Investigator-initiated trials (IIT) are unique clinical trials sponsored and implemented by clinicians to further investigate a specific research question within their field.
The MAPS Public Benefit Corporation (MAPS PBC) investigator-initiated trial (IIT) program is designed to create a network of clinicians whose innovative questioning helps to expand patient access for conditions that MDMA-assisted therapy may assist in treating. The U.S. Food and Drug Administration (FDA) defines an investigator as βan individual who both initiates and conducts a clinical trial, and under whose immediate direction the investigational drug is administered.β The clinician has the responsibility to comply with federal regulations applicable to both the sponsor and the investigator.
IIT Studies
- Location: Remedy Centre, Toronto, Ontario, Canada
- Principal Investigator: Anne Wagner
- Current Status: Enrolling
- Location: Stanford University, Palo Alto, California
- Principal Investigator: Leanne Williams
- Current Status: Enrolling
- Location: Edith Cowan University, Joondalup, Western Australia
- Principal Investigator: Stephen Bright
- Current Status: Enrolling
- Location: Portland Psychotherapy, Portland, Oregon
- Principal Investigator: Jason Luoma
- Study Disclosure
- Current Status: Study Start-Up
- Location: University of Auckland, Auckland, New Zealand & University of Otago, Dunedin, New Zealand
- Principal Investigator: Paul Glue
INOMD1: An Open-Label Feasibility Trial of MDMA-Assisted Psychotherapy for Depression
- Current Status: Study Start-Up
- Location: Ostfold Hospital, Moss, Norway
- Principal Investigator: Ole Andreassen
IUSAD1: MDMA-Assisted Therapy for Adjustment Disorder (AD) in Dyads of Patients with Breast Cancer and a Concerned Significant Other
- Current Status: Study Start-Up
- Location: Sunstone Therapies, Rockville, Maryland
- Principal Investigator: Manish Agrawal