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Today's Topics:
1. MAPS News: July 2006 (Jag Davies)
----------------------------------------------------------------------
To read this MAPS monthly news update online, click here:
www.maps.org/news
Greetings, MAPS Members and Friends!
We have lots of news to report this month:
1. FDA-Approved Changes to US MDMA/PTSD Study Implemented; New Subjects
Receive Supplemental Doses of MDMA or Placebo
2. MAPS Receives $25,000 Donation for US MDMA/PTSD Study
3. MAPS and Swiss Medical Association for Psycholytic Therapy-Sponsored
MDMA/PTSD Research Receives Final Regulatory Approval
4. MAPS Purchases 35 Grams of Research-Grade MDMA from Swiss Manufacturer
5. Israeli MDMA/PTSD Team Receives Permit to Import MDMA for
MAPS-Sponsored Study
6. MAPS-Sponsored MDMA/PTSD Research in Spain Resuming Active Protocol
Design and Approval Process
7. Canadian Institutional Review Board to Review MAPS-Sponsored Ibogaine
Outcome Protocol this Month
8. Findings About LSD/Psilocybin as Treatment for Cluster Headaches
Published in Neurology, the Journal of the American Academy of Neurology
9. Journal of Pychopharmacology and Quarterly Journal of Mental Health
Accept Papers Advocating Psychedelic Research
10. Multiple Sclerosis Foundation Sends Letter of Support to DEA for
MAPS-Sponsored Medical Marijuana Production Facility
11. Upcoming MAPS Fundraiser on July 24 in Asheville, NC
12. Camp with MAPS at Burning Man for MAPS' 20th Anniversary Celebration
13. Now in the MAPS Online Store: Limited Edition Ram Dass Portrait by Dean
Chamberlain
14. Three Prints of Alex Grey's Portrait of Albert Hofmann Now Available!
15. Request for Calendar Art, Calendar Dates, T-Shirt Design
16. Classic 'Good Friday Experiment' Now Posted Online
17. $25,000 Grant to MAPS for Erowid.org
*** Like What You're Reading? Click Here to Support MAPS' Work With A
Financial Contribution: www.maps.org/catalog/ ***
1. FDA-Approved Changes to US MDMA/PTSD Study Implemented; New Subjects
Receive Supplemental Doses of MDMA or Placebo
Dr. Michael Mithoefer has now begun treatment of the 13th and 14th patients
out of 20 in his MAPS-sponsored MDMA/PTSD study, implementing several key
changes recently approved by the FDA, IRB, and Data Safety Monitoring Board.
These changes include administering a supplemental dose of MDMA (or a
placebo) 2 to 2 1/2 hours after the initial dose and adding a third
experimental session to the two that are currently included in the protocol.
The first subject to receive this supplemental dosing experienced an
extended period of therapeutic activity without any worrisome increase in
blood pressure or heart rate. This initial reaction, while in only one
subject, suggests that this protocol change may enhance the therapeutic
effectiveness of the experimental treatment without significantly increasing
risk.
Dr. Mithoefer's MAPS-sponsored FDA-approved protocol:
www.maps.org/mdma/protocol/index.html
2. MAPS Receives $25,000 Donation for US MDMA/PTSD Study
MAPS has just received a $25,000 donation from the Robert T. Keeler
Foundation, restricted for Dr. Mithoefer's MDMA/PTSD study. This is the
second $25,000 donation for Dr. Mithoefer's study from the Robert T. Keeler
Foundation, the first donated a year ago. MAPS is seeking an additional
$100,000 for this study.
3. MAPS and Swiss Medical Association for Psycholytic Therapy-Sponsored
MDMA/PTSD Research Receives Final Regulatory Approval
Switzerland's DEA equivalent, the BAG, has officially given the necessary
licenses for Dr. Peter Oehen's study evaluating MDMA-assisted psychotherapy
as a treatment for subjects suffering from treatment-resistant Posttraumatic
Stress Disorder (PTSD). Permission from BAG was the final regulatory hurdle,
since Dr. Oehen has already received approval from the Ethics Committee
(Switzerland's IRB equivalent) and SwissMedic (Switzerland's FDA
equivalent). In addition, MAPS Clinical Research Associate Valerie Mojeiko
has completed preparation of Case Report Forms (CRFs), Standard Operating
Procedures (SOPs) and other documents that must be submitted to FDA under
MAPS' Investigational New Drug application for MDMA in the treatment of
PTSD. Dr. Oehen will receive the MDMA for his study within a few weeks and
can then begin his study. MAPS is seeking an additional $100,000 for this
study.
Read Dr. Oehen's government-approved protocol here:
www.maps.org/mdma/swissp...ol011806.pdf
MAPS and Dr. Oehen are also going to collaborate with Dr. Franz
Vollenweider, University of Zurich, on an associated study that will examine
the subjects in Dr. Oehen's study before and after treatment with
MDMA-assisted psychotherapy. Dr. Vollenweider is going to measure several
physiological factors that have been associated with PTSD (startle response,
heart rate reactivity) as well as various EEG parameters to see if the
MDMA-assisted psychotherapy results in any changes in these measures.
4. MAPS Purchases 35 Grams of MDMA for Swiss and Israeli MDMA/PTSD Studies
MAPS has completed the purchase of 35 grams of MDMA of a purity of 99.66%
from a Swiss manufacturer for use in MAPS' MDMA studies that take place
outside of the US. The same batch of MDMA has been used before in clinical
research in Switzerland and will be used in Dr. Oehen's MDMA/PTSD study.
This same MDMA will be exported to Israel for use in MAPS' Israeli MDMA/PTSD
study. The cost was about $57 per gram.
5. Israeli MDMA/PTSD Team Receives Permit to Import MDMA for
MAPS-Sponsored Study
The Israeli MDMA/PTSD team received a permit this week to import MDMA from a
Swiss manufacturer for the MAPS-sponsored study set to take place at Beer
Yaakov Mental Health Center near Tel Aviv. Once the Swiss BAG issues an
export permit, the MDMA can be shipped to Israel. This is the final step
before initiation of Dr. Moshe Kotler's clinical trial evaluating
MDMA-assisted psychotherapy in treatment-resistant subjects with war and
terrorism-related PTSD.
MAPS is seeking an additional $50,000 for this study.
Dr. Moshe Kotler's government-approved MAPS-sponsored protocol:
www.maps.org/mdma/israel..._3.16.05.pdf
6. MAPS-Sponsored MDMA/PTSD Research in Spain Preparing to Resume Protocol
Design and Approval Process
Jose Carlos Bouso, Ph.D., has returned to the protocol design and approval
process for his MAPS-sponsored MDMA/PTSD study. This study was the world's
first government-approved MDMA psychotherapy study, with six patients
treated in 2001-02. However, in 2002, in response to positive reports about
the study that appeared in the Spanish media, the Madrid Anti-Drug Authority
pressured the hospital into withdrawing permission. The Ministry of Health
has not withdrawn permission, and we are hopeful that since we have now
obtained government approval for MDMA/PTSD studies in the US, Switzerland,
and Israel, it will be politically feasible to resume research in Spain
around the beginning of 2007, with a different protocol design. As a result
of the political suppression of his initial MDMA/PTSD study, Jose Carlos had
to initiate and complete a different research project for his dissertation
before he was able to return his attention to his MDMA/PTSD study.
Jose Carlos is now in the midst of writing up for publication the results
from the six subjects treated in his initial study. Ilsa Jerome, Ph.D.,
MAPS' expert on the scientific literature on MDMA, is assisting Jose Carlos
by reviewing and commenting on early drafts of his paper.
MAPS' MDMA Research in Spain: www.maps.org/mdma/spain/index.html
7. Canadian Institutional Review Board to Review MAPS-Sponsored Ibogaine
Outcome Protocol this Month
This week, MAPS submitted a revised version of the ibogaine case series
observational study protocol to a Canadian Institutional Review Board (IRB).
We have been negotiating for several months with an IRB for the
observational study of 20 opiate dependent subjects to be treated at the
Iboga Therapy House. We have incorporated the latest set of comments and
suggestions and have submitted the protocol for review at an upcoming
meeting on July 19.
Read more about MAPS' Ibogaine Research: www.maps.org/ibogaine/
Iboga Therapy House in Vancouver, Canada: www.ibogatherapyhouse.net
8. Findings About LSD/Psilocybin as Treatment for Cluster Headaches
Published in Neurology, the Journal of the American Academy of Neurology
A paper by Andrew Sewell, M.D., coauthored by John Halpern, M.D., and
Harrison G. Pope Jr., M.D., describing MAPS-sponsored LSD/psilocybin cluster
headache research, has been published in Neurology, the official journal of
the American Academy of Neurology. The article contains interviews with
people who have treated cluster headaches with LSD or psilocybin mushrooms,
and reviews their medical records. Neurology is a top specialty journal,
read by most neurologists throughout the world, so news of this promising
use of LSD and psilocybin will be widely disseminated among doctors for the
first time.
Read Dr. Sewell's article here:
www.maps.org/w3pb/new/20..._22779_1.pdf
Andrew Sewell, M.D., and John Halpern, M.D., collected and analyzed hundreds
of case reports from Erowid and Clusterbusters, an organization run by and
for people with cluster headaches dedicated to evaluating new treatments for
cluster headache, including the use of psilocybin and LSD. Based on this
data, Drs. Sewell and Halpern are currently developing a protocol for a
randomized, dose-response study of psilocybin and LSD in people with
episodic cluster headaches.
Currently, there is no legal research with LSD in humans taking place
anywhere in the world. We hope that this will be the first study to renew
human research into the therapeutic use of LSD. Due to the previously
expressed concerns of the new McLean Administration, funding for any
clinical study will be provided by Clusterbusters, until the McLean
Administration becomes comfortable again accepting research support from
MAPS.
Read more about MAPS' LSD/psilocybin cluster headache research here:
www.maps.org/research/cl...lsd/#cluster
9. Journal of Pychopharmacology and Quarterly Journal of Mental Health
Accept Papers Advocating Psychedelic Research
Ben Sessa, M.D., a British psychiatrist working courageously and effectively
towards the resumption of psychedelic research in England, recently had two
papers regarding psychedelic-assisted psychotherapy research accepted for
publication in two key international academic journals. The first paper, "Is
there a case for MDMA-assisted Psychotherapy in the UK?" will appear in the
peer-reviewed Journal of Psychopharmacology, and draws on evidence from
MAPS-sponsored FDA Phase I and Phase II research studies. The second paper,
"From Sacred Plants to Psychotherapy: The History and Re-Emergence of
Psychedelics in Medicine," will appear in the peer-reviewed Quarterly
Journal of Mental Health.
10. Multiple Sclerosis Foundation Sends Letter of Support to DEA for
MAPS-Sponsored Medical Marijuana Production Facility
This week, the Multiple Sclerosis (MS) Foundation sent a letter to DEA
Administrator Karen Tandy urging DEA to issue a Schedule I license to Prof.
Lyle Craker for his proposed MAPS-sponsored medical marijuana production
facility at the University of Massachusetts-Amherst. Prof. Craker's proposed
facility would end the government's six decades-long monopoly on the
production of marijuana for research purposes and would create the necessary
independence of supply to justify the time and expense for MAPS to sponsor
clinical research evaluating the risks and benefits of marijuana as a
potential FDA-approved prescription medicine.
The MS Foundation letter is in support of Prof. Craker in his ongoing
MAPS-supported lawsuit against DEA taking place in a DEA Administrative Law
Judge (ALJ) hearing. With oral arguments complete and the final legal briefs
submitted, we are now awaiting a recommendation from ALJ Mary Ellen Bittner,
expected in 2-4 months. In the meantime, we are focusing our attention on
preparing to pressure the DEA to accept Judge Bittner's recommendation if
she actually recommends that the DEA should issue a Schedule I license to
Prof. Craker. DEA has already received letters of support for Prof. Craker's
marijuana growing facility from Americans for Tax Reform, the Lymphoma
Foundation of America, the National Association for Public Health Policy,
the United Methodist Church, the American Medical Students Association,
several state nurses' associations, the Massachusetts Dept. of Public
Health, Massachusetts Senators Kerry and Kennedy, and 38 members of the US
House of Representatives.
This latest letter was the result of work by MAPS' part-time staffer Kelly
Burns, who is currently laying the groundwork for an effort to obtain a
letter from the American Medical Association to DEA, urging DEA to issue
Prof. Crakers license so that the controversy over the medical use of
marijuana can be resolved through scientific research. We expect that such a
letter from the AMA would require action by the AMA House of Delegates at
its November 2006 meeting. Any physicians who belong to their state Medical
Associations who wish to help in this effort should contact Kelly at:
kelly426@gmail.com
For more information about Dr. Craker's MAPS-sponsored medical marijuana
production facility and DEA lawsuit, click here:
www.maps.org/mmj/DEAlawsuit.html
11. Upcoming MAPS Dinner Fundraiser on Monday, July 24 in Asheville, North
Carolina
MAPS will be holding a dinner fundraiser on Monday, July 24 in Asheville,
North Carolina. MAPS researchers Dr. Michael and Annie Mithoefer
(co-therapists for MDMA/PTSD study) and Dr. Andrew Sewell (LSD/psilocybin
research), along with MAPS President Rick Doblin, Ph.D., and MAPS Program
Director and Clinical Research Associate Valerie Mojeiko will each give
presentations. The event will also feature a delicious 5-course tasting menu
courtesy of Sirius Catering and an art installation by Jelena Cvetkova, with
proceeds of art sales going to MAPS.
We have only thirty-five seats available for this special opportunity to
dine intimately with MAPS researchers and staff. Tickets 1-10 will sell for
a minimum donation of $45, tickets 11-20 for a minimum donation of $50, and
tickets 21-35 for a minimum donation of $55. To RSVP, ask questions, and
purchase tickets, please contact Logan MacSporren at
glassbreather@hotmail.com or 772-708-6810.
12. Camp with MAPS at Burning Man for MAPS' 20th Anniversary Celebration
Registration is now open for ENTHEON village at Burning Man, an
interactive theme camp on the Esplanade that is a co-creation of MAPS on the
occasion of its 20th anniversary, artists Alex and Allyson Grey, Robert
Venosa and Martina Hoffmann, and a great team from Chicago building much of
the infrastructure and organizing the community kitchen. Entheon Village is
hosting psychedelic elders Ann and Sasha Shulgin, numerous current
psychedelic researchers, several domes for art, a large tent structure for a
psychedelic research and culture lecture series and music concerts, a Zen
meditation center (Zendo) being built in Switzerland and transported to
Burning Man, and kitchen, showers, shade structures and places for about 250
people in tents and RVs. All you need to bring are your personal camping
structure and supplies, some extra food and water, and a helping hand.
The mission of Entheon is to demonstrate a future in which psychedelic
experiences, emergent from the underground, are a welcomed and integrated
part of society, and where art, spirituality and creativity is central to
that vision. Entheon will be a grounded gathering place offering an
intellectual, therapeutic, artistic and creative cornucopia of interactive
opportunities. The village of Entheon will merge science and healing, art
and spirituality in a site for celebration. As part of its offerings to the
Burning Man community, MAPS is assisting the Burning Man Rangers at
Sanctuary to provide support to people going through difficult emotional
experiences, about half psychedelic-related and half from other causes.
Please note that after you register on the website, you will be sent an
email to which you must respond before your registration is activated. If
you can pay your full camp fee up front, rather than making a deposit,
please do. Each individual must register separately -- the system does not
allow people to register in groups.
We are also accepting applications for volunteers who are interested in
working with us at Sanctuary. To receive more information and an application
to volunteer in Sanctuary, please contact Valerie Mojeiko at:
valerie@maps.org
Note for First-Time Burners: Camp fees for Entheon Village are separate from
tickets to the Burning Man event itself. Everyone MUST purchase their own
Burning Man tickets separately. These are for sale on the Burning Man
website. There you will find an extremely useful first-timers guide which is
recommended reading for anyone who has never been before.
To sign up for the ENTHEON village, click here:
entheonvillage.com/registration/
To visit the Burning Man website, click here: www.burningman.com
13. Limited Edition Ram Dass Portrait Now Available
We are pleased to announce the availability of signed portraits of Ram Dass
(Richard Alpert), the fourth in a special signed and numbered limited
edition of prints selected from Dean Chamberlain's Psychedelic Pioneers
Series. There are only 50 of these beautiful signed and numbered archival
pigment prints. The image is 11"x14" and is printed on fine-art matte paper.
Prints numbered 1-10 are offered at $1000 each, prints numbered 11-40 are
offered at $1500 each, and prints numbered 41-50 are offered at $2000 each.
Profits from the sale of these prints will be used for MAPS-sponsored
research in Switzerland into the use of LSD-assisted psychotherapy in
subjects with anxiety associated with end-of-life issues. MAPS is also
offering signed portraits of Albert Hofmann, Sasha and Ann Shulgin, and
Laura Huxley, also created by Dean Chamberlain. Please visit our online
store or contact orders@maps.org if you would like to purchase one of these
prints.
To purchase artwork online, click here:
www.maps.org/catalog/index.php
14. Three Prints of Alex Grey's Portrait of Albert Hofmann Now Available!
We are now making available for purchase three out of the series of 50
numbered prints of Alex Grey's portrait of Dr. Albert Hofmann, signed by
Albert, for sale for $3000. Forty-six out of 50 prints have already been
sold. Profits from the sales of the portraits will be divided between MAPS,
with funds restricted for LSD and psilocybin research and for supporting
Albert's writings, and Alex and Allyson Grey's Chapel of Sacred Mirrors
(COSM). Please contact orders@maps.org if you would like to purchase one of
these prints.
After these three prints have been sold, MAPS and COSM will auction off on
Ebay the last remaining print, numbered 1/50.
View Alex Grey's portrait of Dr. Hofmann here:
www.maps.org/sys/nq.pl
15. Calling Creative MAPS Supporters: New MAPS T-Shirt Designs and Calendar
Art
We are currently requesting submissions of art for the 2007 MAPS calendar.
If you have a piece of art that you think would go particularly well with a
certain month, or if you have something that is generally psychedelic and
would fit in anywhere, we'd love to see it! Keep in mind that we can only
use high-resolution digital images. The deadline for calendar submissions is
July 21. Please send submissions to: jag@maps.org
On that note, we're also seeking information about interesting and amusing
psychedelic- and marijuana-related events that took place on a specific date
to add to the dates featured in the 2006 MAPS calendar. If you have any
suggestions, please send them to jag@maps.org
View the 2006 MAPS Calendar here:
www.maps.org/calendar/
MAPS will also be producing one (or possibly two) new t-shirts to add some
variety to our MAPS-logo t-shirt and hoodie offerings. If you are inspired
to submit a t-shirt, hoodie, or bag design, please feel free to do so
anytime this summer. Submissions must be in by September 1st and will be
chosen by mid-September. The new t-shirt line will be out mid-autumn 2006.
Please e-mail t-shirt designs to: julia@maps.org
16. Classic 'Good Friday Experiment' Now Posted Online
Dr. Walter Pahnke's classic 1963 Harvard thesis, "Drugs & Mysticism: An
Analysis of the Relationship between Psychedelic Drugs and Mystical
Consciousness," better known as the 'Good Friday Experiment,' has been
scanned by MAPS and is now posted online in PDF format. This landmark study
evaluated the potential of psychedelic drugs to catalyze religious
experiences. Rick Doblin's undergraduate thesis "Pahnke's 'Good Friday
Experiment': A Long-Term Follow-Up and Methodological Critique," consisted
of interviews and questionnaires administered to most of the subjects in the
original study twenty-five years after the experiment took place.
This coming Tuesday, July 11, a prominent peer-reviewed scientific journal
will publish the first attempt to replicate the results of the Good Friday
experiment in over forty years, with a different experimental design and
several remarkable supportive commentaries from well-established scientists.
MAPS has also now posted an amazing and long-lost LSD session report from
Dr. Stan Grof, from 11-17-1970. We recently found this in MAPS' files, after
Stan's copy was burned up years ago in a fire that consumed his home and
collected papers. Stan took 250 micrograms of LSD and was wired to EEG
machines and other monitoring equipment. While under the influence of LSD,
Stan conducted ESP experiments and explored a range of unusual
mystical/spiritual states of mind. The session was conducted by Dr. Walter
Pahnke, who conducted the Good Friday Experiment, on which the new study was
loosely based. The new study and Stan's trip report both point to the
tremendous potential of psychedelic research, which we are only now starting
to explore again after decades of repression.
The classic 'Good Friday Experiment':
www.maps.org/books/pahnke/index.html
Rick Doblin's long-term follow-up study:
druglibrary.org/schaffer/lsd/doblin.htm
"Subjective Experiences During the LSD Training Session," by Dr. Stan Grof:
www.maps.org/research/cl...grof1970.pdf
17. $25,000 Donation to MAPS for Erowid.org
MAPS Patron Member John Gilmore recently donated $25,000 to MAPS, restricted
for Erowid.org. MAPS serves as the fiscal sponsor for Erowid, an educational
website focused on providing information about psychoactive plants and
drugs. Erowid is the most frequently visited psychoactive drug information
site on the web.
We have completed the move to our new office location in Ben Lomond, CA and
are now back in full operation. From everyone at MAPS, thank you for your
support! We couldn't be doing what we do without you!
Have A Gently Jolting July,
Jag Davies, MAPS Director of Communications
--
Jag Davies
Director of Communications
MAPS
10424 Love Creek Rd.
Ben Lomond, CA 95005
jag@maps.org
************************
Advocating Science over Politics,
Replacing Fear with Facts:
MAPS The Multidisciplinary Association for Psychedelic Studies
Join Today: www.maps.org
maps_news@maps.org
To subscribe or unsubscribe via the World Wide Web, visit
www.maps.org/mailman/listinfo/maps_news
or, via email, send a message with subject or body 'help' to
maps_news-request@maps.org
You can reach the person managing the list at
maps_news-owner@maps.org
Today's Topics:
1. MAPS News: July 2006 (Jag Davies)
----------------------------------------------------------------------
To read this MAPS monthly news update online, click here:
www.maps.org/news
Greetings, MAPS Members and Friends!
We have lots of news to report this month:
1. FDA-Approved Changes to US MDMA/PTSD Study Implemented; New Subjects
Receive Supplemental Doses of MDMA or Placebo
2. MAPS Receives $25,000 Donation for US MDMA/PTSD Study
3. MAPS and Swiss Medical Association for Psycholytic Therapy-Sponsored
MDMA/PTSD Research Receives Final Regulatory Approval
4. MAPS Purchases 35 Grams of Research-Grade MDMA from Swiss Manufacturer
5. Israeli MDMA/PTSD Team Receives Permit to Import MDMA for
MAPS-Sponsored Study
6. MAPS-Sponsored MDMA/PTSD Research in Spain Resuming Active Protocol
Design and Approval Process
7. Canadian Institutional Review Board to Review MAPS-Sponsored Ibogaine
Outcome Protocol this Month
8. Findings About LSD/Psilocybin as Treatment for Cluster Headaches
Published in Neurology, the Journal of the American Academy of Neurology
9. Journal of Pychopharmacology and Quarterly Journal of Mental Health
Accept Papers Advocating Psychedelic Research
10. Multiple Sclerosis Foundation Sends Letter of Support to DEA for
MAPS-Sponsored Medical Marijuana Production Facility
11. Upcoming MAPS Fundraiser on July 24 in Asheville, NC
12. Camp with MAPS at Burning Man for MAPS' 20th Anniversary Celebration
13. Now in the MAPS Online Store: Limited Edition Ram Dass Portrait by Dean
Chamberlain
14. Three Prints of Alex Grey's Portrait of Albert Hofmann Now Available!
15. Request for Calendar Art, Calendar Dates, T-Shirt Design
16. Classic 'Good Friday Experiment' Now Posted Online
17. $25,000 Grant to MAPS for Erowid.org
*** Like What You're Reading? Click Here to Support MAPS' Work With A
Financial Contribution: www.maps.org/catalog/ ***
1. FDA-Approved Changes to US MDMA/PTSD Study Implemented; New Subjects
Receive Supplemental Doses of MDMA or Placebo
Dr. Michael Mithoefer has now begun treatment of the 13th and 14th patients
out of 20 in his MAPS-sponsored MDMA/PTSD study, implementing several key
changes recently approved by the FDA, IRB, and Data Safety Monitoring Board.
These changes include administering a supplemental dose of MDMA (or a
placebo) 2 to 2 1/2 hours after the initial dose and adding a third
experimental session to the two that are currently included in the protocol.
The first subject to receive this supplemental dosing experienced an
extended period of therapeutic activity without any worrisome increase in
blood pressure or heart rate. This initial reaction, while in only one
subject, suggests that this protocol change may enhance the therapeutic
effectiveness of the experimental treatment without significantly increasing
risk.
Dr. Mithoefer's MAPS-sponsored FDA-approved protocol:
www.maps.org/mdma/protocol/index.html
2. MAPS Receives $25,000 Donation for US MDMA/PTSD Study
MAPS has just received a $25,000 donation from the Robert T. Keeler
Foundation, restricted for Dr. Mithoefer's MDMA/PTSD study. This is the
second $25,000 donation for Dr. Mithoefer's study from the Robert T. Keeler
Foundation, the first donated a year ago. MAPS is seeking an additional
$100,000 for this study.
3. MAPS and Swiss Medical Association for Psycholytic Therapy-Sponsored
MDMA/PTSD Research Receives Final Regulatory Approval
Switzerland's DEA equivalent, the BAG, has officially given the necessary
licenses for Dr. Peter Oehen's study evaluating MDMA-assisted psychotherapy
as a treatment for subjects suffering from treatment-resistant Posttraumatic
Stress Disorder (PTSD). Permission from BAG was the final regulatory hurdle,
since Dr. Oehen has already received approval from the Ethics Committee
(Switzerland's IRB equivalent) and SwissMedic (Switzerland's FDA
equivalent). In addition, MAPS Clinical Research Associate Valerie Mojeiko
has completed preparation of Case Report Forms (CRFs), Standard Operating
Procedures (SOPs) and other documents that must be submitted to FDA under
MAPS' Investigational New Drug application for MDMA in the treatment of
PTSD. Dr. Oehen will receive the MDMA for his study within a few weeks and
can then begin his study. MAPS is seeking an additional $100,000 for this
study.
Read Dr. Oehen's government-approved protocol here:
www.maps.org/mdma/swissp...ol011806.pdf
MAPS and Dr. Oehen are also going to collaborate with Dr. Franz
Vollenweider, University of Zurich, on an associated study that will examine
the subjects in Dr. Oehen's study before and after treatment with
MDMA-assisted psychotherapy. Dr. Vollenweider is going to measure several
physiological factors that have been associated with PTSD (startle response,
heart rate reactivity) as well as various EEG parameters to see if the
MDMA-assisted psychotherapy results in any changes in these measures.
4. MAPS Purchases 35 Grams of MDMA for Swiss and Israeli MDMA/PTSD Studies
MAPS has completed the purchase of 35 grams of MDMA of a purity of 99.66%
from a Swiss manufacturer for use in MAPS' MDMA studies that take place
outside of the US. The same batch of MDMA has been used before in clinical
research in Switzerland and will be used in Dr. Oehen's MDMA/PTSD study.
This same MDMA will be exported to Israel for use in MAPS' Israeli MDMA/PTSD
study. The cost was about $57 per gram.
5. Israeli MDMA/PTSD Team Receives Permit to Import MDMA for
MAPS-Sponsored Study
The Israeli MDMA/PTSD team received a permit this week to import MDMA from a
Swiss manufacturer for the MAPS-sponsored study set to take place at Beer
Yaakov Mental Health Center near Tel Aviv. Once the Swiss BAG issues an
export permit, the MDMA can be shipped to Israel. This is the final step
before initiation of Dr. Moshe Kotler's clinical trial evaluating
MDMA-assisted psychotherapy in treatment-resistant subjects with war and
terrorism-related PTSD.
MAPS is seeking an additional $50,000 for this study.
Dr. Moshe Kotler's government-approved MAPS-sponsored protocol:
www.maps.org/mdma/israel..._3.16.05.pdf
6. MAPS-Sponsored MDMA/PTSD Research in Spain Preparing to Resume Protocol
Design and Approval Process
Jose Carlos Bouso, Ph.D., has returned to the protocol design and approval
process for his MAPS-sponsored MDMA/PTSD study. This study was the world's
first government-approved MDMA psychotherapy study, with six patients
treated in 2001-02. However, in 2002, in response to positive reports about
the study that appeared in the Spanish media, the Madrid Anti-Drug Authority
pressured the hospital into withdrawing permission. The Ministry of Health
has not withdrawn permission, and we are hopeful that since we have now
obtained government approval for MDMA/PTSD studies in the US, Switzerland,
and Israel, it will be politically feasible to resume research in Spain
around the beginning of 2007, with a different protocol design. As a result
of the political suppression of his initial MDMA/PTSD study, Jose Carlos had
to initiate and complete a different research project for his dissertation
before he was able to return his attention to his MDMA/PTSD study.
Jose Carlos is now in the midst of writing up for publication the results
from the six subjects treated in his initial study. Ilsa Jerome, Ph.D.,
MAPS' expert on the scientific literature on MDMA, is assisting Jose Carlos
by reviewing and commenting on early drafts of his paper.
MAPS' MDMA Research in Spain: www.maps.org/mdma/spain/index.html
7. Canadian Institutional Review Board to Review MAPS-Sponsored Ibogaine
Outcome Protocol this Month
This week, MAPS submitted a revised version of the ibogaine case series
observational study protocol to a Canadian Institutional Review Board (IRB).
We have been negotiating for several months with an IRB for the
observational study of 20 opiate dependent subjects to be treated at the
Iboga Therapy House. We have incorporated the latest set of comments and
suggestions and have submitted the protocol for review at an upcoming
meeting on July 19.
Read more about MAPS' Ibogaine Research: www.maps.org/ibogaine/
Iboga Therapy House in Vancouver, Canada: www.ibogatherapyhouse.net
8. Findings About LSD/Psilocybin as Treatment for Cluster Headaches
Published in Neurology, the Journal of the American Academy of Neurology
A paper by Andrew Sewell, M.D., coauthored by John Halpern, M.D., and
Harrison G. Pope Jr., M.D., describing MAPS-sponsored LSD/psilocybin cluster
headache research, has been published in Neurology, the official journal of
the American Academy of Neurology. The article contains interviews with
people who have treated cluster headaches with LSD or psilocybin mushrooms,
and reviews their medical records. Neurology is a top specialty journal,
read by most neurologists throughout the world, so news of this promising
use of LSD and psilocybin will be widely disseminated among doctors for the
first time.
Read Dr. Sewell's article here:
www.maps.org/w3pb/new/20..._22779_1.pdf
Andrew Sewell, M.D., and John Halpern, M.D., collected and analyzed hundreds
of case reports from Erowid and Clusterbusters, an organization run by and
for people with cluster headaches dedicated to evaluating new treatments for
cluster headache, including the use of psilocybin and LSD. Based on this
data, Drs. Sewell and Halpern are currently developing a protocol for a
randomized, dose-response study of psilocybin and LSD in people with
episodic cluster headaches.
Currently, there is no legal research with LSD in humans taking place
anywhere in the world. We hope that this will be the first study to renew
human research into the therapeutic use of LSD. Due to the previously
expressed concerns of the new McLean Administration, funding for any
clinical study will be provided by Clusterbusters, until the McLean
Administration becomes comfortable again accepting research support from
MAPS.
Read more about MAPS' LSD/psilocybin cluster headache research here:
www.maps.org/research/cl...lsd/#cluster
9. Journal of Pychopharmacology and Quarterly Journal of Mental Health
Accept Papers Advocating Psychedelic Research
Ben Sessa, M.D., a British psychiatrist working courageously and effectively
towards the resumption of psychedelic research in England, recently had two
papers regarding psychedelic-assisted psychotherapy research accepted for
publication in two key international academic journals. The first paper, "Is
there a case for MDMA-assisted Psychotherapy in the UK?" will appear in the
peer-reviewed Journal of Psychopharmacology, and draws on evidence from
MAPS-sponsored FDA Phase I and Phase II research studies. The second paper,
"From Sacred Plants to Psychotherapy: The History and Re-Emergence of
Psychedelics in Medicine," will appear in the peer-reviewed Quarterly
Journal of Mental Health.
10. Multiple Sclerosis Foundation Sends Letter of Support to DEA for
MAPS-Sponsored Medical Marijuana Production Facility
This week, the Multiple Sclerosis (MS) Foundation sent a letter to DEA
Administrator Karen Tandy urging DEA to issue a Schedule I license to Prof.
Lyle Craker for his proposed MAPS-sponsored medical marijuana production
facility at the University of Massachusetts-Amherst. Prof. Craker's proposed
facility would end the government's six decades-long monopoly on the
production of marijuana for research purposes and would create the necessary
independence of supply to justify the time and expense for MAPS to sponsor
clinical research evaluating the risks and benefits of marijuana as a
potential FDA-approved prescription medicine.
The MS Foundation letter is in support of Prof. Craker in his ongoing
MAPS-supported lawsuit against DEA taking place in a DEA Administrative Law
Judge (ALJ) hearing. With oral arguments complete and the final legal briefs
submitted, we are now awaiting a recommendation from ALJ Mary Ellen Bittner,
expected in 2-4 months. In the meantime, we are focusing our attention on
preparing to pressure the DEA to accept Judge Bittner's recommendation if
she actually recommends that the DEA should issue a Schedule I license to
Prof. Craker. DEA has already received letters of support for Prof. Craker's
marijuana growing facility from Americans for Tax Reform, the Lymphoma
Foundation of America, the National Association for Public Health Policy,
the United Methodist Church, the American Medical Students Association,
several state nurses' associations, the Massachusetts Dept. of Public
Health, Massachusetts Senators Kerry and Kennedy, and 38 members of the US
House of Representatives.
This latest letter was the result of work by MAPS' part-time staffer Kelly
Burns, who is currently laying the groundwork for an effort to obtain a
letter from the American Medical Association to DEA, urging DEA to issue
Prof. Crakers license so that the controversy over the medical use of
marijuana can be resolved through scientific research. We expect that such a
letter from the AMA would require action by the AMA House of Delegates at
its November 2006 meeting. Any physicians who belong to their state Medical
Associations who wish to help in this effort should contact Kelly at:
kelly426@gmail.com
For more information about Dr. Craker's MAPS-sponsored medical marijuana
production facility and DEA lawsuit, click here:
www.maps.org/mmj/DEAlawsuit.html
11. Upcoming MAPS Dinner Fundraiser on Monday, July 24 in Asheville, North
Carolina
MAPS will be holding a dinner fundraiser on Monday, July 24 in Asheville,
North Carolina. MAPS researchers Dr. Michael and Annie Mithoefer
(co-therapists for MDMA/PTSD study) and Dr. Andrew Sewell (LSD/psilocybin
research), along with MAPS President Rick Doblin, Ph.D., and MAPS Program
Director and Clinical Research Associate Valerie Mojeiko will each give
presentations. The event will also feature a delicious 5-course tasting menu
courtesy of Sirius Catering and an art installation by Jelena Cvetkova, with
proceeds of art sales going to MAPS.
We have only thirty-five seats available for this special opportunity to
dine intimately with MAPS researchers and staff. Tickets 1-10 will sell for
a minimum donation of $45, tickets 11-20 for a minimum donation of $50, and
tickets 21-35 for a minimum donation of $55. To RSVP, ask questions, and
purchase tickets, please contact Logan MacSporren at
glassbreather@hotmail.com or 772-708-6810.
12. Camp with MAPS at Burning Man for MAPS' 20th Anniversary Celebration
Registration is now open for ENTHEON village at Burning Man, an
interactive theme camp on the Esplanade that is a co-creation of MAPS on the
occasion of its 20th anniversary, artists Alex and Allyson Grey, Robert
Venosa and Martina Hoffmann, and a great team from Chicago building much of
the infrastructure and organizing the community kitchen. Entheon Village is
hosting psychedelic elders Ann and Sasha Shulgin, numerous current
psychedelic researchers, several domes for art, a large tent structure for a
psychedelic research and culture lecture series and music concerts, a Zen
meditation center (Zendo) being built in Switzerland and transported to
Burning Man, and kitchen, showers, shade structures and places for about 250
people in tents and RVs. All you need to bring are your personal camping
structure and supplies, some extra food and water, and a helping hand.
The mission of Entheon is to demonstrate a future in which psychedelic
experiences, emergent from the underground, are a welcomed and integrated
part of society, and where art, spirituality and creativity is central to
that vision. Entheon will be a grounded gathering place offering an
intellectual, therapeutic, artistic and creative cornucopia of interactive
opportunities. The village of Entheon will merge science and healing, art
and spirituality in a site for celebration. As part of its offerings to the
Burning Man community, MAPS is assisting the Burning Man Rangers at
Sanctuary to provide support to people going through difficult emotional
experiences, about half psychedelic-related and half from other causes.
Please note that after you register on the website, you will be sent an
email to which you must respond before your registration is activated. If
you can pay your full camp fee up front, rather than making a deposit,
please do. Each individual must register separately -- the system does not
allow people to register in groups.
We are also accepting applications for volunteers who are interested in
working with us at Sanctuary. To receive more information and an application
to volunteer in Sanctuary, please contact Valerie Mojeiko at:
valerie@maps.org
Note for First-Time Burners: Camp fees for Entheon Village are separate from
tickets to the Burning Man event itself. Everyone MUST purchase their own
Burning Man tickets separately. These are for sale on the Burning Man
website. There you will find an extremely useful first-timers guide which is
recommended reading for anyone who has never been before.
To sign up for the ENTHEON village, click here:
entheonvillage.com/registration/
To visit the Burning Man website, click here: www.burningman.com
13. Limited Edition Ram Dass Portrait Now Available
We are pleased to announce the availability of signed portraits of Ram Dass
(Richard Alpert), the fourth in a special signed and numbered limited
edition of prints selected from Dean Chamberlain's Psychedelic Pioneers
Series. There are only 50 of these beautiful signed and numbered archival
pigment prints. The image is 11"x14" and is printed on fine-art matte paper.
Prints numbered 1-10 are offered at $1000 each, prints numbered 11-40 are
offered at $1500 each, and prints numbered 41-50 are offered at $2000 each.
Profits from the sale of these prints will be used for MAPS-sponsored
research in Switzerland into the use of LSD-assisted psychotherapy in
subjects with anxiety associated with end-of-life issues. MAPS is also
offering signed portraits of Albert Hofmann, Sasha and Ann Shulgin, and
Laura Huxley, also created by Dean Chamberlain. Please visit our online
store or contact orders@maps.org if you would like to purchase one of these
prints.
To purchase artwork online, click here:
www.maps.org/catalog/index.php
14. Three Prints of Alex Grey's Portrait of Albert Hofmann Now Available!
We are now making available for purchase three out of the series of 50
numbered prints of Alex Grey's portrait of Dr. Albert Hofmann, signed by
Albert, for sale for $3000. Forty-six out of 50 prints have already been
sold. Profits from the sales of the portraits will be divided between MAPS,
with funds restricted for LSD and psilocybin research and for supporting
Albert's writings, and Alex and Allyson Grey's Chapel of Sacred Mirrors
(COSM). Please contact orders@maps.org if you would like to purchase one of
these prints.
After these three prints have been sold, MAPS and COSM will auction off on
Ebay the last remaining print, numbered 1/50.
View Alex Grey's portrait of Dr. Hofmann here:
www.maps.org/sys/nq.pl
15. Calling Creative MAPS Supporters: New MAPS T-Shirt Designs and Calendar
Art
We are currently requesting submissions of art for the 2007 MAPS calendar.
If you have a piece of art that you think would go particularly well with a
certain month, or if you have something that is generally psychedelic and
would fit in anywhere, we'd love to see it! Keep in mind that we can only
use high-resolution digital images. The deadline for calendar submissions is
July 21. Please send submissions to: jag@maps.org
On that note, we're also seeking information about interesting and amusing
psychedelic- and marijuana-related events that took place on a specific date
to add to the dates featured in the 2006 MAPS calendar. If you have any
suggestions, please send them to jag@maps.org
View the 2006 MAPS Calendar here:
www.maps.org/calendar/
MAPS will also be producing one (or possibly two) new t-shirts to add some
variety to our MAPS-logo t-shirt and hoodie offerings. If you are inspired
to submit a t-shirt, hoodie, or bag design, please feel free to do so
anytime this summer. Submissions must be in by September 1st and will be
chosen by mid-September. The new t-shirt line will be out mid-autumn 2006.
Please e-mail t-shirt designs to: julia@maps.org
16. Classic 'Good Friday Experiment' Now Posted Online
Dr. Walter Pahnke's classic 1963 Harvard thesis, "Drugs & Mysticism: An
Analysis of the Relationship between Psychedelic Drugs and Mystical
Consciousness," better known as the 'Good Friday Experiment,' has been
scanned by MAPS and is now posted online in PDF format. This landmark study
evaluated the potential of psychedelic drugs to catalyze religious
experiences. Rick Doblin's undergraduate thesis "Pahnke's 'Good Friday
Experiment': A Long-Term Follow-Up and Methodological Critique," consisted
of interviews and questionnaires administered to most of the subjects in the
original study twenty-five years after the experiment took place.
This coming Tuesday, July 11, a prominent peer-reviewed scientific journal
will publish the first attempt to replicate the results of the Good Friday
experiment in over forty years, with a different experimental design and
several remarkable supportive commentaries from well-established scientists.
MAPS has also now posted an amazing and long-lost LSD session report from
Dr. Stan Grof, from 11-17-1970. We recently found this in MAPS' files, after
Stan's copy was burned up years ago in a fire that consumed his home and
collected papers. Stan took 250 micrograms of LSD and was wired to EEG
machines and other monitoring equipment. While under the influence of LSD,
Stan conducted ESP experiments and explored a range of unusual
mystical/spiritual states of mind. The session was conducted by Dr. Walter
Pahnke, who conducted the Good Friday Experiment, on which the new study was
loosely based. The new study and Stan's trip report both point to the
tremendous potential of psychedelic research, which we are only now starting
to explore again after decades of repression.
The classic 'Good Friday Experiment':
www.maps.org/books/pahnke/index.html
Rick Doblin's long-term follow-up study:
druglibrary.org/schaffer/lsd/doblin.htm
"Subjective Experiences During the LSD Training Session," by Dr. Stan Grof:
www.maps.org/research/cl...grof1970.pdf
17. $25,000 Donation to MAPS for Erowid.org
MAPS Patron Member John Gilmore recently donated $25,000 to MAPS, restricted
for Erowid.org. MAPS serves as the fiscal sponsor for Erowid, an educational
website focused on providing information about psychoactive plants and
drugs. Erowid is the most frequently visited psychoactive drug information
site on the web.
We have completed the move to our new office location in Ben Lomond, CA and
are now back in full operation. From everyone at MAPS, thank you for your
support! We couldn't be doing what we do without you!
Have A Gently Jolting July,
Jag Davies, MAPS Director of Communications
--
Jag Davies
Director of Communications
MAPS
10424 Love Creek Rd.
Ben Lomond, CA 95005
jag@maps.org
************************
Advocating Science over Politics,
Replacing Fear with Facts:
MAPS The Multidisciplinary Association for Psychedelic Studies
Join Today: www.maps.org
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