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Official websites use. Share sensitive information only on official, secure websites. This article was submitted to Neuropharmacology, a section of the journal Frontiers in Pharmacology. The use, distribution or reproduction in other forums is permitted, provided the original author s and the copyright owner s are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms. Mental disorders are rising while development of novel psychiatric medications is declining. This stall in innovation has also been linked with intense debates on the current diagnostics and explanations for mental disorders, together constituting a paradigmatic crisis. A radical innovation is psychedelic-assisted psychotherapy PAP : professionally supervised use of ketamine, MDMA, psilocybin, LSD and ibogaine as part of elaborated psychotherapy programs. But more than novel treatments, the PAP model also has important consequences for the diagnostics and explanation axis of the psychiatric crisis, challenging the discrete nosological entities and advancing novel explanations for mental disorders and their treatment, in a model considerate of social and cultural factors, including adversities, trauma, and the therapeutic potential of some non-ordinary states of consciousness. Keywords: psychedelic-assisted psychotherapy, LSD, MDMA, ibogaine, psilocybin, ketamine, explanation in neuroscience, states of consciousness. However, research and development in psychopharmacology—psychiatry's primary mode of intervention—came to a halt in Miller, ; Hyman, These occurrences are part of a complex picture clearly dissected as a triple crisis in psychiatry: of therapeutics, diagnostics and explanation Rose, Problems surrounding psychiatric diagnosis also surfaced in , when the UK Medical Research Council published a strategy for mental health and wellbeing Sahakian et al. It proposed five domains based on specific neural systems that can be impaired in mental illness, a radical departure from the hundreds of discrete conceptual disorders of the much older Diagnostic and Statistical Manual DSM Casey et al. Thus, the RDoC advanced a multidimensional approach to diagnosing mental disorders in a continuous spectra Adam, At around the same time, a network psychopathology perspective was conceptualized and empirically assessed with statistical models for psychometrics based on thousands of patient reports' and hundreds of symptoms Fried et al. The treatment and diagnostic axes of the crisis are connected by the explanatory domain: despite huge investment in neuroscience as the ultimate source for understanding mental illness, both classification and diagnosis Stephan et al. Synthetic substances like Lysergic Acid Diethylamide LSD , 3,4-MethylenodioxyMetamphetamine MDMA , 2- 2-Chlorophenyl methylamino cyclohexanone ketamine and naturally occurring alkaloids including 4-phosphoriloxy-N,N-dimethyltryptamine psilocybin, present in hundreds of Psilocybe mushroom species and Methoxyibogamine ibogaine, from Tabernanthe iboga have been used in a series of studies Passie et al. These substances are orally active but have different mechanisms of action. Data obtained from clinicaltrials. Including registers for depression; major depression; depressive disorder; major depressive disorder; treatment resistant depression; bipolar depression; cancer depression; depression, suicide. Status at clinical trials. Not registered as completed, but published Bogenschutz et al. There were 12 completed patients overlapping suicide and depression, 65 planned patients overlapping depression with alcohol use disorder and 16 planned patients overlapping depression with suicide. Each only counted once in the respective subtotals. Generally infused over 40 min. NA, Not Available at the published paper s. The most studied is ketamine, which in higher doses is an anesthetic in use for decades. In lower dosages it temporarily modify consciousness including changes in mood and cognition Mion, It is the experimental intervention in almost 70 Phase 2 trials for psychiatric disorders and two Phase 3 trials for depression. Protocols involve single or repeated administrations in different doses, routes of delivery and research designs. Nine meta-analysis from depression trials Fond et al. In clinical populations, serious adverse events were very rare, with only one brief and self-limiting case of increased ventricular extrasystoles in more than 1, sessions MAPS, Furthermore, the improvements lasted up to 4 years, mostly without additional treatments and without inducing drug abuse or dependence Mithoefer et al. An independent preliminary meta-analysis found MDMA-assisted psychotherapy was superior to prolonged exposure when evaluated by clinician-observed outcomes, by patient self-report outcomes and also by drop-outs Amoroso and Workman, Psilocybin is the third most studied psychedelic substance for clinical applications. Despite moderately increasing blood pressure Griffiths et al. LSD, the most potent psychedelic currently administered in clinical trials, has very slow dissociation kinetics at the human 5-HT 2A receptor and thus long lasting effects Wacker et al. It has a very high safety ratio Gable, ; Passie et al. It is the active substance in just two recent Phase 2 trials for existential anxiety in the terminally ill Table 1. This paucity is perhaps due to stigma surrounding large-scale recreational use since the 's, with considerable political implications Dyck, ; Nutt et al. However, before political turmoil, more than a 1, studies including 40, patients were done Grinspoon, , mostly showing positive potentials Abraham et al. LSD was thus the prototypical substance in the development of radically new forms of psychotherapy, including psychedelic-assisted psychotherapy Pahnke et al. Despite the paucity of recent trials, a recent meta-analysis with rigorous research from 60 years ago confirmed LSD also has important potential for alcohol use disorders Krebs and Johansen, Finally, ibogaine is the less advanced psychedelic in the development pipeline, with no interventional clinical trials executed or registered since the National Institute on Drug Abuse NIDA cancelled efforts to develop this compound to treat opioid addiction in the 's Alper, And indeed there are important safety concerns, given ibogaine can prolong QT interval Koenig and Hilber, , potentially evolving to fatal cardiac arrhythmias Koenig et al. This critically differentiates ibogaine's safety profile from other psychedelics. However, given the seriousness of drug addiction and the difficulty to treat these patients, observational and retrospective studies for opioid Brown and Alper, ; Noller et al. Given ibogaine is unscheduled in many countries and currently used as an alternative treatment with an unfortunate series of fatalities Alper et al. Safeguarded important differences regarding safety and mechanisms of action, the grouping of these substances in a prototypical PAP model has important practical and theoretical implications. The main feature is the therapeutic use of a potent psychoactive substance currently most are scheduled compounds in very few sessions. With ketamine positive results were obtained with one to 12 administrations, with MDMA just three and with psilocybin and LSD only two, while ibogaine may be effective after a single administration. During drug effects, patients are continuously monitored and supported by trained mental health professionals following available guidelines Johnson et al. Generally patients listen to instrumental evocative music Pahnke et al. Frequency and type of psychotherapeutic interventions varied from a minimum in ketamine studies, sometimes including only music during drug effects, to a more intensive protocol with MDMA including 12 non-drug sessions, which follow a detailed manual based on non-directive transpersonal psychology 3 recently, MDMA has also been tested with cognitive behavioral conjoint therapy. Between these two ends of the spectrum are psilocybin, LSD and ibogaine studies, which used a variety of interventions. Psilocybin studies used psychological support comprised of non-directive preparation, support and integration in few non-drug sessions. LSD included three post-drug integrative sessions. Ibogaine, used in different clinics for drug dependence, included a series of more or less standardized psychotherapies for addiction, pre- and post-drug, like steps, individual and group counseling, among others. Increasing focus on types and frequency of psychotherapeutic interventions can arguably help improve outcomes, as exemplified by older ketamine studies with existentially oriented psychotherapy for drug addiction e. Beyond potential novel treatments, PAP has important practical and theoretical consequences for the three axes of the crisis. The combination of psychotherapy with psychedelics can be conceptualized as the induction of an experience with positive long-term mental health consequences, rather than daily neurochemical corrections in brain dysfunctions Figure 1. When appropriately mediated, these can be deeply meaningful experiences that elicit the emotional, cognitive and behavioral changes reported. However, available therapeutic results for depression with ketamine analogs with less dissociative effects were only modest Iadarola et al. Furthermore, positive correlations between subjective features like ketamine's dissociative effects Luckenbaugh et al. It is thus very hard to strictly reduce PAP to neuropharmacology. In this sense, PAP can benefit from potentially rich interactions with other fields like psychodynamic psychotherapy Plakun, , Furthermore, PAP can help solve many pressing safety concerns in current psychopharmacological treatments by bridging a current gap in knowledge between research and clinical practice. This gap is created because psychiatric clinical trials rarely last longer than 6 months Downing et al. Many current adverse consequences from the use of psychiatric prescription medications arise from this gap, including decreasing drug adherence over time Chapman and Horne, ; Medic et al. By administering psychoactive drugs just a few times, PAP can prevent addiction and the development of side effects after chronic use of medications. And by exclusively licensing psychedelics for especially licensed therapists and physicians, rather than prescription and dispensation to patients, PAP can reduce risks of diversion and abuse. The icon in the center represents the PAP model, located inside the triangle projecting the three axes of the current psychiatric crisis: therapeutics bottom , diagnosis right , and explanation left. The outermost black circle represents the main conceptual formulation for each axis in current psychiatric theory, i. The innermost white circle represents the concepts supported by PAP: mental injuries diagnosed as a multidimensional spectra treated holistically. Besides critical consequences for the therapeutic axis, PAP is also relevant for diagnostic concerns. The fact that ketamine and psilocybin, substances with radically different pharmacological mechanisms of action, can induce positive outcomes in a single disorder, like depression; or that a single substance like psilocybin can be used to treat different disorders, like depression or drug dependence, challenges nosologies which discriminate disorders in mutually-exclusive categories. Thus, PAP supports a multidimensional spectra Figure 1. However, proposals such as the RDoC were criticized by its biomedical reductionism Frances, a ; Parnas, ; Wakefield, , while psychedelic research recognize the concept of set and setting Eisner, ; Hartogsohn, as crucial for the results obtained with these treatments. Set includes circumstances and factors other than drug and pharmacological targets, including people's beliefs, attitudes, preferences, choices and motivations. Setting refers to environment, context, therapists, supporting team etc. This does not imply that neuroscience is not fundamental to understanding PAP and its consequences for psychiatric research and development. On the contrary. Current limitations of neuroimaging in psychiatry include long-term confounders like smoking, weight and metabolic variations Linden, ; Weinberger and Radulescu, , and low prognostic accuracy and predictive validity Linden, ; Berkman and Falk, ; Weinberger and Radulescu, By developing faster treatments and bridging the gap between research and clinical practice, PAP can allow the use of within-subject designs in shorter time spans e. Thus, confidence in translating results from acute psychedelic neuroimaging Vollenweider and Kometer, ; Muthukumaraswamy et al. Finally, detailed study of the subjective aspects of PAP has enormous consequences for the explanatory axis. Recent qualitative and phenomenological research shows that psychedelic experiences involve meaningful autobiographical and social psychological concerns Grof, ; MacLean et al. Therefore, PAP can deepen understanding of which psychological contents of the therapeutic experience are most relevant for treatment outcomes Nour et al. This can not only foster improvements in PAP but corroborates the importance of biopsychosocial aspects in psychiatric explanations. A rich methodological integration can help develop theoretical constructs that are not excessively reductionistic. Thus, PAP can conceptually enrich psychiatric explanations for mental disorders and their treatment. If neglect, trauma, childhood adversities, poverty, abuse, and deprivation—i. Indeed, in the 's and 60's, before drug scheduling and cessation of clinical studies with psychedelics, and before neuroscience took central stage in psychiatric understanding of mental disorders, pioneer psychiatrists like Stanislav Grof and Sidney Cohen already questioned the fundamental theoretical grounds of mental disorders Grof, , , ; Cohen, It is thus possible that instead of brain dysfunctions causing discrete disorders treated with specific drugs, psychiatry can conceptualize mental injuries causing suffering that can be optimally treated with holistic approaches Figure 1 , including those which modulate the state of consciousness. This can greatly contribute to the understanding of how social circumstances and adverse life experiences shape mental health and brain activity, and how meaningful treatment experiences foster resilience. As founder of a startup company the author has a potential conflict of interest due to his involvement with the design of clinical trials with psychedelics in Brazil. He has not been directly involved with any of the previous clinical trials cited in the article. The author would like to thank Leor Roseman for proofreading and for advancing the notion of experience efficacy, mindthegraph. This work was funded by Phaneros, a Brazilian startup founded by the author. As a library, NLM provides access to scientific literature. Front Pharmacol. Find articles by Eduardo Ekman Schenberg. Received Nov 27; Accepted Jun 18; Collection date Open in a new tab. Similar articles. Add to Collections. Create a new collection. Add to an existing collection. Choose a collection Unable to load your collection due to an error Please try again. Add Cancel. Ketamine Route of administration oral, intranasal, i. Number of drug sessions 1— Placebo, lithium, saline, diphenhydramine, nitroprusside, midazolam, minocyclin, ECT. Fond et al. Bloch et al. Feder et al. Ballard et al. Cocaine use disorder. Dakwar et al. Bouso et al. Alcohol use disorder. Psilocybin Route of administration oral Dose range 10—40 mg Number of drug sessions 1—3. Carhart-Harris et al. Grob et al. Bogenschutz et al. Cigarette dependence. Johnson et al. Existential anxiety. Mannitol, 20 mg LSD. Gasser et al.

Psychedelic-Assisted Psychotherapy: A Paradigm Shift in Psychiatric Research and Development

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When in Hungary, do as the Hungarians do! To make your trip as smooth as possible, we would like to walk you through the most important laws and customs of Budapest. Some of them are important to consider when you are planning your trip, some are just cultural bits and pieces that might be good to know before you arrive - hopefully they come in handy! Let's start with the most important: the Hungarian laws about drinking, smoking, using drugs, and being too loud. This doesn't mean that people don't do it all the time, but the police have the right to fine you for it! Usually, they don't stop people for drinking a beer quietly in a park or walking with it, but sometimes they do. So if you see a police officer coming, lower your drink and keep it on your other side. If you are drunk and obnoxious they will definitely stop you! The drinking age in Hungary is 18 and there are no special regulations for lower or higher alcohol content drinks. The stores and bars will ID you - not at every purchase, but anytime they have any doubt, so keep your ID with you. Buying alcohol might be restricted not just by age but by time of day and location. These laws are district regulated and change frequently, so if you are in doubt about your area buy your drinks before 11 pm! Furthermore, if you are considering renting a car you must know there is a zero alcohol tolerance for driving! They take it really seriously, so, yes, not even a sip of beer Rather than take the risk, just sit back and let someone else take the wheel! Call a taxi, or better yet, check out this beer bus, where you can drink unlimited beers while taking in the sights of the city! Hungary has some of the strictest laws about protecting non-smokers from passive smoking in the EU. We have a complete ban on smoking in public indoor areas, on and around public transportation, and around playgrounds. This means it is strictly forbidden to smoke in a tram or bus stop while you are waiting or walking through an underground underpass with your cigarette lit. The Hungarian government has restricted the purchase of tobacco products. They are only available in special nationally run tobacco stores, so don't expect to get a pack in a grocery store or a gas station. The tobacco stores are easy to spot and they are all over town with great opening hours, so you don't need to worry about finding one. Fom the standpoint of the Hungarian government, drugs are a big NO!! In Hungary consumption and possession of drugs are illegal, with no exceptions. There is no classification of drugs in Hungary, so being caught with the smallest amount can result in heavy fines and other punishments. There are no citywide regulations on where and when noise is allowed. There are guidelines, but even apartment houses can create their own internal regulations. The law is 'someone who unreasonably causes noise that is likely to disturb the peace of others or the natural or protected natural value, commits a misdemeanor. Obviously it's up to everyone's discretion to decide what is too noisy, but if police are called you can end up with an official warning, a fine payable on the spot, or even with an official police report. Budapest offers innumerable amazing bars and clubs that are soundproofed to make sure you don't need to worry about anything. Please consider that your vacation time is someone's regular workweek and don't take the party to the streets! Need help finding cool places to go out? Take a pub crawl and let the guides lead you to fun bars with a famous club at the end! Important: It is compulsory to always carry an ID card on you and the police can stop and ID you at any time. This doesn't happen all that often, but you will need ID to get alcohol or to get into clubs, so just make sure you have it on you at all times. When you are picking the dates of your trip you may want to take into consideration Hungarian public holidays. On our public holidays no shops other than hour ones , banks, government offices, or post offices are allowed to be open. Some restaurants and bars choose to close as well, but this is rare in the touristy downtown area. On Hungarian National Holidays, most national museums and important buildings are usually free to visit! They might be a bit crowded or you may have to stand in line for entry, but many times they even offer special programs for visitors. On these dates, there are quite often cultural programs on the streets and for this we have sections of the city closed to traffic, transforming downtown streets to pedestrian zones. Tip: always pay attention to the information boards, as above-ground public transportation lines might be redirected. The most important of the dates listed above is the 20th of August. This is the celebration of our first king, Stephen, and of the founding of the state of Hungary. Life in Budapest completely changes for a couple of days around this national holiday: street festivals take over downtown, the river banks and the castle area. National museums and the Parliament are free to visit. And fireworks help. Join The Club! Laws Let's start with the most important: the Hungarian laws about drinking, smoking, using drugs, and being too loud. Budapest Laws about Smoking Hungary has some of the strictest laws about protecting non-smokers from passive smoking in the EU. Trip Prep Public Holidays Man on a bike There are a couple of Budapest customs to consider when you are planning your trip to Budapest. August 20 - St. Stephen's Day The most important of the dates listed above is the 20th of August. And fireworks help Share Save Share Tweet. Back to Top. See all articles.

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