Research and Clinical Trials

Psychedelic-assisted therapy using MDMA (3,4-methyl​enedioxy​methamphetamine), psilocybin, and other psychedelic compounds represents a new modality for treating patients with posttraumatic stress disorder (PTSD) and other mental health issues. At the Center for Psychedelic Therapy Research, we are conducting clinical trials and investigating the neurobiological mechanisms underpinning psychedelic treatments. This is important and time sensitive work as the U.S. Food and Drug Administration considers approval for MDMA-assisted and other psychedelic-assisted psychotherapies.

The Need

Mental health care need for PTSD has reached a crisis point. Each year, approximately 17 million adults grapple with PTSD, and nearly 6 percent of Americans will experience the condition at some point in their lifetime. Combat veterans are at an even greater risk than the general population, with an estimated 11 percent to 20 percent of veterans who served in Iraq or Afghanistan experiencing PTSD each year. More than half a million veterans have sought treatment for PTSD in the last few years. Some have received it for decades.  Trauma can contribute to other mental health problems, such as depression and anxiety. In addition, significant occupational, familial, and social disruptions are common and often lead to increased health care use, medical comorbidities, substance abuse, suicidality, and family violence.

Clinical Trials

Although industry-sponsored Phase 2 and Phase 3 studies have demonstrated promising results with MDMA for PTSD, it is critical to learn more about how psychedelics work and who may or may not benefit from these therapies. It is also critical to understand the mechanisms involved in resilience and recovery in order to scale and deliver the treatment more effectively. The Center is currently investigating two-dose vs. three-dose MDMA treatment for PTSD with veterans. Further dose optimization studies will be rolling out.

The Center is also looking into issues associated with cost and scaling of MDMA-assisted psychotherapy, as well as developing and tailoring the treatment for settings where there may be barriers, restrictions, or other concerns. These protocols test the efficacy and cost efficiency of different models for delivering MDMA-assisted and psilocybin-assisted psychotherapy, including the number of sessions and group modalities. Simultaneously, the Center is considering contraindications and other barriers to treatment efficacy.

Another area of research is exploring the safety and efficacy of using psychedelics to treat a wider range of concerns, including depression and bulimia.

Some of the clinical trials currently taking place are:

  • Randomized clinical trial comparing MDMA-assisted therapy with two versus three MDMA sessions in veterans with PTSD in an outpatient Veterans Administration setting
  • Open label, two-site study of psilocybin for PTSD, conducted at the Center and Kings College London
  • Study exploring changes in brain functioning associated with MDMA-assisted therapy
  • Research looking at changes in brain functioning associated with psilocybin-assisted therapy
  • Assessment, using functional magnetic resonance imaging, of changes in brain functioning associated with treatment (being performed in conjunction with the MDMA-assisted and psilocybin-assisted therapy studies)
  • Long-term follow-up study of veterans following MDMA-assisted therapy
  • Exploration of psychological and biological changes associated with MDMA-assisted psychotherapy in healthy volunteers

In addition to these ongoing studies, Center researchers and affiliated researchers are also developing several new studies including:

  • Open label, single-dose session of MDMA-assisted therapy for individuals in training to be MDMA-assisted therapists
  • Study of group therapy model for MDMA-assisted treatment
  • Study of MDMA-assisted therapy for bulimia nervosa
  • Examination of ketamine-assisted psychotherapy
  • Stem cell in vitro study of psychedelic compounds
  • Psilocybin study to investigate serotonin receptor role in psychedelic effect
  • Research exploring MDMA-assisted therapy for therapists in training
  • Study looking at MDMA-assisted therapy for borderline personality disorder
  • Research on MDMA-assisted therapy for intergenerational and racial trauma
  • Study assessing MDMA-assisted therapy for couples
  • Research looking at the impact of psychedelics on gene expression networks in neuronal cells
  • Scalability and potential affordability studies of above treatments, to ensure that the therapies are both accessible and equitable
  • Research to identify the underlying biology of integration and transformation, focusing on how drug-induced, short-term alterations result in sustained and dramatic changes in well-being

Neurobiological Research of Psychedelic Compounds

Drawing on the extensive experience of Rachel Yehuda, PhD, as a leader in examining neurobiological mechanisms of psychotherapy and other treatments for PTSD, our Center will investigate the effects of psychedelics on brain function and molecular and cellular biology. This will be accomplished by obtaining brain images and blood samples before and after psychedelic administration in willing participants for the assessment of well-established biomarkers of PTSD and resilience.

Genome-wide epigenetic, gene expression, proteins, metabolites, immune markers, and hormones can be measured before and after treatment. The knowledge gained from these biomarkers will not only allow us to understand biological changes associated with recovery but will also help us understand how recovery with psychedelics may lead to more enduring, transformational changes. In addition, stem cell technology will be used to determine the impact of psychedelics on gene expression networks in neuronal cells reprogrammed from stem cells obtained from persons with and without PTSD.