Study of 3,4-Methylenedioxymethamphetamine-assisted Psychotherapy in People With Posttraumatic Stress Disorder
This study will look at the safety and efficacy of MDMA-assisted psychotherapy in people with posttraumatic stress disorder (PTSD).
Posttraumatic Stress Disorder
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Phase II Pilot Randomized Double-Blind Placebo-Controlled Study of 3,4-methylenedioxymethamphetamine (MDMA)Assisted Psychotherapy in Posttraumatic Stress Disorder (PTSD)- Switzerland|
- Clinician Administered PTSD Scale (CAPS [ Time Frame: baseline, three weeks post-experimental session 2, three weeks post-experimental session 3, two, six and 12 months post-experimental session 3 ] [ Designated as safety issue: No ]
- Posttraumatic Diagnostic Scale (PDS) [ Time Frame: - baseline, three weeks post experimental session 2, three weeks post-experimental session 3, 2, 6 and 12 months post-experimental session 3 ] [ Designated as safety issue: No ]
- Reactions to Research Participation Questionnaire (RRPQ) - 12 months post-experimental session 3; in Phase II participants, 12 months post-MDMA session 3 [ Time Frame: 2 months post-experimental session 3; in Phase II participants, 12 months post-MDMA session 3 ] [ Designated as safety issue: No ]
- Subjective Units of Distress (SUD) [ Time Frame: During each of three experimental sessions, and, if applicable, during each of three Phase II MDMA-assisted session ] [ Designated as safety issue: Yes ]
- EEG and ERP with acoustic startle - [ Time Frame: baseline, three weeks post experimental session 3 ] [ Designated as safety issue: No ]
|Study Start Date:||October 2006|
|Study Completion Date:||February 2011|
|Primary Completion Date:||February 2011 (Final data collection date for primary outcome measure)|
125 and 62.5 mg MDMA
Participants will receive an initial dose of 125 mg MDMA orally and, if investigator and participant deem appropriate, 2-2.5 hours later they receive 62.5 mg MDMA orally in combination with psychotherapy during three day-long sessions scheduled three to five weeks apart.
Other Name: MDMA
Active Comparator: 2
25 and 12.5 mg MDMA
Participants will receive a 25 mg MDMA and if investigator and participant agree, 2 to 2.5 hours later a dose of 12.5 mg MDMA in combination with psychotherapy during three day-long sessions scheduled three to five weeks apart
Other Name: MDMA
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 three six to eight-hour long sessions of methylenedioxymethamphetamine (MDMA)-assisted psychotherapy scheduled three to five weeks apart can be safely administered to participants with PTSD, and whether combining a fully therapeutic dose of MDMA with psychotherapy, when compared with a low ("active placebo") dose of MDMA, will reduce PTSD symptoms, with symptoms measured three times during the study. People who receive the low dose of MDMA have the opportunity to take part in a second "open label" study continuation, wherein the participant will undergo three MDMA-assisted sessions, with the participant and the researchers knowing that a full dose of MDMA is being administered. People who receive the full dose of MDMA, and any person 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 third session. People who take part in the open label study continuation have their PTSD symptoms checked six and 12 months after the third Phase II MDMA-assisted session.
MDMA is a substance possessing 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 (illegal) in the US and Switzerland and cannot be used 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 examine MDMA-assisted psychotherapy in 12 individuals aged 18 years or older diagnosed with PTSD, 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 three experimental sessions. People will be assigned to full or low-dose MDMA "by chance," as by flipping a coin.
The study will last approximately four and a half months. In addition, people assigned to receive full-dose MDMA will have their PTSD symptoms measured six and 12 months later. The study involves up to eleven ordinary psychotherapy visits, without any MDMA, and three low or full-dose MDMA-assisted sessions. One psychotherapy session is scheduled 24 hours after each MDMA-assisted session.
PTSD symptoms will be measured at the start of the study, three weeks after the second of three low or full-dose MDMA sessions, three weeks after the third low or full-dose MDMA session (approximately six weeks after the second session), two months after the third experimental session, and six and 12 months after either the third experimental session, or, if enrolled in Phase II, six and 12 months after the third open-label MDMA-assisted therapy session. Participants will undergo EEG (measuring brain waves) in combination with ERP (evoked response potential) technique before and after MDMA-assisted therapy that aim at spotting specific changes in brain function and structure that might be related to problems with early information processing, for which people with PTSD are known to have difficulties.
|Offices of Peter Oehen MD|
|Biberist, Solothurn, Switzerland|
|Principal Investigator:||Peter Oehen, MD||private practice, Biberist, Switzerland|