A feasibility study of Psychedelic Microdosing-Assisted Meaning Centred Psychotherapy in advanced stage cancer patients (PAM Trial)

This double-blind, placebo-controlled feasibility trial (n=40) investigates Psychedelic Microdosing-Assisted Meaning-Centred Psychotherapy (PA–MCP) in advanced-stage cancer patients. Led by Dr Lisa Reynolds at The University of Auckland, the study aims to evaluate the effects of LSD microdosing (starting at 8 mcg, 2 times a week for 6 weeks) alongside Meaning-Centred Psychotherapy.

Participants, diagnosed with incurable stage IV solid organ malignancy, will be randomly assigned to either PA–MCP or Placebo-MCP. The primary outcomes include feasibility measures (adherence, attendance, treatment fidelity, recruitment, and attrition), acceptability (assessed through open-ended questions and interviews), and safety (vital signs, adverse effects). Secondary outcomes encompass various psychological measures and quality-of-life assessments.

The study is funded by the Health Research Council and MindBio Therapeutics Ltd, with approval from the Southern Health and Disability Ethics Committee. Recruitment is anticipated from June 2023 to June 2024 in Auckland, New Zealand.

The trial protocol has been published as “PAM trial protocol: a randomised feasibility study of psychedelic microdosing–assisted meaning-centred psychotherapy in advanced stage cancer patients.”

Trial Details

Psychedelic compounds have shown clinically significant effects in the treatment of psychological distress in patients with advanced stage cancer. Given the challenges of delivering timely and effective intervention in the advanced cancer context, it is possible that an alternative, more pragmatic, approach lies in psychedelic ‘microdosing’. Microdosing refers to repeated administration of psychedelics such as LSD or psilocybin in doses around the threshold for overtly altering perception. The purpose of this study is to evaluate the feasibility of conducting a full-scale randomised controlled trial comparing Psychedelic-Microdose Assisted – Meaning-Centred Psychotherapy (PA–MCP) to standard Meaning-Centred Psychotherapy (MCP) in people who have a life-threatening cancer diagnosis and symptoms of anxiety and/or depression. Although MCP is a well-established psychotherapeutic treatment in advanced cancer populations (Breitbart et al., 2010; Breitbart et al., 2012), to date, there has been no research that investigates whether the efficacy and effectiveness of this therapy might be improved if delivered alongside a standardised microdose regimen of a psychedelic compound. Participants with advanced stage cancer and symptoms of anxiety and/or depression (N=40; 20 Maori, 20 non-Maori) will be randomised under double-blind conditions to receive MCP alongside repeated doses of either an LSD microdose (PA–MCP) or inactive placebo. The feasibility, acceptability and safety of this intervention and physiological and psychological measures will be recorded at baseline and after completion of each session of MCP and at a one month and six-month follow-up. Our findings will enable a rigorous evaluation of the feasibility of a larger randomised controlled trial and provide initial indication of potential benefits of psychedelic microdosing for psychological distress in advanced stage cancer patients.

NCT Number ACTRN12623000478617

Data attribution

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