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Multidisciplinary Association for Psychedelic Studies

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Multidisciplinary Association for Psychedelic Studies
AbbreviationMAPS Edit this on Wikidata
Established1986 Edit this on Wikidata (38 years ago)
FoundersRick Doblin Edit this on Wikidata
Typesnonprofit organization Edit this on Wikidata
Legal status501(c)(3) organization Edit this on Wikidata
CountryUnited States Edit this on Wikidata
Revenue19,288,186 United States dollar (2018) Edit this on Wikidata
Websitemaps.org Edit this on Wikidata

The Multidisciplinary Association for Psychedelic Studies (MAPS) is an American nonprofit organization working to raise awareness and understanding of psychedelic substances. MAPS was founded in 1986 by Rick Doblin and is now based in San Jose, California.

MAPS helps scientists design, fund, and obtain regulatory approval for studies of the safety and effectiveness of a number of controlled substances. MAPS works closely with government regulatory authorities worldwide such as the United States Food and Drug Administration (FDA) and the European Medicines Agency (EMA) to ensure that all of its sponsored research protocols conform to ethical and procedural guidelines for clinical drug research. Included in MAPS' research efforts are MDMA (methylenedioxymethamphetamine) for the treatment of posttraumatic stress disorder (PTSD); LSD and psilocybin for the treatment of anxiety, cluster headaches, and depression associated with end-of-life issues; ibogaine for the treatment of opiate addiction, ayahuasca for the treatment of drug addiction and PTSD; medical cannabis for PTSD; and alternative delivery systems for medical cannabis such as vaporizers and water pipes. MAPS officials say the organization's ultimate goal is to establish a network of clinics where these and other treatments can be provided together with other therapies under the guidance of trained, licensed physicians and therapists.[1] In December 2023, MAPS submitted a New Drug Application (NDA) to the FDA for MDMA-assisted psychotherapy. [2]

In addition to sponsoring scientific research, MAPS organizes continuing medical education (CME) conferences, sponsors and presents lectures and seminars on the state of psychedelic and medical marijuana research, provides psychedelic harm reduction services through the Zendo Project at events such as music festivals and Burning Man, and publishes a triannual magazine-style publication, the MAPS Bulletin, with updates about its ongoing research efforts, legal struggles, and educational initiatives. MAPS also publishes books dealing with the science, history, and culture of psychedelic research and psychedelic therapy.[3]

History

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Founding MAPS

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Anticipating that the Drug Enforcement Administration (DEA) would move to criminalize MDMA in light of the drug's increasing popularity in recreational use, Rick Doblin, Alise Agar and Debby Harlow organized a nonprofit group called Earth Metabolic Design Laboratories (EMDL) to advocate for the potential therapeutic use of MDMA. By 1984 the DEA had announced its intention to designate MDMA as a Schedule I substance, a categorization that would greatly restrict and regulate the drug's availability, as well as indicate that it held no accepted medical use and a high abuse potential.[4]

EMDL organized supporters to petition the DEA for a scheduling hearing regarding MDMA. George Greer, Lester Grinspoon, Professor James Bakalar, and Professor Thomas Roberts contributed to the argument that MDMA belonged in Schedule III, a category that would more readily enable future research and permit the continuation of its use in psychotherapy. Despite such efforts, the DEA pursued emergency scheduling in 1985, citing an imminent risk to public health.[citation needed]

As MDMA was now deemed illegal, held in the same category as such substances as heroin, the only way for it to be employed in scientific inquiry would be through the lengthy and expensive FDA approval process. Holding the belief that MDMA had the unique potential both to aid psychotherapy and eventually to become a prescription medicine, Rick Doblin sought to gain incorporation for MAPS as a 501(c)(3) nonprofit research and educational organization. The founding of MAPS was a primary step toward the future envisioning of what Doblin has called a "nonprofit psychedelic-pharmaceutical company."[5] Chartered in 1986, MAPS has since contributed over 12 million dollars towards the scientific study of psychedelics and cannabis in therapeutic applications.[6][7]

Controversies

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In 2022, video of MAPS therapists spooning and pinning down a clinical trial participant in a phase 2 trial for MDMA for PTSD emerged as part of the reporting for the Cover Story: Power Trip podcast by New York Magazine and Psymposia.[8] Following treatment, one of the therapists sexually coerced the patient and the patient moved to live with the therapists for two years.

In 2019, MAPS had claimed that "Monitoring of study records throughout the course of the trial and afterwards did not indicate signs of ethical violation....The protective measures in place include having two therapy providers in every therapy visit, video recording of all therapy visits, monitoring of study and therapy activities, and clinical supervision. In this case, none of these measures were sufficient."[9] However, in 2022, MAPS spokesperson Betty Aldworth claimed that MAPS staff did not actually view the videos until November 2021, following an interview with Rick Doblin for Cover Story: Power Trip.[10]

Projects

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Since 1986, MAPS has distributed over $20 million to fund psychedelics and medical cannabis research and education. These include:

  • Erowid and MAPS have been collaborating on two large reference database projects since 2001. Erowid has been providing expertise and work developing and coordinating construction of an online MDMA Reference library and MAPS begun working on doing a similar project with the Albert Hofmann Foundation's LSD and Psilocybin Library.[11]
  • Designed a study to examine vaporized or smoked marijuana in the treatment of war related PTSD in veterans, which will evaluate efficacy and safety of multiple strains of herbal cannabis. The study has received FDA approval. MAPS is pursuing the purchase of appropriate strains from the US federal government.[12]
  • Sponsored efforts by Lyle Craker, Medicinal Plant Program, UMass Amherst Department of Plant and Soil Sciences, to obtain a license from the Drug Enforcement Administration for a marijuana production facility.[13][14]
  • Sponsored analytical research into the effects of the marijuana vaporizer, leading to the first human study of marijuana vaporizers conducted by Donald Abrams of the University of California, San Francisco.[15]
  • Funded the successful efforts of Donald Abrams to obtain approval for the first human study in 15 years into the therapeutic use of marijuana, along with a $1 million grant from the National Institute on Drug Abuse.[12]
  • Obtained orphan drug designation from the FDA for smoked marijuana in the treatment of AIDS Wasting Syndrome.[12]
  • Supported long-term follow-up studies of pioneering research with LSD and psilocybin originally conducted in the 1950s and 1960s.[16]
  • Sponsoring research by Evgeny Krupitsky into ketamine-assisted psychotherapy as a potential treatment for heroin addiction and alcoholism.[17]
  • Sponsoring programs and services at festivals, community events, churches, and schools that provide psychedelic harm reduction and education.[3]
  • A clinical study evaluating the treatment of cluster headaches using low doses of the tryptamine psilocybin (found in psilocybin mushrooms) is being developed by researchers at Harvard Medical School, McLean Hospital in conjunction with MAPS.[16]
  • Performed several small clinical studies described below, and in some cases, published the results in scientific journals.

Organization

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Board and staff

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MAPS is governed by a board of directors including John Gilmore, David Bronner, Robert J. Barnhart, and Rick Doblin. Ashawna Hailey served on the board until her death in 2011.

Funding

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MAPS is a nonprofit 501(c)(3) research and educational organization, funded by donations from individuals and foundations.[18] Donations to MAPS can be restricted to fund a specific project, or be unrestricted.[19] MAPS also receives revenue from conferences and events, such as the Psychedelic Science conference, as well as from the sale of books, merchandise, and art.[20] With a policy of transparency in financial matters, MAPS publishes a detailed annual financial report.[21] On August 20, 2020, having raised $30 million in non-profit donations in less than six months, MAPS and the Psychedelic Science Funders Collaborative (PSFC) announced the completion of the Capstone Campaign, a non-profit fundraising effort to fund the final research required to seek U.S. Food and Drug Administration (FDA) approval of MDMA-assisted psychotherapy for posttraumatic stress disorder (PTSD).[22][23]

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Medical cannabis monopoly

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National Institute on Drug Abuse (NIDA) has a government granted monopoly on the production of cannabis for medical research purposes.[24] In the past, the institute has refused to supply marijuana to researchers who had obtained all other necessary federal permits. Medical marijuana researchers and activists claim that NIDA, which is not supposed to be a regulatory organization, does not have the authority to effectively regulate who does and doesn't get to do research with medical marijuana. Jag Davies of the Multidisciplinary Association for Psychedelic Studies (MAPS) writes in MAPS Bulletin:

Currently, the National Institute on Drug Abuse (NIDA) has a monopoly on the supply of research-grade marijuana, but no other Schedule I drug, that can be used in FDA-approved research. NIDA uses its monopoly power to obstruct research that conflicts with its vested interests. MAPS had two of its FDA-approved medical marijuana protocols rejected by NIDA, preventing the studies from taking place. MAPS has also been trying without success for almost four years to purchase 10 grams of marijuana from NIDA for research into the constituents of the vapor from marijuana vaporizers, a non-smoking drug delivery method that has already been used in one FDA-approved human study.

— [25]

NIDA administers a contract with the University of Mississippi to grow the nation's only legal cannabis crop for medical and research purposes,[26] including the Compassionate Investigational New Drug program. United States federal law registers cannabis as a Schedule I drug. Medical marijuana researchers typically prefer to use high-potency marijuana, but NIDA's National Advisory Council on Drug Abuse has been reluctant to provide cannabis with high THC levels, citing safety concerns:[26]

Most clinical studies have been conducted using cannabis cigarettes with a potency of 2-4% THC. However, it is anticipated that there will be requests for cannabis cigarettes with a higher potency or with other mixes of cannabinoids. For example, NIDA has received a request for cigarettes with an 8% potency. The subcommittee notes that very little is known about the clinical pharmacology of this higher potency. Thus, while NIDA research has provided a large body of literature related to the clinical pharmacology of cannabis, research is still needed to establish the safety of new dosage forms and new formulations. In the most recent rejection of medical marijuana by the Federal Government, the DEA denied Professor Craker, Valerie Corral, and MAPS request to end the federal governments monopoly on medical marijuana production and research.

— [27]

Major events in recent proceedings are notable, as in the 2007 ruling by Administrative Law Judge Mary Ellen Bittner, wherein she recommended that Craker receive a license to grow marijuana for research and that NIDA dismantle its monopoly. The DEA in response overturned the recommended ruling in January 2009, and later denied Craker's Motion to Reconsider in December 2010. In March 2011, Craker's lawyers submitted their final brief in the case. MAPS is pursuing efforts to have the DEA's final ruling rescinded.[12] A detailed timeline of MAPS' attempts to gain access to research-grade marijuana is available on the MAPS website.

In 2016, the Obama administration DEA announced their intent to grant additional licenses to marijuana growers for research, ending the NIDA monopoly on federally legal marijuana.[28] The DEA finalized the proposed rule in early 2020.[29]

See also

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References

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  1. ^ Doblin R (2002). "A clinical plan for MDMA ("Ecstasy") in the treatment of posttraumatic stress disorder (PTSD): partnering with the FDA". Journal of Psychoactive Drugs. 34 (2): 185–94. CiteSeerX 10.1.1.545.1584. doi:10.1080/02791072.2002.10399952. PMID 12691208. S2CID 11089345.
  2. ^ Gilbert, Daniel; Ovalle, David (2023-12-13). "FDA to review MDMA-assisted therapy, a milestone for psychedelics". Washington Post. ISSN 0190-8286. Retrieved 2024-02-05.
  3. ^ a b "Multidisciplinary Association for Psychedelic Studies". MAPS. Archived from the original on 2019-06-20. Retrieved 2019-06-20.
  4. ^ Documents from the DEA Scheduling Hearing of MDMA, 1984-1988, Maps.org, archived from the original on 2012-05-23, retrieved 2012-04-14
  5. ^ Millard, M. (October 8–14, 2004). "This is your brain on drugs: Rick Doblin thinks pot, ecstasy, and other psychedelics could unlock the human mind — and he wants to bring them to Harvard, the FDA, and a doctor's office near you". Boston Phoenix. Archived from the original on 20 November 2013. Retrieved 31 May 2014.
  6. ^ Financial Reports, Maps.org, archived from the original on 2012-04-24, retrieved 2012-04-14
  7. ^ Mission, Maps.org, archived from the original on 2012-04-14, retrieved 2012-04-14
  8. ^ "You Won't Feel High After Watching This Video". 22 March 2022.
  9. ^ "Statement: Public Announcement of Ethical Violation by Former MAPS-Sponsored Investigators". 25 May 2019.
  10. ^ "Footage of therapists spooning and pinning down patient in B.C. trial for MDMA therapy prompts review". CBC News. 2022-04-09. Archived from the original on 2023-07-16.
  11. ^ "MAPS/EROWID Psychedelic Bibliography Projects". www.maps.org. Archived from the original on 2014-04-18. Retrieved 2014-06-16.
  12. ^ a b c d Medical Marijuana, Maps.org, archived from the original on 2012-04-14, retrieved 2012-04-14
  13. ^ Harris, Gardiner (18 January 2010). "Researchers find study of medical marijuana discouraged". The New York Times. Archived from the original on 23 January 2010. Retrieved 22 February 2010.
  14. ^ Stafford, Lindsay (February–April 2010), "The state of clinical cannabis research in the United States", HerbalGram, 85: 64–68, archived from the original on 2010-03-03, retrieved 2010-02-22
  15. ^ Abrams DI; Vizoso HP; Shade SB; Jay C; Kelly ME; Benowitz NL (2007), "Vaporization as a smokeless cannabis delivery system: A pilot study", Clinical Pharmacology & Therapeutics, 82 (5): 572–578, doi:10.1038/sj.clpt.6100200, PMID 17429350, S2CID 14629288
  16. ^ a b LSD & Psilocybin-Assisted Therapy for Anxiety, Maps.org, archived from the original on 2012-04-14, retrieved 2012-04-14
  17. ^ Psychedelic Research Around the World, Maps.org, archived from the original on 2013-12-03, retrieved 2012-04-14
  18. ^ MAPS Bulletin Volume XX, 3, "2010 Annual Report"
  19. ^ "Funding Priorities". Maps.org. Archived from the original on 2011-04-17. Retrieved 2011-04-20.
  20. ^ MAPS Annual Financial Report, Fiscal Year 2009-2010 June 1, 2009 - May 31, 2010
  21. ^ "MAPS' Annual Financial Reports". Maps.org. Archived from the original on 2011-04-17. Retrieved 2011-04-20.
  22. ^ "Psychedelic Research Fundraising Campaign Attracts $30 Million in Donations in 6 Months, Prepares MDMA-Assisted Psychotherapy for FDA Approval". MAPS. 2020-08-20. Archived from the original on 2020-08-24. Retrieved 2020-08-29.
  23. ^ Ramachandran, Shalini (2020-08-20). "WSJ News Exclusive | Silicon Valley and Wall Street Elites Pour Money Into Psychedelic Research". Wall Street Journal. ISSN 0099-9660. Archived from the original on 2020-08-28. Retrieved 2020-08-29.
  24. ^ Jag Davies. "Letting the Science, Not the Politicians, Decide About Marijuana | Drugs". AlterNet. Archived from the original on 2010-01-13. Retrieved 2010-03-17.
  25. ^ MAPS Bulletin Volume XVI Number 3: Winter 2006-7, Maps.org, archived from the original on 2012-03-31, retrieved 2012-04-14
  26. ^ a b Department of Health and Human Services; National Institutes of Health; National Institute on Drug Abuse (January 1998). "NIDA - About NIDA - Organization - NACDA - Provision of Marijuana and Other Compounds For Scientific Research - Recommendations of The National Institute on Drug Abuse National Advisory Council". archives.drugabuse.gov. Archived from the original on April 12, 2014. Retrieved April 11, 2014.
  27. ^ Weed Control Archived 2011-06-02 at the Wayback Machine Boston Globe May 28, 2006. Retrieved on February 15th 2010.
  28. ^ Murphey, Lance (10 August 2016). "Obama Administration Set to Remove Barrier to Marijuana Research". New York Times. Retrieved 6 January 2021.
  29. ^ National Medical Affairs Office. "DEA proposes process to expand marijuana research in the United States". Drug Enforcement Administration. Retrieved 6 January 2021.
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