To the Editor,

In Dr. Fernando Caudevilla's paper entitled: "El extasis: una revision de la bibliografia cientifica sobre la 3,4—metilendioximetanfetamina", ("Ecstasy: A review of the scientific literature about 3,4—Methylenedioximethamphetamine")¹ it is said on page 511 that: "recently, [therapeutic studies with MDMA] have been carried out in Switzerland, Israel and Spain. In our country, a clinical trial with MDMA has been conducted since 2001 June for the treatment of Posttraumatic Stress Disorder in women survivors of sexual assault." In regard to this, we would like to make some clarifications: The only MDMA therapeutic clinical trial that has been started in the world is the one carried out by our research team of the Universidad Autónoma de Madrid and the Hospital Psiquiatrico de Madrid. This study was being carried out in that Hospital until its provisional interruption on May 23, 2002.

Neuropharmacological clinical trials with MDMA and other hallucinogenic drugs are being conducted in Switzerland,² and therapeutic clinical trials are in a preparation phase in Israel.³ In the US, the FDA approved in November 2001 a therapeutic clinical trial with MDMA in order to assess the efficacy of the MDMA in the treatment of Posttraumatic Stress Disorder, but this study has not begun yet.⁴

Our clinical trial was approved by the Ethics Committee of the University Hospital "La Paz" and by the Spanish Medical Agency (Agencía Española del Medicamento — AEM) on February 7, 2000. The objective of the study was to assess the safety and efficacy of a single dose of MDMA as coadjuvant to psychotherapy in women with chronic PTSD secondary to a sexual assault, with women who had been unable to reduce their symptomatology with pharmacotherapy or standard psychotherapy treatments.

In May 2002, a news article appeared in the newspaper El Pais informing the public about the realization of that trial. The next day, our research team received an inspection from the General Direction of Pharmacy and Sanitary Products (Dirección General de Farmacía y Productos Sanitarios — DGFPS) belonging to the State of Madrid. That was the first and only time that the DGFPS contacted us since that the AEM had authorized the trial. Though the Spanish legislation about clinical trials says that reports resulting from inspections should be send to the researchers within 30 days,⁵ the DGFPS never sent that report. However, on May 13, 2002, the manager of the Hospital Psiquiatrico de Madrid decided to disassociate the Hospital from the study. Since then, because we have no another Hospital in which to finish the study, the study cannot be restarted yet and it is now interrupted.

The US Association MAPS (Multidisciplinary Association for Psychedelic Studies — http://www.maps.org) has outlined a clinical plan of 5 years, with a $5 million dollar budget, to carry out the therapeutic clinical trials with MDMA that are required by the FDA in order for MDMA to be approved as prescription medicine to treat PTSD.⁶ MAPS plans to develop these clinical trials in US, Israel and Spain, but because of the impossibility for our research team to find another hospital that it is interested in restarting this research, it is possible that our research team will be definitively dissociated from this clinical research plan.

Jose Carlos Bouso Saiz, Psychologist, U.A.M.
Gregorio Gómez-Jarabo, Psychobiologist Professor, U.A.M.

References

(1) Caudevilla F. El éxtasis: una revisión de la bibliografía científica sobre la 3,4-metilendioximetanfetamina. Med Clin (Bar) 2003; 120(13): 505-15.

(2) Vollenweider FX. Brain mechanisms of hallucinogens and entactogens. Dialogues in Clinical Neuroscience 2001; 3 (4): 265-79.

(3) Doblin, R. MAPS-supported MDMA/PTSD Research in Israel: An update. MAPS Bulletin 2003; 13(1):9. (http://www.maps.org/news -letters/v13n1/13109dob.pdf).

(4) Mithoefer, M. MDMA-Assisted psychotherapy in the treatment of Posttraumatic Stress Disorder (PTSD): A second update on the approval process. MAPS Bulletin 2003; 13(1): 4-6 (http://www.maps.org/news -letters/v13n1/13104mit.pdf).

(5) REAL DECRETO 561/1993, de 16 de abril, por el que se establecen los requisitos para la realización de ensayos cl’nicos con medicamentos, art. 47.2.

(6) Doblin R. A clinical plan for MDMA (Ecstasy) in the treatment of posttraumatic stress disorder (PTSD): partnering with the FDA. J Psychoactive Drugs 2002; 34(2):185-94.