A feasibility study of Psychedelic... — Clinical Trial Details

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.

Participants

Ages

25 – 99

Sexes

Male & Female

BMI

18.5 - +

Psychosis History

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.

Company

Product

Legal

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

Detailed Description

Study Protocol

Preparation

Locations

Related Publications

It's all about the relationship: The caregiver experience of supporting a person with advanced cancer going through an LSD microdosing trial

Dosing

Integration

Therapeutic Protocol

Study Arms & Interventions

LSD microdose + MCP

Interventions

Placebo + MCP

Interventions

Participants

Inclusion Criteria

Exclusion Criteria

Study Details