Spanish Study of MDMA-Assisted Psychotherapy for Posttraumatic Stress Disorder (Concluded)
Started in 2000, this study was the world's first clinical trial to evaluate the safety and effectiveness of MDMA-assisted psychotherapy. This dose-response study, in 29 women with chronic, treatment-resistant PTSD caused by rape or childhood sexual abuse, was designed to compare the effectiveness of five dosages of MDMA in combination with psychotherapy: 50 mg, 75 mg, 100 mg, 125 mg, 150 mg. Six of the 29 subjects were treated before pressure from the Madrid Anti-Drug Authority led to the revocation of permission to use the study site. As of May 13, 2002, when the study was shut down for political reasons, we had completed treating four patients in the 50 mg dose group (three patients received 50 mg and one received a placebo), and two people in the 75 mg dose group (one patient received 75 mg and one received a placebo)
Principal Investigator: José Carlos Bouso, PhD
May 11, 1999:
Location: Madrid, Spain
Study protocol approved by the Research Committee of the Hospital Psiquiátrico de Madrid
July 16, 1999:
Study protocol approved by the Ethics Committee of the Hospital Universitario La Paz
February 7, 2000:
Study approved by the Spanish Agency for Medicines and Health Products
Spanish anti-Ecstasy campaign
May 13, 2002:
Hospital Psiquiåtrico de Madrid revokes permission to use facilities
May 23, 2002:
View the complete timeline for this study.
MAPS colleague Jose Carlos Bouso, Ph.D. Candidate, previous principal investigator of an MDMA/PTSD study in Spain, did not receive a 200,000 Euro government grant he had applied for last year. Jose had hoped to utilize the government grant to conduct a new study of MDMA-assisted psychotherapy for the treatment of PTSD.
In light of the absence of the grant, MAPS Executive Director Rick Doblin, Ph.D. had met with MAPS clinical research team to conceptualize sponsoring and designing a study in Spain for Jose to lead. The basic concept is that MAPS will fund the study for two subjects and then evaluate whether the research team is properly adhering with the protocol, data-gathering, and therapeutic method before funding additional participants. This concept is to insure that we spend our donated research funds on successful, well-managed projects.
Unfortunately, a several hundred thousand euro grant that MAPS colleague and Spanish Researcher Jose Carlos Bouso, Ph.D. Candidate applied for to conduct an MDMA/PTSD study in Spain was rejected. MAPS will now pursue other avenues to conduct additional MDMA/PTSD research within the European Union. One of the ideas that we plan to implement will be to have future studies use an open label dosing regimen for the first two subjects. This means that the first two subjects in a study will receive MDMA, rather than MDMA or placebo. MAPS will use this as a chance to monitor the research teams adherence to the protocol guidelines.
On March 15, 2004, the lead investigator for MAPS' concluded Spanish study of MDMA-assisted psychotherapy for PTSD, Jose Carlos Bouso, PhD, submitted this political analysis:
Now that the progressive party won the national elections, I think drug policies will hopefully change for the better. The disappointing part of the story is that in the regional elections in the State of Madrid that took place last October, the conservative party won again which makes it difficult to restart the study since they are the same politicians who stopped it. Since all the hospitals in the State of Madrid belong to the government of the State of Madrid, it will be quite difficult to restart the study. But I will try anyway.
Since last Thursday all the media are talking about PTSD and now it seems clear that we need better therapeutic approaches. This is the argument, besides the beginning of the US MDMA/PTSD project, that I will use when I start again to ask for permits from the politicians in the State of Madrid. I am not optimistic, but I will try. It is sad, because last October if the progressive party had won, I am sure the study would have been restarted by now. So, though we have now have a new general government, it doesn't have relevance to restarting the study.
On March 12. 2004, Jose Carlos Bouso, PhD, participated in a televissd debate about drug policy. Here is his report:
Neither the Director of the Spanish Antidrug Agency nor the Director of the Madrid Antidrug Agency attended the debate. They delegated their participation in some of their employees. The debate was attended by:
- A representative of the Spanish Antidrug Agency
- A representative of the Madrid Antidrug Agency
- A representative of an Association that works rehabilitating drug abusers
- A social worker
- A psychiatrist on the Universidad Complutense of Madrid
- And me.
The debate was well. It was focused on the problems associated with recreational drugs, above all, cannabis, which it seems is the new "dark beast" to the Spanish authorities. I had to clarify some misconceptions regarding cannabis toxicity, but as time was passing by, the issue of MDMA/PTSD research was being forgotten by the moderator. I used the last minutes of my intervention to talk about the MDMA/PTSD research projects that was/are being developed both in Spain and US. I said that the Spanish project was stopped for political reasons and that the US just approved a similar project. Though it was quite difficult to talk about PTSD/MDMA research because the interest of the debate was focused on other issues, I was able to dedicate a couple of minutes to that. I am quite satisfied with my interventions and I hope that it could serve to transmit to the public opinion another way of understanding forbidden drugs, which includes an understanding of their therapeutic potential.
The TV debate will be released in 2 weeks, but not on important TV channels, but I hope that it could still reach a wide number of people in Spain. On the other hand, during these sad days all the media are talking about PTSD. I hope the upcoming Nature article will serve to call the attention of the Spanish media to MDMA/PTSD research.
On March 4, 2004, the lead investigator for our Spanish study of MDMA-assisted psychotherapy for PTSD, Jose Carlos Bouso, PhD, was invited to participate in a Spanish TV program on March 12, 2004, along with the following other guests:
- The Director of the Spanish Antidrug Agency (Plan Nacional sobre Drogas)
- The Director of the Madrid Antidrug Agency
- The President of the Help Against Drug Addiction Foundation (FAD, Fundacion de Ayuda Contra la Drogadiccion), the most important private organization "against" drugs in Spain
- One famous Spanish sociologist expert in drug abuse
Bouso has an excellent opportunity to raise the issue of the willingness of supporters of the Drug War to suppress science and ignore the welfare of PTSD patients in order to support Drug War propaganda.
One of most important national Spanish
newspapers (El Mundo) published an
article regarding the final approval of the US MDMA/PTSD study
in its Science section. The article is quite favorable and also
tells that the MAPS-sponsored Spanish MDMA/PTSD study was shutdown
for political reasons. We will continue to struggle to reopen the
Spanish MDMA/PTSD study.
Show: American Morning, 7 AM. Dr. Drew Pinsky thinking too reductionistically
about the use of MDMA for the treatment of PTSD, "...it’s quite
legitimate...I think the idea that it creates a psychological effect
may be somewhat naive, the idea that somehow people are more open
to looking at the narrative around their trauma because of the sort
of subjective effects of the drug, that, to me, is kind of naive
because it’s so biologically powerful. It’s almost like looking
at electric shock therapy again."
On September 13, 2003, the Spanish medical journal Medicina Clínica
published Jose Carlos Bouso's letter to the editor
(PDF, page 3) entitled "MDMA ('ecstasy') psychotherapy research." The letter has been translated into English
. A letter by Dr. Fernando Caudevilla Galligo objecting to the political pressures that shut down Bouso's MDMA/PTSD study was also published
On May 28, 2003, José Carlos Bouso, PhD, learned that a Letter to the Editor that he wrote to the Spanish Medical Journal Medicina Clínica (Clinical Medicine), was accepted for publication. The letter was in response to an article in the April issue, "Ecstasy: a review of scientific literature about MDMA by Dr. Fernando Caudevilla," which mentioned MDMA psychotherapy. The original Spanish article can be downloaded here (PDF), and the letter has also been translated into English. MAPS and José Carlos Bouso will continue our efforts to restart the Spanish MDMA/PTSD study and hope that it will eventually be permitted to resume.
On April 28, 2003, a lengthy article in the prominent Spanish magazine Interviu reported on the controversy surrounding the Spanish MDMA/PTSD study and brought to light the fact that the Madrid Anti-Drug Authority actively pressured the Hospital to shut down the study. The article can be seen in the original format in Spanish, and has also been translated into English.
The fourth patient in the Spain MDMA/PTSD
dose-response study was treated on November 28, 2001. We have now
completed the 50 mgs dose group (3 patients received 50 mgs and
1 received a placebo). The next dose level is 75 mgs (5 patients
will receive 75 mgs and 2 will receive a placebo).
The first patient was treated in the
MAPS-supported MDMA/PTSD study being conducted in Madrid, Spain,
under the director of José Carlos Bouso, Ph.D. candidate. José
Carlos and Marcela Ot’alora were the co-therapists. The four hour
session went very well and the patient seemed to have gotten to
a deeper, more therapeutic level. Of course, we won’t know for some
time whether the patient received a dose of 50 mgs or a placebo!
What we do know is that study is off to a great start. Read
more about this study, including the protocol
and informed consent form.
A pilot study of MDMA therapy in
the treatment of PTSD has been approved and will be the first formal
therapy study with MDMA ever conducted. (Read
current update) MAPS has pledged $54,000 for this study; we
have raised $23,000 and are seeking additional contributions.