocybin with psychological support may produce rapid symptom improvement lasting weeks.
NIDA also supports research into psilocybin for substance use disorders, including a large multi-site study comparing it to nicotine patches for smoking cessation.
MDMA for PTSD
MDMA received FDA breakthrough therapy designation in 2017 for post-traumatic stress disorder. However, in August 2024, the FDA declined to approve MDMA-assisted therapy, requesting Lykos Therapeutics conduct an additional Phase 3 trial to establish safety and efficacy.
The decision followed FDA advisory committee concerns about trial design, including effective blinding and safety monitoring. Despite this setback, research continues.
LSD Research
Lysergic acid diethylamide (LSD) has also received FDA breakthrough therapy designation. According to FDA guidance, LSD is a "classic psychedelic" acting on the brain's serotonin system. NIDA reports researchers are investigating LSD alongside psilocybin, though LSD remains in earlier development stages. Studies explore potential benefits for anxiety and cluster headaches.
The FDA's Approach
In 2023, the FDA issued draft guidance on clinical trials with psychedelic drugs—the agency's first formal guidance addressing this field. The document covers classic psychedelics like psilocybin and LSD, plus entactogens like MDMA.
The FDA emphasized that while psychedelic drugs show initial promise for mood, anxiety, and substance use disorders, designing clinical studies presents unique challenges. The evidentiary standard remains the same as for all medications: rigorous, well-controlled trials demonstrating safety and effectiveness.
What This Means for Patients
Currently, esketamine remains the only legal, FDA-approved psychedelic-based treatment available by prescription. Psilocybin and MDMA remain Schedule I controlled substances, unavailable for medical use outside clinical trials.
Patients interested in psychedelic-assisted therapy may consider participating in FDA-approved clinical trials. The National Institutes of Health clinical trials database provides information about ongoing studies.
As research progresses, new treatment options may emerge for patients who haven't found relief through conventional therapies. However, any approved psychedelic therapy will likely require strict oversight in certified clinical settings.
For more information, visit the National Institute on Drug Abuse or FDA guidance on psychedelic drugs.
—
Dr. Caroline Fu is a board-certified adult & child psychiatrist in private practice in Cambridge, Mass.
