PMID- 23172889
OWN - NLM
STAT- MEDLINE
DCOM- 20130903
LR  - 20211021
IS  - 1461-7285 (Electronic)
IS  - 0269-8811 (Print)
IS  - 0269-8811 (Linking)
VI  - 27
IP  - 1
DP  - 2013 Jan
TI  - Durability of improvement in post-traumatic stress disorder symptoms and absence 
      of harmful effects or drug dependency after 
      3,4-methylenedioxymethamphetamine-assisted psychotherapy: a prospective long-term 
      follow-up study.
PG  - 28-39
LID - 10.1177/0269881112456611 [doi]
AB  - We report follow-up data evaluating the long-term outcomes for the first 
      completed trial of 3,4-methylenedioxymethamphetamine (MDMA)-assisted 
      psychotherapy for chronic, treatment-resistant post-traumatic stress disorder 
      (PTSD) (Mithoefer et al., 2011). All of the 19 subjects who received 
      MDMA-assisted treatment in the original trial participated in the long-term 
      follow-up (LTFU), with 16 out of 19 completing all of the long-term outcome 
      measures, which were administered from 17 to 74 months after the original study's 
      final MDMA session (mean = 45.4; SD = 17.3). Our primary outcome measure used was 
      the Clinician-Administered PTSD Scale (CAPS). Secondary outcome measures were the 
      Impact of Events Scale-Revised (IES-R) and the Neuroticism Extroversion Oppenness 
      Personality Inventory-Revised (NEO PI-R) Personality Inventory. We also collected 
      a long-term follow-up questionnaire. Results for the 16 CAPS completers showed 
      there were no statistical differences between mean CAPS score at LTFU (mean = 
      23.7; SD = 22.8) (t (matched) = 0.1; df = 15, p = 0.91) and the mean CAPS score 
      previously obtained at Study Exit (mean = 24.6, SD = 18.6). On average, subjects 
      maintained statistically and clinically-significant gains in symptom relief, 
      although two of these subjects did relapse. It was promising that we found the 
      majority of these subjects with previously severe PTSD who were unresponsive to 
      existing treatments had symptomatic relief provided by MDMA-assisted 
      psychotherapy that persisted over time, with no subjects reporting harm from 
      participation in the study.
FAU - Mithoefer, Michael C
AU  - Mithoefer MC
AD  - mmithoefer@mac.com
FAU - Wagner, Mark T
AU  - Wagner MT
FAU - Mithoefer, Ann T
AU  - Mithoefer AT
FAU - Jerome, Lisa
AU  - Jerome L
FAU - Martin, Scott F
AU  - Martin SF
FAU - Yazar-Klosinski, Berra
AU  - Yazar-Klosinski B
FAU - Michel, Yvonne
AU  - Michel Y
FAU - Brewerton, Timothy D
AU  - Brewerton TD
FAU - Doblin, Rick
AU  - Doblin R
LA  - eng
PT  - Journal Article
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20121120
PL  - United States
TA  - J Psychopharmacol
JT  - Journal of psychopharmacology (Oxford, England)
JID - 8907828
RN  - 0 (Illicit Drugs)
RN  - KE1SEN21RM (N-Methyl-3,4-methylenedioxyamphetamine)
SB  - IM
MH  - Adult
MH  - Female
MH  - Follow-Up Studies
MH  - Humans
MH  - Illicit Drugs/adverse effects
MH  - Male
MH  - N-Methyl-3,4-methylenedioxyamphetamine/adverse effects/*therapeutic use
MH  - Outcome Assessment, Health Care
MH  - Prospective Studies
MH  - Psychotherapy/*methods
MH  - Stress Disorders, Post-Traumatic/drug therapy/*therapy
MH  - Substance-Related Disorders/*drug therapy
MH  - Surveys and Questionnaires
MH  - Treatment Outcome
PMC - PMC3573678
COIS- Conflict of interest: Our sponsor played a role in the study design, data 
      analysis and writing of the report (the investigators performed all data 
      collection). Three authors, Berra Yazar-Klosinski, Lisa Jerome and Rick Doblin, 
      are employed by the sponsor. Michael Mithoefer is a medical monitor for other 
      studies of MDMA-assisted psychotherapy that are currently being conducted by the 
      sponsor. He and Ann Mithoefer both received payment from the sponsor for 
      conducting this research, while also working on the development of a treatment 
      manual, investigator training program, and the design of protocols for additional 
      studies planned by the sponsor. The sponsor paid Mark Wagner for acting as the 
      independent rater for this study.
EDAT- 2012/11/23 06:00
MHDA- 2013/09/04 06:00
CRDT- 2012/11/23 06:00
PHST- 2012/11/23 06:00 [entrez]
PHST- 2012/11/23 06:00 [pubmed]
PHST- 2013/09/04 06:00 [medline]
AID - 0269881112456611 [pii]
AID - 10.1177_0269881112456611 [pii]
AID - 10.1177/0269881112456611 [doi]
PST - ppublish
SO  - J Psychopharmacol. 2013 Jan;27(1):28-39. doi: 10.1177/0269881112456611. Epub 2012 
      Nov 20.