PMID- 32500209
OWN - NLM
STAT- MEDLINE
DCOM- 20201110
LR  - 20240329
IS  - 1432-2072 (Electronic)
IS  - 0033-3158 (Print)
IS  - 0033-3158 (Linking)
VI  - 237
IP  - 8
DP  - 2020 Aug
TI  - Long-term follow-up outcomes of MDMA-assisted psychotherapy for treatment of 
      PTSD: a longitudinal pooled analysis of six phase 2 trials.
PG  - 2485-2497
LID - 10.1007/s00213-020-05548-2 [doi]
AB  - RATIONALE: Posttraumatic stress disorder (PTSD) is a chronic condition that has 
      wide-ranging negative effects on an individual's health and interpersonal 
      relationships. Treatments with long-term benefits are needed to promote the 
      safety and well-being of those suffering from PTSD. OBJECTIVES: To examine 
      long-term change in PTSD symptoms and additional benefits/harms after 
      3,4-methylenedioxymethamphetamine (MDMA)-assisted psychotherapy for treatment of 
      PTSD. METHODS: Participants received two to three active doses of MDMA 
      (75-125 mg) during blinded or open-label psychotherapy sessions with additional 
      non-drug therapy sessions. PTSD symptoms were assessed using the 
      Clinician-Administered PTSD Scale for DSM IV (CAPS-IV) at baseline, 1 to 2 months 
      after the last active MDMA session (treatment exit), and at least 12 months post 
      final MDMA session (LTFU). A mixed-effect repeated-measures (MMRM) analysis 
      assessed changes in CAPS-IV total severity scores. The number of participants who 
      met PTSD diagnostic criteria was summarized at each time point. Participants 
      completed a long-term follow-up questionnaire. RESULTS: There was a significant 
      reduction in CAPS-IV total severity scores from baseline to treatment exit (LS 
      mean (SE) = - 44.8 (2.82), p < .0001), with a Cohen's d effect size of 1.58 (95% 
      CI = 1.24, 1.91). CAPS-IV scores continued to decrease from treatment exit to 
      LTFU (LS mean (SE) = - 5.2 (2.29), p < .05), with a Cohen's d effect size of 0.23 
      (95% CI = 0.04, 0.43). The number of participants who no longer met PTSD criteria 
      increased from treatment exit (56.0%) to LTFU (67.0%). The majority of 
      participants reported benefits, including improved relationships and well-being, 
      and a minority reported harms from study participation. CONCLUSIONS: PTSD 
      symptoms were reduced 1 to 2 months after MDMA-assisted psychotherapy, and 
      symptom improvement continued at least 12 months post-treatment. Phase 3 trials 
      are investigating this novel treatment approach in a larger sample of 
      participants with chronic PTSD. TRIAL REGISTRATION: clinicaltrials.gov 
      Identifier: NCT00090064, NCT00353938, NCT01958593, NCT01211405, NCT01689740, 
      NCT01793610.
FAU - Jerome, Lisa
AU  - Jerome L
AUID- ORCID: 0000-0001-6209-8750
AD  - MAPS Public Benefit Corporations, 1115 Mission St., Santa Cruz, CA, 95060, USA. 
      Ilsa@mapsbcorp.com.
FAU - Feduccia, Allison A
AU  - Feduccia AA
AD  - MAPS Public Benefit Corporations, 1115 Mission St., Santa Cruz, CA, 95060, USA.
FAU - Wang, Julie B
AU  - Wang JB
AD  - MAPS Public Benefit Corporations, 1115 Mission St., Santa Cruz, CA, 95060, USA.
FAU - Hamilton, Scott
AU  - Hamilton S
AD  - Stanford School of Medicine, Stanford University, Stanford, CA, USA.
FAU - Yazar-Klosinski, Berra
AU  - Yazar-Klosinski B
AD  - Multidisciplinary Association for Psychedelic Studies, Santa Cruz, CA, USA.
FAU - Emerson, Amy
AU  - Emerson A
AD  - MAPS Public Benefit Corporations, 1115 Mission St., Santa Cruz, CA, 95060, USA.
FAU - Mithoefer, Michael C
AU  - Mithoefer MC
AD  - Medical University of South Carolina, Charleston, SC, USA.
FAU - Doblin, Rick
AU  - Doblin R
AD  - Multidisciplinary Association for Psychedelic Studies, Santa Cruz, CA, USA.
LA  - eng
SI  - ClinicalTrials.gov/NCT01211405
SI  - ClinicalTrials.gov/NCT01958593
SI  - ClinicalTrials.gov/NCT01793610
SI  - ClinicalTrials.gov/NCT00353938
SI  - ClinicalTrials.gov/NCT01689740
SI  - ClinicalTrials.gov/NCT00090064
PT  - Clinical Trial, Phase II
PT  - Journal Article
PT  - Randomized Controlled Trial
DEP - 20200604
PL  - Germany
TA  - Psychopharmacology (Berl)
JT  - Psychopharmacology
JID - 7608025
RN  - KE1SEN21RM (N-Methyl-3,4-methylenedioxyamphetamine)
SB  - IM
MH  - Adult
MH  - Combined Modality Therapy/methods
MH  - Cross-Over Studies
MH  - Dose-Response Relationship, Drug
MH  - Double-Blind Method
MH  - Female
MH  - Follow-Up Studies
MH  - Humans
MH  - Longitudinal Studies
MH  - Male
MH  - Middle Aged
MH  - N-Methyl-3,4-methylenedioxyamphetamine/*administration & dosage
MH  - Psychotherapy/*methods
MH  - Stress Disorders, Post-Traumatic/diagnosis/*psychology/*therapy
MH  - Surveys and Questionnaires
MH  - Treatment Outcome
PMC - PMC7351848
OTO - NOTNLM
OT  - Long-term follow-up
OT  - MDMA
OT  - MDMA-assisted psychotherapy
OT  - PTSD
COIS- Lisa Jerome, Allison Feduccia, and Julie Wang received salary support for 
      full-time employment with MPBC. Scott Hamilton, Mt Tam Data Analysis, received 
      salary support from MPBC as an independent biostatistician. Berra Yazar-Klosinski 
      received salary support for full-time employment with MAPS. Amy Emerson received 
      salary support for full-time employment with MPBC. Michael Mithoefer received 
      salary support from MPBC as a clinical investigator and clinical trial medical 
      monitor as well as for training and supervision of research psychotherapists. 
      Rick Doblin received salary support for full-time employment with MAPS.
EDAT- 2020/06/06 06:00
MHDA- 2020/11/11 06:00
PMCR- 2020/06/04
CRDT- 2020/06/06 06:00
PHST- 2019/09/18 00:00 [received]
PHST- 2020/05/11 00:00 [accepted]
PHST- 2020/06/06 06:00 [pubmed]
PHST- 2020/11/11 06:00 [medline]
PHST- 2020/06/06 06:00 [entrez]
PHST- 2020/06/04 00:00 [pmc-release]
AID - 10.1007/s00213-020-05548-2 [pii]
AID - 5548 [pii]
AID - 10.1007/s00213-020-05548-2 [doi]
PST - ppublish
SO  - Psychopharmacology (Berl). 2020 Aug;237(8):2485-2497. doi: 
      10.1007/s00213-020-05548-2. Epub 2020 Jun 4.