maps • volume xv number 2 • Summer 2005
MAPS' Proposed Israeli MDMA/PTSD Pilot Study

By Rick Doblin
MAPS' effort to sponsor research in Israel into the use of MDMA-assisted psychotherapy in subjects with war and terrorism-related posttraumatic stress disorder (PTSD) began in 1998, when I first met with Israeli psychiatrist Dr. Moshe Kotler. At that time, MDMA/PTSD research had not yet begun in the United States (that would take six more years) nor had the MAPS-sponsored MDMA/PTSD dose-response study in Spain been approved (that would take about two more years). Three MAPS-sponsored scientific conferences in Israel later (September 1999, MAPS Bulletin online archives Volume 9, Number 3; November 2002, archives Volume 13, Number 1; and March 2005, see page 4), and after FDA had approved two MAPS-sponsored MDMA-assisted psychotherapy studies (Dr. Mithoefer's MDMA/PTSD study, approved in February 2004, and Dr. Halpern's MDMA/cancer anxiety study, approved in December 2004), the Israeli research team felt that the time had arrived to submit the protocol for review.

On May 3, 2005, MAPS donated $5,000 to the Medical Research Fund at Beer Yaakov Mental Health Center, to cover costs and professional time associated with the review of the protocol by the local and national ethics committees. An additional $5,000 will be donated after the protocol has been approved by both the ethics committees, to cover costs associated with the review of the protocol by the Ministry of Health. Once the study becomes fully approved, we have budgeted $75,000, from funds we still need to raise.

On June 6, 2005, the ethics committee at Beer Yaakov Mental Health Center, where the study will take place, approved the protocol. They subsequently passed the protocol on to the national ethics committee for its review. We expect to hear from them around the end of the summer. If approved, the protocol will then be submitted to the Ministry of Health. We're hoping we will have all the approvals required to begin the study before the end of this year.

The Israeli protocol differs from Dr. Mithoefer's US MDMA/PTSD study in several respects. This study focuses specifically on people who have developed PTSD as a result of war or terrorism, while Dr. Mothoefer's study includes victims of rape and sexual assault as well. Instead of an inactive placebo, we're proposing the use of low-dose MDMA as an active placebo that should be more effective at creating uncertainty as to which dose was received. We're also proposing that subjects receive a supplemental dose of half the initial dose, to be administered about 2 1/2 hours after the initial dose. This will extend the period of the peak therapeutic effects into a plateau lasting for several more hours, enabling the subjects and therapists to do additional emotional work. We're going to keep the model of a male/female co-therapist team and use the same primary outcome measure, the Clinician Administered PTSD Scale (CAPS).

MAPS' long-term goals are to obtain permission from the FDA as well as the European Medicines Agency for the use of MDMA-assisted psychotherapy by prescription, in specially-licensed clinics by specially trained and licensed therapists. Our strategy to achieve this goal is to conduct pilot studies and one of the two required large-scale Phase III studies in the US, while also having pilot studies and the other of the two required large-scale Phase III studies conducted in Europe. We hope to develop studies in Israel, Spain, Switzerland and elsewhere, perhaps even Palestine. Around 300 subjects would be enrolled in the US studies and a similar number in those around the world.

Though it may seem surprising, much credit for the progress that we have made so far in the review process is due to the Israeli Anti-Drug Authority. We arranged a meeting at their office the day before our scientific conference to discuss in detail the purpose of the initial pilot study and our longer-term plans. In particular, the chief scientist of the Authority, Dr. Rachel Bar-Hamburger, attended the conference and spoke to the media expressing support for the study. See page 11 for some of her comments.

We look forward to continuing to work closely with all the Israeli regulators to shepherd this study through the approval process. We're eager to reach the point where we are able to actually gather data about whether MDMA- assisted psychotherapy can indeed play a role in reducing the terrible amount of trauma suffered by many people in Israel and Palestine.

Rick Doblin, Ph.D.

Summer 2009 Vol. 19, No. 2 MAPS Research Update 2009
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