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Peter Lewis pledges $250,000 to Veterans Study
On Dec. 1, 2010, philanthropist Peter Lewis pledged to
donate $250,000 in 2011 to MAPS’ U.S. study of MDMA-assisted psychotherapy for
the treatment of posttraumatic stress disorder (PTSD) in war veterans. This
generous pledge brings us to $319,000 out of the projected $500,000 needed to
fund the entire study. We wish to extend our sincere gratitude to Peter Lewis
for recognizing the value of this research and committing to fund it!
First Two Subjects in U.S. Veterans Study Scheduled
for MDMA Session in January
The first two veterans in our newest MDMA-assisted psychotherapy study are now scheduled for their experimental sessions in
January. Clinical Investigators Michael Mithoefer, M.D., and Annie Mithoefer,
B.S.N., are leading this MAPS-sponsored study at their private office in
Charleston, SC. In this study we are only enrolling veterans suffering from
war-related PTSD who have tried other treatments and failed. In preparing the
study, we found that veterans are different from survivors of sexual abuse and
assault in that they are more likely to be taking opiate medications for pain. In
the current protocol, we are using fixed dosages and cannot increase the dose
of MDMA if the opiates blunt the effect. The team was concerned that opiates
could cause MDMA to be less effective. When we learned that one of the
potential subjects was prescribed opiate pain medication, our clinical team
conferred with medical monitor Julie Holland, M.D., to create a policy for
enrolling patients with chronic pain. We decided we would enroll subjects who
are currently taking opiate medications for pain as long as they agreed to
forego or reduce their medication on the day that they receive MDMA. We’ll use
what we learn in this pilot study to decide whether, and under what conditions,
it makes sense in future studies to continue to enroll subjects on opiate pain
medications.
Database for U.S. MDMA/PTSD Long-Term Follow-Up
Study Finalized
On Nov. 5, 2010, MAPS’ clinical research team completed
their review of the data from our flagship MDMA/PTSD study. On Nov. 10, the
team closed and locked the database, officially bringing the data collection
phase of the study to an end. Now that we have the final data set, the research
team can analyze the data and write a paper for submission to a peer-reviewed scientific
journal. Twenty of 21 subjects from the study successfully completed the
long-term follow-up study and, and the review showed that the benefits were maintained
over time. This is especially significant because these subjects were all
treatment-resistant, meaning they had tried other medicines and therapies
without relief. Additionally, of the subjects who were seeing a therapist prior
to the experiment, 45% were no longer seeing a therapist at the time of the
follow-up survey; and 55% of the subjects who were previously receiving
psychiatric medications were no longer taking them.
Amendment to Canadian MDMA Study Submitted to IRB
On Nov. 26, 2010, three days after MAPS’ clinical research
submitted the amendment for our Vancouver study of MDMA-assisted psychotherapy for PTSD, it was approved by the Canadian Institutional Review Board. The
amendment changes the protocol to align it with our other MDMA/PTSD studies and
adds several new aspects, including: a long-term follow-up data collection
point one year after the final experimental treatment session, a measure of
suicidality as required by the U.S. Food and Drug Administration (FDA), a
personality inventory, a new informed consent form, and video recording of the
sessions. By aligning the new protocol with past studies, the amendment enables
us to compare results side-by-side and conduct future meta-analyses.
We’ve also recently heard back from Health Canada in
response to our pharmacist’s Nov. 1 application to serve as the licensed
provider of MDMA for the study. As the licensed provider, the pharmacist would
be able to import MDMA from our supplier in Switzerland for the study. We were
also informed of the type of safe and alarm systems that the pharmacist will be
required to install for the MDMA. We will submit the protocol amendments to
Health Canada after our pharmacist has received the import license. At this point
we still cannot predict a start date, but we continue to be optimistic about starting
in early 2011.
Annual MDMA Report Submitted to the FDA
On Dec. 9, 2010, MAPS’ clinical research team submitted our annual report about MAPS' MDMA/PTSD research to the FDA. Annual reports are designed
to give the FDA an overview of completed, ongoing, and planned studies for
specific Investigational New Drug (IND) Applications. In our report, which
covered all study activity between June 22, 2009, and October 1, 2010, we
provided information about enrollment, including the total number of subjects
enrolled for each study. Demographic information for all subjects (such as height,
weight, race, and cause of PTSD) was included. We also created overview charts
of all serious and severe adverse events experienced by the subjects. Although we
reported four serious adverse events to the FDA (a fractured clavicle due to
auto accident, a fainting episode, a complication due to cancer, and one
psychiatric hospitalization), none of them were related to the administration
of MDMA.
Marijuana for PTSD Protocol Submitted to FDA and
NIDA
On Nov. 11, 2010, MAPS’ clinical research team submitted our
newest marijuana protocol to the FDA. If approved, the study will gather
preliminary information about whether medical marijuana is a safe and efficacious
way to manage symptoms of PTSD. The FDA has already requested more information
about where we would obtain the marijuana for the study. On Nov. 23, MAPS
Executive Director Rick Doblin, Ph.D., wrote to the Chemistry and Physiological
Systems Research Branch at the National Institute of Health (NIH)/National
Institute on Drug Abuse (NIDA) to inquire about the cost and THC content of
NIDA-supplied marijuana. On Dec. 2, we received an email from the agency
informing us that NIDA could provide us with three out of the five potencies of
marijuana we wish to test. According to the agency, NIDA has placebo marijuana cigarettes
(containing just 0.004% THC) and marijuana cigarettes containing 2.1%, 5.6%,
and 6.7% THC. It does not, however, have marijuana cigarettes containing 12%
THC or the combination of 6% THC/6% CBD, which our protocol requires. NIDA also
cautioned us that the THC content of its marijuana deteriorates over time, and
that we should ask for updated potency information prior to ordering. On Dec.
3, Rick wrote back to NIDA asking how much it would cost and how long it would
take for NIDA to develop marijuana that contained 6% THC/6% CBD and 12% THC. A NIDA
representative replied to Rick’s inquiry on Dec. 8, informing him that Mahmoud
Elsohy, Ph.D., the director of NIDA’s marijuana project at the University of
Mississippi, was out of town and that NIDA would respond in several weeks.
Meanwhile, on Nov. 24, a representative from the FDA wrote
to MAPS requesting information on behalf of the FDA’s Chemistry, Manufacturing,
and Controls (CMC) team. They requested information regarding: (1) the source
of the active and placebo marijuana cigarettes, including the name and address
of the manufacturer, (2) the complete composition of each strength and
technical grade of each excipient (the non-marijuana components of each
cigarette), (3) how the specific concentration of THC and CBD in the marijuana
plant is achieved, (4) the method of manufacture of the cigarettes, (5) the specifications
for each strength and description of the analytical procedures, (6) the certificate
of analysis for each strength to be used in the clinical study and the date of
manufacture, and (7) a letter of authorization
to NIDA's Drug Master File for marijuana cigarettes. Rick responded to the FDA
letting them know that the organization has set a precedent of reviewing and
approving protocols before having all the required information for the source
of the drug to be used in the study. In such cases, the protocol can be
approved, but the study is on clinical hold until the FDA CMC review team is
satisfied with the information regarding the drug to be used in the study.
The Public Health Service (PHS)/NIDA protocol review
process, which is required for all studies seeking NIDA marijuana (but which
isn’t required for any of our psychedelic research since we have our own
independent source), can take about six months, and it’s likely that the
reviewers will have questions about the protocol. After we respond to those
questions, it could take another six months for PHS/NIDA to comment on our replies—a
process which will repeat until our protocol is either rejected or approved. Until
those reviews are completed and NIDA approves the protocol, NIDA will not give
MAPS permission to purchase its marijuana and cross-reference its Drug Master
File. Therefore, while it is currently impossible for MAPS to provide the
information requested by the FDA CMC review team, the FDA should be able to continue
with its review.
Twelfth and Final Subject
to be Screened for Swiss LSD Study
The twelfth and final subject in MAPS’ study of LSD-assisted psychotherapy to treat anxiety associated with life-threatening illnesses is
now in the screening process. The study is taking place in Solothurn,
Switzerland, and is led by Clinical Investigator Peter Gasser, M.D. Our goal is
to enroll the twelfth subject and have the study completed by the late spring of
2011. When the study is completed and the data is analyzed, a paper about the
results will be written and submitted for publication in a peer-reviewed
scientific journal.
We are simultaneously sponsoring a long-term follow-up study
of our subjects. This portion of the study will collect data from subjects one
year after their treatment session to see whether results are sustained over
time. One subject has completed the long-term follow-up so far. When this
research is complete, we will prepare a separate paper for a peer-reviewed
journal.
Fifth Subject Enrolled in Ibogaine Study/Protocol
Amended
On Nov. 22, 2010, the fifth subject was enrolled in our
observational study of ibogaine treatment for opiate addiction. On Dec. 2, the
research team, led by Principal Investigator (and MAPS Deputy Director) Valerie
Mojeiko and Co-Investigators Thomas Kingsley Brown, Ph.D., Meg Jordan, Ph.D.,
R.N., and Rishi Karim Gargour, M.A., submitted an amendment to the protocol to
the Human Resources Review Committee (HRRC) at the California Institute for
Integral Studies, which was soon after approved on December 9. The amendment
requested five changes to the protocol:
- Increase the number of subjects from 20 to 30.
This will provide more statistical power to the final analysis.
- Add an additional site for data collection. We
are adding a second clinic, also based just south of the San Diego border in
Mexico, to increase the speed of subject recruitment. This clinic is similar in
many ways to the other clinic from which patients are being recruited, but we
will also analyze data from each clinic site separately to try to detect
differences.
- Add drug testing. Drug testing will allow us to
verify information provided subjects about their substance use. Subjects will
be compensated for their time spent visiting the testing center.
- Utilize the Beck Depression Inventory. This
measure, which has been used in other addiction studies of ibogaine, will track
depression over the course of the study. Treatment providers have observed
relief from depression in some of their clients, and this inventory will
attempt to measure this purported effect of ibogaine.
- Utilize the Trait Emotional Intelligence Questionnaire,
Short Form (TEIQ-sf). This measure will allow us to explore the role that
emotional intelligence may play in addiction recovery.
On Dec. 10, Valerie Mojeiko and Thomas Kingsley Brown conducted
a site visit of the second clinic. They were impressed with the medical
procedures used by the clinic and have decided to enroll subjects from that
clinic in our study.
Beckley Psilocybin/Brain Imaging Study Progresses
On Nov. 24, 2010, study investigator Robin Carhart-Harris,
Ph.D., updated MAPS on the progress of a Beckley Foundation-sponsored psilocybin
project for which on Sept. 29 MAPS provided a grant of $10,000 and to which the
Heffter Research Institute also donated $10,000. The British study, led by
Carhart-Harris and co-led by Richard Wise, David Nutt, Ph.D., and Amanda
Feilding, uses brain imaging to measure the effects of psilocybin on brain
activity. The researchers hypothesize that psilocybin facilitates
autobiographical recollection. If this hypothesis is supported, it will: (1)
indicate that psilocybin can facilitate the recollection of memories, (2) provide
a biological explanation for how this occurs, and (3) indicate how psilocybin
might be used as an adjunct to dynamic psychotherapy.
The first official scans (including the first drug scans)
happened on Dec. 3 and 10. Carhart-Harris wrote to MAPS, "We have piloted the
scan design in two scans off-drug and observed good results in both.
Essentially, the design produced the results we intended, i.e. activations in
memory regions with the memory task and deactivations in the so-called 'default
mode network' with an attentionally demanding task."
Although MAPS generally only supports research involving the
therapeutic applications of psychedelics, we awarded this grant because we
wanted to assist the Beckley Foundation in one of its projects. In addition, we
one day hope to sponsor MDMA/PTSD research in England and the more psychedelic
research that takes place there beforehand, the better our chances will be at
obtaining regulatory permission for our research.
MAPS Year-End Bulletin Online and in Mailboxes
MAPS members have or are about to receive MAPS’ year-end Bulletin in their mailboxes. The Bulletin can also be viewed on the MAPS
website. This edition includes:
- Annual Financial
Report by Rick Doblin, Ph.D.
- MAPS Clinical
Studies Summary
- Update on MDMA/PTSD
Research in Charleston: A New Protocol with Veterans, by Michael Mithoefer,
M.D
- MAPS Attends American
Psychological Association Conference, by Valerie Mojeiko
- New Ibogaine Outcome
Study Begins Enrollment, by Thomas Kingsley Brown, Ph.D., and Valerie
Mojeiko
- The Saga of MAPS’
Lawsuit to Gain Approval to Sponsor a Marijuana Farm, by Rick Doblin,
Ph.D., and Stephen Morseman
- Investigating
Marijuana as a Treatment for PTSD Symptoms, by Rick Doblin, Ph.D.
- The Wizardry of
Psychedelic Science in the 21st Century, by Kynthia Brunette, M.A.
- The Variety of
Ayahuasca Research: Psychedelic Science in the 21st Century Conference Report,
by Lily Ross, Ph.D. Student
- Praise for
Psychedelic Science in the 21st Century
- Drinking the Sacred
Jungle Juice: Three Ayahuasca Book Reviews, by David Jay Brown, M.A.
- Book Review:
Holotropic Breathwork: A New Approach to Self-Exploration and Therapy, by Karey
Pohn, J.D., Ph.D.
- Obituary for Ronald
Sandison, M.D., 1916-2010, by Ben Sessa, M.D.
- In Appreciation for
Dr. Ronald Sandison and His Pioneering Practice, by Scott J. Hill, Ph.D.
- Interview with Larry
Thomas, March 2008: Deceased 2010, by Randolph Hencken, M.A.
- Conscious Parenting
in this Time of Psychoactive Substance use, by Phil Wolfson, M.D.
- MAPS New Continuing
(Medical) Education Program
Videos from Psychedelic Science in the 21st
Century are Online; CME/CE Credit Available
We have posted nearly 80 videos of presentations from our
Psychedelic Science in the 21st Century conference online for
free viewing. Medical doctors, medical professionals, psychologists and social
workers can now earn continuing
medical education (CME)/continuing education (CE) credits for a nominal fee
by watching videos and taking short quizzes. Several videos are already
accredited, and many more will be accredited over the next few months.
A generous donor has pledged $1 for each time that a video
is viewed, for a total of up to $15,000, to encourage the spread of knowledge
from the conference. Please watch one of our videos today, and share them with
your friends and family over the holidays.
"The Entheogenic Evolution"
MAPS Executive Director Rick Doblin discussed his life and
the work of MAPS with Martin W. Ball for "The Entheogenic Evolution" podcast,
which is available in two parts: Part
1 (from Oct. 4) and Part
2 (from Oct. 28).
Randolph Hencken Interview on "Present!" with Mel
Van Dusen
MAPS Director of Communication Randolph Hencken, M.A., was
interviewed on San
Jose’s KMTV television program "Present!" with host Mel Van Dusen.
"Present!" explores creativity, spirituality, and personal growth through
interviews with people pursuing their unique visions. Randy spoke about psychedelics
in the 21st century, his own ibogaine treatment to overcome opiate
addiction, and other MAPS-related issues. Van Dusen also interviewed MAPS guest
editor David Jay Brown in three parts: Part 1, Part 2,
and Part
3.
Videos from the 2010 Horizons Conference Now Online
Videos from the 2010 "Horizons: Perspectives on
Psychedelics" conference are now online. The conference took place on Sept.
24-26 at Judson Memorial Church in New York City. The available videos are:
- Jeffrey Guss, M.D., "The NYU Psilocybin Cancer
Anxiety Research Project’s Psychedelic Psychotherapy Training"
- Matthew W. Johnson, Ph.D., and Mary P. Cosimano,
M.S.W., "Psilocybin in Smoking Cessation: A Pilot Study"
- Neal M. Goldsmith, Ph.D., "Psychedelics,
Psychotherapy, and Change"
- Jill Harris, "Challenges in Changing the Legal
Status of Entheogens"
- JP Harpignies, "Psychedelics, Utopianism, and
Psycho-Spiritual Inflation"
- Erik Davis, "Psychedelics: Between Natural and
Supernatural"
- Rick Strassman, M.D., "Old Testament Prophecy –
A Western Model of the Psychedelic Experience"
"Hallucinogens as Medicines" Featured in Scientific American
An article by Heffter Research Institute researchers Roland
Griffiths, Ph.D., and Charles Grob, M.D., was published in the December issue
of the popular Scientific American
magazine. Grob and Griffiths provide a detailed description of their research on
psilocybin and mystical experiences, and psilocybin-assisted psychotherapy to
treat death anxiety. MAPS’ MDMA/PTSD research is also mentioned. The article,
entitled "Hallucinogens
as Medicines" is available to read on the MAPS website. Also available is a
response article entitled, "High
Light: When a Psilocybin Study Leads to Spiritual Realization" by Maria
Estevez, one of Griffith’s study subjects who had an enlightening experience on
psilocybin.
MAPS Seeks Participants for Online Survey to Assess
Cardiovascular Risks of Ecstasy in People with and without Anxiety-related
Disorders
February 14, 2011: This survey is now closed. We have completed collecting data and are now analyzing the data. Thank you to those who participated!
MAPS is seeking participants for an
online survey created by MAPS’ intern from the Netherlands, Daan De Vries,
about the effects of Ecstasy on the body. Anyone who has used Ecstasy is
welcome to participate, and we are especially interested in recruiting
participants with anxiety-related disorders who have used Ecstasy.
The cardiovascular effects of MDMA, including heart rate and
blood pressure, have been extensively studied in clinical research settings.
Ecstasy tablets used in non-clinical settings, however, contain an
unpredictable amount of MDMA and sometimes consist of a mix of psychoactive
substances or even contain no MDMA at all, with unknown effects on
cardiovascular function.
It is believed that people with anxiety-related disorders such
as PTSD may have a different cardiovascular profile than people without anxiety
disorders, since anxiety disorders in general are associated with higher
cardiovascular risk factors (Watkins et al. 2010). For example, hypertension
occurs more often after military combat deployment, possibly due to stress
(Granado et al. 2009). There is currently very little data outside of MAPS’
studies on the cardiovascular effects of MDMA in people with anxiety-related
disorders.
The online survey focuses on
assessing cardiovascular health and risk factors in Ecstasy users without
anxiety-related disorders and comparing them to users who have
anxiety-related disorders. We are investigating whether any users may have
experienced headache, palpitations, shortness of breath, chest pain, or other
cardiovascular issues while using Ecstasy, or persisting changes in
cardiovascular health after using Ecstasy. With the help of this anonymous
survey, we hope to better understand the effects of Ecstasy use on
cardiovascular health to inform our research design for future clinical trials.
Thank you for setting aside the time to take this brief
survey and for helping us to spread the word!
MAPS Winter Raffle Contest: Ski House Rental
Kirkwood, California (Lake Tahoe area)
MAPS invites you enter our snow chalet vacation raffle and
support psychedelic and marijuana research. The winner will enjoy a lovely private
mountain house in Kirkwood (a ski resort 30 miles from South Lake Tahoe,
California). Use of this house was donated to MAPS. Tickets are $10
each or 12
for $100. The house’s vacation rental value is $800 - $1200. We will
randomly select the winner on Dec. 23, 2010.
The lucky raffle winner can choose to use the home for a ski
weekend or for four days midweek.*
The 1500 sq. foot house sleeps up to ten
people in three bedrooms, has two baths, a large deck, and views of Red Cliffs
and the ski area. It is perched on the highest street in Kirkwood, high above
the bustle of condos and on a perfect sledding hill. It is a short walk to the
edge of the forest and ski area entrance, or a quick traverse onto the runs
without crossing a road. The owners promise a "sweet, easy and quiet, real
mountain experience."
*The home is not available for the busiest holidays: the
week before Christmas, week of Christmas to New Years, Martin Luther King
weekend, Presidents Day weekend. Spring break is negotiable, depending upon the
owner’s plans
Catalysts Conference a Huge Success
From Dec 10-12, 2010, MAPS had a full weekend in Downtown Los
Angeles attended by more than 300 people. On Friday night, we hosted
"Metamorphosis," an open house and art auction at the Temple of Visions art
gallery, and grossed more than $24,000 in sales!
The talks on Saturday and Sunday were recorded by our
friends at Conference Recording,
and are available for purchase from
them. We apologize to anyone who went online to watch live streaming of the
conference, and were unable to see a talk due to technical difficulties.
On Saturday, Dec. 11, the Catalysts conference kicked off
with a keynote address by MAPS Executive Director Rick Doblin, Ph.D. The day’s
programming included presentations by MAPS Clinical Research Associate Berra
Yazar-Klosinski, Ph.D.; MAPS research intern Dana Blu Cohen, Psy.D. candidate… Heffter
Research Institute psilocybin researchers Charles Grob, M.D., and Alicia
Danforth; Larry Hagman, star of "I Dream of Jeannie" and "Dallas;" author Martin
Ball; psychiatrist Julie Holland, M.D.; MAPS ibogaine investigator Thomas
Kingsley Brown, Ph.D.; Erowid senior editor Jon Hanna; Tania Manning, Archivist
for the Alexander Shulgin Research Institute; and Stanislav Grof, M.D., Ph.D., co-founder
of transpersonal psychology and Holotropic Breathwork.
The programming on Sunday, Dec. 12, included author James
Fadiman, Ph.D.; Stanislav Grof; artists Michael Divine and Amanda Sage; author
and activist Charles Shaw; and Lorenzo Hagerty, host of "Psychedelic Salon."
According to Brian Wallace, MAPS Director of Field
Development and the organizer of Catalysts, "The entire weekend was phenomenal.
We were able to bring hundreds of thoughtful, progressive, caring people
together to learn from one another, and we raised a substantial amount of money
for MAPS research and educational projects. I’d personally like to thank all of
the volunteers, presenters, and attendees who came together to make the event a
huge success."
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