Talk:Multidisciplinary Association for Psychedelic Studies: Difference between revisions

According to their mission statement, MAPS ultimately envisions a "world where psychedelics and marijuana are safely and legally available for beneficial uses, and where research is governed by rigorous scientific evaluation of their risks and benefits".<ref>http://www.maps.org/about/mission|MAPS - Mission</ref>. Additionally, MAPS’ harm-reduction efforts are intentionally and carefully designed to avoid backlash and "build a post-prohibition world by assisting non-medical users to transform difficult psychedelic experiences into opportunities for growth".<ref>Emerson, A., Ponté, L., Jerome, L., & Doblin, R. (2014). History and future of the Multidisciplinary Association for Psychedelic Studies (MAPS). Journal of psychoactive drugs, 46(1), 27-36.</ref>

The psychoactive properties of LSD were discovered in 1943 by Swiss chemist [[Albert Hofmann]] when he accidentally ingested a small dose through the skin while studying the compound. Controlled research on human subjects began soon after and Hofmann's colleague Werner Stoll published his findings about the basic effects of LSD on human subjects in 1947.<ref name="Hofmann 2005">{{Cite book|last = Hofmann|first = Albert|title=LSD: My Problem Child|year=2005|publisher=MAPS |location = Santa Cruz|isbn = 0-9660019-8-2}}</ref>

After the earliest European and American research efforts investigated whether LSD could reliably induce psychotic disorders, some began to evaluate the potential for LSD to assist in traditional [[psychoanalysis|Freudian psychotherapy]] in the 1950s. Studies into the effects of LSD on human creativity and spirituality were also conducted during this period.

The next Harvard experiment with crucial implications for the development of psychedelic research was [[Walter Pahnke|Walter Pahnke's]] [[Good Friday Experiment]] of 1962. Pahnke set out to determine if psilocybin could be used to facilitate “mystical” experiences and if these experiences could cause permanent and beneficial personality transformation. In order to do so, he recruited 20 Protestant divinity students, 10 of whom would take synthetic psilocybin and 10 of whom would take a [[placebo]]. The experiment took place in a basement chapel in which the audio from a Good Friday service conducted in the main chapel upstairs was broadcast.  

Throughout the short history of LSD research, people unaffiliated or loosely affiliated with the scientific establishment distributed supplies of LSD outside of laboratory settings. Soon the lines between legitimate research and personal experimentation began to blur for some, and as early as 1962 fellow faculty members at Harvard openly criticized Leary and Alpert for abandoning scientific principles and experimenting with LSD outside official research settings. A few months later the university would dismiss both professors for violating university regulations by providing LSD to undergraduates. The controversy at Harvard coincided with greatly increased FDA restrictions on the procurement of LSD for scientific research; although some research did continue, most studies underway before the new FDA restrictions did not. After restricting its manufacture and distribution in 1965, the US government fully criminalized LSD in 1968, after which the European nations which hosted psychedelic research followed suit.<ref>{{cite book |last= Lattin |first= Don |year= 2010 |title= The Harvard Psychedelic Club: How Timothy Leary, Ram Dass, Huston Smith, and Andrew Weil Killed the Fifties and Ushered in a New Age for America |publisher= Harper Collins |isbn= 0-06-165593-7}}</ref>

In the United States, legal psychedelic research was reduced to only one program – the studies conducted at the Spring Grove Center in Baltimore which primarily focused on end of life therapy and continued through to 1974. The study, which eventually came to be headed by Pahnke and [[Stanislav Grof|Grof]], resulted in the treatment of over 100 terminal patients, including 31 in a controlled LSD psychotherapy study.<ref>{{cite book |last= Grof |first= Stanislav |year= 1994 |title=LSD Psychotherapy: Exploring the Frontiers of the Hidden Mind |publisher=Hunter House |isbn=0-89793-166-1 }}</ref>

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 non-profit 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.<ref name="maps-dea-mdma">{{citation|url=http://www.maps.org/dea-mdma/ |title=Documents from the DEA Scheduling Hearing of MDMA, 1984-1988 |publisher=Maps.org |date= |accessdate=2012-04-14}}</ref>

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) non-profit research and educational organization. The founding of MAPS was a primary step toward the future envisioning of what Doblin has called a "non-profit psychedelic-pharmaceutical company."<ref>{{cite news| title=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| author=Millard, M.| work=Boston Phoenix| date=October 8–14, 2004| url=http://www.bostonphoenix.com/boston/news_features/top/features/documents/04176022.asp| accessdate=31 May 2014}}</ref> Chartered in 1986, MAPS has since contributed over 12 million dollars towards the scientific study of psychedelics and marijuana in therapeutic applications.<ref>{{citation|url=http://www.maps.org/about/fiscal/ |title=Financial Reports |publisher=Maps.org |date= |accessdate=2012-04-14}}</ref><ref>{{citation|url=http://www.maps.org/about/mission/ |title=Mission |publisher=Maps.org |date= |accessdate=2012-04-14}}</ref>

* [[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.<ref>http://www.maps.org/news-letters/v11n1/11119ero.html</ref>

* 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 marijuana.  The study has received FDA approval. MAPS is pursuing the purchase of appropriate strains from the US federal government.<ref name="maps-mmj">{{citation|url=http://www.maps.org/research/mmj/ |title=Medical Marijuana |publisher=Maps.org |date= |accessdate=2012-04-14}}</ref>

MAPS has a primary focus in researching the effectiveness of using 3,4-methylenedioxymethamphetamine (MDMA) to assist psychotherapy in the treatment of posttraumatic stress disorder (PTSD). MAPS is the only organisation in the world funding clinical trials of MDMA-assisted psychotherapy, as it is of little interest to commercial pharmaceutical companies{{Citation needed|date=December 2016}}. Ultimately, MAPS seeks to achieve FDA approval for the use of MDMA as a prescription medicine.<ref name="maps-mdma">{{citation|url=http://www.maps.org/research/mdma/ |title=MDMA-Assisted Psychotherapy |publisher=Maps.org |date= |accessdate=2012-04-14}}</ref>

MAPS is conducting a phase 2 pilot study to assess the effectiveness of MDMA-assisted psychotherapy in the treatment of PTSD among veterans of war. The study is taking place in Charleston, SC and is conducting experimental treatment with 16 veterans, both male and female, suffering war-related PTSD. The study will follow a randomized triple-blind protocol and test three different experimental doses.

Outside of the US, MAPS is pursuing the implementation of MDMA/PTSD studies in Canada, Israel, Jordan, and Switzerland. The Canadian study has full approval from an Institutional Review Board (IRB) and from Health Canada, and is waiting to obtain an import permit to import MDMA into Canada. The Israel Study is awaiting approval from the Israeli Institutional Review Board as well as the Ministry of Health before it can proceed with enrollment.. An Israeli Defense Force official has indicated a willingness to refer war affected soldiers suffering from PTSD, thus greatly enabling recruitment for the study. The Jordan Study is in development with limited approval from the IRB. A protocol amendment is to be submitted in the near future. MAPS is seeking to enroll both Jordanian nationals as well as Iraqi refugees living in Jordan who are suffering from PTSD. The Switzerland study has received full approval from SwissMedic and has been submitted and accepted by the FDA in the form of an Investigational New Drug application. The study is in progress and nearing completion as MAPS is collecting long-term follow-up data following the experimental treatment of all 12 subjects. The study represents in part MAPS' clinical plan to develop MDMA as a prescription medication with both FDA and European Medicines Agency (EMEA) approval.<ref name="maps-mdma"/>

MAPS has developed a training protocol that will allow therapists to take part as subjects in a Phase 1 study on the psychological effects of MDMA-assisted psychotherapy on healthy volunteers. MAPS would thus administer one MDMA-assisted psychotherapy session to the therapists in an effort to offer them training as well as evaluate the effects of MDMA. The study has received approval to proceed by both the US FDA and the IRB. Mithoefer, the primary clinical investigator in this study, has received his Schedule 1 license from the DEA, enabling him to administer MDMA within this study.<ref name="maps-mdma"/>

An explosion of recreational use during the 1960s gained LSD and Psilocybin a great deal of notoriety and ultimately led to their categorization as Schedule I illicit drugs in 1970.<ref name="ReferenceA"/>

MAPS is committed to exploring the potential use of LSD and psilocybin-assisted psychotherapy in the treatment of patients suffering with the deep anxiety associated with life-threatening illness. Developing new research protocols to meet modern drug development standards, MAPS’ pilot LSD and psilocybin studies will be used to guide development of future treatment methodologies.<ref name="ReferenceA"/>

MAPS is conducting a study on LSD-assisted psychotherapy in the treatment of anxiety secondary to life-threatening illness. The study is taking place in Solothurn, Switzerland, and is the first study in 35 years to investigate the therapeutic use of LSD in human subjects. The study's primary focus is to assess the safety and effectiveness of conducting LSD-assisted psychotherapy with a population of individuals who are experiencing anxiety associated with life-threatening illness. The study has received approval from the BAG (the equivalent of the DEA in Switzerland), the Ethics Committee (the Swiss IRB), and [[Swissmedic|SwissMedic]]. Enrolment began in April 2008 and is now complete.<ref name="ReferenceA"/>

The [[National Institute on Drug Abuse]] (NIDA) holds a monopoly on the supply of marijuana grown for research in the United States{{citation needed|date=December 2016}}, as they fund the only laboratory licensed to grow it. Since NIDA is solely interested in researching the negative aspects of marijuana use and abuse, studies to explore its potential medical benefit are impossible within the US.

MAPS is the only organization working to demonstrate the safety and efficacy of botanical marijuana as a prescription medicine to the satisfaction of the FDA{{citation needed|date=December 2016}}. For nearly ten years, MAPS has been involved in lengthy and  ongoing legal battles with the DEA to end NIDA’s monopoly on research grade marijuana.<ref name="maps-mmj"/>

Alternatively, MAPS has received full approval from the FDA to study the effectiveness of marijuana, both smoked and [[Vaporizer (cannabis)|vaporized]], in the treatment of individuals experiencing war related PTSD. This marks the first time the FDA has approved an outpatient marijuana study.<ref>{{citation|url=http://www.maps.org/media/update/maps_news_5_9_11/ |title=MAPS News 2011-May-9 |publisher=Maps.org |date=2011-05-09 |accessdate=2012-04-14}}</ref>

MAPS has also conducted multi-drug studies as well as cross cultural and meta-analysis research.<ref name="maps-research"/>

MAPS has provided psychedelic emergency services at festivals such as Hookahville, [[Burning Man]] and the [[Boom Festival]]. MAPS’ model of psychedelic emergency services is volunteer staffed, peer based and relies on acute intervention.<ref name="Vimeo.com"/> MAPS also provides training and an educational video, which empowers psychedelic users and their peers with therapeutic techniques for use in assisting others through difficult psychedelic experiences. MAPS’ approach to psychedelic harm reduction encourages a new framework for looking at “bad” trips as opportunities for emotional and spiritual growth.

Additionally, MAPS co-sponsors [[EcstasyData.org]], an online resource that provides laboratory testing of [[ecstasy tablets]] for a minimal cost, which allows users to know exactly what they are ingesting and to avoid taking mislabeled or impure substances.  MAPS has also formed a partnership with Bluelight, a web forum dedicated to harm reduction.

NIDA administers a contract with the University of Mississippi to grow the nation's only legal cannabis crop for medical and research purposes,<ref name="autogenerated1">{{cite web |url=http://archives.drugabuse.gov/about/organization/nacda/MarijuanaStatement.html |title=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 |work=archives.drugabuse.gov |date=January 1998 |accessdate=April 11, 2014 |author=Department of Health and Human Services|author2=National Institutes of Health|author3=National Institute on Drug Abuse |archiveurl=//web.archive.org/web/20140412063112/http://archives.drugabuse.gov/about/organization/nacda/MarijuanaStatement.html |archivedate=April 11, 2014 |deadurl=no}}</ref> 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:<ref name=autogenerated1 />{{quote|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 [[Lyle Craker|Professor Craker]], [[Valerie Corral]], and MAPS request to end the federal governments monopoly on medical marijuana production and

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.<ref name="maps-mmj"/> A detailed timeline of MAPS' attempts to gain access to research grade marijuana is available on the MAPS [http://www.maps.org/research/mmj/ website].