maps • volume xv number 1 • Spring 2005
MDMA-Assisted Psychotherapy in the Treatment of Posttraumatic Stress Disorder (PTSD): Fifth Update on Study Progress
By Michael Mithoefer, MD
Since my last update in the Spring of 2004 our study has progressed smoothly and we've gotten permission to expand the protocol in some significant ways. At this point seven subjects have completed the study, one more has been enrolled and is currently participating in the protocol and several others will soon be screened. A brief chronology of recent events is as follows:

8/10/04 Site visit by our Institutional Review Board (IRB) to review documentation and compliance with the protocol

9/3/04 Approval from IRB to continue the study -- this is routinely required every 6 months

11/15/04 Data Safety Monitoring Board (DSMB) met as scheduled to review the records of the first five subjects to complete the study. The DSMB (a psychiatrist, a psychologist and a PharmD pharmacologist not otherwise involved in the study) reported no safety concerns

11/16/04 Based on our experience with the first five subjects, who had completed the study safely and with promising results, we wrote the FDA requesting five modifications in the protocol. These requests were approved by the FDA in December and by the IRB in January. These changes have now been incorporated in the protocol and are as follows:

  1. At the final (17th) visit of the existing protocol the blind is broken and subjects who received placebo during their experimental sessions are offered inclusion in a second stage of the study (Stage 2) in which MDMA is given in an open label fashion (subjects and researchers know ahead of time that MDMA is being administered in both experimental sessions of this stage). This occurs during the same kind of eight-hour MDMA-assisted psychotherapy session as in Stage 1. There are 6 follow-up therapy sessions in stage 2 and outcome measures are repeated approximately 2 months after the second MDMA-assisted therapy session. In order to protect the blind in Stage 1, the blind will not be broken for the last five of the subjects until they have all completed the study. Any placebo subjects in this group will be offered participation in Stage 2 at that point.
  2. In addition to subjects with crime related PTSD we may now also include people with war related PTSD of less than five years duration.
  3. The upper age limit is increased from 65 to 70 years. Before this change we had been obligated to turn away some subjects over 65 who were in good physical health and had no reason for exclusion other than the age limit.
  4. We are able to use more clinical judgment about how often we must measure blood pressure and pulse in certain situations. We are still required to take these measurements at least every 15 minutes for 4 hours and every 30 minutes for 2 more hours.
  5. Although subjects are required to be off all psychotropic medications, we may now make an exception for gabapentin (Neurontin) in a subject who needs it for pain related to traumatic nerve injury.
We are now in the process of sending out another round of recruitment letters to psychiatrists, psychologists and other therapists giving an update on the progress of the study and informing them about these protocol changes. The IRB has now also given us permission to use newspaper advertising for recruitment. This is expensive so it will be used sparingly but we hope it will be helpful with ongoing recruitment. We're in competition for subjects with several PTSD studies going on at the Medical University in Charleston (not using MDMA!) that appear to have large advertising budgets from drug companies or government grants. Pending these additional recruitment methods, some new subjects have been referred by therapists already familiar with the study; some have called because they learned about it by word of mouth from previous subjects or from media coverage of MDMA research. There's been another upsurge in this coverage recently with the approval of John Halpern's MAPS sponsored MDMA study at Harvard. His approval is not only great news in general, it's helpful because it demonstrates that we're not the only ones crazy enough to think the therapeutic potential of MDMA is worth studying.

We're very pleased with the recent adjustments in the protocol. The fact that we can now offer MDMA-assisted sessions to subjects who got placebo is likely to help with recruitment, and it will add valuable data, as these subjects will serve as their own placebo controls. In addition, the preliminary results are encouraging and, most importantly, there has been no indication of harm to the subjects.

Spring 2009 Vol. 19, No. 1 Special Edition: Psychedelics and Ecology
Winter 2008/09 Vol. 18, No. 3 MAPS 2008 Financial Report
Summer 2008 Vol. 18, No. 2 Phoenix Rising: A Review of MAPS Research
Spring 2008 Vol. 18, No. 1 Special Edition: Technology and Psychedelics
Winter 2007 Vol. 17, No. 3 MAPS 06-07 Fiscal Yearly Report
Autumn 2007 Vol. 17, No. 2 Special Edition: Psychedelics and Self-Discovery
Spring/Summer 2007 Vol. 17, No. 1 The Chrysalis Stage
Winter 2006-7 Vol. 16, No. 3 Low Maintenance/High Performance
Autumn 2006 Vol. 16, No. 2 Technologies of Healing
Spring 2006 Vol. 16, No. 1 MAPS' 20th Anniversary
Winter 2005 Vol. 15, No. 3 MAPS final year as a teenager
Summer 2005 Vol. 15, No. 2 Israel Conference: MDMA/PTSD Research
Spring 2005 Vol. 15, No. 1 Accelerating flow of work and time
Autumn 2004 Vol. 14, No. 2 Rites of Passage: Kids and Psychedelics
Summer 2004 Vol. 14, No. 1 10 stamps and $250,000
Winter 2003 Vol. 13, No. 2 Holy Fire
Spring 2003 Vol. 13, No. 1 60th Anniversary of the Discovery of LSD
Autumn 2002 Vol. 12, No. 3 Vision
Summer 2002 Vol. 12, No. 2 "From celebration to frustration, and back again."
Spring 2002 Vol. 12, No. 1 Sex, Spirit & Psychedelics 2002
Autumn 2001 Vol. 11, No. 2 "In the future, it will be called Despair."
Spring 2001 Vol. 11, No. 1 "A Tidal Wave of Ecstasy!"
Autumn 2000 Vol. 10, No. 3 Creativity 2000
Summer 2000 Vol. 10, No. 2 Endings and Beginnings
Spring 2000 Vol. 10, No. 1 Making History in Slow Motion
Winter 1999/00 Vol. 9, No. 4 To the Ends of the Earth for MDMA Research...
Autumn 1999 Vol. 9, No. 3 MAPS' long-standing efforts to conduct...
Summer 1999 Vol. 9, No. 2 MAPS has come full circle...
Spring 1999 Vol. 9, No. 1 Patience, persistence and passion
Winter 1998/99 Vol. 8, No. 4 One of special pleasures of directing MAPS...
Autumn 1998 Vol. 8, No. 3 The Ayahuasca Issue (with Hofmann interview)
Summer 1998 Vol. 8, No. 2 Emotionally Powerful Anecdotes...
Spring 1998 Vol. 8, No. 1 Death Has a Way of Focusing One's Attention
Autumn 1997 Vol. 7, No. 4 Celebration is in Order
Summer 1997 Vol. 7, No. 3 Time Horizons
Spring 1997 Vol. 7, No. 2 Synchronicity
Winter 1996/97 Vol. 7, No. 1 Learning to Crawl
Autumn 1996 Vol. 6, No. 4 An Invitation for Dialogue
Summer 1996 Vol. 6, No. 3 Budding Research
New Year 1996 Vol. 6, No. 2 Sending Down Roots
Autumn 1995 Vol. 6, No. 1 Baby Steps
Summer 1995 Vol. 5, No. 4 Opportunity Amidst Obstacles
Winter 1994/95 Vol. 5, No. 3 Clinical Trials and Tribulations
Autumn 1994 Vol. 5, No. 2 Building Towards Clinical Trials
Summer 1994 Vol. 5, No. 1 Politics and Protocols: In Search of a Balance
Spring 1994 Vol. 4, No. 4 Laying the Groundwork
Winter 1993/94 Vol. 4, No. 3 A Time of Tests
Summer 1993 Vol. 4, No. 2 So Close Yet So Far
Spring 1993 Vol. 4, No. 1 Remembrance and Renewal
Winter 1992/93 Vol. 3, No. 4 Forging New Alliances
Summer 1992 Vol. 3, No. 3 Building on Common Ground
Spring 1992 Vol. 3, No. 2 Small Steps, Gradual Progress, New Opportunities
Winter 1991/92 Vol. 3, No. 1 The Rekindling of a Thousand Points of Light
Summer 1991 Vol. 2, No. 2 MDMA protocol development with cancer patients
Winter 1990/91 Vol. 2, No. 1 MAPS' Swiss pharmacologically-assisted psychotherapy conference
Autumn 1990 Vol. 1, No. 3 What and Who is MAPS?
Summer 1989 Vol. 1, No. 2 Switzerland Leads the Way
Summer 1988 Vol. 1, No. 1 MDMA can become a legal medicine