title: Potential Psychiatric Uses for MDMA.
abstract: Phase II trials of 3,4-methylenedioxymethamphetamine (MDMA)-assisted psychotherapy have demonstrated initial safety and efficacy for treatment of posttraumatic stress disorder (PTSD), with potential for expansion to depression and anxiety disorders. In these trials, single doses of MDMA are administered in a model of medication-assisted psychotherapy, differing from trials involving daily drug administration without psychotherapy. This model presents an opportunity to utilize accelerated regulatory pathways, such as the US Food and Drug Administration (FDA) Breakthrough Therapy Designation, to most effectively and expeditiously test such novel approaches.
authors.affiliation: Multidisciplinary Association for Psychedelic Studies, Santa Cruz, California, USA.
authors.forename: B B
authors.initials: BB
authors.lastname: Yazar-Klosinski
authors.affiliation: Multidisciplinary Association for Psychedelic Studies, Santa Cruz, California, USA.
authors.forename: M C
authors.initials: MC
authors.lastname: Mithoefer
mesh_terms: D018759:Adrenergic Uptake Inhibitors / Q000008:administration & dosage / Q000627:therapeutic use*; D017322:Clinical Trials, Phase II as Topic; D006801:Humans; D018817:N-Methyl-3,4-methylenedioxyamphetamine / Q000008:administration & dosage / Q000627:therapeutic use*; D011613:Psychotherapy / Q000379:methods*; D011619:Psychotropic Drugs / Q000008:administration & dosage / Q000627:therapeutic use*; D013313:Stress Disorders, Post-Traumatic / Q000628:therapy*; D014481:United States; D014486:United States Food and Drug Administration
chemical_list: D018759:Adrenergic Uptake Inhibitors; D011619:Psychotropic Drugs; D018817:N-Methyl-3,4-methylenedioxyamphetamine