2019: A year of expansion in psychedelic research, industry, and deregulation

Aday, Jacob S.; Bloesch, Emily K.; Davoli, Christopher C.

doi:10.1177/2050324520974484

Cited by 37 publications

(34 citation statements)

References 17 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…Psychiatry and psychotherapy need to acknowledge these practices and establish borders between safe and evidence-based clinical strategies versus self-development and recreational uses outside of medical contexts. Additionally, a growing number of companies and entrepreneurs enter the public discourse who are shaping a developing psychedelic industry [53]. Letcher (2007;[52]) simplified this into 2 competing polarities.…”

Section: Communicating Psychedelic Therapies Within the Scientific Community And To The Larger Public And Patientsmentioning

confidence: 99%

The Potential Role of Psychedelic Drugs in Mental Health Care of the Future

Gründer

Jungaberle

2021

Pharmacopsychiatry

View full text Add to dashboard Cite

Serotonergic psychedelics such as psilocybin, lysergic acid diethylamide (LSD), or dimethyltryptamine (DMT), as well as psychoactive drugs that trigger phenomenologically- related experiences like 3,4-methylenedioxymethamphetamine (MDMA) and ketamine, belong to the most promising treatment approaches in contemporary psychiatry. Psychedelic-assisted psychotherapy is not only a new treatment paradigm in psychopharmacology, but it also requires a redefinition of psychotherapeutic processes and the contextualization of psychopharmacological interventions within a new treatment infrastructure. Crucial for future practice and research in the field are (1) informed patient referral and co-treatment practices, (2) screening (e. g., choosing the right patients for these therapies), (3) the dosing preparation sessions, (4) the assisted dosing sessions as well as after-care procedures such as (5) psychological integration and (6) supporting the development of structured patient communities. Definition of future treatment delivery infrastructures and requirements for therapist training are further challenges for research and practice. Finally, the implementation of psychedelic-assisted psychotherapy in routine mental health care must be embedded into public communication about the potential and risks of these innovative therapeutic approaches. This paper provides a synopsis of challenges for practitioners, researchers, and regulators to be addressed in the approval processes of psychedelics.

show abstract

Section: Communicating Psychedelic Therapies Within the Scientific Community And To The Larger Public And Patientsmentioning

confidence: 99%

The Potential Role of Psychedelic Drugs in Mental Health Care of the Future

Gründer

Jungaberle

2021

Pharmacopsychiatry

View full text Add to dashboard Cite

show abstract

“…If the challenges related to expectations and masking with psychedelics preclude rigorous RCTs, natural experiments may be another method of evaluating the treatment's effects. With the recent legalization of psilocybin therapy in Oregon as well as successful decriminalization movements across the US (Aday et al 2020a;Marks and Cohen 2021), it is possible that objective indices related to mental health (e.g., suicide rates, emergency room visits for psychiatric issues) could precipitously decrease at the population level if psychedelics are indeed an effective treatment for a variety of psychiatric conditions. Although it is unclear what the initial accessibility of these treatments will be to individuals in states such as Oregon (Williams and Labate 2020), if positive trends in mental health are observed at the population level after introduction of legal psychedelic therapy, the role of expectations may be considered immaterial to the broader benefits to society.…”

Section: Beyond the Scope Of Rctsmentioning

confidence: 99%

Great Expectations: Recommendations for improving the methodological rigor of psychedelic clinical trials

Aday¹,

Heifets²,

Pratscher³

et al. 2021

Preprint

View full text Add to dashboard Cite

Rationale: Psychedelic research continues to garner significant public and scientific interest with a growing number of clinical studies examining a wide range of conditions and disorders. However, expectancy effects and effective condition masking have been raised as critical limitations to the interpretability of the research.Objective: In this article, we review the many methodological challenges of conducting psychedelic clinical trials and provide recommendations for improving the rigor of future research.Results: We found that although some challenges are shared with psychotherapy and pharmacology trials more broadly, psychedelic clinical trials have to contend with several unique sources of potential bias. The subjective effects of a high-dose psychedelic are often so pronounced that it is difficult to mask participants to their treatment condition; the significant hype from positive media coverage on the clinical potential of psychedelics influences participants’ expectations for treatment benefit; and participant unmasking and treatment expectations can interact in such a way that makes psychedelic therapy highly susceptible to large placebo and nocebo effects. Specific recommendations to increase the success of masking procedures and reduce the influence of participant expectancies concern study development, participant recruitment and selection, incomplete disclosure of the study design, choice of active placebo condition, as well as the measurement of participant expectations and masking efficacy.Conclusion: Incorporating these design elements is intended to reduce the risk of bias in psychedelic clinical trials and thereby increase the ability to discern treatment-specific effects of psychedelic therapy

show abstract

“…This is particularly relevant and urgent as a recent YouGov survey revealed that public attitudes to psilocybin assisted therapy are largely positive and supportive of changes to the law to enable patient access (drugscience.org.uk, 2021). For a recent update on clinical trials of psychedelic medicine, and regulation changes in certain countries to enable patient access, see Aday et al, 2020 andGonda et al, 2021.…”

Section: Recent Evidence For the Medical Value Of S1 Drugsmentioning

confidence: 99%

Schedule 1 barriers to research in the UK: An in-depth qualitative analysis

Howard

Neill

Schlag

et al. 2021

Drug Science, Policy and Law

View full text Add to dashboard Cite

Background There is increasing research to suggest that certain Schedule 1 drugs, most notably psychedelics, can be effective in treating a range of mental health disorders. However, due to several practical, financial, and bureaucratic barriers, there is a lack of large-scale trials into their efficacy. This study aimed to explore the barriers, and any facilitators, to undertaking Schedule 1 research through examining the different positions Schedule 1 and other controlled drug researchers place themselves in, and the impact this has on their experiences. Method Semi-structured interviews were conducted with 12 participants. Eight Schedule 1 researchers and four researchers who conduct other controlled drug research. Participants were recruited via purposive and snowball sampling. Interview questions explored how participants’ experiences of controlled drug research were impacted by scheduling laws, and how they might differ from the other group. Results Using discourse analysis, four themes were identified. Three themes differentiated the two groups of researchers and their positions ( differential burden of duties, the importance of privileges, and motivations); the differential burden of duties acted as a barrier to non-Schedule 1 researchers, whereas Schedule 1 researchers were better able to deal with this burden due to higher levels of motivation and more privileges (facilitating Schedule 1 research). One theme suggested solidarity between the groups; others acted as barriers to Schedule 1 research, with government officials preventing changes to drug legislation, and those lacking scientific understanding being discriminatory, causing difficulties getting Schedule 1 projects started. Conclusion Findings highlight the challenges that Schedule 1 researchers are currently facing and suggest that the government should commission an urgent review into this by the Advisory Council on the Misuse on the Misuse of Drugs to make Schedule 1 research process smoother and more accessible. For example, reducing the barriers to research of Schedule 1 substances so as to be in line with the regulations controlling those in Schedule 2.

show abstract

2019: A year of expansion in psychedelic research, industry, and deregulation

Cited by 37 publications

References 17 publications

The Potential Role of Psychedelic Drugs in Mental Health Care of the Future

The Potential Role of Psychedelic Drugs in Mental Health Care of the Future

Great Expectations: Recommendations for improving the methodological rigor of psychedelic clinical trials

Schedule 1 barriers to research in the UK: An in-depth qualitative analysis

Contact Info

Product

Resources

About