Fuente: Prohibición Partners Lugar: General Report Contents
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Introduction →
Definitions And Scope →
Executive Summary →
Key Trends →

Market Value →
Legislation and Regulation →
Consumer Attitudes →
Healthcare Providers’ Attitudes →

Spotlight On Health →
Psychedelics – Timeline of Key Developments →
Countries to Watch →
Psychedelic Profiles →

Key Psychedelics Deep Dive →
Other Psychedelics of Note →
Psychedelics as Medicine: Potential Therapies →
Psychedelics and Technology →

Psychedelics Per Country →
Psychedelics and The Law →
Patents and Intellectual Property →
Therapy Practitioners →

Psychedelic Research →
Glossary →


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Key Takeaways



Conventional psychiatric medications, including antidepressants, are associated with a range of negative side effects, and increasing evidence suggests potential adverse effects with long-term use. By contrast, participants in psychedelic studies consistently report fewer negative side effects, and psychedelics are widely acknowledged to have a low potential for abuse or dependence.



A major challenge in developing psychedelic therapies lies in transforming unstable, plant-based compounds into consistent, replicable pharmaceutical products that meet regulatory standards such as FDA approval. Without approval and insurance coverage, the combined cost of the medicine itself and the required psychological support from trained therapists could remain prohibitive for many patients.



Psychedelic-assisted therapy places central importance on set and setting. Set refers to the patient’s mindset, while setting refers to the physical, social, and therapeutic environment in which the session occurs. Following the supervised psychedelic experience, structured integration through talk therapy is essential to achieving lasting therapeutic benefit.



Clarifying the Language of Psychedelic Therapies



As regulatory frameworks begin to emerge, the psychedelic field is developing its own terminology. This report refers to both psychedelic-assisted therapy and psychedelic treatments, with the latter also encompassing medications that may be self-administered and combined with psychotherapy.



For clarity, psychedelic therapies can be broadly grouped into three categories:




Psychedelic-assisted psychotherapy



Infusion therapy



Prescription-based treatments




Psychedelic-Assisted Psychotherapy



Psychedelic-assisted psychotherapy refers to the use of a psychedelic substance alongside a structured programme of psychotherapy. Patients typically undergo between one and three full-day psychedelic sessions, with two sessions being the most common approach. Each psychedelic session is supported by multiple preparatory and integration therapy sessions, usually totalling between six and ten.



A leading example is COMPASS Pathways’ protocol for major depressive disorder, which has received Breakthrough Therapy designation from the US FDA. Similarly, MDMA-assisted psychotherapy for PTSD is currently in late-stage clinical development, with FDA approval expected in 2023.



Infusion Therapy



Infusion therapy involves the intravenous administration of psychedelic compounds, either alongside psychotherapy or as a stand-alone medical intervention. Ketamine infusions have been approved in both the United States and the European Union, though administration must occur in controlled medical settings.



In 2021, several companies initiated clinical trials exploring intravenous DMT. These studies aim to better understand DMT’s pharmacokinetic properties and assess whether continuous intravenous infusion could extend the compound’s therapeutic efficacy.



Prescription-Based Psychedelic Treatments



Although psychedelic medicines are not yet widely available through pharmacies, several companies are developing products designed for self-administration at home. During the COVID-19 pandemic, some ketamine providers began shipping ketamine directly to patients, with clinician guidance delivered via video consultation.



Making psychedelic treatments available on prescription could significantly reduce costs and increase access. MindMed, for example, is conducting clinical trials on LSD microdosing for ADHD, with the long-term goal of making the treatment available over the counter.



The Importance of Set, Setting and Integration



The therapeutic effects of psychedelics depend heavily on set, setting, and dose.



Set refers to the patient’s mindset, shaped by expectations, mood, personality, and prior experiences. A person entering a session while grieving, for example, may have a very different experience than someone who is well-rested and emotionally stable, even when dose and setting are identical.



Setting encompasses both the physical environment and the interpersonal context of the session. Although many clinical trials take place in hospitals or research centres, therapy rooms are typically designed to feel calm, comfortable and non-clinical. Sessions usually involve two therapists. Patients may sit or lie on a couch, wear an eye mask, and listen to carefully selected music. Psychedelics are most commonly administered orally in capsule form, and sessions can last up to eight hours.



Dose refers to the quantity of the psychedelic administered. Many trials use one or two high-dose sessions, or up to three, depending on the protocol. Typical doses include 20–30 mg of psilocybin or 35 mg of ketamine per 70 kg of body weight. Research suggests no meaningful difference in response between men and women beyond body weight, though certain genetic factors may influence individual sensitivity.



Following the psychedelic session, patients engage in integration therapy, usually in the days immediately afterward. These sessions help individuals process, interpret and apply insights from the experience to their daily lives. Integration is considered a critical component of psychedelic-assisted therapy and is included in nearly all clinical studies, with the notable exception of many ketamine trials.








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The post Psychedelics as Medicine: Potential Therapies – PSYCH: The Psychedelics As Medicine Report 3rd Edition appeared first on Prohibition Partners.