PARTING: Assessing the feasibility, acceptability and safety of Psilocybin-Assisted suppoRtive psychoTherapy IN the treatment of prolonged Grief in bereaved cancer carers.

QIMR Berghofer Medical Research Institute0 个研究点目标入组 15 人开始时间: 2023年8月1日最近更新: 2024年9月2日

适应症

试验速览

暂无简介。

•Adult bereaved carer of a patient who died from cancer more than 12 months ago
•Meets the threshold for prolonged grief disorder as measured on the validated Prolonged Grief Disorder Scale (PG-13-Revised) and in a clinical interview.
•Under the care of a psychiatrist, psychologist, physician, or general practitioner
•Proficient in English, such that their literacy and comprehension is sufficient for understanding the consent form and study questionnaires
•Living in Brisbane QLD or able to travel to Brisbane for the in-person intervention sessions
•Intention to complete all 8 intervention sessions
•Agree to have their drug dosing sessions recorded to video for treatment fidelity and clinical supervision.
•Able to swallow pills.
•Treating medical doctor can confirm patient has safely tapered and washed-out current antidepressant pharmacotherapy prior to baseline assessment.
•Agree to be abstinent from illicit drugs or medications outside of your usual and allowed prescribed medications and alcohol use for at least 2 days prior to psilocybin dosing.

•Disorder with known central nervous system involvement
•In treatment in another clinical trial involving an investigational product
•Hepatic dysfunction
•Hypercalcaemia, Cushing's syndrome, hypoglycaemia, syndrome of inappropriate antidiuretic hormone secretion, or carcinoid syndrome.
•Cardiovascular conditions
•Currently on preventative medication for migraines
•Positive pregnancy test or trying to get pregnant
•Current hypothyroidism or hyperthyroidism as identified by blood test
•Weight less than 40 kg or has a body mass index <15.
•Use of any hallucinogen or psychedelic drug within the past 12 months
•Any significant adverse events after prior use of any hallucinogen or psychedelic
•Medications that may have interactions with psilocybin
•Diagnosed psychotic disorder or severe post-traumatic stress disorder
•First-degree family member with a diagnosed psychotic disorder
•History of suicide attempts or mania
•Moderate-severe drug or alcohol dependence
•Are unable to give adequate informed consent

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