Abstract
Background and aims
The recent resurgence of psychedelic research has led to increased interest in extra-pharmacological factors shaping drug effects (set and setting). Habitually discussed in the context of psychedelic therapy, the relevance of set and setting to determining the outcome of non-psychedelic psychiatric interventions receives strong theoretical and empirical support in the literature. Unfortunately, there has been little research on the subject. The current study addresses this lacuna and investigates the potential of using non-pharmacological interventions to improve the outcomes of psychiatric care including safety, satisfaction, efficacy, and non-habituation.
Methods
110 participants (patients prescribed with psychiatric medication) took part in workshops focused on 1) Relaxation (Anxiolytics) 2) [n = 70] Focus (Stimulant ADHD Medication) [n = 40]. Workshops included a) an educational section designed to increase participants' understanding of their medical conditions and prescribed medications b) an experiential section that included the guided, mindful ingestion of the prescribed drug in a supportive setting including reinforcing cues and the practice of non-pharmacological techniques for coping with underlying medical conditions.
Results
Survey questionnaires (n = 33) indicated a significant improvement in participants' understanding of their medical conditions and the properties of their prescribed medication. Semi-structured interviews demonstrated a strong interest in the idea of mindful use of medication, benefit from the communal setting of ingestion, as well as recurring themes of greater satisfaction with- and improved ability to derive benefit from the use of prescribed drug.
Conclusions
The results of this pilot study demonstrate the impressive potential of providing patients with extra-pharmacological tools to improve the outcomes of prescription drug use and supports the need for further study.
Introduction
Discussions about extra-pharmacological factors shaping the effects of psychoactives have grown in recent years, supported by a resurgence of interest in the medical and non-medical use of psychedelics, popularly dubbed 'the psychedelic renaissance' (Carhart-Harris et al., 2018; Hartogsohn, 2020; Pollan, 2018). This paper reports on a recent and uncommon project that aimed to improve the subjective experience of patients prescribed with psychiatric medicine and enhance treatment outcomes using approaches and practices that gained prominence in the context of the psychedelic resurgence, and which make use of non-pharmacological interventions.
The fundamental role of non-pharmacological context is a topic of perennial discussion within psychedelic theory and practice. It is typically subsumed under the rubric of set and setting, a broad term used to explain and manage the role of non-pharmacological agents in shaping psychedelic drug effects (Hartogsohn, 2017). Coined in the early 1960s, within the context of mid-twentieth-century psychedelic drug research (Leary, 1961),1 the concept of set and setting is considered essential to any discussion of psychedelic effects. It crucially considers psychedelics to be non-specific agents, agents whose effects are not predetermined by pharmacology. Rather, psychedelic effects are considered flexible, ranging from the medical to the spiritual, from the creative to the political, depending on diverse elements of context like expectancy, intention, sensory, social and cultural environment (Hartogsohn, 2022). The context dependency of psychedelics is sometimes viewed as an outcome of their tendency to ‘enhance meaning’ (Hartogsohn, 2018). Alternatively, and on a different explanatory level, it was suggested that the pro-plasticity effects of serotonin and the 5-HT2a receptor, involved in psychedelic action, are responsible for the exceptional dependence of their outcomes on context (Carhart-Harris et al., 2018; Carhart-Harris & Nutt, 2017). Dupuis provides us with a rich and nuanced account of the ways in which the experiences of participants in a Peruvian ayahuasca retreat are socially reinterpreted, massaged and remolded to make them fit with particular psychological and cosmological explanatory schemes (Dupuis, 2021a, 2021b). Through the discerning means of language, sound, symbolic elements, the cultivation of specific expectations and intentions the same agent may play a role in enhancing artistic creativity (Cortés, 2018), or fostering technical innovation (Harman & Fadiman, 1970), assisting therapy (Garcia-Romeu & Richards, 2018) or enhancing spiritual practice (Hartogsohn, 2021). Such effects are furthermore mediated collectively, so that broader historical, societal and cultural contexts determine the the types of intentions, interpretative frameworks and social relations which are allowed to emerge and which consequently shape the experiences of individuals (Dupuis, 2021a, 2021b; Hartogsohn, 2020, 2022; Pedersen & Steglich-Petersen, 2024).
The extreme context dependency of psychedelics obliges the utmost attention in the management of context in its diverse elements, to minimize the probability and intensity of adverse effects while maximizing the probability and depth of benefits. Theorists and practitioners of psychedelic medicine thus pay considerable attention to the elaborate ways in which such non-pharmacological factors shape response to psychedelic drugs and attempt to methodically assess and manipulate them in order to regulate drug response and achieve optimal therapeutic results (Aday, Davis, Mitzkovitz, Bloesch, & Davoli, 2021; Borkel, Rojas-Hernández, Henríquez-Hernández, Santana Del Pino, & Quintana-Hernández, 2023; Gandy, 2022; Noorani, 2021; Strickland, Garcia-Romeu, & Johnson, 2020).
Outside the field of psychedelics, discussions about extra-pharmacological factors shaping drug response typically take place under the well-established concept of placebo. Since the mid-twentieth-century an extensive body of research has attempted to decipher the significant role of the 'powerful placebo' (Beecher HK, 1955) in shaping the effects of pharmaceuticals generally, and of psychoactive psychiatric medication specifically (Colloca & Barsky, 2020; Price, Finniss, & Benedetti, 2008; Stewart-Williams, 2004). This research has produced impressive evidence on the ubiquity and potency of placebo response. Indeed, some have argued that in many instances placebo response is responsible for a greater portion of treatment outcomes than the effect produced by the pharmaceutical itself (Howick et al., 2013; Jakobsen et al., 2017; Kirsch, 2019; Kirsch, Moore, Scoboria, & Nicholls, 2002).
The discussions regarding placebo and set and setting resonate strongly. Most crucially, they share the notion that drug effects are far from universal and objective, but rather mediated by a number of common extra-pharmacological factors including expectation, intention, physical environment, social environment and cultural beliefs (Hartogsohn, 2016). Some have additionally argued that psychedelics, owing to their ability to increase suggestibility, are not only responsive to placebo effects but enhance them as well (Dupuis & Veissière, 2022).” However, there are also several fundamental differences in the terms and assumptions guiding these two discourses (Hartogsohn, 2016). One such difference regards the proactive, interventionist character of the set and setting paradigm, which stands in contrast to placebo discourse, where the emphasis is on an ethic of objectivity, blinding, and non-interference. While the discourse on set and setting aims to enhance drug effects using non-pharmacological means, discussions about placebo commonly evince a preoccupation with the minimization of the placebo response in the name of scientific objectivity (as in the case of RCTs) or medical integrity (in clinical practice). Despite attempts to argue for the ethicality and efficacy of harnessing the power of placebo for enhancing clinical practice, the subject has mostly been evaded so far (For some notable exceptions, see Priebe, Conneely, McCabe, & Bird, 2019; Pronovost-Morgan, Hartogsohn, & Ramaekers, 2023). Thus, while astute practitioners are aware of the considerable clinical benefits that can be derived by employing simple measures like consulting the patient in a positive manner (Thomas, 1987) or allowing prolonged interaction with the medical practitioner (Kaptchuk et al., 2008), and of the harmful (nocebo) effect which innocuous suggestions by the practitioner may cause (Hansen & Zech, 2019), many are oblivious to such considerations (DeGrandpre, 2002, 2010; Healy, 2002).
This state of affairs is unfortunate. The crucial role of extra-pharmacological factors cannot be ignored, most certainly not when dealing with psychiatric medication with pronounced psychoactive effects. The (mental/social/cultural) extra-pharmacological matrix in which psychoactive drugs and medicines are consumed is paramount in shaping the outcomes of drug use. In the absence of any conscious attempt to positively shape the extra-pharmacological conditions in which psychiatric medicine is used, medication is habitually used in sub-optimal and sometimes destructive ways. Users ingest substances casually, without understanding their mechanisms and properties, without reflecting on the grounds and goals for ingestion, on the environment for their drug use,2 or on the potential long-term trajectories of psychiatric drug use. The result of such illiteracy regarding the non-pharmacological conditions that shape the prospects of pharmaceutical treatment is sub-optimal efficacy, increased adverse effects, and the development of habituation.
This paper reports on a unique pilot study that aimed to address the challenge of integrating extra-pharmacological considerations into psychiatric care by employing methods inspired by the field of psychedelic therapy.3 Group sessions that involved guided, mindful use of psychiatric medicines were facilitated over 14 months from March 2022 to May 2023, including the participation of 110 individuals in 16 different occasions. This preliminary report describes the reasoning behind this rare and unusual project (we were unable to find similar studies experimentally examining extra-pharmacological interventions in psychiatric care); the methods used, and results from surveys and interviews conducted with workshop participants. A discussion of these results is included as well as suggestions for further research and analysis of some of the culturally based objections and barriers to this and similar attempts to integrate extra-pharmacological considerations into medicine. Finally, a model is proposed for the integration of set and setting into everyday psychiatric care.
Integrating ritual and mindfulness in psychiatric care: lessons from the psychedelic renaissance
The power of ritual to dramatically alter perception has long been documented by anthropologists and scholars of religion (Bell, 1992; Beyer, 2010; McLaren, 1984). Religious rituals habitually use elements such as music, chants, prayers, symbols, and objects in order to direct and manipulate experience. The power of such rituals to alter perception has been documented widely and has not been limited to the field of religion but also observed in many other domains of culture including politics, sports and even business (Bartošová, Burešová, Dacerová, & Valcová, 2017; Koschmann & McDonald, 2015; Kottak, 1978; Piepiora, Bagińska, Szczepańska, & Piepiora, 2022).
The current resurgence of popular interest in psychedelics has been accompanied by an attendant rise of interest in ritual. Ceremonial settings involving the ingestion of natural psychedelics, most notably ayahuasca, psilocybin mushrooms, and peyote, have introduced great numbers of Westerners to rituals and their ability to shape perception, experience and efficacy (Beyer, 2010; Fotiou, 2012; Gearin & Labate, 2018; Labate, Cavnar, & Gearin, 2017; Marcus, 2020). In many such instances, ritual is recognized as playing a no smaller, or even greater role, than the direct effects of said psychedelics. Reports have circulated of control-group participants who experienced psychedelic effects and experiences while receiving only placebo (Olson, Suissa-Rocheleau, Lifshitz, Raz, & Veissiere, 2020; Uthaug et al., 2021) and of ayahuasca communities which (for legal reasons) undergo transformational processes while performing rituals that involve nothing but water (Hartogsohn, 2021).
Ritual plays an integral part in many non-medical modalities of psychedelic therapy (Pollan, 2018). And while medical science is characteristically reluctant to incorporate ritual into its set of tools, current psychedelic therapy protocols employ many of the elements of ritual as part of its consideration of set and setting, including careful preparation, the setting of intention, the setting apart of spatial and temporal boundaries, the use of music, mindfulness, and meditative practices (Guss, Krause, & Sloshower, 2020; Haden, 2023; Oak et al., 2015).
The Psychoactive Clinic project emerged from the insight that patients prescribed psychiatric medication may derive benefit from the thoughtful use of ritualistic principles, inspired in part by the types of carefully arranged spaces characteristic of the psychedelic therapy movement, and informed by the broader literature about ritual and its utility described above. The project's main hypothesis is that improving set and setting conditions will lead to improvements in treatment outcomes: including safety, subjective experience, satisfaction, perceived efficacy of the drug, and generally the establishment of a healthy relationship between the patient and the prescribed drug. As noted above, psychedelics appear to be particularly context-dependent in their effects (Becker, 1967; Hartogsohn, 2020), perhaps due to the action of the 5-HT2A receptor as suggested by Carhart-Harris et al. (2018), Carhart-Harris and Nutt (2017) or their meaning enhancing properties (Hartogsohn, 2018). Nevertheless, research provides support for the more modest but nevertheless highly significant role of extra-pharmacological variables (set and setting) in shaping the effects of many other non-psychedelic psychoactives including alcohol, cocaine, opiate medication, and methamphetamines (Chauvet, Goldberg, Jaber, & Solinas, 2012; Dwyer & Moore, 2013; Hart, 2013; Heath, 1998; MacAndrew & Edgerton, 2003; Stairs, Klein, & Bardo, 2006; Zinberg, 1984). Among other things it has been shown that extra-pharmacological factors have dramatic effects on crucial parameters which are not commonly viewed as susceptible to suggestion such as rates of addiction development, the development of tolerance and occurrence of drug overdoses (Alexander, Coambs, & Hadaway, 1978; Carroll & Lac, 1993; Dworkin, Mirkis, & Smith, 1995; Robins, Helzer, Hesselbrock, & Wish, 2010; Siegel, Hinson, Krank, & McCully, 1982). Additionally, recent research has focused attention on the potential of mindfulness techniques in reducing drug abuse and substance dependence (Cavicchioli, Movalli, & Maffei, 2018; Dundas, Ravnanger, Binder, & Stige, 2020; Tang, Tang, & Posner, 2016; Witkiewitz, Marlatt, & Walker, 2005).
Methods
Keeping the well-documented phenomenon of prescription drug abuse in mind, the project aligns itself with established principles of harm reduction: most notably, a humanist emphasis on inclusively and non-judgmentally using education to empower individuals to make better choices, with the aim of reducing harm and increasing benefits. The psychoactive workshops performed as part of the Psychoactive Clinic were designed with these three main types of purposes in mind:
- a.Providing patients with a better (scientifically grounded and attuned to subjective experience) understanding of their diagnosed conditions (Anxiety/ADHD) and the action mechanisms and properties of their prescribed medication (anxiolytics/stimulant ADHD medication).
- b.Providing patients with a supportive setting and guidance on how to consume their prescription medication more mindfully (e.g. instructing participants in ways that raise awareness to the effects of medication and to the individual's ability to act in ways that supports or negates medicative effects).
- c.Providing patients with non-pharmacological techniques for coping with their medical conditions (e.g. using breathwork and mindfulness to cope with anxiety, thereby reducing the need for medication).
The project was led by an MD and supported by a philanthropic grant throughout its existence (14 months). A comfortable, pleasant space was secured where workshops were held, with between 6 and 14 participants. Overall, a total of 110 participants took part in 16 sessions. These participants were recruited from the patient population of the leading MD, through use of social media advertising, and through word of mouth. Workshops were 4–5 h long and included a lecture on the relevant psychiatric condition (anxiety disorders/ADHD), the action mechanism of the relevant psychiatric medicine (anxiolytics/simulant ADHD medication) and non-pharmacological mitigating strategies for medical conditions. The two types of workshops differed significantly from each other in certain parts as detailed below. The educational as well as the experiential segments of the workshops were led by the MD that initiated the project, who is an experienced group facilitator.
Relaxation (Anxiolytics) workshop. (N = 70)
The workshop included a sharing circle that allowed users to share the stories of their condition and their personal history of psychiatric medication use. A lecture on the subject of anxiety disorders and the properties of anxiolytics medication was held, and some non-pharmacological mitigating strategies were presented such as breathing and meditation. The ACT (Acceptance Commitment Therapy) model was presented to participants as a helpful model for confronting their mental challenges. Patients were encouraged to become more mindful of their psychiatric drug use by paying concerted attention to their mental states and reasons for use at the time of ingestion, in an effort to de-automate ingestion. Patients were encouraged to allow the creation of an awareness buffer between the stimulus for use and actual use, in which a more conscious type of intention can be invoked.
A communal and mindful ingestion of the relevant psychiatric medicine occurred towards the end of the first part of the workshop. This part included encouragement to set an intention for use and to sensually engage the sight and tactile sensations of the pill. The second part of the evening, which was timed to begin as the effects of the drug were making themselves felt, was held in a separate space where participants lay on yoga mattresses. It consisted of an experiential journey which included guided practice and live music by experienced sound healers. The experiential session was followed by another round where participants shared their experiences and insights from the musical session, and what parts of it may prove useful in the future, encouraging introspection and reflection.
In the days after the events participants received an email with a link to an anonymous survey about their workshop experience (the event's social media posts included a request to participate in the survey) and were contacted by an anthropologist, the second author, who was not directly involved in leading the workshops, for short semi-structured interviews. A relaxation/focus playlist with tracks from the workshop was also included. Some (n = 58 for both workshop types) of the participants returned to the regular treatment by the MD leading the study and workshop. The rest returned to their primary care physician with a letter by the MD leading the event, which provided details on the workshop.
Focus (Stimulant ADHD medication) workshop. (n = 40)
The focus workshops were similar in form to the relaxation workshops, but with educational materials focused on the subject of ADHD focus, and control, and on the mechanisms and properties of stimulant ADHD medication. Participants were instructed on techniques for improving focus and non-pharmacological, interventions which may support the efficacy of medication (e.g. planning and focusing on specific tasks; using visual cues like markers and orderly workspace environment; 'warming up' to the task using movement/music/crossword puzzles).
The other significant difference between the two workshops was the experiential stage. Rather than a musical relaxation session experienced supine, the experiential session was divided in two. The first part included an experience of concentration and loss of concentration induced through a video of concentration-dependent optical illusion in which participants were able to clearly identify in which moments they are getting distracted, and which 'internal muscle' is used to retain concentration (eChalk, 2015; McEwen, Paton, Tsuchiya, & van Boxtel, 2020). The second part was a guided musical experience where participants were asked to focus their attention on different instruments participating in a musical piece (Afternoon Break, 2021). A second listening session was held to highlight the insight that the diverse instruments present in the piece can be perceived or not perceived, depending on attention and focus.
Financial model and limitations for research
While the workshops were not intended to turn in a financial profit, participants paid a nominal fee of 70 NIS (around 20 USD) for their participation. This was done in order to increase participants' commitment to the workshop process, but also because the project was originally conceived less as a research project, and more as an attempt for creating a financially viable model that could be implemented without philanthropic support and operate continually (This was not achieved. The real cost of the event, had it not been for the philanthropic funds made available, would have been several times higher). Importantly, owing to the primarily practical motivations for the current project, the results are limited and incomplete and should be viewed as a preliminary report which requires further investigation. It is our hope that future research will examine more rigorously the promising avenues for exploration charted in this paper.
Ethics
Participants were patient prescribed with psychiatric medication and expressed interested in and gave consent to participating in an experiential workshop intended to facilitate the mindful use of psychiatric medication.
Results
Quantitative
The quantitative survey included a relatively small number of participants (n = 33) and its results should therefore be viewed as preliminary only. The most significant results regarded participants' self-assessed understanding of the drug and its effects. More particularly, self-assessed knowledge regarding the medication's mechanism of action rose 75% from 1.6 to 2.8 (on a scale of 1–5); knowledge regarding the timing and duration of medicative effects rose 52% from 2.1 to 3.2; and knowledge regarding the interactions between medication and mental state rose 77% from 1.8 to 3.2. (insignificant results were arrived at in 5 other measures of knowledge). These results were in line with the workshop's goal of providing participants with better understanding of drug action and effects that can assist them in making apt decisions regarding their prescription drug intake. Other indices in this domain yielded only unsignificant differences.
Participants demonstrated a high level of satisfaction with their participation in the workshop as demonstrated both in interviews and in the qualitative surveys measuring their satisfaction with the theoretical knowledge taught (4.1), the experiential session (4.4), the quality of instruction and guidance (4.5), physical conditions (4.4) and sense of safety (4.4). A lower rating was given to the practical tools provided (3.5). Participants rated the experience as interesting (4.4), instructive (4.1), enjoyable (4) and meaningful (3.9).
On the subjects of skills, participants indicated a better understanding of the body's mechanism of natural relaxation (70% increase, from 2.2 to 3.4); being better able to identify factors amplifying anxiety (18% increase from 3.3 to 3.9); and identify their thought patterns (13% increase, from 3.7 to 4.2). Nevertheless, on five other measures the survey did not yield statistically significant results.
Qualitative
Semi-structured interviews with workshop participants yielded significant insights on participants' experiences. One theme that recurred in the interviews was an interest in psychedelic therapy, which apparently contributed to the interest in participating in a workshop that was advertised as including elements and methods inspired by psychedelic therapy.
Participants were additionally enthusiastic about the communal, group character of the workshop and indicated deriving benefit from meeting others who deal with similar conditions. Some indicated that listening to others who confront similar problems provided them with a helpful perspective on their own situation. Others were thankful for the opportunity to share. These results are in line with the growing discourse that argues for the benefits of the communal aspect of set and setting in psychedelic research and critiques the individualist, solitary nature of psychedelic therapy (Gonzalez et al., 2021; Newson et al., In Review). Many of the participants indicated an interest in participating in future workshops of the kind.
Many participants were particularly interested in the concept of mindful ingestion of their psychiatric medication. Participants described this concept as novel and meaningful and were enthused about the idea of introducing intention into their medication use as a way to better control its outcomes. As one participant described it: “my main takeaway is that there is no contradiction between chemical medication and spiritual processes.” Some of the participants indicated that they have been able to integrate these ideas into their daily routine – investing greater attention and intention into moments of drug ingestion, and the period following ingestion.
Selected case studies
To add depth to the results described above, three case studies are provided, which include greater detail on the types of processes reported by workshop participants. These are not intended to be representative but rather to highlight the significant efficacy of the described intervention in selected cases.
Amir
“The effect was profound. I see a significant difference since the workshop. I'm better able to relax. It's like taking a higher dosage but without taking a higher dosage, and this persists even after the pill has subsided – in the hours and days that follow.”
Question: What particularly did you find helpful about the workshop?
“We learned about the GABA system, and about GABA being produced by the body, and that it's good to practice relaxation techniques before taking the pill and taking it with intention. Not just taking it without paying attention. And then doing these relaxation techniques in the minutes and even first hour of the effect. When you combine these techniques together with the pill the effect is much greater.”
Question: has there been a change to the way you view the pills since the workshop?
“I view them as a very powerful and meaningful tool. I don’t take them as often, to be honest, but when I do, they give me a stronger, more meaningful effect. I feel a kind of respect for their potential.
What kind of value did you derive from the workshop?
“There are two types of doctors. Conventional MDs and spiritually minded healers. Spiritually minded healers speak about relaxation and are often against conventional medication. Conversely, MDs are in favor of pills but don't go as much into the right way of taking them and how to use other tools to reinforce the effect of the pill. What I liked about this workshop is that it combines conventional knowledge and mental techniques to produce an effect that would be impossible to achieve by using only one of the two.”
Sivan
“It was a shame that I couldn't use Clonex [and therefore was not able to treat her condition and save the pregnancy], so I thought to myself maybe I should give it [Clonex] a dry run, and see if anything changed about my response to it. I arrived in the workshop and went through a very different process than what happened when I was just prescribed a pill, back then. I did not have any of the side-effects I was so worried about. … I felt a lot of confidence, and above all, it became part of my toolbox, so today I know that if anything happens and I need assistance on an SOS level, I have another tool. It's not like SSRI which takes a long time to build up in the blood.”
Question: How has the way you view these pills changed?
“I don't use them anymore. As long as I don't have anxiety, I don’t need to. I only had one goal: to know that if there's an emergency situation there's something I can do.
I now understand the meaning of intention. It matters how you approach mind-altering pills. Now I don’t experience fear anymore. So, it completely changed my perception from something that would be useless to me, to something that with the right guidance of how to take it provides me with reassurance and a valid life-saving option. Thinking back that during the pregnancy I could perhaps have taken the Clonex and endure that situation. There was nothing inherently bad about the pill.”
Question: What type of value did you derive from the workshop?
“I think it's sad not everybody knows about this. This could be a life changer, and in my case, it could have saved a life. You can't just prescribe these pills like that. The value is tremendous.”
Martin
Martin participated in two of the workshops of the psychoactive clinic. One related to pain killers, and the other for anxiolytics. Regarding the painkiller workshop they indicated that it was highly effective, reporting that during the workshop “80% of the pain subsided using breathing techniques” and relating that they have since stopped using the pills. Martin also indicated deriving great benefit from the anxiolytics workshop. He indicated lowering the dosage of his medication and taking medication less often “because as it was explained, this can be unhealthy for the mind and the body. I use the breathing techniques and take a dosage that I'm able to handle, so that the work is not only happening chemically in the brain. I'm very conscious of the possibility of addiction. I don't take the pills every day but only on weekends. I now returned to doing exercise and this works best for me.”
Discussion
Barriers and prospects for future research and practice
Considering that the literature on placebo and the impact of extra-pharmacological factors on drug use outcomes is established and unequivocal, it is surprising that the idea of allowing users prescribed psychiatric medicines to educate themselves about their effects and to approach them mindfully, in a supportive setting, should encounter resistance.
Despite the apparently solid theoretical foundations of this project, and perhaps unsurprisingly, it has encountered opposition from many sides. The organizers' attempts to advertise the sessions to patients prescribed psychiatric medication on social media have led to unexpectedly indignant responses. Members in social media groups dedicated to psychedelics expressed not only a negative, judgmental view of psychiatric medicine but revulsion at the idea of borrowing elements from psychedelic practice (such as the setting of intention) and using it in conjunction with psychiatric medicine. Individuals holding anti-pharmaceutical positions observed the workshop suspiciously, as a cynical attempt of dressing up dangerous synthetic chemicals to appear harmless and attractive. Concurrently, personal communications revealed that many MDs are uncomfortable with too closely engaging the subjective, experiential realms attendant to the use of psychiatric medicine. However, the most daunting opposition came from the Israeli Ministry of Health. After word of the campaign had reached certain government officials, the MD leading the project was called in for an extended questioning by members of Israeli ministry of health.
Overall, the project appears to have challenged many established views about psychiatric medication from both their anti-establishment opponents, as well as from members of the medical establishment. In the case of psychedelic enthusiasts, the objection can be viewed as the fruit of cultural tendency to produce distinctions between purity and taboo (Douglas, 1966) and project a profane other, which is viewed as contrasting with revered psychedelic medicines and natural medicine. In the case of establishment figures such as MDs and health officials, it appears to be a reluctance to openly discuss the subjective, experiential effects of psychiatric medicine, and an attempt to produce a clear distinction between medical use and anything that might resemble pleasurable, recreational use. A striking example of this line of thought is the ban, imposed by the Israeli ministry of Health, for prescribed users of cannabis to use their prescription in company. Cannabis patients are required by law to consume the drug only in isolation from others, presumably to exclude any suspicion of hedonic, social effects (Israeli Ministry of Health, The Medical Cannabis Unit, 2022). Importantly, this runs counter to evidence that communal ingestion of psychedelics often produces superior results (Gonzalez et al., 2021; Newson et al., In Review).
Future research
Alongside these barriers, the enthusiastic response from workshop participants indicates the strong interest of many psychiatric patients in educating themselves about their prescription medication, and ways to increase its efficacy and reduce harm. We believe that, considering the solid theoretical foundations of this approach, further research into this approach is called for. Future research could repeat the current experiment but include control groups and more rigorous follow-up on the manner in which individuals' perceptions and use of their prescribed medication have changed. It may examine, among other things, whether undergoing a workshop of this kind has led to a reduction or rise in the use of psychiatric medication (and in which cases), as well as examining the hypothesis of improved medicative efficacy and their overall satisfaction.
Model for integration into healthcare
The Psychoactive Clinic operated on the basis of a philanthropic grant that was awarded to support alternative initiatives in the field of mental health. While the Israeli Ministry of Health was manifestly unenthusiastic about the project, we believe that the most sensible and viable model for integrating the benefits of this type of intervention into the field of mental health would be for it to be included as an integral part of the array of treatment options offered by state health systems of the kind prevalent in many European countries, as well as in Israel. Educational workshops that foster skills to better manage the effects of prescription medication can be offered as a complementary service to patients prescribed psychiatric medicine, similar to the way that alternative medicine treatments (e.g. acupuncture, reflexology) are made available to patients. Alternatively, they may become an integral part of the process of medication prescription. Israeli patients prescribed with cannabis are required to attend an instructive tutorial on the use of the drug. While such tutorials are commonly excessively technical, focusing on ingestion modes and strains rather than on the subjective experience, a similar model may incorporate greater consideration of complementary techniques, and literacy of the subjective effects of medication.
Importantly, there is room for several varieties of models, tailored to suit the specific pharmacodynamics and effects of different psychiatric psychoactives. The current paper focuses on two types of workshops, but the leading MD has also made experiments with workshops intended to enhance patient literacy regarding additional psychoactives including alcohol, cannabis, opioid pain medication and SSRI medication. The set and setting factors most relevant to each of these substances may be idiosyncratic. Thus, in the case of SSRI medication, where the effects of medication are not instantaneous but accrue over a period of weeks, the relevant model is a 6-week group model where participants begin taking the medication together in the first meeting, and attend weekly meetings which allow space for reflection, discussion, group formation and a process of learning.
Conclusions
The current resurgence in psychedelic research has stimulated interest in extra-pharmacological factors shaping drug effects. This trend has been influential to the current project, which sought to examine the effect of enhancing set and setting conditions for improving subjective and clinical outcomes. The results of this preliminary research support the hypothesis that a workshop aimed to increase knowledge, understanding and skills in using psychiatric drugs may lead to improvements in drug efficacy, safety, and subjective satisfaction.
Funding sources
Authors YY and OBE received a philanthropic grant which enabled the facilitation of the reported study. IH did not receive any funding.
Author contributions
OBE developed the concept for the reported study, arranged and led the study. YY was responsible for interviews and survey results. IH was responsible for the writing and preparation of the manuscript, with consultation from OBE.
Conflict of interests
The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.
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While Leary coined the term, others before him have provided the theoretical scaffolding on which the concept rests. Savage (1956) even uses the terms “set” and “setting” though not in conjunction and as a coherent concept. (For more early explorations of the subject see Eisner & Cohen, 1958; Hyde, 1960).
This environment includes among other things the social and operative environment. A salient social difference is that while non-medical (traditional and recreational) users of psychoactives typically prefer taking them in groups, a group dimension is absent from medical use. Operatively, it is different to take an anxiolytic and focus on one's breathing than it is to take the pill and watch the evening news.
One may ask: is a psychedelic therapy-inspired model optimal for non-psychedelic drugs? Importantly, while some of deployed techniques are inspired by psychedelic therapy and the psychedelic renaissance more generally (e.g. mindful ingestion, cultivating intention and use of music), the aim of the project was not to replicate the protocols of psychedelic therapy. Different psychoactives call for different forms of interventions. For instance, an SSRI focused workshop was envisaged, which includes group meetings over the duration of several weeks, with greater focus on day-to-day reflection and group building, in accordance with the gradual accretion of SSRI medication effects.