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Psychedelic

Psilocybin for Emotional Distress

Phase 1 & 2

Recruiting

Led By James Downar, MDCM, MSc

Research Sponsored by Ottawa Hospital Research Institute

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Advanced illness under palliative care management, defined as having 1 to <12 months life expectancy (in the judgment of the palliative care provider)

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion, up to 1 year

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to study the safety and effectiveness of using small doses of psilocybin (a compound found in certain mushrooms) to help patients with advanced illness who are experiencing psychological distress. The trial

Who is the study for?

This trial is for adults over 18 with advanced illnesses and a life expectancy of less than 12 months, who are under palliative care and experiencing significant psychological distress. Participants must be able to communicate in English or French.

What is being tested?

The study tests the safety and initial effectiveness of microdosing psilocybin (1-3mg daily) for four weeks to alleviate psychological distress in palliative care patients. It's an open-label, single-arm phase I/II trial involving forty participants.

What are the potential side effects?

Potential side effects may include changes in mood, perception, cognition, and possible physical reactions like nausea or headaches. The low dose aims to minimize risks while assessing therapeutic benefits.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

My doctor expects I have less than 12 months to live and I am receiving palliative care.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion, up to 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through study completion, up to 1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, up to 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Anxiety

Change in Psychological Distress - Anxiety, Depression, and Well-being

Dosing

+11 more

Secondary study objectives

Existential Distress

Global Distress

Participant Quality of Life

+2 more

Side effects data

From 2021 Phase 2 trial • 95 Patients • NCT02061293

Nausea

Pain

Viral upper resp. tract infection

Back pain

Bronchitis

Diarrhea

Influenza

Headache

Sinus headache

Depressed mood

Depression

Insomnia

Suicidal Ideation

Lower resp. tract congestion

Oropharyngeal pain

Alcohol withdrawal syndrome

Migraine

Thrombocytosis

Constipation

Vomiting

Oedema

Peripheral swelling

Pyrexia

Dermatitis contact

Bronchitis bacterial

Eye infection

Fungal infection

Traumatic lung injury

Hyponatremia

Arthralgia

Musculoskeletal pain

Pain in extremity

Malignant melanoma

Dizziness

Hypoesthesia

Sedation

Anger

Anxiety

Restlessness

Cough

Rhinorrhea

Sinus congestion

Sexual abuse

Endodontic procedure

Mallory-Weiss Syndrom

Anemia

Influenza like Illness

Gingivitis

Arthoscopic surgery

100%

80%

60%

40%

20%

Study treatment Arm

Diphenhydramine

Psilocybin

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Psilocybin MicrodosingExperimental Treatment1 Intervention

Participants will receive a 4-week psilocybin microdosing intervention (1-3mg/day, Monday-Friday for up to 4 weeks; start at 1mg with opportunity to increase dose each week)

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Psilocybin

2021

Completed Phase 2

~530

0 / 1Eligibility criteria met