Clinical trial NCT00402298
Conditions: Posttraumatic Stress Disorder
Keywords: PTSD MDMA therapy Posttraumatic stress disorder Israel
Sponsor: Lykos Therapeutics
Start date: 2007-05-27; Completion date: 2010-05-05
Enrollment: 5 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The goal of this clinical trial is to learn if MDMA-assisted therapy can treat PTSD in participants with PTSD. Researchers will compare two sessions of MDMA-assisted therapy with two sessions of low dose (active placebo) MDMA-assisted therapy to determine if MDMA-assisted therapy is safe and works to treat PTSD symptoms.

Participants will be randomly assigned to receive either the full dose of MDMA or low active placebo dose of MDMA during each of two experimental sessions. PTSD symptoms will be measured throughout the study.

Detailed description:
This study will examine whether two six to eight-hour long sessions of 3,4-methylenedioxymethamphetamine (MDMA)-assisted therapy scheduled two to four weeks apart are safe, and whether combining a fully therapeutic dose of MDMA with psychotherapy, compared with a low ("active placebo") dose of MDMA, will reduce PTSD symptoms, with symptoms measured four times, once at baseline and again 2, 6, and 12 months after the second experimental session. People who received the active placebo dose of MDMA can then take part in an "open label" study continuation, with the participant receiving a fully active dose of MDMA on two more six to eight hour-long psychotherapy sessions. Open-label means that the participants and the researchers know that the participant will receive the fully active dose of MDMA. People who take part in the open label study continuation have their PTSD symptoms checked six and 12 months after the second open label MDMA-assisted session.

This study will look at MDMA-assisted therapy in 12 individuals aged 18 years or older, with PTSD symptoms not improving after trying at least one treatment. At least two-thirds of participants will have diagnosed PTSD arising from war or terrorism-related trauma. Eight of 12 participants will be assigned to receive the full dose of MDMA, and four will be assigned to receive a low or "active placebo" dose of MDMA during each of two experimental sessions. The fully active dose consists of an initial dose of 125 mg MDMA HCl and a supplemental dose of 62.5 mg given 2 to 2.5 hours later. The active placebo dose consists of an initial dose of 25 mg MDMA HCl and a supplemental dose of 12.5 mg.

The study will will include two sixty minute long introductory therapy sessions, two active placebo or fully active dose MDMA-assisted therapy sessions, a sixty to ninety minute long therapy session 24 hours after each experimental session, and one to two hour-long therapy sessions occurring weekly between the first and second experimental session, and between the second experimental session and the end of the study.

Arms: arm 1: Participants will receive an initial dose of 125 mg midomafetamine HCl followed 2.5 hours later by a supplemental dose of 62.5 mg midomafetamine HCl during the course of two day-long therapy sessions. arm 2: Participants will receive an initial dose of 25 mg midomafetamine HCl followed 2.5 hours later by a supplemental dose of 12.5 mg midomafetamine HCl during the course of two day-long therapy sessions.
Interventions: intervention 1: Full Dose Midomafetamine HCl intervention 2: Low Dose Midomafetamine HCl
Intervention descriptions: intervention 1: Participants will receive an initial dose of 125 mg midomafetamine HCl orally followed 2.5 hours later by 62.5 mg midomafetamine HCl orally during the course of a day-long therapy session. intervention 2: Participants will receive an initial dose of 25 mg midomafetamine HCl orally followed 2.5 hours later by a supplemental dose of 12.5 mg midomafetamine HCl orally during the course of each of two day-long therapy sessions.

Protocol documents: