PMID- 27859039 OWN - NLM STAT- MEDLINE DCOM- 20170529 LR - 20181113 IS - 1532-6535 (Electronic) IS - 0009-9236 (Print) IS - 0009-9236 (Linking) VI - 101 IP - 2 DP - 2017 Feb TI - Potential Psychiatric Uses for MDMA. PG - 194-196 LID - 10.1002/cpt.565 [doi] AB - 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. CI - (c) 2016, The Authors. Clinical Pharmacology & Therapeutics published by Wiley Periodicals, Inc. on behalf of American Society for Clinical Pharmacology and Therapeutics. FAU - Yazar-Klosinski, B B AU - Yazar-Klosinski BB AD - Multidisciplinary Association for Psychedelic Studies, Santa Cruz, California, USA. FAU - Mithoefer, M C AU - Mithoefer MC AD - Multidisciplinary Association for Psychedelic Studies, Santa Cruz, California, USA. LA - eng PT - Journal Article PL - United States TA - Clin Pharmacol Ther JT - Clinical pharmacology and therapeutics JID - 0372741 RN - 0 (Adrenergic Uptake Inhibitors) RN - 0 (Psychotropic Drugs) RN - KE1SEN21RM (N-Methyl-3,4-methylenedioxyamphetamine) SB - IM MH - Adrenergic Uptake Inhibitors/administration & dosage/*therapeutic use MH - Clinical Trials, Phase II as Topic MH - Humans MH - N-Methyl-3,4-methylenedioxyamphetamine/administration & dosage/*therapeutic use MH - Psychotherapy/*methods MH - Psychotropic Drugs/administration & dosage/*therapeutic use MH - Stress Disorders, Post-Traumatic/*therapy MH - United States MH - United States Food and Drug Administration PMC - PMC5260336 EDAT- 2016/11/20 06:00 MHDA- 2017/05/30 06:00 PMCR- 2017/01/13 CRDT- 2016/11/19 06:00 PHST- 2016/08/12 00:00 [received] PHST- 2016/10/31 00:00 [revised] PHST- 2016/11/06 00:00 [accepted] PHST- 2016/11/20 06:00 [pubmed] PHST- 2017/05/30 06:00 [medline] PHST- 2016/11/19 06:00 [entrez] PHST- 2017/01/13 00:00 [pmc-release] AID - CPT565 [pii] AID - 10.1002/cpt.565 [doi] PST - ppublish SO - Clin Pharmacol Ther. 2017 Feb;101(2):194-196. doi: 10.1002/cpt.565.