[MAPS] News 03/07: LSD Psychotherapy Study Awaiting IRB Approval

[Jag Davies]

To read this online w/ hyperlink, go to: http://www.maps.org/news


MAPS Members, Supporters, and Friends,

MAPS has been attempting for years to put marijuana through FDA-approved
clinical trials to resolve the controversy over medical marijuana¹s safety
and efficacy, with the aim of distributing and developing as a prescription
medicine if its meets the FDA¹s standards.

In light of our recent hard-won victory in Prof. Craker's lawsuit against
the DEA, we're ramping up for a lobbying campaign of unprecedented
significance and scale. Shortly after March 26, when DEA's lawyers submit
their objections to DEA Administrative Law Judge Bittner's recommendation
that DEA issue a license to Prof. Craker for a MAPS-sponsored medical
marijuana production facility, we are planning to initiate a new
Congressional sign-on letter campaign aimed at pressuring DEA to accept
Judge's Bittner's recommended ruling.

Meanwhile, MAPS' psychedelic research agenda continues to make leaps (see
Items 3-10).
 
If you are a MAPS member, we are deeply grateful for your support and glad
to have you on our team.  We couldn¹t do our work without you. If you are
not a MAPS member, please consider joining us. Reading updates about the
burgeoning renewal of psychedelic therapy research is way more fulfilling
when you know that you are helping to make it happen.
 
Please visit http://www.maps.org/donate to become part of this force today!

Read on:

1. Update on Craker/DEA Lawsuit for MAPS-Sponsored Marijuana Production
Facility
2. MAPS and Chemic Labs Negotiate Vaporizer Protocol
3. Ninth Circuit Court Rejects Raich Medical Marijuana Right-to-Life Case
4. Ethics Committee Meeting for Historic Swiss LSD/End-of-Life Anxiety Study
5. Crucial Media Provision Approved on Appeal by IRB for Dr. Mithoefer's
MAPS-Sponsored MDMA/PTSD Study
6. Final Five Subjects Recruited for Dr. Mithoefer¹s Flagship MDMA/PTSD
Study 
7. Second Subject Treated in Dr. Oehen's Swiss MDMA/PTSD Study
8. MAPS Funds Secondary Study Measuring EEG/ERP for Subjects in Dr. Oehen's
MDMA/PTSD Study
9. MAPS-Sponsored LSA/Cluster Headache Study Receives Conditional Approval
from IRB
10. Iboga Therapy House Now Recruiting Patients; MAPS-Sponsored
Observational Case Study Poised to Begin
11. MAPS/Heffter-Sponsored Ketamine Research Published
12. The Women¹s Visionary Congress ‹ Web Site and Registration Now Available
13. Raffle for MindStates Costa Rica
14. Pioneering Psychedelic Researcher Duncan Blewett Passes On


For MAPS memberships, special donations, merchandise, books, artwork, and
more: 
http://www.maps.org/catalog


1. Update on Craker/DEA Lawsuit for MAPS-Sponsored Marijuana Production
Facility

In light of our recent hard-won victory in Prof. Craker's lawsuit against
the DEA, we're ramping up for a lobbying campaign of unprecedented
significance and scale. MAPS must show DEA that there is substantial public
support for scientific freedom in marijuana research. That¹s why MAPS is
coordinating a lobbying campaign aimed at pressuring DEA to actually accept
Judge Bittner's recommended ruling.

On March 26, DEA's lawyers will submit their critique to DEA Administrative
Law Judge (ALJ) Mary Ellen Bittner's  recommended ruling that DEA grant a
Schedule I license to Prof. Lyle Craker for his proposed MAPS-sponsored
production facility. On May 4, our lawyers will submit a reply to the DEA
lawyers' critique, and then within a few weeks the ALJ will formally submit
her recommendation and the dueling comments from the two legal teams to DEA.
The DEA has an unlimited amount of time to make a final ruling.

MAPS has already utilized over $250,000 in resources to help Prof. Craker
win his lawsuit against DEA, mostly in the form of pro bono legal services.
Now, we must harness the momentum from this victory to demonstrate to DEA
that the public wants to see the safety and efficacy of marijuana determined
by rigorous scientific research, not by the vested political interests of
NIDA and DEA. The opportunity to resolve the controversy over medical
marijuana through FDA-approved clinical trials hangs in the balance.

We estimate that the odds of prevailing over DEA are 2-1 against us ‹ in
other words, more favorable than many of MAPS' long-shot efforts. Even if we
lose, we win in some important ways. If the DEA rejects the ALJ's
recommendation, it will highlight DEA obstruction of FDA-approved research
and will help build support for state-level medical marijuana reform
efforts.

Last week, our lobbying campaign received a big boost with news that MAPS
has been awarded a grant of $45,000 from the Marijuana Policy Project (MPP).
Over the next few weeks, we¹ll be formulating a strategy. Then, we¹ll ask
MAPS members and many others to contact their Congressional legislators to
request that they write to DEA urging the agency to accept the ALJ's
recommendation.

For background information on the case and Prof. Craker¹s proposed facility,
see: http://www.maps.org/mmj/DEAlawsuit.html


2. MAPS and Chemic Labs Negotiate Vaporizer Protocol

On February 16, MAPS President Rick Doblin met with Joe St. Laurent and
Scott Goodrich, the founders of Chemic Labs, the analytical laboratory that
has conducted prior MAPS/CaNORML-funded vaporizer research. They discussed
the development of a new vaporizer research protocol to submit to NIDA for
review, once again seeking to purchase 10 grams from NIDA and seeking DEA
permission to import 10 grams of high THC/high CBD marijuana from the
Netherlands, with a cannabinoid content that NIDA doesn't have available.
The design work and the study itself, should we eventually obtain approval
from NIDA, will be co-funded by MAPS and CaNORML, as have all our previous
vaporizer research projects.

This new protocol seeks to analyze the constituents of the vapor produced in
the Volcano vaporizer, from samples of NIDA marijuana that contain THC and
samples of imported marijuana that contain both THC and CBD. During the
meeting at Chemic, we reviewed in detail the critiques of the original
vaporizer research protocol that the PHS/NIDA reviewers offered back in
August 2005 [link to critique]. We will make a few changes in the protocol
so that this will be a new submission and we will respond in detail to each
critique. The proposed methodology will call for testing at various
temperatures, and will measure for carbon monoxide levels, cannabinoids and
certain particulates.

PHS/NIDA's handling of the original version of this protocol was another
classic case of the dysfunctional nature of NIDA's monopoly on
research-grade marijuana. After waiting for more than two years for PHS/NIDA
to review the protocol, during which time we unsuccessfully sued NIDA for
unreasonable delay in the DC Circuit Court of Appeals, the critique that was
finally issued contained several important misunderstandings and seemed to
come from people who had barely even read the protocol. Chemic filed a
response to the critiques in September 2005, which PHS/NIDA has totally
ignored for more than 17 months. There seems to be no appeal process at all
in the PHS/NIDA review of medical marijuana research proposals and there are
certainly no deadlines that compel PHS/NIDA to respond within any reasonable
period of time. This is in contrast to FDA, which must reply to protocol
submissions within 30 days and has a clearly defined and prompt appeal
process. Chemic¹s critique of NIDA¹s rejection is posted online at:
http://www.maps.org/mmj/chemic_letter_9.9.05.pdf

The new vaporizer protocol will be submitted to NIDA in April. Then, we
anticipate a long wait. NIDA has successfully ignored Chemic's response to
its critiques but it will be more difficult for NIDA to ignore a new
protocol submission.

For background on MAPS¹ vaporizer research efforts, see
http://www.maps.org/mmj/vaporizer.html


3. Ninth Circuit Court Rejects Raich Medical Marijuana Right-to-Life Appeal

Earlier today, the Ninth Circuit Court of Appeals unanimously rejected (3-0)
an appeal by medical marijuana patient Angel Raich, ruling that the 10th
amendment does not protect her right to use medical marijuana and that there
is no constitutional right to use marijuana to treat pain and suffering.
MAPS and MPP had submitted an amicus curiae brief for the appeal, as well as
for Raich¹s previous cases, detailing the federal government¹s obstruction
of medical marijuana research. Raich, a mother of two, uses marijuana to
treat severe chronic pain, an inoperable brain tumor, wasting syndrome, and
seizures.

Judge Harry Pregerson wrote, "We agree with Raich that medical and
conventional wisdom that recognizes the use of marijuana for medical
purposes
is gaining traction in the law as well. But that legal recognition has not
yet reached the point where a conclusion can be drawn that the right to use
medical marijuana is Œfundamental¹ and Œimplicit in the concept of ordered
liberty.¹

In Raich¹s 2005 US Supreme Court case, Gonzalez v. Raich, medical marijuana
suffered a judicial setback when the Court ruled that the federal government
can continue arresting patients who use medical marijuana legally under
their state laws. Almost a year ago, on March 27, 2006, Raich returned to
the Ninth Circuit Court in Pasadena, California, with a new legal strategy.
Her attorney, Prof. Randy Barnett, emphasized that the case was about
Raich¹s "fundamental right to life," arguing that her right to use marijuana
is constitutionally protected under the 5th & 9th amendments and by the
common law doctrine of medical necessity.

During oral arguments last year, Justice Arlen Beam cited the MAPS/MPP
amicus curiae brief. However, the Judge did not cite the primary message of
the brief -- that the federal government has obstructed research, hence
making state reform efforts necessary -- instead, to our disappointment, he
only focused on the brief's acknowledgment that there is not enough current
clinical research for the FDA to approve marijuana for prescription use.

MAPS/MPP amicus curiae brief:
http://www.maps.org/mmj/mpp_amicus_11.30.05.pdf

With Raich¹s appeal lost, one more potential door to federally-legal medical
marijuana is firmly shut, making the route through FDA even more necessary
than before. There is no constitutional refuge for medical marijuana
patients. The federal government is using its full authority to crack down
on medical marijuana users and providers, even in medical marijuana states,
while also making sure patients stay criminals by obstructing FDA-approved
research. 


4. Ethics Committee Meeting for Historic Swiss LSD/End-of-Life Anxiety Study

On March 8, the Ethics Committee (Swiss IRB equivalent) for Dr. Peter
Gasser's proposed MAPS-sponsored LSD-assisted psychotherapy study met to
review his protocol. The committee is writing him a letter with their
decision later this week. During the meeting, Dr. Gasser answered questions
for 40 minutes. According to Peter, the meeting went well, and the committee
seemed comfortable with the doses and the size of the study. Most of the
information they requested was about videotaping and protecting the privacy
of the subjects. One member of the committee did express some worries about
the overwhelming power of the LSD experience itself. These concerns were
addressed by Dr. Gasser, who stressed the psychological preparation of the
subjects, the controlled clinical setting, and the supportive relationship
with the therapists as being the key ways that the power of the LSD
experience can be utilized in a therapeutic and beneficial manner.

This was the first of three formal regulatory reviews for the protocol to
obtain full government approval. Depending on the outcome of the Ethics
Committee evaluation, and the subsequent reviews by SwissMedic (Swiss FDA)
and BAG (Swiss DEA), we could be ready to begin the study by this summer.
The study is budgeted at $180,000 - MAPS has already raised $50,000 so far,
but we need your help to bring the final $130,000 to fruition. Once approved
and completed, this study will be the first government-approved study in
over 35 years evaluating LSD's therapeutic applications.

For more information of Dr. Gasser¹s proposed LSD psychotherapy study, see:
http://www.maps.org/research/cluster/psilo-lsd/#swlsd


5. Crucial Media Provision Approved on Appeal by IRB for Dr. Mithoefer's
MAPS-Sponsored MDMA/PTSD Study

After several years of effort, three rejections, and an appeal, the
Institutional Review Board (IRB) for Dr. Michael Mithoefer's flagship
MAPS-sponsored US MDMA/PTSD study approved an amendment to the study's
protocol. The IRB decided that it will not object to subjects speaking with
the media and/or documentary filmmakers following completion of each
subject's participation in the study. The IRB originally insisted that
patients not speak with the media even after the entire study is complete.
After years of careful consideration, the IRB has now determined that it has
no jurisdiction to control subjects' decisions about whether or not to speak
to the media.

Due to the resolution of  the media policy, we are now ready to move forward
with our 12-month follow-up evaluations, which the IRB has previously
approved.


6. Final Five Subjects Recruited for Dr. Mithoefer¹s Flagship MDMA/PTSD
Study 

Another encouraging advancement is that we may be close to enrolling the
final five subjects needed to complete Dr. Mithoefer¹s study. We've focused
more attention on recruitment with ads on various psychedelic-related
websites and websites for PTSD support groups and currently have more than
five subjects going through the screening process. Two of these potential
subjects are Iraq War veterans.

Fifteen out of 20 subjects have completed the experimental procedures and
their final follow-up evaluation session. Efficacy data at this stage is
promising, so far making a strong case for continuing the research into FDA
Phase 3 studies. 

Wondering what an FDA Phase 3 study is?
FDA: http://www.fda.gov/cder/handbook/phase3.htm
Wikipedia: http://en.wikipedia.org/wiki/Clinical_trial#Phase_III

For more information on Dr. Mithoefer¹s MDMA/PTSD protocol see:
http://www.maps.org/mdma/protocol/index.html


7. Second Subject Treated in Dr. Oehen's  Swiss MDMA/PTSD Study

Dr. Peter Oehen's MAPS-sponsored study evaluating MDMA-assisted
psychotherapy for subjects with chronic posttraumatic stress disorder (PTSD)
has been making swift progress. Last Thursday, March 8, the second subject
in Dr. Oehen's study underwent the second experimental treatment session.
The third subject will undergo the first experimental session later this
week, and the fourth and 5th subjects have already been recruited.

Dr. Oehen¹s MDMA/PTSD protocol:
http://www.maps.org/mdma//swissmdmaptsd/protocol1608.pdf


8. MAPS Funds Secondary Study Measuring EEG/ERP for Subjects in Dr. Oehen's
MDMA/PTSD Study

MAPS has committed $5,300 to Dr. Franz Vollenweider at the Psychiatric
University Hospital in Zurich to co-sponsor a secondary study that will
gather data for physiological assessments of subjects in Dr. Oehen's
MDMA/PTSD study. The additional study will use several different measures to
assess the psychophysiology of PTSD by using EEG/ERP and other biological
measures such as heart rate variability (HRV) and pre-pulse inhibition
(PPI). These parameters will be measured before and after the MDMA-assisted
psychotherapy to allow researchers to evaluate changes in various areas of
the brain and body. We expect  that this additional neurophysiological and
biological data will document the efficacy of MDMA-assisted psychotherapy.
The amendment to Dr. Oehen's protocol to include Dr. Vollenweider's research
was previously approved by Dr. Oehen's Ethics Committee (IRB) in September
2006.

For more on this study, see Dr. Oehen¹s article in the Fall 2006 MAPS
Bulletin: http://www.maps.org/news-letters/v16n2/mdma_ptsd_swiss.pdf


9. MAPS-Sponsored LSA/Cluster Headache Study Receives Conditional Approval
from IRB

Earlier today, R. Andrew Sewell, M.D., received conditional approval from an
IRB, pending a few minor changes in  the informed consent form, for his
protocol for a case series of the effects of LSA-containing seeds (morning
glory, Hawaiian baby woodrose, or Rivea corymbosa) on cluster headache. The
study, funded by a donation to MAPS from Seth Hollub, collects reports from
people with cluster headache who have tried to treat this extremely painful
condition through the use of seeds that contain this psychedelic compound.

For more about this study, see the Memorandum of Understanding between MAPS
and Dr. Sewell at: http://www.maps.org/MOUSewell.htm


10. Iboga Therapy House Now Recruiting Patients; MAPS-Sponsored
Observational Case Study Poised to Begin

MAPS Clinical Research Associate Valerie Mojeiko is in Vancouver, Canada
this week to conduct a study initiation visit for a MAPS-sponsored
observational case study evaluating the long-term efficacy of
ibogaine-assisted therapy in participants seeking treatment for opiate
addiction at the Iboga Therapy House. 

If you are interested in receiving ibogaine therapy, you can learn more
about the Iboga Therapy House and apply to their program
at: http://www.ibogatherapyhouse.net/cms


11. MAPS/Heffter-Sponsored Ketamine Research to be Published March 31

Evgeny M. Krupitsky, M.D., Ph.D., Chief of the Research Laboratory at St.
Petersburg Regional Center of Addictions and Psychopharmacology, will
publish "Single Versus Repeated Sessions of Ketamine-Assisted Psychotherapy
for People with Heroin Dependence" in the March 31 issue of the Journal of
Psychoactive Drugs. Krupitsky and his team found that multiple sessions of
ketamine-assisted psychotherapy were more effective than single sessions,
helping take an important step forward from the "magic bullet, miracle cure"
theory.

Unfortunately, since this research was conducted, all ketamine research in
Russia has been halted by its increasingly repressive regime, although
heroin-related harm has risen considerably in recent years.


12. Women¹s Visionary Congress: Web Site and Registration Now Up!

The Women's Visionary Congress is a gathering of healers, activists,
researchers and artists who are redefining the use of entheogens. This is a
rare opportunity to meet the women doing critical work in the entheogenic,
medical cannabis and harm reduction communities. The event will feature 25
mostly women speakers including Val Corral, Earth and Fire Erowid, Amanda
Feilding, Carolyn (Mountain Girl) Garcia, Kathleen Harrison, Mariavittoria
Mangini, Hilary McQuie, Annie Mithoefer, Cindy Palmer, Steph Sherer and
Annie Sprinkle. The V Congress is a benefit for the Women's Entheogen Fund
(WEF) which was created in 2002 to support the work of women who spend a
significant portion of their professional lives researching psychoactive
plants and chemicals. MAPS is the non-profit fiscal sponsor for WEF.

Co-sponsored by The Sibyl Society and MAPS, the V Congress will take place
at Wilbur Hot Springs in Northern California from July 27-29th. Tickets are
$375 and include the cost of all events, meals, camping and yoga classes. A
limited number of rooms are available at the Wilbur Hot Springs Hotel for an
additional cost. This event is open to both women and men.

For more information and to register, visit the V Congress Web site at
http://www.visionarycongress.org or call MAPS Membership and Sales Manager
Sarah Hufford at (831) 252-0023.


13. Raffle for MindStates Costa Rica

Want to win a trip to the Mind States Costa Rica seminar, June 13-17, 2007?
Try your luck and support MAPS by purchasing a ticket for the MindStates
raffle! Raffle tickets are $20.00 each, and winning tickets are worth
approximately $2,100 in event costs and airfare. Ten percent of the price of
each raffle ticket goes to MAPS.

To purchase a raffle ticket, see http://www.mindstates.org/maps-raffle.html

Winner(s) airfare (up to $700), attendance fee, food, and resort room costs
will all be covered. Seminar presenters include Joe Coleman, Erik Davis,
Earth Erowid, Fire Erowid, Stanislav Grof, Jon Hanna, Liz McIntyre, Mark
Pesce, Alexander Shulgin, Ann Shulgin, and Margaret Wertheim, with
Holotropic Breathwork offered by Sheelo Bohm.

For more information on the event, see http://www.mindstates.org


14. Pioneering Psychedelic Researcher Duncan Blewett Passes On

On February 24, Duncan Blewett died at Nanaimo Hospital, British Columbia,
after two years of loving post-stroke care at his home on Gabriola Island.
Dr. Blewett was an athlete, husband, father, PHD from University of London
(UK), WWII veteran, founding chairman of University of Saskatchewan's
department of Psychology, and one of the earliest western scientists to
study the effects and therapeutic applications of psychedelics. Blewett
published numerous books, such as Handbook for the Use of Lysergic Acid
Diethylamide-25: Individual and Group Procedures and The Frontiers of Being.

Handbook for the Use of LSD-25... is available in electronic format in the
"Free Books" section of the MAPS website: http://www.maps.org/freebooks.html

Blewett and a team of forward-thinking research psychologists were recruited
to work at the U. of Saskatchewan's (later known as the U. of Regina¹s)
Weyburn Hospital by Dr. Humphrey Osmond in the early 1950s, where they
conducted a wide variety of patient studies and observations. Osmond, of
course, is known for introducing Aldous Huxley to psychedelics (as described
in The Doors of Perception) and for coining the term "psychedelic," in
addition to his myriad research.

According to the Gabriola Sounder, Duncan "lived his life fabulously in the
moment to the very end: the power of his joy will resonate on for many
lifetimes ... The afterlife just got a little lighter."

Following Duncan¹s death, Larry Schor wrote:

³Duncan was a trickster, a magician, an alchemist. In his company and under
his spell, you could almost witness reality and imagination dancing together
on the head of a pin. With Duncan by your side, you were always capable of
more. More love. More compassion. More courage. One of his favorite quotes
was of the Chinese philosopher Mencius, who said, ŒThe ways are but two,
love and want of love.¹ For Duncan, the only path was love.²

****************************************************************************
***********

The power is in our hands to create our future, and the future of
psychedelics.

Now that MAPS¹ agenda is gathering momentum, your support is more important
than ever.  If you are a MAPS member, we are deeply grateful for your
support and glad to have you on our team. We couldn¹t do our work without
you. If you are not a MAPS member, please consider joining us.

For MAPS memberships, special donations, merchandise, books, artwork, and
more: 
http://www.maps.org/catalog


Happy Spring! 

Jag


Jag Davies
Director of Communications
The Multidisciplinary Association for Psychedelic Studies
MAPS :: 10424 Love Creek Road :: Ben Lomond, CA 95005
Tel. 831.336.HEAL (4325) :: Cel. 831.252.0023 :: Fax. 831.336.3665
jag at maps.org 


**********************************************************
Advocating Science over Politics,
Replacing Fear with Facts:
Your Support is Needed! http://www.maps.org/catalog

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