A feasibility study of Psychedelic Microdosing-Assisted Meaning Centred Psychotherapy in advanced stage cancer patients (PAM Trial)
- Conditions
- Stage IV Solid Organ MalignancyEnd-of-life distressCancer - Any cancerMental Health - AnxietyMental Health - Depression
- Registration Number
- ACTRN12623000478617
- Lead Sponsor
- The University of Auckland
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 40
Diagnosis with an incurable stage IV solid organ malignancy.
- Prognosis of at least 6 months life expectancy from the time of screening.
- A score 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 the 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).
- Currently participating in a clinical trial of a systemic anti-cancer treatment
- Pregnancy 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.
- Upon review of psychiatric history (i.e., responses to the relevant modules of MINI (Standard version 7.0.2)), participants must not have any current or past diagnosis that would be considered a risk to participation in the study:
- Lifetime history of schizophrenia or other psychotic disorders, or bipolar I or II disorder assessed through participant interview.
- Or a current diagnosis of PTSD, panic disorder, agoraphobia, OCD, anorexia, and bulimia.
- Liver function test >3 times the upper limit of normal or creatinine clearance <30 mL/min.
- Have a history of any medical condition that could make receiving a sympathomimetic drug harmful because of potential increases in blood pressure and heart rate. This includes, but is not limited to, a history of myocardial infarction, cerebrovascular accident, or aneurysm. Participants with other mild, stable chronic medical problems may be enrolled if the site physician, CI, and Study Physician agree the condition would not significantly increase the risk of LSD administration or be likely to produce significant symptoms during the study that could interfere with study participation or be confused with side effects of the IMP. Examples of stable medical conditions that could be allowed include, but are not limited to Diabetes Mellitus (Type 2), Human Immunodeficiency Virus (HIV) infection, Gastroesophageal Reflux Disease (GERD), etc. Any medical disorder judged by the investigator to significantly increase the risk of LSD administration by any mechanism would require exclusion.
- Blood pressure not exceeding 160 mmHg (systolic) and 90 mmHg (diastolic) (measured at three time-points).
- Current serious suicide risk, as determined through psychiatric interview, responses to The Columbia-Suicide Severity Rating Scale (C-SSRS), and clinical judgement of the investigator, however, history of suicide attempts is not an exclusion. Any participant who is likely to require hospitalization related to suicidal ideation and behaviour, in the judgement of the investigator, will not be enrolled. Any participant presenting with the following on the Baseline C-SSRS will be excluded:
- Suicidal ideation score of 4 or greater within the last month of the assessment at a frequency of once a week or more;
- Suicidal ideation score of 5 within the last 6 months of the assessment;
- Any suicidal behaviour, including suicide attempts or preparatory acts, within the last 6 months of the assessment. Participants with non-suicidal self-injurious behaviour may be included if approved by the Study Physician.
- 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 the study physician.
- Current THC usage will prompt exclusion if the participant does not agree to cease. However, CBD is permitted, and usage will be recorded.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method