Clinical TrialPalliative & End-of-Life DistressLSDPlaceboNot yet recruiting

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 evaluates LSD microdosing (starting at 8 µg, twice weekly for 6 weeks; 13 doses total) alongside Meaning-Centred Psychotherapy.

Target Enrollment
40 participants
Study Type
Phase II interventional
Design
Randomized, single Blind

Detailed Description

Randomised, parallel-group, double-blind feasibility trial comparing LSD microdosing plus manualised Meaning-Centred Psychotherapy (7 weekly 1-hour sessions) versus MCP plus matched placebo vials in people with stage IV solid tumours.

Active dosing is sublingual LSD microdoses delivered from single-use vials with a titration protocol (min 4 µg, start 8 µg, max 12 µg) taken twice weekly for a total of 13 occasions; some doses supervised at clinic visits and others self-administered at home; up to seven break-weeks permitted.

Feasibility outcomes include medication adherence, MCP attendance and fidelity, use of break-weeks, recruitment and attrition; sense of meaning assessed with the Personal Meaning Index at baseline, mid- and end-treatment, and at 1- and 6-month follow-up.

Study Protocol

Preparation

7 sessions
60 min each

Dosing

13 sessions

Integration

sessions

Therapeutic Protocol

existential humanistic

Study Arms & Interventions

LSD microdose + MCP

experimental

Lysergic acid diethylamide microdosing combined with Meaning-Centred Psychotherapy (MCP).

Interventions

  • LSD8 - 12 µg
    via Sublingual• twice weekly• 13 doses total

    Sublingual LSD microdose titration (min 4 µg, max 12 µg, adjust by 1 µg); starting 8 µg; vials up to 15 µg; mixed supervised (clinic) and unsupervised (home) dosing; 13 doses over 43 days.

Placebo + MCP

inactive

Meaning-Centred Psychotherapy with matched inert vial (placebo) administered sublingually.

Interventions

  • Placebo
    via Sublingual• twice weekly• 13 doses total

    Inert liquid (water/saline) in identical vials; same extraction/administration procedure; supervised and home dosing as per active arm.

Participants

Ages
25 – 99
Sexes
Male & Female

Inclusion Criteria

  • Diagnosis of an incurable stage IV solid organ malignancy.
  • Prognosis of at least 6 months life expectancy from the time of screening.
  • Score of 4 or higher on the distress thermometer.
  • Agree to have study visits video and/or audio recorded.
  • Agree to inform the Investigators within 48 hours of any medical conditions and procedures being undertaken.
  • Willing for the Investigators to communicate directly with their medical team to determine medical suitability for study participation (oncologist, GP, palliative care physician, etc).
  • Agree to refrain from starting any new psychiatric medication and/or psychotherapy during the study period.
  • Agree to have transportation other than driving themselves to where they are staying on the days of medication dosing.
  • Able and willing to be contacted via telephone for all necessary telephone contacts.
  • Agree to use an effective form of contraception if of child-bearing potential for the duration of medication dosing.
  • Must provide a contact/support person in the event of being unreachable by study staff or in the event of severe distress or suicidality.
  • Proficient in speaking and reading English.
  • Agree to not use any medications on the prohibited medications list during the course of the study.
  • Agree not to take any herbal supplement for the duration of medication dosing (except with prior approval of the research team).

Exclusion Criteria

  • Currently participating in a clinical trial of a systemic anti-cancer treatment.
  • Pregnancy or lactating.
  • BMI < 18.5.
  • Diagnosis of cerebral metastases.
  • Karnofsky performance score below 50 or other physical limitations that preclude participation in weekly psychotherapy and microdosing of LSD.
  • Upon review of psychiatric history (MINI v7.0.2), participants must not have any current or past diagnosis that would be considered a risk to participation: lifetime history of schizophrenia or other psychotic disorders, or bipolar I or II disorder.
  • Current diagnosis of PTSD, panic disorder, agoraphobia, OCD, anorexia, or bulimia.
  • Liver function test >3 times the upper limit of normal or creatinine clearance <30 mL/min.
  • History of any medical condition that could make receiving a sympathomimetic drug harmful (e.g., prior myocardial infarction, cerebrovascular accident, aneurysm); other mild, stable chronic medical problems may be allowed at investigator discretion.
  • Recent or current use of illicit drugs including methamphetamine, heroin and synthetic cannabis; other non-prescribed drugs excluded at discretion of study physician.
  • Current THC usage will prompt exclusion if participant does not agree to cease (CBD permitted and recorded).
  • Any medical disorder judged by the investigator to significantly increase the risk of LSD administration or likely to produce symptoms that could be confused with side effects of the IMP will require exclusion.
  • Any lifetime history of psychedelic microdosing (repeated low-dose psychedelic usage for more than a week at a time).
  • Use of a psychedelic within the last year.

Study Details

Locations

Unknown facility — Australia

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