Investigator-Initiated Trials (IIT)

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 β€œan individual who both initiates and conducts a clinical trial, and under whose immediate direction the investigational drug is administered.” The clinician has the responsibility to comply with federal regulations applicable to both the sponsor and the investigator.

IIT Studies

ICAN1: A Phase 2 Open-Label Treatment Development Study of MDMA-Assisted Psychotherapy in Conjunction with Cognitive Processing Therapy (CPT) for Chronic Posttraumatic Stress Disorder (PTSD)

  • Location: Remedy Centre, Toronto, Ontario, Canada
  • Principal Investigator: Anne Wagner

IUSA4: A Randomized, Double-Blind, Placebo-Controlled, Within-Subject Study on the Influence of MDMA on Risk and Reward Circuits of the Brain

  • Current Status: Enrolling
  • Location: Stanford University, Palo Alto, California
  • Principal Investigator: Leanne Williams

IAUS1: An Open-label Feasibility Study to Assess the Safety and Effect of Manualized MDMA-Assisted Psychotherapy for the Treatment of Severe Posttraumatic Stress Disorder Among Four Australians

  • Current Status: Enrolling
  • Location: Edith Cowan University, Joondalup, Western Australia
  • Principal Investigator: Stephen Bright

IUSA5: A Randomized Delayed Treatment Control Phase 2 Study of the Safety and Effect of Manualized MDMA-Assisted Psychotherapy for the Treatment of Social Anxiety Disorder

  • Current Status: Enrolling
  • Location: Portland Psychotherapy, Portland, Oregon
  • Principal Investigator: Jason Luoma
  • Study Disclosure

INZL1: A Double-Blinded Randomized Controlled Trial of Low-dose MDMA Versus Standard-dose MDMA in Therapy for Mood and Anxiety Symptoms in Advanced-stage Cancer Patients

  • 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