PMID- 31308191
OWN - NLM
STAT- MEDLINE
DCOM- 20200113
LR  - 20210716
IS  - 1757-790X (Electronic)
IS  - 1757-790X (Linking)
VI  - 12
IP  - 7
DP  - 2019 Jul 15
TI  - First study of safety and tolerability of 3,4-methylenedioxymethamphetamine 
      (MDMA)-assisted psychotherapy in patients with alcohol use disorder: preliminary 
      data on the first four participants.
LID - 10.1136/bcr-2019-230109 [doi]
LID - e230109
AB  - We present the preliminary data in an ongoing open-label safety and tolerability 
      proof of concept study exploring the potential role for 
      3,4-methylenedioxymethamphetamine (MDMA)-assisted psychotherapy in treating 
      patients with alcohol use disorder. At this stage, seven participants have 
      completed the full 8-week MDMA-assisted psychotherapy course, including two 
      therapy sessions each with MDMA. This paper focuses on the safety and 
      tolerability of the therapeutic course for the first four participants to 
      complete treatment. Longer-term outcomes of drinking behaviour will be presented 
      later when the full project data are published. Results show all four 
      participants have successfully tolerated the treatment. There have been no 
      serious adverse events related to MDMA, no unexpected physiological responses to 
      the MDMA sessions or changes to blood results or electrocardiograms, measured 
      before and after the 8-week course. We conclude that the treatment is well- 
      tolerated and are making plans to expand the project into a randomised 
      placebo-controlled study.
CI  - (c) BMJ Publishing Group Limited 2019. No commercial re-use. See rights and 
      permissions. Published by BMJ.
FAU - Sessa, Ben
AU  - Sessa B
AD  - Neuropsychopharmacology, Department of Medicine, Imperial College London, London, 
      UK.
FAU - Sakal, Chloe
AU  - Sakal C
AD  - Department of Medicine, Avon and Wiltshire Mental Health Partnership NHS Trust, 
      Bath, UK.
FAU - O'Brien, Steve
AU  - O'Brien S
AD  - Neuropsychopharmacology, Department of Medicine, Imperial College London, London, 
      UK.
FAU - Nutt, David
AU  - Nutt D
AD  - Neuropsychopharmacology, Department of Medicine, Imperial College London, London, 
      UK.
LA  - eng
PT  - Case Reports
PT  - Journal Article
DEP - 20190715
PL  - England
TA  - BMJ Case Rep
JT  - BMJ case reports
JID - 101526291
RN  - 0 (Alcohol Deterrents)
RN  - KE1SEN21RM (N-Methyl-3,4-methylenedioxyamphetamine)
SB  - IM
MH  - Adult
MH  - Alcohol Deterrents/*administration & dosage/adverse effects
MH  - Alcoholism/*rehabilitation
MH  - Combined Modality Therapy
MH  - Drug Administration Schedule
MH  - Female
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - N-Methyl-3,4-methylenedioxyamphetamine/*administration & dosage/adverse effects
MH  - Psychotherapy/*methods
MH  - Treatment Outcome
PMC - PMC6663239
OTO - NOTNLM
OT  - alcohol-related disorders
OT  - drugs misuse (including addiction)
OT  - psychotherapy
COIS- Competing interests: None declared.
EDAT- 2019/07/17 06:00
MHDA- 2020/01/14 06:00
PMCR- 2021/07/15
CRDT- 2019/07/17 06:00
PHST- 2019/07/17 06:00 [entrez]
PHST- 2019/07/17 06:00 [pubmed]
PHST- 2020/01/14 06:00 [medline]
PHST- 2021/07/15 00:00 [pmc-release]
AID - 12/7/e230109 [pii]
AID - bcr-2019-230109 [pii]
AID - 10.1136/bcr-2019-230109 [doi]
PST - epublish
SO  - BMJ Case Rep. 2019 Jul 15;12(7):e230109. doi: 10.1136/bcr-2019-230109.