Husband and wife team, Michael Mithoefer, MD, a clinical psychiatrist, and Annie Mithoefer, BSN, a registered nurse, are Clinical Investigators for MDMA and PTSD studies at the Multidisciplinary Association for Psychedelics Studies (MAPS). They specialize in treating PTSD with experimental psychotherapy through clinical research and outpatient clinical practice. Between 2004 and 2018, Michael and Annie completed two of the six MAPS-sponsored Phase II clinical trials testing MDMA-assisted psychotherapy for PTSD. Together, they have over 25 years of experience treating trauma patients.

Although MDMA-assisted psychotherapy has been hailed as a groundbreaking treatment for PTSD, its path to legitimacy has been thwarted by methodological and ethical challenges. How can researchers balance the demands of rigorous scientific inquiry with the relational complexities of psychotherapy to advance this innovative approach?

Drug therapy researchers Michael and Annie Mithoefer faced significant criticisms of their methods as they worked to integrate MDMA into trauma therapy. Conventional drug trial models, which rely on strict double-blind methodologies, clashed with the participatory nature of psychotherapy. To address bias and ethical concerns, the Mithoefers designed studies with independent, remote reviewers trained to evaluate outcomes objectively. They also adjusted their protocols to prioritize participant safety after initial low-doses of MDMA increased anxiety rather than offered therapeutic benefits. Despite these challenges, the Mithoefers collaborate with the FDA continuously to create rigorous protocols that balance scientific standards with real-world therapeutic applications.

In this part-two episode of Living Medicine, Dr. Sandy Newes continues her discussion with Michael and Annie Mithoefer about the barriers they face in their MDMA research studies. Together, they discuss the unique challenges of drug research in psychotherapy, the ethical dilemmas they face, and how their work aims to transform mental health care.