Research & Development
Advancing Innovation Through Evidence-Based Research
Integrating clinical research, innovation, and practice for transformative care.
Our team has extensive experience with clinical trial research. Between 2012 and 2023 our founders led clinical trials using MDMA-Assisted Therapy for PTSD and for Healthy Volunteers. The following studies were sponsored by Lykos Therapeutics and conducted in Boulder, Colorado by our team.
Phase I - MT-1
A Phase 1 Placebo-Controlled, Double-Blind, Multi-Site Crossover Study to Assess Psychological Effects of MDMA when administered to Healthy Volunteers. This study offered health care professional practitioners who had completed their training in MDMA-assisted therapy the opportunity to experience an MDMA and placebo session with experienced investigators.
Phase II - MP12
A Randomized, Double-Blind, Dose Response Phase 2 Pilot Study of Manualized MDMA-Assisted Psychotherapy in Subjects with Chronic, Treatment-Resistant Posttraumatic Stress Disorder (PTSD). This was a crossover study evaluating the effectiveness of MDMA-assisted therapy using different doses of MDMA for people with treatment-resistant PTSD.
Phase II - MP16
An Open-Label, Multi-Site Phase 2 Study of the Safety and Effect of Manualized MDMA-Assisted Psychotherapy for the Treatment of Severe Posttraumatic Stress Disorder. This study was a critical part of preparing sub-investigators for working with MDMA-assisted therapy for the first time, as an open label study in a research setting, where they received close supervision. All Phase III sub-investigators were given the opportunity to participate.
Phase III - MAPP1
A Randomized, Double-Blind, Placebo-Controlled, Multi-Site Phase 3 Study of the Efficacy and Safety of Manualized MDMA-Assisted Psychotherapy for the Treatment of Severe Posttraumatic Stress Disorder. This was the first half of a large multisite study evaluating the safety and effectiveness of MDMA-Assisted Therapy for people with PTSD.
MAPP2
A Randomized, Double-Blind, Placebo-Controlled, Multi-Site Phase 3 Study of the Efficacy and Safety of Manualized MDMA-Assisted Psychotherapy for the Treatment of Posttraumatic Stress Disorder of Moderate or Greater Severity. This was a large multisite study evaluating the safety and effectiveness of MDMA-assisted therapy for people with PTSD.
MAPPUSX
A Multi-Site Open Label Safety Extension Study of Manualized MDMA-Assisted Therapy for the Treatment of Participants with Posttraumatic Stress Disorder. This was a crossover study for participants from MAPP1 and MAPP2 studies who received a placebo during their participation in the above and wanted to experience MDMA-assisted therapy, some of whom no longer met criteria for PTSD as a result of their placebo sessions.
