The need for publicly funded research on therapeutic use of psychedelic drugs

This perspective paper (2021) advocates the need for public funding of independent evaluations of the efficacy of psychedelic drugs, given that current research efforts spurred by private philanthropic interests may propel a widespread use of psychedelics and demands to implement them as a first-line treatment, ahead of the evidence on their safety, efficacy, and long-term effects.

Authors

  • Hall, W.

Published

World Psychiatry
meta Study

Abstract

No abstract provided.

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Research Summary of 'The need for publicly funded research on therapeutic use of psychedelic drugs'

Introduction

The paper opens by defining psychedelic drugs as substances that produce unusual changes in thought, mood and perception without causing major physiological dependence or profound cognitive impairment. Classic psychedelics listed include mescaline, psilocybin, LSD and DMT, and the author notes that these agents share action at the 5‑HT2A serotonin receptor; MDMA is also discussed, although it differs in that it does not produce the classic perceptual effects. Hall places this pharmacological and historical background in the context of a two‑decade revival of clinical research, driven in part by encouraging Phase II results for psilocybin in treatment‑resistant depression and for MDMA‑assisted psychotherapy in PTSD, and by regulatory interest from agencies such as the US Food and Drug Administration. Against that backdrop, the article sets out to argue for publicly funded, independent research on therapeutic uses of psychedelic drugs. Hall highlights gaps and risks in the existing evidence base — notably small, philanthropically funded trials, potential investigator enthusiasm bias, short follow‑up durations, and methodological challenges such as blinding — and frames the paper as a rationale for larger, representative trials with longer safety and efficacy follow‑up to inform clinical practice and policy decisions.

Methods

The extracted text does not present a formal Methods section or describe a systematic literature search. Rather, the paper is a narrative commentary that synthesises findings from recent clinical trials, regulatory developments, population surveys and selected safety follow‑ups to build an argument for public funding. Key sources referenced in the text include Phase I–II clinical trials of psilocybin and MDMA, follow‑up safety data from laboratory studies (for example, a longitudinal report of 110 participants), epidemiological comparisons of population use and abuse potential, and examples of policy developments such as citizen initiatives and compassionate access requests. Because the paper is an opinion/position piece, there is no primary data collection, randomisation, statistical analysis plan or risk‑of‑bias assessment described in the extracted text. Statements about trial design challenges (for example, difficulties with blinding) and about patterns of use and tolerance are reported from earlier studies rather than derived from novel methods presented here.

Results

Hall summarises the recent empirical and regulatory landscape for psychedelic therapies. He reports that Phase II trials have produced substantial benefits: psilocybin showed clinically meaningful effects in treatment‑resistant depression, and MDMA‑assisted psychotherapy showed benefits in PTSD, prompting FDA encouragement of further research. Psilocybin is preferred in current trials over LSD because it has a shorter duration of action (approximately 4–6 hours versus 8–12 hours), a better‑understood pharmacology, and is perceived as less likely to produce 'bad trips' or carry cultural stigma. The author describes methodological challenges in controlled trials: full participant and therapist blinding is effectively impossible because the experiential effects are obvious, so recent trials have used active placebos (examples given are methylphenidate or dextroamphetamine) or dose‑ranging designs to probe dose–response. On safety and abuse potential, Hall cites arguments and data indicating a relatively low abuse liability for psilocybin: it does not typically produce euphoria or animal self‑administration, population surveys show much lower rates of regular use than for cannabis, cocaine or opioids, and tolerance develops rapidly so continued use is uncommon. He summarises a follow‑up report by Studerus et al. of 110 laboratory participants (40% had used a psychedelic at least once) followed 8–16 months: common short‑term adverse effects were minor (fatigue, headache, lack of energy, difficulty concentrating the day after), while 11 individuals reported negative changes in psychological well‑being and/or mental functioning; one person experienced persistent emotional instability, anxiety and depressive feelings attributed to suppressed memories released by the drug and later improved with psychotherapy. Hall also characterises psilocybin as a potentially 'disruptive' treatment because single doses can produce rapid clinical responses—unlike SSRIs that require weeks—and benefits can be sustained for up to six months in a substantial subset of patients. Nonetheless, he emphasises interconnected limitations of the evidence base: most trials are small because philanthropic rather than public or industry funding predominates; investigators involved often have pro‑therapeutic beliefs about psychedelics; and follow‑up durations and representative sampling are limited. Finally, the paper outlines potential policy and clinical risks should approval occur without broader evidence: demands for off‑label and first‑line use, relaxed therapist qualification standards, compassionate access for untested plant‑based psychedelics (for example, ibogaine or ayahuasca), and political pressure toward legalisation via citizen initiatives.

Discussion

Hall interprets the assembled evidence and policy context to argue that public funding of independent research is urgently needed. He contends that reliance on philanthropic sources and investigator‑led small trials risks biased or incomplete evidence, and that clinical uptake or legalisation could outpace robust assessments of safety, efficacy and long‑term outcomes. The discussion emphasises that approval for narrow indications (for example, treatment‑resistant depression or PTSD) may provoke broader use—first‑line prescribing, off‑label prescribing for other anxiety or depressive disorders, or demands for access to other psychedelic substances—if regulators and health systems do not insist on appropriately powered and representative trials. The author highlights the difficulty of maintaining rigorous trial methods in psychedelic research, particularly the impossibility of perfect blinding, and notes that some safety concerns have emerged even in controlled laboratory settings. He therefore calls for larger trials with patient samples representative of the clinical populations likely to receive these treatments, longer follow‑up to assess sustainability of benefit and late adverse events, and independent evaluation funded by public agencies to reduce conflicts of interest. Hall frames these steps as necessary both to protect patients and to inform policy decisions about clinical implementation, compassionate access schemes and potential liberalisation of adult nonmedical use. The extracted text acknowledges the central limitations of current evidence—small sample sizes, investigator enthusiasm, limited follow‑up—and uses these to justify the recommendation for publicly supported research.

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WAYNE HALL

University of Queensland National Centre for Youth Substance Use Research, Brisbane, QLD, Australia 1. Grinspoon L, Bakalar J. Psychedelic drugs reconsidered. New York: Basic. Yaden D, Anderson D, Mattar M. In: Ellens J, Robers T (eds). Psychedelic policy quagmire: health, law, freedom, and society. Santa Barbara: Praeger, 2015:267-93. 9. Ribeiro S. In: Labate BC, Cavnar C (eds). Plant medicines, healing and psychedelic science. Cham: Springer International, 2018:133-49. DOI:10.1002/wps.20847

RATIONALE FOR AND USEFULNESS OF THE INCLUSION OF GAMING DISORDER IN THE ICD-11

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