Authors: Logan Kelly, Center for Health Care Strategies

Recent federal and state policy actions are designed to increase access to psychedelic drugs for people with mental health conditions and/or substance use disorders (SUDs). In April 2026, the Trump administration released an executive order, “Accelerating Medical Treatments for Serious Mental Illness,” which seeks to reduce restrictions on psychedelic access, expand pathways to access specific psychedelics granted a Breakthrough Therapy designation, and increase funding for state psychedelic research programs. While this order does not indicate immediate approval by the U.S. Food and Drug Administration (FDA) or rescheduling by the Drug Enforcement Administration (DEA), it does advance access and accelerate the FDA review process. In addition, recent state policy activity has included legislation related to medical research, state-regulated medical access, state-regulated non-prescription adult access, and pilot programs for psychedelic treatment.

In this rapidly changing policy environment, the evidence base and implementation landscape for psychedelic-assisted therapy (PAT) has also evolved. PAT is broadly defined as the use of psychedelics or psychedelic-like drugs combined with therapy to treat an array of behavioral health conditions, such as post-traumatic stress disorder (PTSD), treatment-resistant depression, major depressive disorder, and SUD. Drugs often termed psychedelics or with psychedelic-like properties include: psilocybin; 3,4-Methylenedioxymethamphetamine (MDMA); 3,4-methylenedioxy-N-methylcathinone (MDMC ormethylone); ketamine, esketamine (Spravato), and ibogaine. Generally, these drugs may impact perception, sense of self, mood, affect, and social connection. Each drug has a specific body of research for how it may be used to support treatment of specific behavioral health conditions. Only Spravato is FDA-approved for treatment of mental health conditions; ketamine is not FDA-approved specifically for behavioral health treatment but may be administered “off-label.”

What does psychedelic-assisted therapy for people with serious behavioral health conditions involve?

PAT refers to a wide range of therapeutic applications of psychedelic drugs used for different psychiatric conditions and SUDs. Elements of PAT typically include:

  • An intake screening and assessment to identify whether PAT is appropriate for a patient;
  • Preparation sessions with a therapist to develop a trusting relationship, provide education, establish safety measures, and set intentions;
  • Medication session, a multi-hour appointment in which the patient takes the determined dose of a psychedelic under the supervision of trained therapists in the treatment setting, which is designed to support a reflective state of mind; and
  • Integration sessions, in which patients process their experiences and explore how to apply the insights from this experience to set goals and inform lasting changes in their behaviors and/or perspective.

There are different models for delivery of PAT being piloted, including individual or group sessions for preparation, treatment, and integration. Usually, there are a limited number of sessions, with the number, total duration, and setting varying based on the drug and the treatment goals. The roles of practitioners may vary, including roles within different PAT sessions. A recent article described the nuances of a “psychological safety” approach, in which the interpersonal interaction between practitioner and patient is solely focused on safety, and a “psychotherapy” approach in which the interaction is focused on safety as well as enhancing efficacy of the psychedelic through a therapeutic process.

What is the evidence on PAT for behavioral health conditions?

Randomized controlled trials have demonstrated the potential of PAT to support better health outcomes for individuals with certain mental health conditions and SUD, including for individuals who have not experienced improvements with other treatments, such as serotonin reuptake inhibitors (SSRIs) and cognitive behavioral therapy. Some key potential benefits of PAT compared to these existing treatments include: 1) relatively fast improvement in symptoms; 2) limited side effects; 3) short treatment duration; and 4) support for enhanced emotional processing, which may increase the effectiveness of therapy to promote lasting changes.

Evidence for PAT efficacy varies based on the type of psychedelic treatment and the patient population. Key studies providing an overview of this evidence are summarized below.

What resources can support providers and other stakeholders to understand and implement PAT?

The following resources offer providers and state policymakers insights into the implementation and policy landscape of PAT.

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