MAPS Email Newsletter: DEA Approves License for New MDMA Study; Medical Marijuana Research Still Blocked

 

 

 

 

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MAPS Email Newsletter: DEA Approves License for New MDMA Study; Medical Marijuana Research Still Blocked February 6, 2014 Dear Thomas, Watch the Principles of MDMA-Assisted Psychotherapy Workshop from Psychedelic Science 2013. Whether you've been a supporter since our founding in 1986 or just learned about our work, the psychedelic and medical marijuana research community is always growing, so you'll always have a lot to learn. The February 2014 edition of the Multidisciplinary Association for Psychedelic Studies (MAPS) Email Newsletter is no exception. We've cleared the final regulatory hurdle for our upcoming study of MDMA-assisted therapy for autistic adults with social anxiety. On January 13, we received the Schedule I pharmacy license from the U.S. Drug Enforcement Administration, and the official study initiation is happening this weekend at the Harbor-UCLA Medical Center/Los Angeles Biomedical Research Institute. It's been three and a half months since we resubmitted the protocol for our study of marijuana for symptoms of PTSD in U.S. veterans to the Public Health Service, and we're still waiting for their response. The protocol has all other required approvals, and the PHS is standing in the way. "We remain eager to engage in a dialogue with the PHS reviewers," MAPS Founder Rick Doblin reminded the agency. "This delay is itself an obstruction of medical marijuana drug development research." There's much more in this edition, including: More subjects are enrolled in our ongoing U.S. studies of MDMA-assisted psychotherapy for posttraumatic stress disorder (PTSD) in Colorado and South Carolina. The Chicago Tribune publishes an editorial calling on President Obama to end the obstructive Public Health Service review process for medical marijuana research. The MDMA-Assisted Psychotherapy for PTSD workshop with Dr. Michael and Annie Mithoefer from Psychedelic Science 2013 is now available online. A supporter explains why he donates bitcoins to MAPS. Since our last newsletter, over 4,000 people have joined us on Facebook. I also encourage you to stay connected to psychedelic and medical marijuana research on Twitter, YouTube, Google+, and reddit. Please enjoy this newsletter and share it with anyone who may want to learn about our mission and support our work.   For balance and growth, Brad Burge MAPS Director of Communications and Marketing MDMA-Assisted Therapy for Social Anxiety in Autistic Adults 1.     DEA Approves Schedule I License for Study Pharmacy; Initiation Scheduled Treating PTSD with MDMA-Assisted Psychotherapy 2.     Boulder: Fifth Subject Enrolled; MDMA Encapsulated for New Dose Group 3.     U.S. Veterans: 15th Subject Enrolled; Brain Imaging and Heart Rate Sub-Study Starts 4.     Israel: Site Monitoring Visit Completed Medical Marijuana Research 5.     Over Three Months Later, Still Waiting for Public Health Service Response Support MAPS 6.     The New Year Brings New Gifts 7.     This Is Your Brain on Bitcoin Media 8.     International Business Times, Medline Plus, The Chicago Tribune, and more... MAPS Store 9.     Manifesting Minds edited by Rick Doblin and Brad Burge (SALE: 25% OFF) 10.   Actual Contact Artwork by Jason Tucker Events 11.   Aya Awakenings Film Screening and Q&A: February 8, Santa Cruz, CA 12.   Global Transpersonal Symposium: Unity within Diversity: February 8, Palo Alto, CA 13.   Cannabinoid Medical Science and Political Ecology: March 4, New York, NY 14.   Pathway to Reform: March 20, Auckland, New Zealand More News 15.   Johns Hopkins Survey: Psychedelics and Smoking Cessation 16.   Ayahuasca Dialogues Webinar Now Online   Dr. Richard Rockefeller speaks with Dr. Larry Brilliant about healing trauma with MDMA-assisted psychotherapy at the Commonwealth Club of California. Clearing the final hurdle: Dr. Charles Grob receives the DEA Schedule I pharmacy license for our upcoming study MDMA-ASSISTED THERAPY FOR SOCIAL ANXIETY IN AUTISTIC ADULTS 1. DEA Approves Schedule I License for Study Pharmacy; Initiation Scheduled On January 13, 2014, Principal Investigator Charles Grob, M.D., received from the U.S. Drug Enforcement Administration the Schedule I pharmacy license for our new study of MDMA-assisted therapy for social anxiety in autistic adults. The license was issued on December 27, 2013. With this final regulatory permission in hand, Dr. Grob and co-investigator Alicia Danforth, Ph.D., are now creating the initial waiting list. The official study initiation is scheduled to take place from February 7-10, and the MDMA for the study will be encapsulated in mid-February. Learn more... $311,000 estimated study cost • $1,000 raised + $15,000 donated by the Betsy Gordon Foundation • $295,000 still needed TREATING PTSD WITH MDMA-ASSISTED PSYCHOTHERAPY 2. Boulder: Fifth Subject Enrolled; MDMA Encapsulated for New Dose Group On January 22, the fifth subject was enrolled in our ongoing study of MDMA-assisted psychotherapy for PTSD taking place in Boulder, Colorado. (Note: We are now subtracting dropouts from the total number of subjects treated to more accurately reflect study progress.) The fourth subject received their second experimental treatment on January 17. The second subject, who dropped out after one treatment session due to scheduling difficulties despite feeling improved, has agreed to return for her one-year follow-up. On January 21, the MDMA was encapsulated for the new 100 mg dose group and for Stage 2 of the study protocol. Led by Principal Investigator Marcela Ot'alora, this study will treat 17 subjects with chronic, treatment-resistant PTSD resulting from sexual assault, military service, violent crime, or other causes. As of January 31, we have received 214 inquiries for participation in this study. Learn more... $592,000 estimated study cost • $193,000 raised • $399,000 still needed Watch the Principles of MDMA-Assisted Psychotherapy for Posttraumatic Stress Disorder Workshop with Michael Mithoefer, MD, and Annie Mithoefer, BSN, from Psychedelic Science 2013. 100+ more videos available at psychedelicscience.org. 3. U.S. Veterans: 15th Subject Enrolled; Brain Imaging and Heart Rate Sub-Study Starts On January 29, the 15th subject was enrolled in our ongoing study in 24 U.S. veterans, fire fighters, and police officers with chronic, treatment-resistant PTSD. This will also be the first subject enrolled in our new brain imaging and heart rate sub-study, which will use heart rate variability (HRV) and functional magnetic resonance imaging (fMRI) to measure the physiological effects of MDMA-assisted psychotherapy and explore correlations between those effects and clinical outcomes. Nine subjects have now completed the study following their one-year follow-up. The regularly scheduled site monitoring visit was completed from January 17-20. As of January 31, the site had received 496 participation inquiries. Learn more.... $1,376,000 estimated study cost • $1,027,000 raised • $349,000 still needed Help us make psychedelics and marijuana into prescription medicines—donate today! 4. Israel: Site Monitoring Visit Completed On January 7, 2014, MAPS Clinical Research Associate Mimi Peleg completed the regularly scheduled site monitoring visit for our ongoing Israeli study of MDMA-assisted psychotherapy for PTSD. The study is taking place at Beer Ya'akov Mental Hospital in Israel, and is led by Principal Investigator Moshe Kotler, M.D. Learn more... $492,000 estimated study cost • $39,000 raised • $453,000 still needed Learn more about MDMA-assisted psychotherapy on or at mdmaptsd.org. MEDICAL MARIJUANA RESEARCH 5. Over Three Months Later, Still Waiting for Public Health Service Response On January 24, 2013, MAPS Executive Director Rick Doblin, Ph.D., sent an email to the U.S. Department of Health and Human Services reminding the agency that three full months had passed since we resubmitted the protocol for our Food and Drug Administration (FDA) and Institutional Review Board (IRB)-approved study of marijuana for symptoms of PTSD in 50 U.S. veterans with chronic, treatment-resistant PTSD. "We remain eager to engage in a dialogue with the PHS reviewers regarding methodological issues," Doblin writes "This delay is itself an obstruction of medical marijuana drug development research." Read Rick Doblin's email to HHS | Learn more... $10,000 needed for protocol development and approval • $10,000 raised The Winter 2013 MAPS Bulletin includes the MAPS Sustainability Plan, in-depth research updates, and much more. SUPPORT MAPS 6. The New Year Brings New Gifts In January 2014, 210 people gave $39,382 to support MAPS' research and education programs. Many thanks to Ian Brown for his gift of $10,000, and to James Evens and Chris Rico who each gave 10 bitcoins worth over $8,000. We are very grateful to Board Member David Bronner, who gave $2,500 to support Richard Rockefeller's and Larry Brilliant's talk at the Commonwealth Club in San Francisco; to Neil Boyer, who gave $850 in general support, and to an anonymous donor for 1 bitcoin worth $803. We also processed $50,085 for fiscally sponsored projects that share our mission and vision, including the Ayahuasca Association, Bluelight.org, and the Ethnobotanical Stewardship Council. A special thank you goes to Max and Elena Talan for giving $450 each month through our Sustainers Program, and to the other 123 people who maintain their support by giving between $5 and $100 a month. These consistent monthly gifts give us a reliable income stream and make it easier to plan for the future. To sign up for our Sustainers Program, visit maps.org/donate and choose the "Monthly" option. Thank you to each and every donor for helping realize the potential of psychedelics and marijuana for healing and spiritual growth. 7. This Is Your Brain on Bitcoin Since we began accepting bitcoins (BTC) on December 3, 2013, 65 donors have donated a total of 41.12253776 BTC, which we immediately exchanged for $30,220.77 USD. On January 10, an anonymous supporter offered to match the next 10 BTC donated to MAPS; within a week 22 donors responded and met the entire match. "Bitcoin is revolutionizing digital payments, and it will do the same for online philanthropy. The ability to quickly, securely transfer value without the fees associated with traditional banking can radically change the way donations are collected. In January, I decided to donate 10 BTC to MAPS because of their important work in bringing new treatments to those who cannot be cared for through currently available medications." —James Evans, bitcoin donor Check out the January 28 Motherboard article about supporting psychedelic and medical marijuana research with bitcoins: "This Is Your Brain on Bitcoin." Learn more.... MEDIA 8. International Business Times, Medline Plus, The Chicago Tribune, and more... The Chicago Tribune: Obama Retreats from the Drug War | view Steve Chapman | January 23, 2014 Motherboard: This Is Your Brain on Bitcoin | view Steven Melendez | January 28, 2014 The Daily Beast: Longtime Sufferers of Cluster Headaches Find Relief in Psychedelics | view Valerie Vande Panne | February 5, 2014 International Business Times: MDMA a Potential Treatment for Anxiety and PTSD | view Hannah Osborne | January 17, 2014 Medline Plus: Could Ecstasy Help People With Anxiety, PTSD? | view Robert Preidt | January 17, 2014 Psychotherapy Networker: Ecstasy in the Consulting Room | view Kathleen Smith | January 28, 2014 Good Men Project: What Your Doctor Never Taught You About PTSD | view Jed Diamond, Ph.D. | January 27, 2014 Motherboard: In a World of Opiate Addicts, the Internet Plays Doctor and Therapist | view Steven Melendez | January 15, 2014 Examiner.com: Brad Burge on "Manifesting Minds" | view Jeffery Pritchett | January 27, 2014 The Libertarian: Ibogaine Still Illegal in US, Despite Medical Potential | view Brendan Ferreri-Hanberry | January 23, 2014 Explore MAPS in the Media for more psychedelic and medical marijuana research news. MAPS STORE 9. Manifesting Minds edited by Rick Doblin and Brad Burge Manifesting Minds: A Review of Psychedelics in Science, Medicine, Sex, and Spirituality edited by Rick Doblin, PhD, and Brad Burge 304 pages | Evolver Editions | Released January 7, 2014 "What an excellent book to courageously transmit psychedelic research into tomorrow." —Ben Sessa, MD, psychiatrist and author of The Psychedelic Renaissance Now 25% off the retail price! $19.95 $14.95 | Now available 10. Actual Contact Artwork by Jason Tucker Actual Contact Artwork series by Jason Tucker These signed, matted, limited edition, 12" x 9" art prints were donated to MAPS by artist Jason Tucker. All proceeds directly support our research and education projects. "My drawings are never pre-planned. I focus only on the line, not knowing what the entire image will look like when finished. The experience is one of total control, but with no control at all." —Jason Tucker $60 | Prints Now Available All purchases from the MAPS Store support our research and education projects. EVENTS 11. Aya: Awakenings Film Screening and Q&A: February 8, Santa Cruz, CA Join Aya: Awakenings director Rak Razam and MAPS on Saturday, February 8, from 7:00 to 10:00 PM at the Pacific Cultural Center in Santa Cruz, CA, for a screening and Q&A. Aya: Awakenings is a narrative documentary into the world and visions of ayahuasca shamanism. Buy tickets now | RSVP on Facebook. 12. Global Transpersonal Symposium: Unity within Diversity: February 8, Palo Alto, CA Sofia University and the Association for Transpersonal Psychology (ATP) will co-host a one day Global Transpersonal Symposium on Saturday, February 8. The symposium will bring together three international transpersonal associations—the Association for Transpersonal Psychology (ATP), the European Transpersonal Association (EUROTAS), and the International Transpersonal Association (ITA) around the theme "Unity Within Diversity." Includes keynote speeches by Stanislav Grof, MD, PhD, and James Fadiman, PhD. Learn more... 13. Cannabinoid Medical Science and Political Ecology: March 4, New York, NY Sunil Kumar Aggarwal, MD, PhD, will give a free presentation on March 4 at the New School for Social Research on chronic pain management and health-related quality of life in medical cannabis patients. Register... 14. Pathway to Reform: March 20, Auckland, New Zealand Pathway to Reform is a unique opportunity to hear how New Zealand became the first country in the world to regulate the "legal highs" industry and where it is going from here. International speakers include Amanda Feilding of the Beckley Foundation, Ethan Nadelmann of the Drug Policy Alliance, and Rick Doblin of MAPS. Buy tickets... View our Event Calendar for more. Can ayahuasca help treat addiction? MORE NEWS 15. Johns Hopkins Survey: Psychedelics and Smoking Cessation Researchers from the Johns Hopkins University School of Medicine are currently recruiting individuals who have quit smoking cigarettes or reduced their smoking (even temporarily) after an experience with a psychedelic, for participation in an online survey. Learn more... 16. Ayahuasca Dialogues Webinar Now Online The Ethnobotanical Stewardship Council's inaugural Ayahuasca Dialogues Webinar provides an overview of the ESC's international work to build consensus around the sustainability and safe use of ayahuasca. The webinar includes a brief introduction from the ESC's Chief Advisor, followed by comments from Ben De Loenen, Rick Doblin, and Dennis McKenna, and an audience Q&A. Watch now... Learn about our current Funding Priorities. MAPS 1215 Mission Street, Santa Cruz, CA 95060-9989 USA tel: +1 831 429 MDMA (6362) fax: +1 831 429 6370 SHARE UNSUBSCRIBE ABOUT MAPS DONATE