Bedi G, Cotton SM, Guerin AA, Jackson HJ. MDMA-assisted psychotherapy for post-traumatic stress disorder: the devil is in the detail. Aust NZ J Psychiatry. 2023;57:476–81.

Article  Google Scholar 

Muthukumaraswamy SD, Forsyth A, Lumley T. Blinding and expectancy confounds in psychedelic randomized controlled trials. Expert Rev Clin Pharmacol. 2021;14:1133–52.

Article  CAS  PubMed  Google Scholar 

Mitchell JM, Bogenschutz M, Lilienstein A, Harrison C, Kleiman S, Parker-Guilbert K, et al. MDMA-assisted therapy for severe PTSD: a randomized, double-blind, placebo-controlled phase 3 study. Nat Med. 2021;27:1025–33.

Article  CAS  PubMed  PubMed Central  Google Scholar 

Mitchell JM, Ot’alora GM, van der Kolk B, Shannon S, Bogenschutz M, Gelfand Y, et al. MDMA-assisted therapy for moderate to severe PTSD: a randomized, placebo-controlled phase 3 trial. Nat Med. 2023;29:2473–80.

Sessa B, Higbed L, O’Brien S, Durant C, Sakal C, Titheradge D, et al. First study of safety and tolerability of 3,4-methylenedioxymethamphetamine-assisted psychotherapy in patients with alcohol use disorder. J Psychopharmacol. 2021;35:375–83.

Article  CAS  PubMed  Google Scholar 

Danforth AL, Grob CS, Struble C, Feduccia AA, Walker N, Jerome L, et al. Reduction in social anxiety after MDMA-assisted psychotherapy with autistic adults: a randomized, double-blind, placebo-controlled pilot study. Psychopharmacol (Berl). 2018;235:3137–48.

Article  CAS  Google Scholar 

Wolfson PE, Andries J, Feduccia AA, Jerome L, Wang JB, Williams E, et al. MDMA-assisted psychotherapy for treatment of anxiety and other psychological distress related to life-threatening illnesses: a randomized pilot study. Sci Rep. 2020;10:20442.

Article  CAS  PubMed  PubMed Central  Google Scholar 

Siegel AN, Meshkat S, Benitah K, Lipsitz O, Gill H, Lui LMW, et al. Registered clinical studies investigating psychedelic drugs for psychiatric disorders. J Psychiatr Res. 2021;139:71–81.

Article  PubMed  Google Scholar 

Therapeutic Goods Administration. Notice of final decision to amend (or not amend) the current Poisons Standard - June 2022 ACMS #38 - Psilocybine and MDMA 2023 [Available from: https://www.tga.gov.au/resources/publication/scheduling-decisions-final/notice-final-decision-amend-or-not-amend-current-poisons-standard-june-2022-acms-38-psilocybine-and-mdma

Reardon S. US could soon approve MDMA therapy — opening an era of psychedelic medicine. Nature. 2023;616:428–30.

Article  CAS  PubMed  Google Scholar 

Vizeli P, Liechti ME. Safety pharmacology of acute MDMA administration in healthy subjects. J Psychopharmacol. 2017;31:576–88.

Article  CAS  PubMed  Google Scholar 

McNamee S, Devenot N, Buisson M. Studying harms is key to improving psychedelic-assisted therapy—participants call for changes to research landscape. JAMA Psychiatry. 2023;80:411–2.

Article  PubMed  Google Scholar 

Meikle S, Carter O, Bedi G. Psychedelic-assisted psychotherapy, patient vulnerability and abuses of power. Aust NZ J Psychiatry. 2023:00048674231200164.

Breeksema JJ, Kuin BW, Kamphuis J, van den Brink W, Vermetten E, Schoevers RA. Adverse events in clinical treatments with serotonergic psychedelics and MDMA: A mixed-methods systematic review. J Psychopharmacol. 2022;36:1100–17.

Article  PubMed  PubMed Central  Google Scholar 

Amoroso T, Workman M. Treating posttraumatic stress disorder with MDMA-assisted psychotherapy: A preliminary meta-analysis and comparison to prolonged exposure therapy. J Psychopharmacol. 2016;30:595–600.

Article  CAS  PubMed  Google Scholar 

Bahji A, Forsyth A, Groll D, Hawken ER. Efficacy of 3,4-methylenedioxymethamphetamine (MDMA)-assisted psychotherapy for posttraumatic stress disorder: A systematic review and meta-analysis. Prog Neuro-Psychopharmacol Biol Psychiatry. 2020;96:109735.

Article  CAS  Google Scholar 

Luoma JB, Chwyl C, Bathje GJ, Davis AK, Lancelotta R. A meta-analysis of placebo-controlled trials of psychedelic-assisted therapy. J Psychoact Drugs. 2020;52:289–99.

Article  Google Scholar 

Psiuk D, Nowak E, Cholewa K, Łopuszańska U, Samardakiewicz M. The potential role of serotonergic hallucinogens in depression treatment. Life. 2021;11:765.

Article  PubMed  PubMed Central  Google Scholar 

Schimmers N, Breeksema JJ, Smith-Apeldoorn SY, Veraart J, van den Brink W, Schoevers RA. Psychedelics for the treatment of depression, anxiety, and existential distress in patients with a terminal illness: a systematic review. Psychopharmacology. 2022;239:15–33.

Article  PubMed  Google Scholar 

Smith KW, Sicignano DJ, Hernandez AV, White CM. MDMA-assisted psychotherapy for treatment of posttraumatic stress disorder: a systematic review with meta-analysis. J Clin Pharmacol. 2022;62:463–71.

Article  CAS  PubMed  Google Scholar 

Tedesco S, Gajaram G, Chida S, Ahmad A, Pentak M, Kelada M, et al. The efficacy of MDMA (3,4-Methylenedioxymethamphetamine) for post-traumatic stress disorder in humans: a systematic review and meta-analysis. Cureus. 2021;13:e15070.

PubMed  PubMed Central  Google Scholar 

Varker T, Watson L, Gibson K, Forbes D, O’Donnell ML. Efficacy of psychoactive drugs for the treatment of posttraumatic stress disorder: a systematic review of MDMA, ketamine, LSD and psilocybin. J Psychoact Drugs. 2021;53:85–95.

Article  CAS  Google Scholar 

Illingworth BJ, Lewis DJ, Lambarth AT, Stocking K, Duffy JM, Jelen LA, et al. A comparison of MDMA-assisted psychotherapy to non-assisted psychotherapy in treatment-resistant PTSD: A systematic review and meta-analysis. J Psychopharmacol. 2021;35:501–11.

Article  CAS  PubMed  Google Scholar 

Kisely S, Connor M, Somogyi AA, Siskind D. A systematic literature review and meta-analysis of the effect of psilocybin and methylenedioxymethamphetamine on mental, behavioural or developmental disorders. Aust NZ J Psychiatry. 2023;57:362–78.

Article  Google Scholar 

Junqueira DR, Zorzela L, Golder S, Loke Y, Gagnier JJ, Julious SA, et al. CONSORT Harms 2022 statement, explanation, and elaboration: updated guideline for the reporting of harms in randomised trials. BMJ. 2023;381:e073725.

Article  PubMed  Google Scholar 

Page MJ, McKenzie JE, Bossuyt PM, Boutron I, Hoffmann TC, Mulrow CD, et al. The PRISMA 2020 statement: an updated guideline for reporting systematic reviews. BMJ. 2021;372:n71.

Article  PubMed  PubMed Central  Google Scholar 

Higgins J, Thomas J, Chandler J, Cumpston M, Li T, Page M, et al. Cochrane Handbook for Systematic Reviews of Interventions version 6.4 (updated August 2023): Cochrane; 2023

Mithoefer MC, Feduccia AA, Jerome L, Mithoefer A, Wagner M, Walsh Z, et al. MDMA-assisted psychotherapy for treatment of PTSD: study design and rationale for phase 3 trials based on pooled analysis of six phase 2 randomized controlled trials. Psychopharmacology. 2019;236:2735–45.

Article  CAS  PubMed  PubMed Central  Google Scholar 

Taillefer de Laportalière T, Jullien A, Yrondi A, Cestac P, Montastruc F. Reporting of harms in clinical trials of esketamine in depression: a systematic review. Psychological Med. 2023;53:4305–15.

Article  Google Scholar 

Yuniar CT, Pratiwi B, Ihsan AF, Laksono BT, Risfayanti I, Fathadina A, et al. Adverse events reporting quality of randomized controlled trials of COVID-19 vaccine using the CONSORT criteria for reporting harms: a systematic review. Vaccines. 2022;10:313.

Article  CAS  PubMed  PubMed Central  Google Scholar 

National Institutes of Health. Clinical trials registration and results information submission. Final rule. Fed Regist. 2016;81:64981–5157.

Google Scholar 

Sterne JAC, Savović J, Page MJ, Elbers RG, Blencowe NS, Boutron I, et al. RoB 2: a revised tool for assessing risk of bias in randomised trials. BMJ. 2019;366:l4898.

Article  PubMed  Google Scholar 

Loke YK, Price D, Herxheimer A, the Cochrane Adverse Effects Methods G. Systematic reviews of adverse effects: framework for a structured approach. BMC Med Res Methodol. 2007;7:32.

Article  PubMed  PubMed Central  Google Scholar 

Schünemann H, Brozek J, Guyatt G, Oxman A GRADE handbook for grading quality of evidence and strength of recommendations: The GRADE Working Group, 2013; 2013 [updated October 2013. Available from: https://gdt.gradepro.org/app/handbook/handbook.html

Jardim, Jardim AV, Chaves DV, Steglich BR, Ot’alora GM M, Mithoefer MC, et al. 3,4-methylenedioxymethamphetamine (MDMA)-assisted psychotherapy for victims of sexual abuse with severe post-traumatic stress disorder: an open label pilot study in Brazil. Braz J Psychiatry. 2021;43:181–5.

Article  PubMed  Google Scholar 

Mithoefer MC, Wagner MT, Mithoefer AT, Jerome L, Doblin R. The safety and efficacy of +/-3,4-methylenedioxymethamphetamine-assisted psychotherapy in subjects with chronic, treatment-resistant posttraumatic stress disorder: the first randomized controlled pilot study. J Psychopharmacol. 2011;25:439–52.

Article  CAS  PubMed  PubMed Central  Google Scholar 

Monson CM, Wagner AC, Mithoefer AT, Liebman RE, Feduccia AA, Jerome L, et al. MDMA-facilitated cognitive-behavioural conjoint therapy for posttraumatic stress disorder: an uncontrolled trial. Eur J Psychotraumatol. 2020;11:1840123.

Article  PubMed  PubMed Central  Google Scholar 

Oehen P, Traber R, Widmer V, Schnyder U. A randomized, controlled pilot study of MDMA (±3,4-Methylenedioxymethamphetamine)-assisted psychotherapy for treatment of resistant, chronic Post-Traumatic Stress Disorder (PTSD). J Psychopharmacol. 2013;27:40–52.

Article  CAS  PubMed  Google Scholar 

Oehen P, Gasser P. Using a MDMA- and LSD-group therapy model in clinical practice in Switzerland and highlighting the treatment of trauma-related disorders. Front Psychiatry. 2022;13:863552.

Ot’alora M, Grigsby J, Poulter B, Van Derveer JW, Giron SG, Jerome L, et al. 3,4-Methylenedioxymethamphetamine-assisted psychotherapy for treatment of chronic posttraumatic stress disorder: A randomized phase 2 controlled trial. J Psychopharmacol. 2018;32:1295–307.

Article  Google Scholar 

Mithoefer MC, Mithoefer AT, Feduccia AA, Jerome L, Wagner M, Wymer J, et al. 3,4-methylenedioxymethamphetamine (MDMA)-assisted psychotherapy for post-traumatic stress disorder in military veterans, firefighters, and police officers: a randomised, double-blind, dose-response, phase 2 clinical trial. Lancet Psychiatry. 2018;5:486–97.

Article  PubMed  Google Scholar 

Bouso JC, Doblin R, Farré M, Alcázar MÁ, Gómez-Jarabo G. MDMA-assisted psychotherapy using low doses in a small sample of women with chronic posttraumatic stress disorder. J Psychoact Drugs. 2008;40:225–36.

Article