Dose-Response Study of MDMA-assisted Psychotherapy in People With PTSD
Status:
Completed
Trial end date:
2017-02-01
Target enrollment:
Participant gender:
Summary
Posttraumatic stress disorder (PTSD) is a debilitating psychiatric disorder that can develop
after a traumatic life experience that severely reduces quality of life. This Phase 2 pilot
study examined the safety and efficacy of MDMA-assisted psychotherapy in 23 subjects with
chronic, treatment-resistant posttraumatic stress disorder (PTSD). This study is part of a
global series of Phase 2 pilot clinical trials. This randomized, double-blind, dose response
study assessed two active doses of MDMA, 100 mg and 125 mg, to a comparator dose of MDMA (40
mg) during psychotherapy sessions. The initial dose was followed 1.5 to 2.5 hours later by an
optional supplemental dose of MDMA that was half the size of the first dose. MDMA was
administered in two experimental sessions lasting up to eight hours and scheduled three to
five weeks apart. Subjects were prepared for MDMA-assisted psychotherapy prior to the first
session in three preparatory sessions, and worked with the same pair of therapists throughout
the study. After each MDMA-assisted psychotherapy session, subjects had three integrative
sessions with their therapist team to process and understand their experience.
This study assessed the change in symptoms of PTSD, as measured by the Clinical Administered
PTSD Scale (CAPS) [Blake et al., 1995], as well as symptoms of depression, as measured by the
Beck Depression Inventory II (BDI-II) [Beck, A.T. and R.A, 1984; Beck, A.T., et al., 1996]
from baseline enrollment to one month after the second MDMA-assisted psychotherapy session
(primary endpoint).
Participants who received the comparator dose of MDMA (40 mg) were given the option to enroll
in Stage 2, where they underwent three open-label MDMA-assisted psychotherapy sessions with
an active dose of MDMA. People who received either of the active doses of MDMA in Stage 1 had
a third MDMA-assisted psychotherapy session with another active dose of MDMA.
Phase:
Phase 2
Details
Lead Sponsor:
Multidisciplinary Association for Psychedelic Studies