PMID- 35166140
OWN - NLM
STAT- MEDLINE
DCOM- 20220502
LR  - 20230519
IS  - 1461-7285 (Electronic)
IS  - 0269-8811 (Print)
IS  - 0269-8811 (Linking)
VI  - 36
IP  - 3
DP  - 2022 Mar
TI  - A randomized controlled trial of 3,4-methylenedioxymethamphetamine (MDMA) and 
      fear extinction retention in healthy adults.
PG  - 368-377
LID - 10.1177/02698811211069124 [doi]
AB  - BACKGROUND: Fear conditioning and extinction are well-characterized cross-species 
      models of fear-related posttraumatic stress disorder (PTSD) symptoms, and recent 
      animal data suggest that 3,4-methylenedioxymethamphetamine (MDMA) enhances fear 
      extinction retention. AIMS: This study investigated the effect of MDMA on fear 
      learning, extinction training, and retention in healthy humans. METHODS: The 
      study involved a randomized placebo-controlled, two-group, parallel design trial 
      in a sample of healthy adults, age 21-55 recruited from a major metropolitan 
      area. The experimental paradigm included a fear acquisition session followed by 
      an extinction training session 24 hours later, and 2 hours after study drug 
      administration. Fear extinction retention was measured 48 hours after extinction 
      training. Participants (N = 34; 70.6% male and 29.4% female) were randomly 
      assigned in 1:1 ratio to 100 mg MDMA or placebo. All randomized participants 
      completed the trial and were included in primary analyses. Safety was monitored 
      via adverse events and vital signs. MDMA was well-tolerated with no serious 
      adverse events. RESULTS: Results indicated a significant main effect of session 
      between extinction training and retention with no significant group differences. 
      Significantly more participants in the MDMA group retained extinction learning 
      compared to the placebo group (chi(2) = 7.29, p = 0.007). CONCLUSION: Although we 
      did not observe the hypothesized facilitation of extinction retention, the 
      findings from this initial human trial provide compelling rationale to continue 
      to explore the potential for MDMA to impact extinction retention.Clinical Trials 
      Registry Name and Identifier: Evaluation of MDMA on Startle Response (NCT0318176) 
      https://clinicaltrials.gov/ct2/show/NCT03181763?term = MDMA&draw = 2&rank = 9.
FAU - Maples-Keller, Jessica L
AU  - Maples-Keller JL
AUID- ORCID: 0000-0003-4768-7332
AD  - Department of Psychiatry and Behavioral Sciences, Emory University School of 
      Medicine, Atlanta, GA, USA.
FAU - Norrholm, Seth D
AU  - Norrholm SD
AD  - Department of Psychiatry and Behavioral Neurosciences, Wayne State University 
      School of Medicine, Detroit, MI, USA.
FAU - Burton, Mark
AU  - Burton M
AD  - Department of Psychiatry and Behavioral Sciences, Emory University School of 
      Medicine, Atlanta, GA, USA.
FAU - Reiff, Collin
AU  - Reiff C
AD  - Department of Psychiatry, New York University, New York, NY, USA.
FAU - Coghlan, Callan
AU  - Coghlan C
AD  - Department of Psychiatry and Behavioral Sciences, Emory University School of 
      Medicine, Atlanta, GA, USA.
FAU - Jovanovic, Tanja
AU  - Jovanovic T
AD  - Department of Psychiatry and Behavioral Neurosciences, Wayne State University 
      School of Medicine, Detroit, MI, USA.
FAU - Yasinski, Carly
AU  - Yasinski C
AD  - Department of Psychiatry and Behavioral Sciences, Emory University School of 
      Medicine, Atlanta, GA, USA.
FAU - Jarboe, Kathleen
AU  - Jarboe K
AD  - Department of Psychiatry and Behavioral Sciences, Emory University School of 
      Medicine, Atlanta, GA, USA.
FAU - Rakofsky, Jeffrey
AU  - Rakofsky J
AD  - Department of Psychiatry and Behavioral Sciences, Emory University School of 
      Medicine, Atlanta, GA, USA.
FAU - Rauch, Sheila
AU  - Rauch S
AD  - Department of Psychiatry and Behavioral Sciences, Emory University School of 
      Medicine, Atlanta, GA, USA.
AD  - Atlanta VA Healthcare System.
FAU - Dunlop, Boadie W
AU  - Dunlop BW
AUID- ORCID: 0000-0002-4653-0483
AD  - Department of Psychiatry and Behavioral Sciences, Emory University School of 
      Medicine, Atlanta, GA, USA.
FAU - Rothbaum, Barbara O
AU  - Rothbaum BO
AD  - Department of Psychiatry and Behavioral Sciences, Emory University School of 
      Medicine, Atlanta, GA, USA.
LA  - eng
SI  - ClinicalTrials.gov/NCT03181763
GR  - K12 HD085850/HD/NICHD NIH HHS/United States
GR  - P50 MH100023/MH/NIMH NIH HHS/United States
GR  - UL1 TR002378/TR/NCATS NIH HHS/United States
PT  - Journal Article
PT  - Randomized Controlled Trial
PT  - Research Support, N.I.H., Extramural
PT  - Research Support, U.S. Gov't, Non-P.H.S.
DEP - 20220215
PL  - United States
TA  - J Psychopharmacol
JT  - Journal of psychopharmacology (Oxford, England)
JID - 8907828
RN  - KE1SEN21RM (N-Methyl-3,4-methylenedioxyamphetamine)
SB  - IM
MH  - Animals
MH  - Extinction, Psychological
MH  - Fear
MH  - Female
MH  - Humans
MH  - Male
MH  - *N-Methyl-3,4-methylenedioxyamphetamine/adverse effects
MH  - Reflex, Startle
MH  - *Stress Disorders, Post-Traumatic/drug therapy
PMC - PMC10191244
MID - NIHMS1897336
OTO - NOTNLM
OT  - *Fear extinction
OT  - *MDMA
OT  - *fear-potentiated startle
OT  - *psychophysiology
OT  - *randomized trial
EDAT- 2022/02/16 06:00
MHDA- 2022/05/03 06:00
PMCR- 2023/05/17
CRDT- 2022/02/15 08:51
PHST- 2022/02/16 06:00 [pubmed]
PHST- 2022/05/03 06:00 [medline]
PHST- 2022/02/15 08:51 [entrez]
PHST- 2023/05/17 00:00 [pmc-release]
AID - 10.1177/02698811211069124 [doi]
PST - ppublish
SO  - J Psychopharmacol. 2022 Mar;36(3):368-377. doi: 10.1177/02698811211069124. Epub 
      2022 Feb 15.