{
  "abstract": "Background Despite growing interest in the therapeutic potential of 3,4-methylenedioxymethamphetamine (MDMA), no targeted measure to systematically assess side effects of MDMA-assisted psychotherapy (MDMA-AP) exists.Objective Our aim was to develop an MDMA-Assisted Psychotherapy Side Effects Tool (M-SET) to capture side effects over the course of MDMA-AP.Methods Informed by a systematic review and a review of other relevant questionnaires, we drafted a list of potential side effects. Face and content validation were obtained via a modified two-round online Delphi process involving experts in MDMA-AP and the neuropsychopharmacology of MDMA.Findings Twelve experts consented to participate over two rounds of Delphi panel deliberations (response rate: Round 1 = 83–92%, Round 2 = 75%). The Delphi panellists were asked to keep, discard, modify or suggest additional items. The final version of the M-SET consists of 165 items across four questionnaires that collect information at screening, baseline, the day of medication sessions and longer term follow-up.Conclusions The use of a modified Delphi technique proved a successful method to generate content for the first structured tool designed to evaluate side effects specifically associated with MDMA-AP.Clinical implications The M-SET is recommended for use in both research and clinical settings. Its implementation has the potential to improve the safety of delivering MDMA-AP as well as support the development of a more systematic and robust evidence base on its safety and tolerability.",
  "authors": [
    {
      "affiliations": [
        "Melbourne School of Psychological Sciences, University of Melbourne, Melbourne, Victoria, Australia"
      ],
      "name": "Julia Colcott"
    },
    {
      "affiliations": [
        "Centre for Youth Mental Health, University of Melbourne, Melbourne, Victoria, Australia",
        "Orygen, Melbourne, Victoria, Australia"
      ],
      "name": "Alexandre A Guerin"
    },
    {
      "affiliations": [
        "Melbourne School of Psychological Sciences, University of Melbourne, Melbourne, Victoria, Australia"
      ],
      "name": "Olivia Carter"
    },
    {
      "affiliations": [
        "Tactogen, Inc, Palo Alto, California, USA"
      ],
      "name": "Matthew J Baggott"
    },
    {
      "affiliations": [
        "UCLA Semel Institute for Neuroscience and Human Behavior, Los Angeles, California, USA"
      ],
      "name": "Anya Bershad"
    },
    {
      "affiliations": [
        "The Lundquist Institute for Biomedical Innovation, Harbor-UCLA Medical Center, Torrance, California, USA"
      ],
      "name": "Alicia Danforth"
    },
    {
      "affiliations": [
        "Department of Psychiatry and Behavioral Neuroscience, The University of Chicago, Chicago, Illinois, USA"
      ],
      "name": "Harriet de Wit"
    },
    {
      "affiliations": [
        "Department of Research Development, MAPS Public Benefit Corp, Santa Cruz, California, USA"
      ],
      "name": "Allison A Feduccia"
    },
    {
      "affiliations": [
        "University of Southern California Keck School of Medicine, Los Angeles, California, USA"
      ],
      "name": "Matthew G Kirkpatrick"
    },
    {
      "affiliations": [
        "Department of Clinical Research, University Hospital Basel, Basel, Switzerland",
        "Division of Clinical Pharmacology and Toxicology, University Hospital Basel, Basel, Switzerland",
        "Department of Biomedicine, University of Basel, Basel, Switzerland"
      ],
      "name": "Matthias E Liechti"
    },
    {
      "affiliations": [
        "Private Practice of Psychiatry and Psychotherapy, Biberist, Switzerland"
      ],
      "name": "Peter Oehen"
    },
    {
      "affiliations": [
        "Department of Clinical Research, University Hospital Basel, Basel, Switzerland",
        "Division of Clinical Pharmacology and Toxicology, University Hospital Basel, Basel, Switzerland",
        "Department of Biomedicine, University of Basel, Basel, Switzerland"
      ],
      "name": "Yasmin Schmid"
    },
    {
      "affiliations": [
        "Centre for Youth Mental Health, University of Melbourne, Melbourne, Victoria, Australia",
        "Orygen, Melbourne, Victoria, Australia"
      ],
      "name": "Gillinder Bedi"
    }
  ],
  "title": "Development of the MDMA-Assisted Psychotherapy Side Effects Tool (M-SET): a Delphi study",
  "uid": "e74d9d61-8097-511f-afc8-17517d96523e"
}