Randomized, Double-blind, Controlled of MDMA-assisted Psychotherapy in 12 Subjects With PTSD
Status:
Terminated
Trial end date:
2017-04-01
Target enrollment:
Participant gender:
Summary
This small ("pilot") study is designed to provide information on whether the combination of
psychotherapy with the drug MDMA is safe and helpful for people with post traumatic stress
disorder (PTSD). The researchers will use the results of this study to design more studies of
this treatment. The study compares a comparator (placebo) and a full dose. For each session,
there will be an initial dose possibly followed 1.5 to 2.5 hours later by a dose half the
size of the initial dose. The study will measure symptoms of PTSD, depression, general
psychological well-being, sleep quality, feelings that the self or world is unreal
(dissociation), potentially positive effects of surviving traumatic events and cognitive
function (thinking, memory and attention). People experiencing pain or tinnitus (ringing in
the ears) will record their symptoms throughout the study. Seven people will be randomly (by
chance) assigned to receive full-dose MDMA and five will be randomly assigned to receive a
comparator. There will be three preparatory psychotherapy sessions before the first
experimental session, and subjects will have supportive or "integrative" sessions after each
MDMA-assisted psychotherapy session. Subjects will meet with a male and female
psychotherapist for all experimental sessions and for sessions before and after each
experimental session. Subjects who received comparator can enroll in Stage 2, where they will
have three open-label MDMA-assisted psychotherapy sessions, meaning everyone will know they
are receiving an active dose of MDMA. Subjects receiving full dose in Stage 1 will have a
third experimental session.. Symptoms of PTSD and other symptoms will be measured again at
least 12 months after each subject has started the study.
Phase:
Phase 2
Details
Lead Sponsor:
Multidisciplinary Association for Psychedelic Studies