|
|
|
|
|
Our preliminary
clinical impression
is that the
supplemental dose
extends the period
during which
the most intense
emotional
processing
occurs. |
|
|
|
MDMA-Assisted Psychotherapy in the Treatment
of Posttraumatic Stress Disorder (PTSD):
Eighth Update on Study Progress
Michael Mithoefer, M.D.
Since my last update both the Food and Drug Administration (FDA)
and our Institutional Review Board (IRB) have given us approval to
make two significant protocol changes:
1) To add a supplemental dose of 62.5 mg of MDMA (or placebo)
two to two- and-a-half hours after the initial dose of 125 mg. 2) To
add a third MDMA-assisted psychotherapy session both for subjects
who receive MDMA in the first two experimental sessions and for
subjects who initially receive placebo and then go on to participate in
the open-label MDMA portion of the protocol.
Thus far three subjects have received the supplemental dose of
MDMA or placebo on a total of 6 occasions and one subject has had
a third MDMA-assisted “experimental session” in the open label stage.
Our preliminary clinical impression is that the supplemental dose is
useful. It does not appear to change the intensity of the experience, but
it does extend the period during which the most intense emotional
processing occurs. There have been no problems associated with the
supplemental dose. In one case the blood pressure and pulse did go
higher than they had before the supplemental dose, but did not reach
dangerous levels or require treatment. It is also our impression that the
third MDMA session may provide additional benefit, though we do not
yet have formal outcome data following this session.
The overall progress of the study is as
follows:
-Fifteen subjects have been enrolled,
one has dropped out, twelve have completed
the original double blind protocol
and two are currently enrolled.
-After receiving placebo in the first
stage, four subjects have gone on to the
open-label stage (which includes two or
three MDMA-assisted psychotherapy
sessions along with additional non-drug
follow-up psychotherapy sessions). Three
have completed this stage and the third
recently underwent the third experimental
session but has not yet completed the
follow-up sessions and final symptom
measures.
-We have completed telephone
screening on 99 potential subjects.
-One potential new subject has
passed formal screening and two others
are scheduled to have it.
Recruitment has still been somewhat
slow and our recent limited newspaper
advertising was not effective in changing
that. Nevertheless, we are slowly continuing
to recruit people with crime-related
PTSD, and anticipate being able to find the
remaining five subjects we need within
the next six months. However, we would
like to recruit some veterans with warrelated
PTSD of less than five years
duration. We are pursuing some possible
referral sources at VA hospitals and we now have permission from the IRB to post
an advertisement on websites that serve
veterans.
We are currently working on a
request to the IRB to conduct long-term
follow up of our subjects. We plan to
repeat symptom measures as well as a
more general questionnaire six months or
more after completion of the present
protocol. In the case of our earliest subjects
the follow-up will occur more than two
years from the study sessions. Along with
this added protocol request we will seek to
clarify the IRB’s media policy regarding
our study.
Another important event since my
last update was a vissssit from Drs. Rael
Strous and Rakefet Rodrigez, two of the
Israeli psychiatrists who have permission
for and are on the verge of starting a
MAPS-sponsored study very similar to
ours investigating MDMA-assisted
therapy for war- and terrorism-related
PTSD. Annie and I really enjoyed the
chance to show them our approach to
working with subjects and to learn from
their insights and ideas. Now, of course,
the sad reality is that their work to find
better treatments for PTSD is even more
urgently needed in Israel and the whole
region. |