PMID- 34114250
OWN - NLM
STAT- MEDLINE
DCOM- 20211210
LR  - 20240403
IS  - 1573-6598 (Electronic)
IS  - 0894-9867 (Print)
IS  - 0894-9867 (Linking)
VI  - 34
IP  - 4
DP  - 2021 Aug
TI  - Sleep Quality Improvements After MDMA-Assisted Psychotherapy for the Treatment of 
      Posttraumatic Stress Disorder.
PG  - 851-863
LID - 10.1002/jts.22696 [doi]
AB  - Sleep disturbances (SDs) are among the most distressing and commonly reported 
      symptoms in posttraumatic stress disorder (PTSD). Despite increased attention on 
      sleep in clinical PTSD research, SDs remain difficult to treat. In Phase 2 
      trials, 3,4-methylenedioxymethamphetamine (MDMA)-assisted psychotherapy has been 
      shown to greatly improve PTSD symptoms. We hypothesized that MDMA-assisted 
      psychotherapy would improve self-reported sleep quality (SQ) in individuals with 
      PTSD and be associated with declining PTSD symptoms. Participants in four studies 
      (n = 63) were randomized to receive 2-3 sessions of active MDMA (75-125 mg; n = 
      47) or placebo/control MDMA (0-40 mg, n = 16) during all-day psychotherapy 
      sessions. The PSQI was used to assess change in SQ from baseline to the primary 
      endpoint, 1-2 months after the blinded sessions. Additionally, PSQI scores were 
      measured at treatment exit (TE) and 12-month follow-up. Symptoms of PTSD were 
      measured using the CAPS-IV. At the primary endpoint, CAPS-IV total severity 
      scores dropped more after active MDMA than after placebo/control (-34.0 vs. 
      -12.4), p = .003. Participants in the active dose group showed more improvement 
      in SQ compared to those in the control group (PSQI total score DeltaM = -3.5 vs. 
      0.6), p = .003. Compared to baseline, SQ had improved at TE, p < .001, with 
      further significant gains reported at 12-month follow-up (TE to 12-months DeltaM = 
      -1.0), p = .030. Data from these randomized controlled double-blind studies 
      provide evidence for the beneficial effects of MDMA-assisted psychotherapy in 
      treating SDs in individuals with PTSD.
CI  - (c) 2021 MAPS Public Benefit Corporation. Journal of Traumatic Stress published by 
      Wiley Periodicals LLC on behalf of International Society for Traumatic Stress 
      Studies.
FAU - Ponte, Linnae
AU  - Ponte L
AD  - Department of Psychiatry, Yale School of Medicine, New Haven, Connecticut, USA.
FAU - Jerome, Lisa
AU  - Jerome L
AD  - MAPS Public Benefit Corporation, San Jose, California, USA.
FAU - Hamilton, Scott
AU  - Hamilton S
AD  - Department of Neurology and Neurological Sciences, Stanford School of Medicine, 
      Stanford, California, USA.
FAU - Mithoefer, Michael C
AU  - Mithoefer MC
AD  - Department of Psychiatry and Behavioral Sciences, Medical University of South 
      Carolina, Charleston, South Carolina, USA.
FAU - Yazar-Klosinski, Berra B
AU  - Yazar-Klosinski BB
AD  - MAPS Public Benefit Corporation, San Jose, California, USA.
FAU - Vermetten, Eric
AU  - Vermetten E
AD  - Department of Psychiatry, Leiden University Medical Center, Leiden, The 
      Netherlands.
AD  - ARQ National Psychotrauma Center, Diemen, The Netherlands.
FAU - Feduccia, Allison A
AU  - Feduccia AA
AD  - Psychedelic Support, Santa Cruz, California, USA.
LA  - eng
GR  - Multidisciplinary Association for Psychedelic Studies/
PT  - Journal Article
PT  - Randomized Controlled Trial
DEP - 20210610
PL  - United States
TA  - J Trauma Stress
JT  - Journal of traumatic stress
JID - 8809259
RN  - KE1SEN21RM (N-Methyl-3,4-methylenedioxyamphetamine)
SB  - IM
MH  - Combined Modality Therapy
MH  - Humans
MH  - *N-Methyl-3,4-methylenedioxyamphetamine/therapeutic use
MH  - Psychotherapy
MH  - Sleep
MH  - Sleep Quality
MH  - *Stress Disorders, Post-Traumatic/drug therapy
MH  - Treatment Outcome
PMC - PMC8453707
EDAT- 2021/06/12 06:00
MHDA- 2021/12/15 06:00
PMCR- 2021/09/21
CRDT- 2021/06/11 07:05
PHST- 2021/03/19 00:00 [revised]
PHST- 2019/12/18 00:00 [received]
PHST- 2021/03/22 00:00 [accepted]
PHST- 2021/06/12 06:00 [pubmed]
PHST- 2021/12/15 06:00 [medline]
PHST- 2021/06/11 07:05 [entrez]
PHST- 2021/09/21 00:00 [pmc-release]
AID - JTS22696 [pii]
AID - 10.1002/jts.22696 [doi]
PST - ppublish
SO  - J Trauma Stress. 2021 Aug;34(4):851-863. doi: 10.1002/jts.22696. Epub 2021 Jun 
      10.