Spanish Study of MDMA-Assisted Therapy 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
Location: Madrid, Spain
- Study Protocol (PDF)
- Informed Consent Form (PDF)
- Peer-Reviewed Paper on Study Results (PDF)
May 11, 1999: 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
March 2002: Spanish anti-Ecstasy campaign
May 13, 2002: Hospital Psiquiåtrico de Madrid revokes permission to use facilities
May 23, 2002: Study concluded
