PMID- 36405928
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20221122
IS  - 1664-0640 (Print)
IS  - 1664-0640 (Electronic)
IS  - 1664-0640 (Linking)
VI  - 13
DP  - 2022
TI  - Therapeutic setting as an essential component of psychedelic research 
      methodology: Reporting recommendations emerging from clinical trials of 
      3,4-methylenedioxymethamphetamine for post-traumatic stress disorder.
PG  - 965641
LID - 10.3389/fpsyt.2022.965641 [doi]
LID - 965641
AB  - Research of psychedelic assisted therapies is at an all-time high, though few 
      studies highlight extra-pharmacological factors that may affect treatment 
      efficacy. One critical set of attributes includes the therapeutic setting itself, 
      which describe the physical and socio-cultural environments in which the 
      drug-assisted session occurs. Despite enduring consensus of the influence of 
      setting, recommendations for establishing and reporting key setting variables 
      remain sparse across clinical trial protocols and published research 
      methodologies. The purpose of this paper is to: (1) present what is known of the 
      influence and implications of setting to psychedelic-assisted therapies, with a 
      particular focus on 3,4-methylenedioxymethamphetamine (MDMA); and (2) propose a 
      set of reporting guidelines for operationalizing and reporting key setting 
      variables in clinical trials of psychedelic-assisted therapies, based on 
      recommendations emerging from clinical trials of MDMA for PTSD. In fact, 
      recommendations should be expanded to "set" - the subject's mood, expectations, 
      and broader psychological condition - once this is more fully developed in the 
      field. The proposed reporting guidelines offer a means of increasing the volume 
      and variability of data necessary for future empirical examination of key setting 
      attributes influencing treatment efficacy, while preserving practitioner and 
      patient autonomy to co-construct adaptive therapy settings according to their 
      respective needs and expertise.
CI  - Copyright (c) 2022 Okano, Jones, Deyo, Brandenburg and Hale.
FAU - Okano, Lauren
AU  - Okano L
AD  - Department of Training and Supervision, Multidisciplinary Association for 
      Psychedelic Studies, Santa Cruz, CA, United States.
FAU - Jones, Gregory
AU  - Jones G
AD  - Department of Psychiatry and Behavioral Sciences, McGovern Medical School, 
      University of Texas Health Science Center at Houston, Houston, TX, United States.
FAU - Deyo, Bri
AU  - Deyo B
AD  - Department of Data Management, Multidisciplinary Association for Psychedelic 
      Studies, Santa Cruz, CA, United States.
FAU - Brandenburg, Alida
AU  - Brandenburg A
AD  - Department of Research Development and Regulatory Affairs, Multidisciplinary 
      Association for Psychedelic Studies, Santa Cruz, CA, United States.
FAU - Hale, Wesley
AU  - Hale W
AD  - Department of Training and Supervision, Multidisciplinary Association for 
      Psychedelic Studies, Santa Cruz, CA, United States.
LA  - eng
PT  - Journal Article
DEP - 20221103
PL  - Switzerland
TA  - Front Psychiatry
JT  - Frontiers in psychiatry
JID - 101545006
PMC - PMC9668859
OTO - NOTNLM
OT  - MDMA
OT  - psychedelic assisted therapy
OT  - recommendations
OT  - research methodologies
OT  - setting
COIS- Authors WH, BD, and AB receive full salary support from MAPS-PBC. The remaining 
      authors declare that the research was conducted in the absence of any commercial 
      or financial relationships that could be construed as a potential conflict of 
      interest.
EDAT- 2022/11/22 06:00
MHDA- 2022/11/22 06:01
PMCR- 2022/11/03
CRDT- 2022/11/21 04:07
PHST- 2022/06/10 00:00 [received]
PHST- 2022/10/17 00:00 [accepted]
PHST- 2022/11/21 04:07 [entrez]
PHST- 2022/11/22 06:00 [pubmed]
PHST- 2022/11/22 06:01 [medline]
PHST- 2022/11/03 00:00 [pmc-release]
AID - 10.3389/fpsyt.2022.965641 [doi]
PST - epublish
SO  - Front Psychiatry. 2022 Nov 3;13:965641. doi: 10.3389/fpsyt.2022.965641. 
      eCollection 2022.