We are pleased to report that we submitted our newest protocol to the FDA. The proposed study will investigate if marijuana is suitable for managing symptoms of posttraumatic stress disorder (PTSD). Meanwhile, the Office of Public Health and Science at the Department of Health and Human Services (HHS) is evaluating the protocol for scientific merit before they decide whether they will give us permission to purchase marijuana from the National Institute on Drug Abuse (NIDA), the monopoly provider of marijuana for research. NIDA has already informed us that it does not have the potencies and varieties of marijuana that we require for this investigation. Specifically, it has neither marijuana containing cannabidiol (CBD), a naturally occurring component of marijuana that has been reported to reduce anxiety, nor marijuana containing 12% THC. We are now waiting to learn whether NIDA will produce this marijuana for our study. NIDA’s lack of marijuana with CBD or high amounts of THC highlights the inadequacy of their supply and shows why the NIDA monopoly should end. There are more details about our protocol submission below.
We are coming to the end of our 2010 membership drive. Our goal is to reach 5,750 donors before the end of the year. As of today we are at 5,377. If you aren’t yet a member, now is a great time to join and be part of the rising tide of psychedelic and marijuana research. If you are already a member, you can give a gift membership to one of your friends this holiday season. Your donation of $10 or more will be matched by an additional $25 for MAPS from a generous donor, and will allow you or your friend to receive the MAPS Bulletin.
Best wishes for a festive holiday season,
Randolph Hencken, M.A.
Director of Communication and Marketing, MAPS
What’s happening this month at MAPS:
- MDMA/PTSD News:
- Peter Lewis pledges $250,000 to Veterans Study
- First Two Subjects in U.S. Veterans Study Scheduled for MDMA Session in January
- Database for U.S. MDMA/PTSD Long-Term Follow-Up Study Finalized
- Amendment to Canadian MDMA Study Submitted to IRB
- Annual MDMA Report Submitted to the FDA
- Marijuana for PTSD Protocol Submitted to FDA and NIDA
- Twelfth and Final Subject to be Screened for Swiss LSD Study
- Fifth Subject Enrolled in Ibogaine Study/Protocol Amended
- Beckley Psilocybin/Brain Imaging Study Progresses
- MAPS Year-End Bulletin Online and in Mailboxes
- Videos from Psychedelic Science in the 21st Century are Online; CME/CE Credit Available
- “The Entheogenic Evolution”
- Randolph Hencken Interview on “Present!” with Mel Van Dusen
- Videos from the 2010 Horizons Conference Now Online
- “Hallucinogens as Medicines” Featured in Scientific American
- MAPS Seeks Participants for Online Survey to Assess Cardiovascular Risks of Ecstasy in People with and without Anxiety-related Disorders
Winter Raffle Contest: Ski House Rental Kirkwood, California (Lake Tahoe area)
- Catalysts Conference a Huge Success
Other Research News:
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!
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.
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.
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.
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.
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 requeste
d 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.
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.
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.
On Nov. 24, 2010, study investigator Robin Carhart-Harris, Ph.D., updated MAPS on the progress of a Beckley Founda
tion-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 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
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.
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).
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: 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”
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.
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 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: th
e 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
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.”
|Share||Unsubscribe||MAPS Website||Join MAPS|