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MAPS Bulletin Spring 2014: Special Edition: Psychedelics and Education
 
Media > Newsletter: April 13, 2007



MAPS Members, Supporters & Friends,

With all the good news about the resurgence of psychedelic research and changing public attitudes about psychedelics and medical marijuana, it is sometimes easy to forget that there are people who are desperate to discredit us. One of the more amusing insults hurled at MAPS appears in the DEA's recent response to the favorable recommendation we received from the DEA Administrative Law Judge last month. They insinuate that MAPS is a criminal "front" and that MAPS President Rick Doblin is analogous to Pablo Escobar!

If we had even a smidgeon of the international drug cartel's budget, we'd be able to fund all of our research without asking for your help. ; -- )

Later this month, we'll be initiating a Congressional sign-on letter campaign to pressure the DEA through Congress to accept the DEA Administrative Law Judge's favorable recommendation that it is in the public interest for DEA to issue a license for Prof. Lyle Craker's MAPS-sponsored marijuana production facility. We'll be sending out a special announcement soon with details about contacting your elected representatives.

Meanwhile, the state of psychedelic research is at an historic crossroads.

MAPS-sponsored psychedelic therapy research is flourishing around the globe. MAPS now has four FDA Phase 2 clinical research trials underway (in the US, Switzerland and Israel) evaluating psychedelic-assisted psychotherapy and four more in the protocol design and approval process. If the preliminary data continues to be promising, the dream of creating legal contexts for the therapeutic use of psychedelics for treating some of the most intractable mental health problems facing society is seeming more and more like a question of "when," not "if."

Now that our applications to conduct psychedelic research are finally being granted, the biggest thing limiting progress is no longer the government. It is our ability to fund the research and the work that goes into it.

We are roughly $140,000 short on commitments to fund MAPS' operational expenses for FY 2006-07. MAPS operational expenses fund our efforts to establish an independent supply of research-grade marijuana and conduct marijuana vaporizer research, harm reduction education, media and other educational materials like the MAPS Web site, email updates, Bulletin, and general operations.

The future is in our hands. Throw your weight behind MAPS' work today at the MAPS Online Store.

1. Promising Comments from Ethics Committee for Historic Swiss LSD Study

2. Subject Recruitment Underway in Israel for MDMA/PTSD Study

3. Special Thanks to the Robert T. Keeler Foundation

4. Iboga Therapy House Recruiting Patients for MAPS-Sponsored Study

5. MAPS/Heffter-Sponsored Ketamine Research Published

6. Rick Doblin = Pablo Escobar? DEA Files "Exceptions," Congress About to Weigh In on MAPS' Behalf

7. Signed Copies of Acclaimed Book Marihuana, The Forbidden Medicine Available from MAPS

8. MAPS Educational Video Now Available to Public on YouTube

9. Looking for Dedicated Volunteer to Manage Sanctuary Application and Scheduling Process

10. Just Confirmed: Visionary Artists Robert Venosa and Martina Hoffmann Performance Painting at MAPS Fundraiser 4/28 in San Francisco

11. Thresholds of Consciousness: Annual Meeting of Anthropologists Interested in Consciousness

12. MAPS Gets Sirius

13. Trouble Reading Last Week's MAPS in the Media Email Update?

**********For MAPS memberships, special donations, merchandise, books, artwork, and more, visit the MAPS Online Store.**********

1. One Step Closer to Approval of First LSD Psychotherapy Study in 35 Years

Dr. Peter Gasser initially submitted his protocol to the Swiss Ethics Committee on January 10, 2007, for a study to evaluate the safety and efficacy of LSD-assisted psychotherapy for subjects with end-of-life anxiety secondary to life-threatening illness. On March 19, we learned that Dr. Gasser had a promising discussion with the Chair of the Ethics Committee (Swiss IRB equivalent) about the design of his proposed MAPS-sponsored pilot study. Dr. Gasser was informed that the Ethics Committee had several concerns about the protocol design that would be expressed to him in writing before the end of April. He was also informed that these concerns were about how the study should be conducted, not about whether the study should be conducted. We'll soon have a clearer idea as to how the Ethics Committee thinks the protocol should be modified.

Obtaining Ethics Committee approval is the first of three formal regulatory reviews for the protocol to obtain full government approval. After Ethics Committee approval, the protocol will be submitted for review to SwissMedic (the Swiss equivalent of FDA). After SwissMedic approves the study, Dr. Gasser will submit an application to the BAG (Swiss DEA) for a license to possess and administer the LSD to be used in the study. We hope to begin the study before the end of the summer. When fully approved, this will become the first government-approved study investigating LSD's therapeutic benefits in over 35 years. Click here for more information and background on Dr. Gasser's proposed LSD study.

The study is budgeted at $180,000 - MAPS has already raised $60,000 so far, but we need your help to raise the final $120,000 so this historic study can move forward.

One way we are raising funds for this study is by selling a signed, limited edition hardcover edition of Albert Hofmann's autobiographical book, LSD: My Problem Child. 100% of the proceeds from sales will be restricted to MAPS-sponsored LSD and psilocybin research. Sixty out of 100 copies have been sold; #s 61-80 are available at $400, and #s 81-100 are available at $500.

2. Subject Recruitment Underway in Israel for MDMA/PTSD Study

The MAPS-sponsored study in Israel evaluating MDMA-assisted psychotherapy for subjects with war-and terrorism-related posttraumatic stress disorder (PTSD) has full government approval and is now in the subject recruitment stage. The study will be conducted at Beer Yakhov Mental Health Center, near Tel Aviv, under the direction of Principal Investigator Moshe Kotler, M.D., former chief psychiatrist of the Israeli Defense Forces. The therapeutic team has been expanded and will now include Sergio Marchevsky, M.D., in addition to Rakefet Rodrigez, M.D., and Rael Strous, M.D. The first two potential subjects were scheduled to be screened on April 11 and 12.

MAPS has sponsored three international scientific conferences in Israel on MDMA research to facilitate the protocol approval process. MAPS has already donated $45,000 to this study, with another $50,000 needed to complete it. In addition, MAPS' clinical research monitoring team will monitor the study to pharmaceutical company standards, at MAPS' expense.

In December 2006, this study and the parallel MAPS-sponsored MDMA/PTSD study underway in Switzerland were submitted to FDA for review and approval. Last month, MAPS submitted chemistry information to FDA about the MDMA that is being used in these studies. Although these protocols do not need to be approved by the US FDA to be conducted in their home countries (they have already been approved by their home country's regulatory agency equivalent to FDA and by local ethics committees), FDA review and approval enables us to submit to FDA the data from these two studies as part of MAPS' Investigational New Drug (IND) application for MDMA-assisted psychotherapy in the treatment of PTSD. Once accepted, the data from these studies will be used to help negotiate with FDA regarding the design of larger Phase 3 studies intended to gather data to determine whether or not MDMA meets the requirements necessary to be approved as a legal prescription medicine.

3. Special Thanks to the Robert T. Keeler Foundation

The Robert T. Keeler Foundation has awarded MAPS a $25,000 grant to support Dr. Michael and Annie Mithoefer's MDMA/PTSD study. This is the third annual grant of $25,000 that has been donated by the Robert T. Keeler Foundation for this study. MAPS is grateful to the Keeler Foundation for their ongoing support of our work.

4. Iboga Therapy House Recruiting for MAPS-Sponsored Study

The Iboga Therapy House is now enrolling clients in MAPS IRB-approved long-term observational case study. The study will examine changes in substance use in 20 consecutive individuals undergoing ibogaine-based addiction treatment for opiate dependence at the Iboga Therapy House near Vancouver, Canada.

People with substance abuse problems have found that psychedelic doses of iboga, an African root used for centuries, can significantly reduce symptoms of opiate withdrawal and eliminate substance-related cravings for an extended period of time. The US is one of only a few countries in the world where ibogaine is scheduled, but in Canada, Mexico, and other countries, there are clinics where ibogaine is legally administered to individuals. Yet, there is still no data from prospective research published in a peer-reviewed journal reporting any long-term follow-up data that could be used to evaluate ibogaine's efficacy in reducing addiction-related harm.

This study is intended to gather information to evaluate whether ibogaine-assisted therapy helps people who are dependent on opiates to stop using opiates, use less, or practice moderated use after the therapy. For one year after therapy we will be collecting data from participants in the study, enabling us to examine whether ibogaine-assisted therapy facilitates positive changes or improvements in quality of life that result in decreased harms associated with chronic or mismanaged opiate use.

5. MAPS/Heffter-Sponsored Ketamine Research Published

Evgeny M. Krupitsky, M.D., Ph.D., Chief of the Research Laboratory at St. Petersburg Regional Center of Addictions and Psychopharmacology, published "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 also published an article in the March issue of the American Journal of Psychiatry about alcohol craving (Am J Psychiatry 164:3, March 2007, 519-523). 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.

6. Rick Doblin = Pablo Escobar? DEA Files "Exceptions," Congress About to Weigh In on MAPS' Behalf

On March 26, DEA Attorney Charles Trant submitted DEA's "exceptions" to the February 12, 2007 Opinion and Recommended Ruling of DEA Administrative Law Judge (ALJ) Mary Ellen Bittner. DEA objected to ALJ Bittner's recommendation that it would be in the public interest for DEA to grant Prof. Lyle Craker a Schedule I license for a MAPS-sponsored medical marijuana production facility. Lacking much in the way of a good argument, Trant focused on criticizing MAPS President Rick Doblin, at one point loosely comparing him to Pablo Escobar. A detailed rebuttal is being prepared by Prof. Craker's legal team, which will be submitted to the ALJ's office by May 4, 2007. A few weeks after that, ALJ Bittner will forward her recommendation, along with the dueling legal documents, to DEA for a formal ruling. Unfortunately, DEA has no time limit for when it must issue its final ruling.

A coalition of medical marijuana and drug policy reform groups such as Americans for Safe Access (ASA), Drug Policy Alliance (DPA), Marijuana Policy Project (MPP) and the National Organization for the Reform of Marijuana Laws (NORML) will attempt to generate pressure on DEA from Congress, seeking Representatives and Senators willing to sign a letter to DEA Administrator Tandy, urging her to accept ALJ Bittner's recommendation. MAPS has hired Lauren Anderson Payne and Michael D. Ostrolenk, co-founder and National Director of the Liberty Coalition, to work on the ground in Washington, D.C., for the next several months. As we reported last month, MAPS has received a $45,000 grant from MPP for lobbying efforts related to the DEA lawsuit.

MAPS staffers Rick Doblin and Jag Davies co-authored an extensive article about Prof. Craker's case, MAPS' quest to put marijuana through FDA trials, and the problems with NIDA's monopoly in the current issue of the Bulletin of Cannabis Reform

7. Now Available from MAPS: Marihuana, The Forbidden Medicine Signed by Co-Author Lester Grinspoon, M.D.

In honor of our recent legal victory over the DEA, we're adding the acclaimed book Marihuana, The Forbidden Medicine to the MAPS Online Store. The first 20 copies available are signed by co-author Lester Grinspoon, M.D. This 320-page revised and expanded edition is 60% longer than the original 1993 edition. One of the chapters from the book, "Measuring the Risks," was submitted as rebuttal evidence during Prof. Craker's recent DEA Administrative Law Judge hearing when one of the DEA's witnesses made inaccurate claims about the addictive nature of marijuana and its link to mental illness.

The book is co-authored by http://www.rxmarihuana.com" target="_blank">Lester Grinspoon, M.D., an Associate Professor of Psychiatry (Emeritus) at Harvard Medical School, and James Bakalar, J.D., who is a Lecturer in Law in the Department of Psychiatry at Harvard Medical School.

8. MAPS Educational Video Now Available to Public on YouTube

MAPS' educational video Working With Difficult Psychedelic Experiences is now available for viewing to the public on YouTube. A high quality version of the video is also available for viewing and download on the MAPS Web site.

This 20-minute educational video was created by MAPS to teach young adults when and how to help a friend, peer, or loved one make the most out of a difficult experience with psychedelics. Narrated by Donna Dryer, M.D., the video explains how to minimize psychological risks and use difficult experiences as an opportunity for possible beneficial and/or therapeutic outcomes. The video elaborates on the four basic principles of psychedelic therapy:

1) Create a safe space
2) Sitting, not guiding
3) Talk through, don't talk down
4) "Difficult" is not necessarily "bad."

MAPS will be working later this year to produce a modified version of the video for use in harm reduction educational contexts.

9. Looking for Dedicated Volunteer to Manage Sanctuary Application and Scheduling Process

Have you worked in Sanctuary before? Can you commit about 5-10 hours a week for 4 months? We're looking for a dedicated Sanctuary volunteer to help us with the application and scheduling process for our psychedelic emergency services at Burning Man. The work can be done from home over email. Requirements: 1) at least one year of prior experience working with us in Sanctuary and are in good standing, 2) have regular access to email and phone, 3) plan to attend Burning Man this year and volunteer in Sanctuary.

Contact valerie at http://www.maps.org if youre interested. Compensation is a gift of one Burning Man ticket.

10. Just Confirmed: Visionary Artists Robert Venosa and Martina Hoffmann Performance Painting at MAPS Fundraiser 4/28 in San Francisco

Visionary artists Robert Venosa and Martina Hoffmann have just confirmed their participation in the MAPS fundraiser on April 28 in San Francisco. A screening of the film Entheogen has also been added to the schedule. Other special guests include Stan and Christina Grof, Ralph Metzner, Matt Baggott, Erik Davis, Angel Raich, ASA Executive Director Steph Scherer, Dale Gieringer (CA NORML), Allen Hopper and Anjuli Verma (ACLU Drug Law Reform Project).

We have several $100-$300 tickets remaining for "The Final Frontier." We also have a limited number of $400 sponsorship tickets available that enable you to purchase the ticket of one of our special guests and come early to a cocktail reception with them and MAPS staff. Click here for more information and to purchase tickets.

11. Thresholds of Consciousness: Annual Meeting of Anthropologists Interested in Consciousness

The Society for the Anthropology of Consciousness held its annual spring meeting last week in San Diego, with the theme "Thresholds of Consciousness." The programming contained several lectures on psychedelic-related topics including a presentation by Marlene Dobkin de Rios on "Ayahuasca and Drug Tourism" and a panel on Ecopsychology that included MAPS Director of Operations Valerie Mojeiko.

12. MAPS Gets Sirius

I (MAPS Director of Communications Jag Davies) gave an interview on the RU Sirius show, transcribed and published in print as "Prescription Ecstasy and Other Pipe Dreams." The interview is about 20 minutes long and covers a broad range of topics related to MAPS' research.

13. Trouble Reading Last Week's MAPS in the Media Email Update?

Our sincerest apologies for the glitches in last week's email -- we are working to ensure it doesn't happen again. If you had trouble reading last week's MAPS in Media email update, it is available here.

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

Working together, we can create legal contexts for the beneficial uses of psychedelics and marijuana. Now that MAPS' 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 couldn't do our work without you. If you are not a MAPS member, please consider joining us.

Best Wishes,
Jag Davies, MAPS Director of Communications

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