Brad Burge, MAPS <[email protected]> To
Today at 22:00
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[TD="class: yiv4531401473mobile, width: 600, align: center"] August 12, 2016
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[TD="class: yiv4531401473mobile yiv4531401473title-container, width: 500"] [h=1]DEA Eliminates Federal Monopoly on Marijuana for Research[/h] Keep festival attendees safe this summer—the Zendo Project needs your help
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[TD="class: yiv4531401473mobile, width: 600"] Dear ,
For the past 30 years, the Multidisciplinary Association for Psychedelic Studies (MAPS) and our supporters worldwide have created new opportunities for careful research and honest education about the risks and beneficial uses of psychedelics and marijuana. This month, I'm excited to share with you the latest news from this fast-growing field.
On August 11, 2016, the Drug Enforcement Administration (DEA) announced their intention to grant licenses to additional marijuana growers for research, thereby ending the 48-year monopoly on marijuana legal for research. This decision marks a decisive turning point our partnership with Prof. Lyle Craker of the University of Massachusetts-Amherst, begun almost 17 years ago in 1999, to end the National Institute on Drug Abuse (NIDA) monopoly on the supply of marijuana for research. Prof. Craker will file his new application to DEA to grow marijuana with the expectation that DEA will finally just say yes.
The NIDA monopoly fundamentally blocked marijuana from ever becoming an FDA-approved prescription medicine because NIDA marijuana can only be used for research and cannot be sold as a prescription medicine. This made NIDA marijuana unacceptable to FDA for use in future Phase 3 studies which must be conducted with the exact same drug that would be marketed, if the research proves safety and efficacy. In addition, NIDA has been unable to provide the exact strain we requested for MAPS' upcoming Phase 2 clinical trial of marijuana for posttraumatic stress disorder (PTSD) in 76 U.S. veterans, resulting in the study proceeding with lower potency marijuana than we requested.
"There is no government monopoly on the production of any other Schedule I drug, such as MDMA or LSD—only the cannabis plant. Licensing non-government cannabis producers, and thereby creating a path to FDA approval, will potentially facilitate the removal of marijuana from Schedule I, and can ultimately allow patients to receive insurance coverage for medical marijuana," said Rick Doblin, Ph.D., MAPS Founder and Executive Director.
Meanwhile, our Phase 2 clinical trials of MDMA-assisted psychotherapy for PTSD are nearing completion. On July 30, the final participant completed their one-year follow-up interview in our largest Phase 2 study of of MDMA-assisted psychotherapy for 24 U.S. veterans, firefighters, and police officers with PTSD. This fall, will meet with the FDA in the context of an End of Phase 2 meeting, to come to an agreement on the design of our upcoming Phase 3 trials, the final stage of research required to make MDMA-assisted psychotherapy a legal prescription treatment for PTSD.
In the August 2016 edition of the MAPS Email Newsletter, you'll also find:
PLUS: Get ready for a special announcement about Psychedelic Science 2017, taking place from April 19-24, 2017, in Oakland, Calif. I hope you'll join us for this historic five-day gathering of the global psychedelic research community — watch this video for an inspiring look at what we'll create together.
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Upwards together,
Brad Burge
MAPS Director of Communications and Marketing
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[TD="class: yiv4531401473mobile, width: 600"] [h=1]Contents[/h]
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[TD="class: yiv4531401473mobile, width: 600"] [h=2]Medical Marijuana[/h] [/TD]
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[TD="class: yiv4531401473mobile, width: 600"] [h=2]Treating PTSD with MDMA-Assisted Psychotherapy[/h] [/TD]
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[TD="class: yiv4531401473mobile, width: 600"] [h=2]More MDMA Research[/h] [/TD]
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[TD="class: yiv4531401473mobile, width: 600"] [h=2]Ayahuasca Research[/h] [/TD]
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[TD="class: yiv4531401473mobile, width: 600"] [h=2]Psychedelic Harm Reduction[/h] [/TD]
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[TD="class: yiv4531401473mobile, width: 600"] [h=2]Support MAPS[/h] [/TD]
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[TD="class: yiv4531401473mobile, width: 600"] [h=2]Media[/h] [/TD]
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[TD="class: yiv4531401473mobile, width: 600"] [h=2]MAPS Store[/h] [/TD]
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[TD="class: yiv4531401473mobile, width: 600"] [h=2]Events[/h] [/TD]
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[TD="class: yiv4531401473mobile, width: 600"] [h=2]More News[/h] [/TD]
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Today at 22:00
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[TD="class: yiv4531401473mobile, width: 600, align: center"] August 12, 2016
maps.org
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[TD="class: yiv4531401473mobile yiv4531401473title-container, width: 500"] [h=1]DEA Eliminates Federal Monopoly on Marijuana for Research[/h] Keep festival attendees safe this summer—the Zendo Project needs your help
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[TD="class: yiv4531401473mobile, width: 600"] Dear ,
For the past 30 years, the Multidisciplinary Association for Psychedelic Studies (MAPS) and our supporters worldwide have created new opportunities for careful research and honest education about the risks and beneficial uses of psychedelics and marijuana. This month, I'm excited to share with you the latest news from this fast-growing field.
On August 11, 2016, the Drug Enforcement Administration (DEA) announced their intention to grant licenses to additional marijuana growers for research, thereby ending the 48-year monopoly on marijuana legal for research. This decision marks a decisive turning point our partnership with Prof. Lyle Craker of the University of Massachusetts-Amherst, begun almost 17 years ago in 1999, to end the National Institute on Drug Abuse (NIDA) monopoly on the supply of marijuana for research. Prof. Craker will file his new application to DEA to grow marijuana with the expectation that DEA will finally just say yes.
The NIDA monopoly fundamentally blocked marijuana from ever becoming an FDA-approved prescription medicine because NIDA marijuana can only be used for research and cannot be sold as a prescription medicine. This made NIDA marijuana unacceptable to FDA for use in future Phase 3 studies which must be conducted with the exact same drug that would be marketed, if the research proves safety and efficacy. In addition, NIDA has been unable to provide the exact strain we requested for MAPS' upcoming Phase 2 clinical trial of marijuana for posttraumatic stress disorder (PTSD) in 76 U.S. veterans, resulting in the study proceeding with lower potency marijuana than we requested.
"There is no government monopoly on the production of any other Schedule I drug, such as MDMA or LSD—only the cannabis plant. Licensing non-government cannabis producers, and thereby creating a path to FDA approval, will potentially facilitate the removal of marijuana from Schedule I, and can ultimately allow patients to receive insurance coverage for medical marijuana," said Rick Doblin, Ph.D., MAPS Founder and Executive Director.
Meanwhile, our Phase 2 clinical trials of MDMA-assisted psychotherapy for PTSD are nearing completion. On July 30, the final participant completed their one-year follow-up interview in our largest Phase 2 study of of MDMA-assisted psychotherapy for 24 U.S. veterans, firefighters, and police officers with PTSD. This fall, will meet with the FDA in the context of an End of Phase 2 meeting, to come to an agreement on the design of our upcoming Phase 3 trials, the final stage of research required to make MDMA-assisted psychotherapy a legal prescription treatment for PTSD.
In the August 2016 edition of the MAPS Email Newsletter, you'll also find:
- The first participants are enrolled and treated in our new study of MDMA-assisted psychotherapy for PTSD in couples
- The peer-reviewed scientific journal Cell publishes a commentary entitled "MDMA as a Probe and Treatment for Social Behaviors" concluding with the statement, "The world's populations need more compassion and empathy for one another. The study of MDMA provides one small but potentially important step toward reaching that goal."
- The Zendo Project needs your help to provide compassionate care for people having difficult psychedelic experiences at Burning Man and elsewhere— right now your gift will be doubled!
- June was PTSD Awareness Month! View our press release to learn more about why we need more effective treatments for PTSD.
PLUS: Get ready for a special announcement about Psychedelic Science 2017, taking place from April 19-24, 2017, in Oakland, Calif. I hope you'll join us for this historic five-day gathering of the global psychedelic research community — watch this video for an inspiring look at what we'll create together.
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Upwards together,
MAPS Director of Communications and Marketing
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[TD="class: yiv4531401473mobile, width: 600"] [h=1]Contents[/h]
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[TD="class: yiv4531401473mobile, width: 600"] [h=2]Medical Marijuana[/h] [/TD]
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| DEA Eliminates Federal Monopoly on Marijuana for Research |
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| Marijuana for PTSD: NIDA Approves Order of 6.3kg of Marijuana |
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[TD="class: yiv4531401473mobile, width: 600"] [h=2]Treating PTSD with MDMA-Assisted Psychotherapy[/h] [/TD]
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| U.S. Veterans: Final Participant Completes Long-Term Follow-Up |
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| Conjoint Therapy for PTSD: First Pair of Participants Receive Treatment |
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| Therapist Training Study: Third Amendment Approved by IRB |
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[TD="class: yiv4531401473mobile, width: 600"] [h=2]More MDMA Research[/h] [/TD]
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[TD="class: yiv4531401473mobile, width: 600"] [h=2]Ayahuasca Research[/h] [/TD]
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[TD="class: yiv4531401473mobile, width: 600"] [/TD]
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[TD="class: yiv4531401473mobile, width: 600"] [h=2]Psychedelic Harm Reduction[/h] [/TD]
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[TD="class: yiv4531401473mobile, width: 600"] [/TD]
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[TD="class: yiv4531401473mobile, width: 600"] [h=2]Support MAPS[/h] [/TD]
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[TD="class: yiv4531401473mobile, width: 600"] [h=2]Media[/h] [/TD]
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[TD="class: yiv4531401473mobile, width: 600"] [h=2]MAPS Store[/h] [/TD]
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| Envisioning Our Psychedelic Future: August 13-14, 2016, Southampton, NY |
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| Beyond Psychedelics: September 30-August 2, 2016, Prague, Czech Republic |
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| Psychedelic Psychotherapy Forum: October 14-15, 2016, Victoria, BC |
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| World Ayahuasca Conference: October 17-22, 2016, Rio Branco, Brazil |
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| Science and Non-Duality Gathering: October 19-23, 2016, San Jose, CA |
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| Psychedelic Science 2017: April 19-24, 2017, Oakland, CA |
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