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Table 2 Full exclusion criteria

From: PAM trial protocol: a randomised feasibility study of psychedelic microdosing–assisted meaning-centred psychotherapy in advanced stage cancer patients

 

Exclusion criteria

Treatment

Currently participating in a clinical trial of a systemic anti-cancer treatment

Physical health

Pregnant or lactating BMI < 18.5

Diagnosis of cerebral metastases

Karnofsky performance scores below 50 or other physical limitations that preclude participation in weekly psychotherapy and microdosing of LSD

Lab work

Liver function test > 3 times the upper limit of normal or creatinine clearance < 30 mL/min

Diagnosis

Have a current diagnosis or history of any medical condition that could make receiving a sympathomimetic drug harmful because of potential increases in blood pressure and heart rate as assessed by a study physician

Vital signs

Cardiovascular conditions including abnormal heart rate seen by ECG

Blood pressure not exceeding 160 mmHg (systolic) and 90 mmHg (diastolic) (measured at three time points)

Mental health

 Diagnosis

Lifetime history of schizophrenia or other psychotic disorders, or bipolar I or II disorder as assessed by the Standard MINI (Standard version 7.0.2)

A current diagnosis of PTSD, panic disorder, agoraphobia, OCD, anorexia, and bulimia as assessed by the Standard MINI (Standard version 7.0.2)

 Current risk

Elevated risk of suicide as determined by the Columbia-Suicide Severity Rating Scale (C-SSRS) or by a study psychiatrist

 Drug use

Any lifetime history of psychedelic microdosing; defined as repeated low-dose psychedelic usage for more than a week at a time

Use of a psychedelic within the last year

Recent or current use of illicit drugs including methamphetamine, heroin, and synthetic cannabis. Other non-prescribed drugs will prompt exclusion at the discretion of a study physician

Current THC/cannabis usage will prompt exclusion if the participant does not agree to cease. However, CBD is permitted, and usage will be recorded