Disclosure: IUSA5: A Randomized, Delayed Treatment Control Phase 2 Study of the Safety and Effectiveness of Manualized MDMA-Assisted Therapy for the Treatment of Social Anxiety Disorder

Social Anxiety MDMA-Assisted Therapy Investigation (SAMATI) 

Jason Luoma, Ph.D., of Portland Psychotherapy, is the sponsor and Principal Investigator for SAMATI, an exploratory study to investigate the safety and preliminary efficacy of MDMA-assisted therapy for social anxiety in adults, and examine the physiological mechanisms through which it may be effective. The study is a randomized, open-label, delayed control study that aims to treat 20 participants diagnosed with moderate-to-severe social anxiety disorder (SAD) of the generalized subtype. 

SAD is the fourth most common psychiatric disorder in the United States with widespread impact on individuals and society. SAD commonly leads to increased isolation, prevention of meaningful social relationships and employment, and contribution to comorbid psychiatric conditions such as Alcohol Use Disorder and Major Depressive Disorder. Despite its widespread impact, there is insufficient research into novel treatments for SAD. Improving the possible treatments for this condition has the potential for very high public health impact.

Dr. Luoma’s clinical work and research focuses on factors that impede individuals’ sense of belonging and social functioning with a particular focus on shame, avoidance, and self-criticism, all of which are characteristics of SAD. Research suggests that MDMA-assisted therapy may target these feelings, therefore Dr. Luoma hypothesizes that MDMA-assisted therapy may demonstrate effectiveness in individuals with SAD. 

A previous MAPS-sponsored Phase 2 pilot study on the potential for MDMA-assisted therapy to treat social anxiety in twelve autistic adults showed promising results: Participants had statistically significant reductions in social anxiety as measured by the Liebowitz Social Anxiety Scale (LSAS) both one and five months after treatment. This trial aims to build on those results and further evaluate the potential of MDMA-assisted therapy for treating SAD within the general population. 

The study, for which MAPS Public Benefit Corporation (MAPS PBC) is providing MDMA, will be carried out by a team from the Portland Psychotherapy Clinic, Research, and Training Center in collaboration with the Oregon Research Institute Center for Evaluation Services. Portland Psychotherapy is self-funding this trial, relying on the organization’s social enterprise model and support from partners and donors. The researchers hope to pursue further studies in the future with larger sample sizes and access government funding. You can visit the study’s website to find out more and donate if you wish to help.