# Science Standards Fail Psychedelic-Assisted Psychotherapy January 14, 2025 *By Christine Hauskeller.* *Edited by* [*Aaron Michael Ullrey*](https://cswr.hds.harvard.edu/people/aaron-michael-ullrey)*.* *This Research Reflection by Christine Hauskeller, Visiting Scholar (Fall 2024), is part of an ongoing series highlighting the research work of CSWR's affiliates.* After decades of legal prohibition of psychedelic drugs starting in the 1970s, psychiatrists are once again conducting research to advance psychedelic-assisted psychotherapies (PAP). Experiments entail exceptional experiences brought about using psychedelic substances and followed by psychotherapeutic integration sessions to process these experiences. Such PAP has helped patients diagnosed with severe depression, anxiety, addiction, or trauma. More research is needed to calibrate PAP treatments and identify the best treatment for different patients. Such research is challenged by the criminalization of these drugs and also by tightly regulated protocols for medical research in clinical trials. These protocols stand in sharp contrast to PAP’s patient-centered orientation. As discussed in the anthology Philosophy and Psychedelics (2022), exceptional experiences of the powerful dance of life and self-transcendence can arise through yoga, meditation, or drugs, including psychedelics. Extraordinary experiences stand out from everyday life and can motivate life changes. PAP has proved effective in small-scale trials when the subjectivity of psychedelic experience is recognized and when psychotherapy sessions focus on the individual patient and their specific needs. The methodological requirements for large-scale clinical trials attempt to standardize and control every aspect of a new treatment in order to derive generalizable data. This undermines the patient-centered approach of PAP in which treatments combine a professional personal relationship during psychotherapy with psychedelic drug prescription. Many factors in PAP beyond biochemical effects influence treatment outcomes. The approach to knowledge imposed by clinical trials demands objectivity and methods to discover the exact percentage of relative improvement for patients receiving the new treatment compared to those receiving standard care or placebo. Trials across thousands of patients should be double-blinded, meaning neither patients nor the research team know whether any individual patient has been randomized to the treatment or placebo group. Ideally, researchers quantify the effects of the new treatment in relation to existing treatments. Psychedelics challenge these methods. Despite efforts to conceal who is and who is not in the treatment group, the intensity of the experiences engendered by a full-dose psychedelic drug enables researchers and patients to judge correctly who has been given the treatment and who has not. This is called functional unblinding, and it was one reason given by the U.S. Food and Drug Administration (FDA) in 2024 for rejecting the evidence presented that MDMA (3,4-Methylenedioxymethamphetamine, commonly known as the tablet “ecstasy” and the crystal “molly”) plus psychotherapy was sufficient to show this treatment alleviates post-traumatic stress disorder (PTSD). Notably, the FDA licenses drugs and not the efficacy or quality of psychotherapy, and it has no facilities to do the latter. The rejection was about drug treatment, whereas the application for a license and the trial evidence provided were for a PAP of MDMA with psychotherapy. Another issue with clinical trials is that the value of new therapies is also judged by their cost, and psychotherapy is the costly part of PAP. Furthermore, the psychotherapy component aiming to support the participant in making their experience meaningful should ideally be standardized in trials. Therapy sessions as a therapist-client relationship cannot be objectified and standardized across larger patient populations. For interpersonal interactions, standardization is impossible. Instead, to find something measurable, a portion of the face-to-face personal conversation is often replaced by standard psychometric questionnaires that allegedly give more objective data. Psychedelic experiences in clinical trials are directed and mellowed so they won’t be “bad” ones. Music playlists played for all participants are curated to soften the experience, for there is not enough time in therapy sessions to integrate a very challenging trip. These measures throttle the therapeutic potential of PAP. An exceptional experience is promised in PAP, but in a context where the participant can discuss that exceptional experience with a competent and trustworthy therapist. Therapy in trials, however, does not fit ideal PAP treatment because patient individuality is subordinated to the pursuit of scientific objectivity and commercial interests to find new blockbuster drugs. Like Odysseus wanting to hear the sirens without being lured to irrational action by their chants, PAP is tamed by focusing on psychedelic substances as medicines. Moderating trip experiences in clinical trials focuses on specific outcomes specified by the trial, adapting PAP to serve the needs of the industry rather than finding the best possible treatment outcomes for individual patients. Sound science requires picking research methods that match what is under study. Regulators in Australia have realized that psychedelic medicine may progress without large clinical trials. The Therapeutic Goods Administration announced that Australia would approve the use of Psilocybin and MDMA in medical treatment from July 2023 onward. Both substances can now be prescribed by approved psychiatrists to treat mental health patients. Oversight for this practice has been put in place. Research approaches that build on a community-based and person-centered approach to psychedelic substances in psychiatry seem fitting and promising. See also:- [ Researcher Reflections ](/topic-tags/researcher-reflection) - [ Psychedelics and Ethics ](/programming-threads/psychedelics-and-ethics)