Multidisciplinary Association for Psychedelic Studies
American nonprofit organization
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Multidisciplinary Association for Psychedelic Studies
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 opiateaddiction, 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
Founding MAPS
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
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
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]
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]
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.
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.
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]
