Randomized Placebo-controlled Study of MDMA-assisted Psychotherapy in People With PTSD - Israel
|Posttraumatic Stress Disorder||Drug: 3,4-methylenedioxymethemphetmaine (MDMA_ Drug: 3,4-methylenedioxymethamphetamine||Phase 2|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||MDMA-assisted Psychotherapy in Twelve People With War and Terrorism-related Posttraumatic Stress Disorder (PTSD)|
- Clinician-Administered PTSD Scale (CAPS) [ Time Frame: Baseline, two months aftter second MDMA-assisted session, 6 and 12-months after second MDMA-assisted session ]
- SCID diagnostic interview [ Time Frame: Screening ]
- Impact of Events Scale (IES), baseline, two months after second experimental session, and six and 12 months after the second experimental session [ Time Frame: Baseline, two months after second MDMA-assisted session, 6 and 12 months after second MDMA-assisted session ]
- Posttraumatic Diagnostic Scale (PDS) [ Time Frame: Baseline, day of MDMA sesison 1, day of MDMA sesison 2, two months after second MDMA-assisted session, 6 and 12 months after MDMA-assisted session ]
- Symptom Checklist 90 - Revised (SCL90R), n [ Time Frame: at baseline, two months post second MDMA session, six and 12 months after second experimental MDMA sessio ]
- Subjective Units of Distress [ Time Frame: every sixty to ninety minutes throughout each experimental or open-label session ]
- Reactions to Research Participation Questionnaire (RRPQ), [ Time Frame: Twelve months after second experimental or open-label session ]
|Study Start Date:||January 2008|
|Study Completion Date:||February 2011|
|Primary Completion Date:||November 2010 (Final data collection date for primary outcome measure)|
Participants will receive an initial dose of 125 mg MDMNA followed 2.5 hours later by a supplemental dose of 62.5 mg MDMA during the course of two day-long psychotherapy sessions.
Drug: 3,4-methylenedioxymethemphetmaine (MDMA_
Participants will receive an initial dose of 125 mg MDMA orally followed 2.5 hours later by 62.5 mg MDMA orally during the course of a day-long psychotherapy session.
Active Comparator: 2
25 and 12.5 mg MDMA
Participants will receive an initial dose of 25 mg MDMA orally followed 2.5 hours alter by a supplemental dose of 12.5 mg MDMA orally during the course of each of two day-long psychotherapy sessions.
Posttraumatic stress disorder (PTSD) occurs after experiencing a traumatic event or events. PTSD is a public health problem that causes a great deal of suffering. This study will examine whether two six to eight-hour long sessions of 3,4-methylenedioxymethamphetamine (MDMA)-assisted psychotherapy scheduled three to five 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, twice during the study, and during two follow-up assessments six and twelve 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 receive the full dose of MDMA, and anyone who received low-dose MDMA and does not undergo the open-label study continuation will have PTSD symptoms measured six and twelve months after the second fully active or low dose MDMA session. 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.
MDMA is a substance that has unique effects that make it well suited to intensive psychotherapy. MDMA may belong to a new class of drugs, called entactogens, that produce feelings of closeness to others, empathy, well being, and insightfulness. Currently, MDMA is scheduled in the US and Israel, and doctors and therapists cannot give it to people outside of research studies like this one. Anecdotal reports of therapy conducted before MDMA was made illegal suggest that MDMA-assisted psychotherapy may benefit people with PTSD, and there is an ongoing placebo-controlled study of MDMA-assisted psychotherapy in people with crime or war-related PTSD occurring in the US.
This study will look at MDMA-assisted psychotherapy in 12 individuals aged 18 years or older diagnosed with PTSD that arose out of war or terrorism-related trauma, with PTSD symptoms not improving after trying at least one treatment. 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. People will be assigned to full or low-dose MDMA "by chance," as by flipping a coin. The fully active dose consists of an initial dose of 125 mg MDMA 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 and a supplemental dose of 12.5 mg.
The study will last approximately four months, and will include two sixty minute long introductory psychotherapy sessions, two active placebo or fully active dose MDMA-assisted psychotherapy sessions, a sixty to ninety minute long psychotherapy session 24 hours after each experimental session, and one to two hour-long psychotherapy sessions occurring weekly between the first and second experimental session, and between the second experimental session and the end of the study.
PTSD symptoms will be measured at the start of the study and eight weeks (two months) after the second experimental session. PTSD symptoms are assessed six and twelve months after the second experimental session in people who do not take part in the open-label study continuation. People who take part in the open-label study continuation will have their PTSD symptoms measured six and twelve months after the second MDMA-assisted psychotherapy session.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00402298
|Beer Yaakov Mental Health Center|
|Beer Yaakov, Israel|
|Principal Investigator:||Moshe Kotler||Director of Psychiatry, Beer Yaakov Mental Health Center and Chair, Dept of Psychiatry, Tel Aviv University|