maps • volume xv number 1 • Spring 2005
MDMA-Assisted Psychotherapy in the Treatment of Anxiety
In Advanced Cancer Patients
By John H. Halpern, M.D.
Assistant Director
Alcohol and Drug Abuse Research Center,
Harvard Medical School/McLean Hospital
As MAPS members are probably well aware, our projects are finally drawing a considerable amount of publicity. Even as I typed this first sentence, a reporter from the L.A. Times called to talk about the resurgence of interest in research of psychedelics! She must have been referring only to media interest, as MAPS efforts are longstanding. All this attention is justified: we truly are on the cusp of commencing research at Harvard. The first project will be to enroll 12 subjects with advanced-stage cancer, a prognosis of less than 12 months of life remaining, and who have a diagnosis-associated anxiety disorder that is not sufficiently improving with standard treatments/medications. All subjects will receive six non-drug psychotherapy sessions and up to two MDMA-mediated treatment sessions, two to three weeks apart.

Eight enrolled subjects will be randomly assigned to a full test-dose group and the other four will be assigned to the control group. The full test-dose of MDMA in session one is 83.3 mg followed 2.5 hours later by 41.7 mg (125 mg total) and, in session two, 125 mg followed 2.5 hours later by 62.5 mg (187.5 mg total). Those subjects assigned to the control group will receive 25 mg followed 2.5 hours later by 12.5 mg (37.5 mg total). This is too small a dose to be considered fully psychoactive but should be enough MDMA to serve as a psychoactive placebo. All doses are divided such that the first 2/3rds are administered first and then the final 1/3 is given 2.5 hours later if all parties agree and we believe it remains safe to do so. By splitting the dose of MDMA this way, we will evaluate whether extending the MDMA experience can deepen the therapeutic work.

Thanks to you all for your dedication to making it possible for my collaborators and me to do what some would have thought impossible.
In the months following these sessions, we will be collecting data on continued use of medications for anxiety and pain while continuing to assess how much the experimental treatments may have impacted anxiety and quality of life measures. The MDMA/Cancer study now awaits only our DEA Schedule I registration so that we may prescribe MDMA. We already have Schedule I registration from the Massachusetts Department of Public Health, and, once the DEA registration is issued, we will be ordering 3.25 grams of MDMA. Also, suitable facilities for this project have finally been arranged for us here at McLean Hospital. The space is in a modern building that has large skylights in the treatment room.

Members of the research team have already met with Ms. Amy Emerson, who provides us with the clinical research monitoring procedures to ensure that we gather our data in a professional manner. Ms. Emerson is currently providing these services for Dr. Mithoefer's MDMA/PTSD study in South Carolina. Dr. Umadevi Naidoo, my co-therapist, will visit Michael and Ann Mithoefer soon to observe a treatment session and to discuss special issues that may arise when MDMA is administered in a research setting. We estimate that our study will be enrolling cancer patients within the next two to three months! To read more or to find out the latest breaking news related to the study, please go to the MAPS website.

Another extremely exciting project at McLean Hospital is described on page 18 of this Bulletin. Dr. Andrew Sewell, my lab's first post-doctoral fellow, details our progress on studying how LSD and psilocybin may offer significant relief for people who live with the devastating chronic illness of cluster headaches. Very few physicians have completed residencies in psychiatry as well as neurology, so we are quite fortunate that Dr. Sewell has agreed to forgo the lucrative draw of private practice in favor of collaborating with us. If we do activate a study in which LSD is administered to these headache sufferers, someone with Dr. Sewell's unique training should prove essential in study design, implementation, and in that ever-important issue of convincing all those powers that be that, just like in the MDMA/Cancer study, we have brought together an exemplary team to conduct this work. After publication of our case series describing what current cluster headache sufferers have found from their personal experimentation with LSD or psilocybin (we have medical records on more than 30 patients so far!), we will be drafting all the documents needed for an eventual controlled study, just like we've achieved for the MDMA/Cancer project. If all goes as planned, MAPS could soon be sponsoring the only clinical research project with LSD in the world! And wouldn't that be a remarkable surprise if it occurs during Dr. Albert Hofmanns 100th birthday year in 2006? Stay tuned and please continue to check the MAPS website for further developments as they occur. Many years of hard work are starting to realize some of MAPS most important missions for competent and thorough research. Thanks to you all for your dedication to making it possible for my collaborators and me to do what those of lesser vision would have thought impossible. Thanks to you all for your dedication to making it possible for my collaborators and me to do what some would have thought impossible.

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