PMID- 25818246 OWN - NLM STAT- MEDLINE DCOM- 20160531 LR - 20150908 IS - 1878-4216 (Electronic) IS - 0278-5846 (Linking) VI - 64 DP - 2016 Jan 4 TI - MDMA-assisted therapy: A new treatment model for social anxiety in autistic adults. PG - 237-49 LID - S0278-5846(15)00060-3 [pii] LID - 10.1016/j.pnpbp.2015.03.011 [doi] AB - The first study of 3,4-methylenedioxymethamphetamine (MDMA)-assisted therapy for the treatment of social anxiety in autistic adults commenced in the spring of 2014. The search for psychotherapeutic options for autistic individuals is imperative considering the lack of effective conventional treatments for mental health diagnoses that are common in this population. Serious Adverse Events (SAEs) involving the administration of MDMA in clinical trials have been rare and non-life threatening. To date, MDMA has been administered to over 1133 individuals for research purposes without the occurrence of unexpected drug-related SAEs that require expedited reporting per FDA regulations. Now that safety parameters for limited use of MDMA in clinical settings have been established, a case can be made to further develop MDMA-assisted therapeutic interventions that could support autistic adults in increasing social adaptability among the typically developing population. As in the case with classic hallucinogens and other psychedelic drugs, MDMA catalyzes shifts toward openness and introspection that do not require ongoing administration to achieve lasting benefits. This infrequent dosing mitigates adverse event frequency and improves the risk/benefit ratio of MDMA, which may provide a significant advantage over medications that require daily dosing. Consequently, clinicians could employ new treatment models for social anxiety or similar types of distress administering MDMA on one to several occasions within the context of a supportive and integrative psychotherapy protocol. CI - Copyright (c) 2015 Elsevier Inc. All rights reserved. FAU - Danforth, Alicia L AU - Danforth AL AD - Los Angeles Biomedical Research Institute, Torrance, CA, United States. Electronic address: adanforth@labiomed.org. FAU - Struble, Christopher M AU - Struble CM AD - Department of Psychiatry, Harbor-UCLA Medical Center, Torrance, CA, United States. Electronic address: cstruble.md@gmail.com. FAU - Yazar-Klosinski, Berra AU - Yazar-Klosinski B AD - Multidisciplinary Association for Psychedelic Studies, Santa Cruz, CA, United States. Electronic address: Berra@MAPS.org. FAU - Grob, Charles S AU - Grob CS AD - Department of Psychiatry, Harbor-UCLA Medical Center, Los Angeles Biomedical Research Institute, Torrance, CA, United States. Electronic address: cgrob@labiomed.org. LA - eng SI - ClinicalTrials.gov/NCT02008396 PT - Journal Article PT - Randomized Controlled Trial PT - Research Support, Non-U.S. Gov't DEP - 20150325 PL - England TA - Prog Neuropsychopharmacol Biol Psychiatry JT - Progress in neuro-psychopharmacology & biological psychiatry JID - 8211617 RN - 0 (Psychotropic Drugs) RN - KE1SEN21RM (N-Methyl-3,4-methylenedioxyamphetamine) SB - IM MH - Adult MH - Anxiety Disorders/complications/*drug therapy/physiopathology MH - Autistic Disorder/complications/*drug therapy/physiopathology MH - Double-Blind Method MH - Follow-Up Studies MH - Humans MH - N-Methyl-3,4-methylenedioxyamphetamine/*administration & dosage/adverse effects MH - Patient Selection MH - Pilot Projects MH - Prospective Studies MH - Psychotropic Drugs/*administration & dosage/adverse effects MH - Research Design MH - Social Perception OTO - NOTNLM OT - Autism OT - Ecstasy OT - MDMA OT - Psychedelics OT - Psychotherapy OT - Social anxiety EDAT- 2015/03/31 06:00 MHDA- 2016/06/01 06:00 CRDT- 2015/03/31 06:00 PHST- 2015/01/01 00:00 [received] PHST- 2015/03/16 00:00 [revised] PHST- 2015/03/17 00:00 [accepted] PHST- 2015/03/31 06:00 [entrez] PHST- 2015/03/31 06:00 [pubmed] PHST- 2016/06/01 06:00 [medline] AID - S0278-5846(15)00060-3 [pii] AID - 10.1016/j.pnpbp.2015.03.011 [doi] PST - ppublish SO - Prog Neuropsychopharmacol Biol Psychiatry. 2016 Jan 4;64:237-49. doi: 10.1016/j.pnpbp.2015.03.011. Epub 2015 Mar 25.