British Journal of Pharmacology
December 19, 2024
David J Nutt, Peter Hunt, Anne Katrin Schlag et al.
21 citations
In 2023, the Australian Therapeutic Goods Administration (TGA) approved psilocybin for treatment-resistant depression and MDMA for PTSD, effective from 1 July 2023. The approval followed a campaign led by Mind Medicine Australia, Professor David Nutt, Drug Science, and Monash University professors, supported by clinical, academic, and patient groups. Prescribing rights are limited to psychiatrists authorized under the TGA's Authorised Prescriber Scheme. This paper reviews the background of the decision, its implications for approvals in other jurisdictions, and development pathways for other psychedelic drugs.
Frontiers in Psychology
May 11, 2023
Hannah Thurgur, Meg J. Spriggs, Ashleigh Murphy-Beiner et al.
13 citations
A framework called Access, Reciprocity and Conduct (ARC) is proposed to build an ethical and equitable infrastructure for psychedelic-assisted therapy (PAT). ARC rests on three pillars: ensuring equal access to PAT for those needing mental health treatment, promoting safety for those delivering and receiving therapy, and respecting traditional and spiritual uses of psychedelic medicines. The framework is being developed through a dual-phase co-design approach, first co-creating ethics statements with stakeholders from research, industry, therapy, community, and Indigenous settings, then inviting broader collaborative review. The authors aim to spark dialogue and help organizations and practitioners address complex ethical questions in PAT.
Drug Science Policy and Law
September 1, 2025
David Nutt, David Erritzøe, Anne Katrin Schlag et al.
9 citations
The field of psychedelic research lacks standardized terminology for clinical development, dosing, safety monitoring, and regulatory classification. A comprehensive framework is proposed that classifies psychedelics by pharmacology (serotonergic, glutamatergic, kappaergic, GABAergic, and atypical), introduces dose-dependent categories (microdose, minidose, mididose, macrodose), and standardizes terms like “short-acting” with specific pharmacokinetic parameters. Safety considerations include cardiovascular and psychological effects, with risk mitigation protocols for higher-risk compounds like ibogaine. A three-phase treatment model—preparation, dosing, and integration—is recommended as a minimum standard. The lack of comparative research on psychotherapy modalities is identified as a critical gap.
Drug Science Policy and Law
January 1, 2022
Plinio Ferreira, Adam Winstock, Anne Katrin Schlag et al.
9 citations
Nitrous oxide (laughing gas) and alkyl nitrites (poppers) rank among the least harmful recreational drugs when assessed on 16 criteria including dependence, injury, and economic cost. An expert panel using Multi-Criteria Decision Analysis scored nitrous oxide at 6 and poppers at 5 on a 0–100 overall harm scale, placing them just above magic mushrooms (psilocybin). Nitrous oxide scored higher for dependence, environmental damage, mental impairment, and family adversities; poppers scored higher for injury, drug-related damage, economic cost, and mortality. The findings aim to inform UK policy decisions, as nitrous oxide possession is not currently controlled under the Misuse of Drugs Act.
Drug Science Policy and Law
January 1, 2022
Rayyan Zafar, Dustin Sulak, Jaime Brambila et al.
3 citations
A 49-year-old woman with metastatic breast cancer (ER+, PR-, HER2+, BRCA-) received targeted chemotherapy and a ketogenic diet for 26 months, then added a high-dose cannabinoid regimen (CBD and THC) and psilocybin-assisted psychotherapy. After five months, PET/CT scans showed no evidence of metastatic disease, and chemotherapy was stopped. A one-year follow-up CT found no residual or recurrent disease. Recurrence appeared at 18 months, when the cannabis dose had been reduced to 60% of the initial protocol; increasing it back to the original dose was followed by receding cancer progression over 16 months. The case suggests potential therapeutic utility of adjunctive cannabinoids and psychedelics in metastatic breast cancer.
Qualitative Health Research
February 17, 2026
Zaynab Khan, Sterre Weaver, Rachael V. Dando et al.
1 citation
Seven women in the United Kingdom with a current or previous cancer diagnosis were interviewed about their attitudes toward using psilocybin for mental health. Four had used psilocybin and three had considered it. Participants viewed psilocybin as a needed alternative to traditional treatments for depression and anxiety linked to their cancer diagnosis, but they felt its illegal status was a major barrier to access. Three themes emerged: somatic healing needs, illegality as both a burden and boundary, and reconnecting self, nature, and mortality. The authors suggest a compassionate access scheme in the UK could transform mental health care for people with cancer.
PLoS ONE
June 18, 2026
Elisa Liberati, Hv Curran, Peter Fonagy et al.
MDMA-assisted psychotherapy shows promise for treating PTSD, but the psychological mechanisms behind its effects are not well understood. This qualitative study will have approximately 25 experienced psychodynamic psychotherapists receive two doses of MDMA (80-120 mg, oral) in an open-label design. Participants will complete interviews before, during, and after MDMA sessions, plus daily journals. Researchers will use phenomenological and thematic analysis, along with grounded theory, to develop a model of MDMA's psychological mechanisms of action. The study treats therapists as expert observers of their own psychological processes, aiming to generate insights that can inform future treatment models and offer a framework for qualitative mechanistic research on psychedelics.