[MAPS] MAPS News: August 2006

[Jag Davies]

If you would prefer to read this in html, click here:
http://www.maps.org/news

Greetings, MAPS Members, Supporters, and Friends!
 
The prospects for international psychedelic drug development are looking
better than ever. Last month, our Israeli  MDMA/PTSD research team received
government approval to import MDMA into Israel and then our Swiss MDMA
manufacturer received government approval to export MDMA to Israel. In the
meantime, MAPS learned that philanthropist Peter Lewis agreed to donate
$250,000 to fund MAPS-sponsored MDMA/PTSD pilot studies in the US, Israel
and Switzerland. As misunderstanding and violence continues to escalate in
the Middle East, it's clear that technologies of peace and healing--like
MDMA-assisted psychotherapy--will continue to be desperately needed in the
coming years.
 
Later this month, MAPS will celebrate its 20th Anniversary at Burning Man,
where this year's theme is "The Future: Hope and Fear." For us at MAPS, this
theme seems to synchronize with our current outlook: encouraged, given the
seemingly-impossible obstacles we have already overcome, but humbled, aware
that our greatest work still lies ahead.
 
Here's the headlines for August:

1. Peter Lewis Donates $250,000 for MAPS-Sponsored MDMA/PTSD Research in the
US, Switzerland and Israel
2. Israeli Import Permit and Swiss Export Permit Approved; MDMA Arrives in
Israel
3. Swiss MDMA/PTSD Study Fully Approved, Set to Begin in September
4. Dr. Mithoefer Treats 13th and 14th Patients in US MDMA/PTSD Study
5. Swiss LSD/End-of-Life Anxiety Study Design Expanded to 12 Subjects
6. Provisional Approval from Canadian IRB for MAPS-Sponsored Long-Term
Ibogaine Observational Case Study
7. MAPS Teams Up with MPP to Lobby AMA, Awaiting Recommendation in Prof.
Craker's MAPS-Sponsored Lawsuit for Marijuana Production Facility
8. Headed to Burning Man? Here's Where to Find MAPS
9. MAPS-Sponsored Psychedelic Harm Reduction at Portugal's Boom Festival
10. John Hopkins Study Demonstrates Link Between Psilocybin and Spiritual
Experience
11. Alex Grey's "St. Albert" Auction Set for October
12. Call for Papers: "Pleasure and Drugs"
13. Watch "The ACLU Freedom Files: Drug Wars" Online
14. Asheville Fundraiser Builds Support for MAPS; Robert Barnhart Donates
$20,000
 
*** Want to renew your MAPS membership? Make a restricted donation? Browse
our online store? Click here: http://www.maps.org/catalog ***


1. Peter Lewis Donates $250,000 for MAPS-Sponsored MDMA/PTSD Research in the
US, Switzerland and Israel
 
On July 28, philanthropist Peter Lewis awarded MAPS a grant of $250,000 to
fund MAPS-sponsored Phase II pilot studies of MDMA-assisted psychotherapy
for subjects with treatment-resistant posttraumatic stress disorder (PTSD)
in the US, Switzerland and Israel. For more on the current status of these
studies, see items #2 and #3.
 
Peter Lewis¹ new grant is in addition to his donation in March 2006 of
$250,000 to McLean Hospital for Dr. John Halpern¹s MAPS-initiated (but no
longer MAPS-sponsored) study of MDMA-assisted psychotherapy in
advanced-stage cancer patients with anxiety.
 

2. Israeli Import Permit and Swiss Export Permit Approved; MDMA Arrives in
Israel
 
On Thursday, August 3rd, in the midst of war, about 5 grams of MDMA arrived
in Israel for MAPS¹ MDMA/PTSD study, imported  into Israel from Switzerland.
The MAPS-sponsored MDMA/PTSD pilot study is being directed by Moshe Kotler
M.D., with Dr. Rael Strous and Dr. Rakefet Rodrigez serving as the
male/female co-therapist team. This study has full government approval and
will be initiated in Fall 2006. If she is able to leave her psychiatric work
in Israel, Dr. Rodrigez will be coming to Burning Man to work with and
receive further training from Dr. Mithoefer and others at "Sanctuary."
 
Dr. Kotler's MDMA/PTSD protocol:
http://www.maps.org/mdma/israel_protocol_3.16.05.pdf
 

3. Swiss MDMA/PTSD Study Fully Approved, Set to Begin in September
 
Dr. Peter Oehen's MAPS-sponsored MDMA/PTSD trial also has full government
approval and has also received the necessary MDMA from the same Swiss
manufacturer that supplied our Israeli study. The study is expected to begin
this September.
 
Dr. Oehen's MDMA/PTSD protocol:
http://www.maps.org/mdma/swissptsd/protocol011806.pdf
 
 
4. Dr. Mithoefer Treats 13th and 14th Patients in US MDMA/PTSD Study
 
Dr. Michael Mithoefer continued treatment of the 13th and 14th patients out
of 20 in his flagship 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.
On July 21, after treating the 13th patient with the second experimental
session that included the supplemental dose, Dr. Mithoefer described the
experience as "impressive." We're grateful to the FDA for negotiating with
us to modify and enhance the protocol based on data gathered during the
early stages.

Dr. Mithoefer's MDMA/PTSD protocol:
http://www.maps.org/mdma/protocol/index.html
 
MAPS¹ MDMA/PTSD pilot studies in the US, Switzerland and Israel will take
the next two years to complete. Then we¹ll evaluate the data to determine
whether to proceed with large-scale Phase III studies that will be required
to demonstrate to FDA the safety and efficacy of MDMA-assisted psychotherapy
for PTSD for possible prescription use. For more information on MAPS' $5
million, 5-year plan, see "A Clinical Plan for MDMA (Ecstasy)
in the Treatment of Post-Traumatic Stress Disorder (PTSD)," by Rick Doblin,
Ph.D., at http://www.maps.org/research/mdmaplan.html
 
 
5. Swiss LSD/End-of-Life Anxiety Study Design Expanded to 12 Subjects
 
As we reported in the June 2006 email update, MAPS and Dr. Peter Gasser have
begun work on the design of a study that will investigate LSD-assisted
psychotherapy in subjects suffering from anxiety associated with
advanced-stage cancer and other life-threatening illnesses. Dr. Gasser's
study is in the early stages of protocol design.

MAPS originally pledged to donate $50,000 for this study, which MAPS has
already raised from the sale of art and books signed by Albert Hofmann.
Because of budgetary concerns, we had initially intended to design an
open-label study with four subjects to gather basic information on safety
for this patient population and to develop a treatment approach. However, as
a result of MAPS¹ increasing fundraising capacity and optimism, we¹ve
decided to expand the study design to 12 subjects and increase the budget to
$150,000. MAPS will be seeking grants for the additional $100,000 and hopes
to raise the remaining funds before the study is fully approved, which we
expect will take place around December, 2006 (prior to Albert Hofmann's
101st birthday on January 11, 2007). If approved, this will be the first
LSD-assisted psychotherapy study conducted in about 35 years.
 
This LSD/end-of-life anxiety study will complement Dr. John Halpern's
MAPS-initiated research investigating MDMA-assisted psychotherapy and Dr.
Charles Grob's Heffter-sponsored research investigating psilocybin-assisted
psychotherapy, both with subjects suffering from anxiety associated with
advanced-stage cancer.
 
MAPS¹ grand plan is to complete three MDMA/PTSD pilot studies and two pilot
studies (in MDMA and LSD) addressing anxiety associated with end-of-life
issues over the next two years, so that we will have a wide range of data to
help us plan strategically for potential Phase III studies.
 
For information about purchasing art and books signed by Albert Hofmann,
see: http://www.maps.org/catalog/
 
 
6. Provisional Approval from Canadian IRB for MAPS-Sponsored Long-Term
Ibogaine Observational Case Study
 
After years of work and a number of significant changes to the original
protocol, a MAPS-sponsored research team has received "conditional approval"
from a Canadian Institutional Review Board (IRB) to proceed with a long-term
observational case study that will examine changes in substance use in 20
consecutive people seeking ibogaine-based addiction treatment for opiate
dependence at Iboga Therapy House in Vancouver. While originally designed as
an "outcome study," the protocol was later changed to an observational
case-study when the IRB expressed concerns that the initial design was too
close to a clinical trial, which has a much stricter approval process, and
was never the intention of the research team anyhow. The Principal
Investigator is none other than Rick Doblin, Ph.D., and he'll be aided by
Dr. Ken Alper and Leah Martin, with data analysis to be conducted by MAPS
Research Associate Ilsa Jerome, Ph.D.
 
 
7. MAPS Teams Up with Marijuana Policy Project to Lobby American Medical
Association, Still Awaiting Recommendation in Prof. Craker's MAPS-Sponsored
Lawsuit for Marijuana Production Facility
 
MAPS and medical marijuana reform advocates nationwide are eagerly awaiting
a recommendation from DEA Administrative Law Judge (ALJ) Mary Ellen Bittner
within the next several months in Prof. Craker's MAPS-supported lawsuit
against the DEA for refusing to license a privately-funded medical marijuana
production facility at 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. This MAPS-funded facility
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.
 
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. Towards this end,
MAPS initiated a campaign last week with David Ostrow, M.D., who is funded
by the Marijuana Policy Project (MPP), to lobby the American Medical
Association (AMA) to pass a two-fold resolution at this November's annual
meeting. The first part of the resolution says that privately-funded,
FDA-approved research into marijuana's potential therapeutic uses should be
encouraged, and that privately-funded production facilities that meet all
regulatory requirements should be licensed by DEA to produce
pharmaceutical-grade marijuana for use exclusively in FDA- and DEA-approved
research. The second part of the resolution says that in states where
patients are permitted to use medical marijuana for serious and/or chronic
illnesses and the patient's physician has recommended its use in accordance
with that state¹s medical practice standards, that patients should not be
subject to federal criminal penalties for such appropriate medical use.
 
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, 38 members of the US House of
Representatives, and the California and Texas State Medical Associations,
the two largest US state medical associations. If we do receive a positive
recommendation, we will need all MAPS supporters to contact their
Congressional Representatives, so keep an eye out for news on this front!
 
For more information, see MAPS' DEA Lawsuit page:
http://www.maps.org/mmj/dealawsuit.html
 
 
8. Headed to Burning Man? Here's Where to Find MAPS
 
As you probably know by now, MAPS will be celebrating its 20th anniversary
at Burning Man in Nevada's Black Rock Desert from Aug. 28 to Sep. 3. MAPS
will be hosting a theme camp in association with artists Alex and Allyson
Grey, Roberto Venosa, Martina Hoffmann, and a great team from Chicago
organizing the infrastructure. We will also be assisting the Black Rock
Rangers to provide psychedelic emergency services in an area known as
"Sanctuary" as well as helping coordinate a lecture series in the Entheon
Village theme camp. Coincidentally, this is also Burning Man's 20th
anniversary. If you are planning to attend Burning Man, but not camping with
us, you can find the lecture series at 4:00 and Esplanade. To check out the
amazing line-up for this year's lecture series, featuring Sasha & Ann
Shulgin, Rob Kampia, Ethan Nadelmann, Alex & Allyson Grey, Daniel Pinchbeck,
Earth & Fire Erowid, John Gilmore, Dr. Michael Mithoefer, MAPS President
Rick Doblin, and many more, click here:
http://www.matrixmasters.com/pn/BM-talks/TESTBM2006PNschedule.html
 
We are no longer accepting applications for volunteers at Sanctuary. For
those of you who have applied to volunteer at Sanctuary but have yet to
receive official reply, you will be contacted within the next week.
 
There are a few spots remaining to camp with MAPS at Entheon Village. Click
here to register: http://entheonvillage.com/registration
 
For more about Entheon Village, please see the thick description in July's
email update, item #12.
 
 
9. MAPS-Sponsored Psychedelic Harm Reduction at Portugal's Boom Festival
 
As a result of MAPS' work at Burning Man, MAPS has been asked to provide
psychedelic emergency services at the Boom Festival in Portugal from August
3-9. The Boom Festival organizers awarded MAPS $9600 for staff travel and
other expenses and provided 23 free tickets and a week¹s worth of food to
our eight core team members and our 15 volunteers.

Our team of therapists consists of Dr. Peter and Verena Oehen from
Switzerland (MDMA/PTSD researchers), Dr. Andrew Sewell from Harvard
(LSD/Psilocybin in cluster headache researcher), Jose Carlos Bouso, Ph,D.,
from Spain (MDMA/PTSD researcher), Sandra Karpetas (ibogaine researcher) and
several others from Vancouver, Canada, along with fifteen other volunteers.
 
Boom website: http://www.boomfestival.org
 

10. Modern Continuation of Classic "Good Friday" Experiment at John Hopkins
Demonstrates Link Between Psilocybin and Spiritual Experience; Media Reacts
Enthusiastically
 
On Tuesday, July 11, a National Institute on Drug Abuse (NIDA) and Council
on Spiritual Practices (CSP)-funded research team from John Hopkins
University published in Psychopharmacology the first modern-day continuation
of the Good Friday Experiment, finding that psilocybin induced spiritual
experiences in most subjects. A former NIDA director and a former deputy
director of ONDCP supported the results of the study in associated
commentaries published with the article, but the current NIDA director
issued a statement distancing NIDA from the study. The study attracted a lot
of serious media coverage and is a major step toward the legitimization of
psychedelic research.
 
Read the Psychopharmacology article here:
http://www.maps.org/w3pb/new/2006/2006_Griffiths_22780_1.pdf

Read media coverage from the week of July 11 here:
http://www.maps.org/media

Associated commentaries published with the article:
http://www.maps.org/w3pb/new/2006/2006_Griffiths_22780_1.pdf
 
Statement by NIDA Director Nora Valkow in response to the study:
http://www.nida.nih.gov/about/welcome/messagepsilocybin706.html

Council on Spiritual Practices (CSP)
http://www.csp.org

Read the classic "Good Friday" experiment here:
http://www.maps.org/books/pahnke/index.html

Read Rick Doblin's, Ph.D., destined-to-be-classic 25-year "Good Friday"
follow-up study here:
http://www.erowid.org/plants/mushrooms/mushrooms_journal2.pdf


11. Alex Grey's "St. Albert" Auction Set for October
 
Now that 49 out of 50 of Alex Grey's limited edition signed portraits of
Albert Hofmann have been sold, MAPS and the Chapel of Sacred Mirrors (COSM)
will hold an Ebay auction in October to sell the last remaining print,
numbered 1/50. We will announce the exact date of the auction in next
month's email update. Profits from the sales of the portraits have been
divided between MAPS, with funds restricted for LSD and psilocybin research
and for supporting Albert's writings, and COSM. MAPS and COSM have raised
over $42,000 each from sales of these portraits.
 
Alex Grey's portrait of Albert Hofmann:
http://www.maps.org/sys/nq.pl?id=790&fmt=page
 
Alex and Allyson Grey's Chapel of Sacred Mirrors (COSM):
http://www.cosm.org
 
 
12. Call for Papers: "Pleasure and Drugs"
 
The International Journal of Drug Policy (IJDP) has issued a call for papers
for a special upcoming issue with a focus on the role of pleasure in drug
use and harm reduction, which will be guest edited by Martin Holt and Carla
Treloar of the National Centre in HIV Social Research, Australia. Outline
abstracts (no more than 250 words) are invited before September 5. If you're
interested, reply to this email and I'll send you a document with a full
summary of the call for papers.
 
 
13. Watch "The ACLU Freedom Files: Drug Wars" Online
 
"The ACLU Freedom Files: Drug Wars" premiered on Court TV on June 15, and is
available to watch online at: http://aclu.tv/episodes/drugwars
 
This riveting 30-minute documentary focuses on four issues: racist drug
raids, the Drug War in schools, excessive prison sentencing, and medical
marijuana.
 
The ACLU Drug Law Reform Project, based in Santa Cruz, CA, is one our new
drug policy neighbors, and has supported MAPS by providing pro bono legal
services in Prof. Lyle Craker's ongoing lawsuit against DEA/NIDA/HHS for
obstructing his proposed MAPS-sponsored medical marijuana production
facility.
 
 
14. Asheville Fundraiser Builds Support for MAPS; Robert Barnhart Donates
$20,000
 
On July 24, MAPS held a dinner fundraiser in Asheville, NC, featuring
presentations by 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. Thank you to event
organizer Logan MacSporren, artist Jelena Cvetkova, chef Josh Sonstroem of
Sirius Catering, and Jinx at the Flood Gallery, for making this event
possible.
 
The event was successful, particularly thanks to Robert Barnhart, who
traveled all the way from Austin, Texas, for the dinner. He was so inspired
by the event that he donated $20,000 to MAPS a week later in an unrestricted
gift! Thank you, Robert!
 
 
Have an Awesome August,

Jag





--
Jag Davies
Director of Communications
MAPS
10424 Love Creek Rd.
Ben Lomond, CA 95005
jag at maps.org 


************************
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Replacing Fear with Facts:
MAPS ­ The Multidisciplinary Association for Psychedelic Studies
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