Spain has joined Switzerland and Germany as a European country where studies with psychedelics are actively developed by a small group of researchers. In September 1999, Jordi Camí, MD, Ph.D., Magi Farré, MD, Ph.D. and José Carlos Bouso, Ph.D.(c) presented their studies at the MAPS MDMA symposium in Israel.

The MDMA psychotherapy study with PTSD has been approved and is the first controlled government-approved MDMA psychotherapy study ever conducted. The protocol and the informed consent form describe the study in detail. Six subjects have been successfully treated, with some suggestion of benefit and no lasting negative effects. However, in response to positive reports about the study that appeared in the Spanish media, the Madrid Anti-Drug Authority pressured the hospital into withdrawing permission for the study. The Ministry of Health has not withdrawn permission, so we hope that after the US MDMA/PTSD protocol has been fully approved, it will become possible for the Spain study to be resumed. This is yet another classic case of police authorities suppressing scientific research that threatens to contradict government propaganda about the terrible harms and total absence of benefits of an illegal drug.

A timeline of the study including approval dates and dates of Spanish media articles, withdrawal of approval, and talks in Spain about the dangers of MDMA by Dr. George Ricaurte that have hindered our efforts to restart the study (and the contents of his talks), is now available.

March 15, 2004. Jose Carlos sent 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."

March 12. 2004. Jose Carlos Bouso participated in a TV 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.

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.

March 4, 2004. Jose Carlos Bouso has been 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.

Jose Carlos 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.

February 26, 2004 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.

September 13, 2003.The Spanish Medical Journal, "Medicina Clinica," published Jose Carlos' letter (in PDF format, on page 3), entitled, "MDMA ('ecstasy') psychotherapy research." Jose Carlos Bouso has translated his letter into English.
A letter by Dr. Fernando Caudevilla Galligo, objecting to the political pressures that shut down Jose Carlos's MDMA/PTSD study, was also published, and has been translated into English.

May 28, 2003.José Carlos Bouso learned that a Letter to the Editor that he wrote to the Spanish Medical Journal, "Medicina Clinica" (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. Jose Carlos Bouso has translated his letter 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.

May 19, 2003. An interview with José Carlos Bouso was included in a Spanish TV program about the consequences and treatment of survivors of sexual assault.

April 28, 2003.A lengthy article in the prominent Spanish magazine, Interviu, reported on the controversy surrounding the MDMA/PTSD study and brought to light the fact that the Madrid Anti-Drug Authority actively pressured the Hospital to shut down the study. That article can be seen in the original format in Spanish, and has also been translated into English.

Read a personal account of MDMA in the treatment of PTSD resulting from sexual abuse.

MDMA Psychotherapy in the Treatment of Post Traumatic Stress Disorder
Subjects: women survivors of sexual abuse
Investigators: Pedro Sopelana Rodriguez, psychiatrist at the Psychiatric Hospital of Madrid (Hospital Psiquiatrico de Madrid); José Carlos Bouso Saiz, Ph.D. candidate, U. de Autonoma de Madrid, Spain
Contact:
A dose-finding study with the purpose of obtaining an efficacy dose for a second pilot study of therapeutic efficacy. The protocol was approved by the Research Committee of the Psychiatric Hospital of Madrid, and on July 15, 1999 by the Ethics Committee of Clinical Research of the University Hospital "La Paz" (Hospital Universitario "La Paz"). August 11, 1999 the protocol was submitted to the Ministry of Health. They responded November 10, 1999 with a set of 12 reasonable questions and requested that the PI respond within 10 days, which he did. Letters of support were submitted by F. Vollenweider, M. Tancer, G. Greer and M. Baggott. On December 20, 1999, José Carlos Bouso, Dr. Pedro Sopelana and Dr. Maria Angeles Corral met with the Spanish Ministry of Health to discuss their MDMA/PTSD protocol. The Ministry requested several changes, most notably lower doses (high dose is now 150 mg, not 175 mg) and the elimination of the use of a booster dose several hours after the initial dose. A revised protocol for the initial dose-finding study was submitted to the Ministry on December 27, 1999. The Ministry approved the study February 17, 2000.

As of April 16, 2002, six of the 29 subjects have been treated. We have completed treating the patients in the 50 mgs dose group (3 patients received 50 mgs and 1 received a placebo), and have treated two people in the 75 mg dose group (5 patients will receive 75 mgs and 2 will receive a placebo).

Read more in MAPS:
Autumn 1999
Spring 1999 correspondance about study design
Autumn 1997

The authorized experimental design's outline is the following:

- Group 1 (4 subjects): 50 mg of MDMA (3 subjects), placebo (1 subject)
- Group 2 (7 subjects): 75 mg of MDMA (5 subjects), placebo (2 subjects)
- Group 3 (7 subjects): 100 mg of MDMA (5 subjects), placebo (2 subjects)
- Group 4 (7 subjects): 125 mg of MDMA (5 subjects), placebo (2 subjects)
- Grupo 5 (4 subjects): 150 mg of MDMA (3 subjects), placebo (1 subject)

Published papers include:

Pacifici R, Zuccaro P, Farré M, Pichini S, Di Carlo S, Roset PN, Ortuño J, Segura J, de la Torre R. (1999) Immunomodulating properties of MDMA alone and in combination with alcohol: a pilot study. Life Sci; 65: 309-316 .

Pacifici R, Zuccaro P, Farré M, Pichini S, Di Carlo S, Roset PN, Hernandez Lopez C, Ortuño J, Segura J, Camí J, de la Torre R(2000) Immunomodulating activity of MDMA. Ann N Y Acad Sci. 914:215-224.

Pacifici R, Zuccaro P, Farré M, Pichini S, Di Carlo S, Roset PN, Ortuño J, Pujadas M, Bacosi A, Menoyo E, Segura J, de la Torre R (2001). Effects of repeated doses of MDMA ("ecstasy") on cell-mediated immune response in humans. Life Sci 69: 2931-41.

Pacifici R, Zuccaro P, Farré M, Pichini S, Di Carlo S, Roset PN, Palmi I, Ortuño J, Menoyo E, Segura J, de la Torre R (2002) Cell-mediated immune response in MDMA users after repeated dose administration: studies in controlled versus noncontrolled settings. Ann N Y Acad Sci 965: 421-433.

Pacifici R, Zuccaro P, Lopez CH, Pichini S, di Carlo S, Farré M, Roset PN, Ortuño J, Segura J, de la Torre R (2001) Acute effects of 3,4-methylenedioxymethamphetamine alone and in combination with ethanol on the immune system in humans, J Pharmacol Exp Ther. ;296:207-215.

Pacifici R, Pichini S, Zuccaro P, Farré M, Segura M, Ortuño J, Di Carlo S, Bacosi A, Roset P, Segura J, De La Torre R. (2004) Paroxetine Inhibits Acute Effects of MDMA on the Immune System in Humans. J Pharmacol Exp; [Epub ahead of print].

Pharmacological Effects of MDMA in Humans
Investigator: Jordi Camí, M.D., Magi Farré, M.D., et al.
Institut Municipal d'Investigacio Medica - Barcelona, Spain
Contact:
Sponsor: funded in part by several government grants
Studies include: Quantification of MDMA and its metabolites in plasma and urine by gas chromatography with nitrogen-phosphorus detection; Human pharmacology of MDMA, Psychomotor performance and subjective effects.

Published papers include:

Camí J, Farré M, Mas M, Roset PN, Poudevida S, Mas A, San L, de la Torre R. (2000) Human pharmacology of 3,4-methylenedioxymethamphetamine ("ecstasy"): psychomotor performance and subjective effects. J Clin Psychopharmacol 20: 455-66.

de la Torre R, Ortuño J, Mas M, Farré M, Segura J. Fatal MDMA intoxication. Lancet 1999; 353: 593

de la Torre R, Ortuño J, Segura J, Mas M, Camí J, Farré M, Mas M. Non-linear pharmacokinetics of MDMA (ecstasy) in humans. Br J Clin Pharmacol 2000; 49: 104-109.

Hernandez-Lopez C, Farré M, Roset PN, Menoyo E, Pizarro N, Ortuño J, Torrens M, Camí J, de La Torre R (2002). 3,4-Methylenedioxymethamphetamine (ecstasy) and alcohol interactions in humans: psychomotor performance, subjective effects, and pharmacokinetics. J Pharmacol Exp Ther 300: 236-44.

Mas M, Farré M, de la Torre R, Roset PN, Ortuño J, Segura J, Camí J. Cardiovascular and neuroendocrine effects, and pharmacokinetics of MDMA in humans. J Pharmacol Exp Ther 1999; 290: 136-145.

Navarro, M, Pichini, S, Farré, M, Ortuño, J, Roset, PN, Segura, J, de la Torre, R (2001). Usefulness of saliva for measurement of 3,4-methylenedioxymethamphetamine and its metabolites: Correlation with plasma drug concentrations and effect of salivary pH. Clinical Chemistry, 47: 1788-1795.

Ortuño J, Pizarro N, Farré M, Mas M, Segura J, Camí J, Brenneisen R, de la Torre R. Quantification of 3,4-methylenedioxymetamphetamine and its metabolite in plasma and urine by gas chromatography with nitrogen-phosphorous detection. J Chromatogr B 1999; 723: 221-232.

Pichini S, Navarro M, Farré M, Ortuño J, Roset PN, Pacifici R, Zuccaro P, Segura J, de la Torre R (2002). On-site testing of 3,4-methylenedioxymethamphetamine (ecstasy) in saliva with Drugwipe and Drugread: a controlled study in recreational users. Clin Chem 48: 174-6.

Pichini S, Navarro M, Pacifici R, Zuccaro P, Ortuño J, Farré M, Roset PN, Segura J, de la Torre R. (2003) Usefulness of sweat testing for the detection of MDMA after a single-dose administration. J Anal Toxicol 27: 294-303.

Pizarro N, Ortuño J, Farré M, Hernandez-Lopez C, Pujadas M, Llebaria A, Joglar J, Roset PN, Mas M, Segura J, Camí J, de la Torre R (2002). Determination of MDMA and its metabolites in blood and urine by gas chromatography-mass spectrometry and analysis of enantiomers by capillary electrophoresis. J Anal Toxicol 26: 157-165.

Pizarro N, Llebaria A, Cano S, Joglar J, Farré M, Segura J, de la Torre R. (2003) Stereochemical analysis of 3,4-methylenedioxymethamphetamine and its main metabolites by gas chromatography/mass spectrometry. Rapid Commun Mass Spectrom 17: 330-336

Segura, M, Ortuño, J, Farré, M, McLure, JA, Pujadas, M, Pizarro, N, Llebaria, A, Juglar, J, Roset, PN, Segura, J, de la Torre, R. (2001). 3,4-dihydroxymethamphetamine (HHMA): a major in-vivo 3,4-methylenedioxymethamphetamine (MDMA) metabolite in humans. Chem Res Toxicol 14: 1203-1208.