Investigators' Background and Experience: The principal investigator is the first psychiatrist to conduct a Phase II pilot study of MDMA-assisted psychotherapy in people with PTSD. Participants in this study receive twelve psychotherapy sessions, including ten 60 to 90-minute non-drug assisted psychotherapy sessions, and two six to eight-hour long experimental sessions with either 125 mg MDMA or placebo, with experimental sessions scheduled three to five weeks apart. Twelve participants will receive MDMA and eight will receive placebo. This study now includes an open-label continuation for participants assigned to the placebo condition. Mithoefer and cotherapist Ann Mithoefer BSN have recorded all psychotherapy sessions to audio.
The principal investigator is a board-certified psychiatrist with ten years of experience treating PTSD. He has previously worked as an emergency physician and is a trained Holotropic Breathwork facilitator. Holotropic Breathwork refers to a non-pharmacological technique for inducing and working with altered states of consciousness (Grof 2000) largely based on Grof's work with LSD psychotherapy, making it similar to the approach used in the study of MDMA-assisted therapy in people with PTSD. He and Ann Mithoefer have had ten years of experience using Holotropic Breathwork with patients, including people with PTSD.
Other investigators include June May Ruse PsyD, Lisa Jerome PhD, Rick Doblin PhD and Elizabeth Gibson MS. Dr. Ruse is a clinical psychologist who has collaborated on earlier drafts of the treatment manual and has listened to session audio recordings. Dr. Jerome is a research associate working for MAPS with a background in social psychology who assisted in the initial stages of treatment manual development who will use her expertise on human MDMA research to inform the treatment manual, as well as offering editorial assistance. Dr. Doblin is president of MAPS, and Ms. Gibson is on the faculty of [college or university deleted] and edits a Holotropic Breathwork publication (the Inner Door). Both Doblin and Gibson are also certified Holotropic Breathwork facilitators. Dr. Doblin and Ms. Gibson will also offer editorial support during treatment manual development. She will continue to review and examine session material and collaborate on treatment manual development. Sherry Falsetti PhD, a psychotherapy researcher with a strong publication history, will act as a consultant and will be involved in treatment manual structure and design. Taken together the research team have authored or coauthored over 36 publications in peer-reviewed journals (e.g. Doblin 2002; Falsetti 2003; Freeman and Urschel (Ruse) 1997; Gamma et al. 2005; Mithoefer et al. 1972).
We (Dr. Mithoefer and Dr. Ruse) began developing a standardized treatment manual in 2002, assisted by research associate Lisa Jerome PhD and with financial support from MAPS. We laid the foundation of the manual with information drawn from literature detailing related psychotherapy models (for example Grof 2000), anecdotal accounts and case reports of MDMA-assisted therapy (for example Adamson 1985; d'Otalora 2000; Greer and Tolbert 1998; Stolaroff 2004; Widmer 1998), and Phase 1 trials of MDMA (for example Cami et al. 2000; Grob et al. 1996; Harris et al. 2002; Lester et al. 2000; Liechti et al. 2001; Mas et al. 1999; Pacifici et al. 2004; Tancer and Johanson 2001; Tancer and Johanson 2003; Vollenweider et al. 1998). Once the pilot study of MDMA-assisted psychotherapy was underway, the team of investigators made use of observations from the study to inform the treatment manual draft, drawing on quotes and transcripts of recorded sessions. The principal investigator has been instrumental in developing MDMA-assisted psychotherapy, and the Mithoefers and Ruse are familiar with procedures used in behavioral and treatment outcome research. Along with editorial assistance from Jerome, they have produced three editions of the treatment manual. Elizabeth Gibson has edited the most recent manual draft. The current draft of the manual addresses the introductory, MDMA-assisted and post-MDMA-assisted (or "follow up") sessions of MDMA-assisted psychotherapy. The current draft does not contain evaluative guidelines, and the investigators have not generated measures of therapist adherence or competency. Further, procedures for training of other therapists have not yet been developed.
Pilot Study Data: To date, seven participants have completed the course of the Phase II MDMA/PTSD study. None of the participants experienced serious, drug-related adverse events. Elevation in blood pressure and pulse occurred in all participants who received MDMA, but in no case were the levels dangerous and no participants required medical intervention. [Preliminary data and discussion of findings excised here and below.]
Difficulties inherent in maintaining the blind in placebo-controlled studies of psychoactive drugs raise issues concerning the impact that the placebo effect and experimenter bias may have had on study results, and the current sample size is small. [Additional text reviewing preliminary findings deleted.] These preliminary findings suggest that MDMA-assisted therapy can be safely performed in people with PTSD and that it reduces PTSD symptoms.