A Phase 1, Open-Label, Single-Site Study to Assess Psychological Effects of MDMA-Assisted Therapy when Administered to Healthy Volunteers (MAE1)

A Phase 1, Open-Label, Single-Site Study to Assess Psychological Effects of MDMA-Assisted Therapy when Administered to Healthy Volunteers

This protocol is a Phase 1, open-label, single-site study with a primary purpose of evaluating the safety and efficacy of MDMA-assisted therapy in healthy volunteer therapists. This study will provide Phase 1 healthy volunteer data, while also supporting the expansion of the trainees’ knowledge of the subjective effects and therapeutic potential of MDMA-assisted therapy.

The primary outcome measures to assess the efficacy of MDMA-assisted therapy will be assessed will be the Psychedelic Preparedness Scale (PPS) and the Integration Engagement Scale (IES).  The ability to prepare clients for the MDMA experience and help them to integrate the lessons learned from their medicine experience are two crucial skills for all therapists. The extent to which the level of preparation is correlated to the level of integration would assist in the development of best practices in the future.