The Study

Project SAMATI: Social Anxiety MDMA-Assisted Therapy Investigation

This study is informed by previous research on MDMA-assisted therapy for post-traumatic stress disorder and social anxiety in autistic adults.

Study Goals

The goal of this study is to evaluate the safety and effectiveness of MDMA-assisted psychotherapy for social anxiety in adults. The benefits of this treatment are currently unknown, as little investigation has been conducted into precisely how MDMA-assisted psychotherapy appears to work. Therefore, this study will focus on understanding the mechanisms through which it operates.

Sponsor-Investigator

Jason Luoma, Ph.D. is the sponsor investigator and Portland Psychotherapy Clinic, Research, & Training Center is the site for this clinical trial. Portland Psychotherapy is based on a social enterprise model where profits go to fund scientific research and other kinds of social good such as low fee services, rather than into the pockets of the owners. Much of the funding for this trial comes from Portland Psychotherapy, but we are also seeking additional donations to continue our work.

Study Information

Participants: 20 adults who are diagnosed with social anxiety disorder (SAD)

Design: The 20 participants will be randomized to receive two sessions of MDMA-assisted psychotherapy either immediately or after a delay.

Location: Portland, Oregon, USA

Principal Investigator: Jason Luoma, Ph.D.

Co-Investigator: Chris Stauffer, M.D.

Clinicaltrial.gov Listing

Study Drug: The MDMA for this study will be provided by the Multidisciplinary Association for Psychedelic Studies, a 501(c)(3) non-profit research and educational organization that develops medical, legal, and cultural contexts for people to benefit from the careful uses of psychedelics.

Participating Organizations: Portland Psychotherapy Clinic, Research, & Training Center is the sponsor of this clinical trial. Our partner in this trial is Oregon Research Institute Community and Evaluation Services (ORI CES). ORI CES is an independent nonprofit organization dedicated to improving individual and community health and well-being through providing evaluation and intervention and through providing expertise to administer grants and contracts for scientific projects, evaluations, and intervention services.

Oversight: This clinical trial will be conducted under the guidance and regulations of the U.S. Food and Drug Administration (FDA) and all federal regulations including the Drug Enforcement Administration (DEA).

Study Timeline

January 6, 2021Protocol submitted to FDA for review

March 3, 2021 – Initial FDA response

June 17, 2021Second protocol submitted to FDA for review

July 16, 2021FDA clinical hold removed, allowing trial to proceed

September, 14, 2021 – IRB Approval Obtained

October 7, 2021 – DEA Application Submitted

Dec 27, 2021 – DEA Permission Received

If you’d like to donate to the study, please go here. ORI CES is a 501(c)(3) so any donation you make is tax-deductible.