Psilocybin-assisted Existential, Attachment and... — Clinical Trial Details

Single-group Phase II feasibility and safety study of a single 25 mg oral psilocybin dose delivered within PEARL psychotherapy (preparatory sessions, dosing session, and integration) for caregivers of patients with advanced cancer.

Outcomes include feasibility, acceptability, psychological measures (depression, anxiety, anticipatory grief, quality of life), and safety assessments including vital signs and adverse events; participants must meet screening laboratory and contraceptive requirements.

Participants

Ages

18 – 99

Sexes

Male & Female

BMI

Psychosis History

Excluded

Inclusion Criteria

Inclusion Criteria:
18 years of age or older.
Participant must reside in Ontario, Canada.
Ability to speak and read English (participant to provide written informed consent and participate in PEARL intervention, as determined by study personnel).
No cognitive impairment indicated in medical record or by the primary care physician.
Primary or significant caregiver of a patient with advanced cancer enrolled in a companion trial of PEARL for patients with advanced cancer or caregiver of a patient receiving psilocybin-therapy through the Special Access Program (SAP) at University Health Network (UHN); such patients will have been recruited from psychosocial oncology or palliative care clinics at Princess Margaret (study physicians to assess appropriateness of inclusion and whether treatment will support the family system).
At least mild anxiety or depression symptoms, defined as a score of >5 on the General Anxiety Disorder-7 (GAD-7) or >8 on the Patient Health Questionnaire-9 (PHQ-9).
Interest in and ability to participate in and complete the PEARL intervention and protocol as outlined.
Normal hepatic functioning as determined by prior medical history or/and screening bloodwork ([INR]<1.5, AST/ALT < 2x upper limit of normal, normal range bilirubin, platelets ≥150).
Normal renal functioning as determined by prior medical history or/and screening bloodwork (estimated glomerular filtration rate [eGFR]>45).
Participants who are sexually active and could become pregnant or inseminate a partner must be using one method of highly effective contraception or a combination of two or more effective methods; negative serum pregnancy test at screening and urine pregnancy test on morning of dosing as applicable; not pregnant or nursing for study duration.
If using prescribed medications or other substances, participants must agree to refrain from taking them if instructed by study investigators (exceptions evaluated by Sponsor-Investigator; acetaminophen, common doses of vitamins/minerals allowed).
Not using nicotine for at least 2 hours before psilocybin administration and not again until ~7 hours after administration.
Consume approximately the same amount of caffeine on session day as usual morning intake.
Not taking any as-needed medications on psilocybin mornings (except daily and as-needed opioid pain medication).
Refrain from using any psychoactive drugs, including alcohol, within 24 hours of psilocybin administration.
Must have a responsible individual to drive them after dosing and accompany/attend to them; agree not to drive or operate machinery for at least 24 hours after dose administration.
Therapist/PI will provide contact phone number for emergency support in the 24 hours following dosing.

Exclusion Criteria

Exclusion Criteria:
History of past intolerability to psilocybin or other psychedelics.
Past/present psychiatric diagnoses of bipolar disorder, any psychotic disorder, active substance use disorders (except permitted mild/moderate early remission alcohol or cannabis use disorder), or dementia.
- Participants may have current mild alcohol or cannabis use disorder (3 of 11 DSM-5 criteria) or moderate alcohol or cannabis use disorder in early remission for the 3 months prior to enrollment (5 of 11 DSM-5 criteria).
Clinically significant suicidal ideation either currently or within the past 6 months, as judged by study clinicians.
Participant under the age of 30 years who has a first-degree relative with a primary psychotic disorder.
Other personal circumstances or behaviour judged to be incompatible with establishment of rapport or safe exposure to psilocybin.
Severe hypertension (systolic >140 or diastolic >90) based on two readings on same day; may be re-screened once controlled.
Hepatic dysfunction (history of cirrhosis and/or abnormal parameters [INR]>1.5, elevated AST/ALT >2x ULN, elevated bilirubin, platelets <150) or liver failure.
Cardiovascular conditions including uncontrolled hypertension, class IV heart failure, angina, clinically significant ECG abnormality (e.g., atrial fibrillation without rate control, prolonged QTc >450 ms males or >470 ms females), TIA in last 6 months, stroke, peripheral or pulmonary vascular disease.
Uncontrolled epilepsy or history of seizures.
Diabetes with inability to skip a meal requiring medication more than twice daily or symptomatic hypoglycaemia in prior 30 days.
GI bleed in last 6 months.
Use of other investigational agents inappropriate with psilocybin, psychoactive prescription medications (e.g., benzodiazepines, lithium, SSRIs), medications affecting 5-HT2A (e.g., olanzapine, mirtazapine, trazodone), MAO inhibitors, potent metabolic inducers or inhibitors (examples listed in protocol); inhibitors of UGT1A9/1A10 or aldehyde/alcohol dehydrogenase inhibitors should be discontinued per protocol.
Contraindicated medications may be tapered by a study physician when safe and appropriate.

Company

Product

Legal

Psilocybin-assisted Existential, Attachment and RelationaL (PEARL) Therapy for Caregivers of Patients With Advanced Cancer (PEARL-C1)

Detailed Description

Study Protocol

Preparation

Dosing

Locations

Integration

Therapeutic Protocol

Study Arms & Interventions

PEARL Therapy

Interventions

Participants

Inclusion Criteria

Exclusion Criteria

Study Details

Study Team

Sponsors & Collaborators