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Psychedelic

Psilocybin Microdosing for Depression and Anxiety

Q: Are there any vacancies available for patients to participate in this trial?

<p>Clinicaltrials.gov indicates that this specific clinical trial is not actively seeking participants. The trial was initially posted on March 1st, 2022 and the most recent update occurred on November 17th, 2021. However, it is worth noting that there are currently a total of 1268 other ongoing trials actively recruiting patients at present.</p>

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

Study 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.Check my eligibility

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.See study design

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Anxiety

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

Dosing

+11 more

Secondary outcome measures

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

Suicidal Ideation

Oropharyngeal pain

Insomnia

Influenza

Depression

Diarrhea

Headache

Sinus headache

Depressed mood

Lower resp. tract congestion

Alcohol withdrawal syndrome

Restlessness

Fungal infection

Rhinorrhea

Pyrexia

Oedema

Vomiting

Musculoskeletal pain

Hypoesthesia

Peripheral swelling

Thrombocytosis

Eye infection

Constipation

Dermatitis contact

Bronchitis bacterial

Traumatic lung injury

Hyponatremia

Arthralgia

Pain in extremity

Dizziness

Migraine

Sedation

Anger

Anxiety

Cough

Sexual abuse

Sinus congestion

Malignant melanoma

Endodontic procedure

Mallory-Weiss Syndrom

Anemia

Influenza like Illness

Gingivitis

Arthoscopic surgery

100%

80%

60%

40%

20%

Study treatment Arm

Diphenhydramine

Psilocybin

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

~730

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Ottawa Hospital Research InstituteLead Sponsor

561 Previous Clinical Trials

2,785,474 Total Patients Enrolled

CHU de Quebec-Universite LavalOTHER

167 Previous Clinical Trials

107,137 Total Patients Enrolled

St. Joseph's Healthcare HamiltonOTHER

196 Previous Clinical Trials

25,524 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any vacancies available for patients to participate in this trial?

"Clinicaltrials.gov indicates that this specific clinical trial is not actively seeking participants. The trial was initially posted on March 1st, 2022 and the most recent update occurred on November 17th, 2021. However, it is worth noting that there are currently a total of 1268 other ongoing trials actively recruiting patients at present."

Answered by AI

Who else is applying?

What site did they apply to?

Bruyere Continuing Care

The Ottawa Hospital

What portion of applicants met pre-screening criteria?

Met criteria

Did not meet criteria

Why did patients apply to this trial?

I’ve been on many antidepressants from 15-41 and nothing is working. I have taken so many different medications and I want to be able to try something that may help me reconnect with myself and my family.

PatientReceived 1 prior treatment

I’ve had anxiety for 20 years. I would like to try something that will potentially help me live a better life. I’m also a veteran of the Canadian army.

PatientReceived 2+ prior treatments

I’ve tried multiple SSRIs, TMS therapy, CBT therapy without any success. I have not been able to function normally & independently due to my mental health instability.

PatientReceived no prior treatments

Had a traumatic experience last year that caused my anxiety to skyrocket leading to depression as well. Tried two antidepressants and other medications for sleep but looking for alternatives to heal.

PatientReceived 2+ prior treatments

What questions have other patients asked about this trial?

How many times would I need to come in person during the trial? I am on quite a few prescriptions and I really don’t want to be on so many is it an issue that I am on prescriptions for my condition currently?

PatientReceived no prior treatments

Recent research and studies

Quality of Life ResearchJournal

The World Health Organization's WHOQOL-BREF Quality of Life Assessment: Psychometric Properties and Results of the International Field Trial. A Report from the WHOQOL Group

Skevington, S.M., M. Lotfy, and K.A. O'Connell. 2004. “The World Health Organization's WHOQOL-BREF Quality of Life Assessment: Psychometric Properties and Results of the International Field Trial. A Report from the WHOQOL Group”. Quality of Life Research. Springer Science and Business Media LLC. doi:10.1023/b:qure.0000018486.91360.00.

Journal of Pain and Symptom ManagementJournal

A Multicenter Study Comparing Two Numerical Versions of the Edmonton Symptom Assessment System in Palliative Care Patients

Watanabe, Sharon M., Cheryl Nekolaichuk, Crystal Beaumont, Laureen Johnson, Jeff Myers, and Florian Strasser. 2011. “A Multicenter Study Comparing Two Numerical Versions of the Edmonton Symptom Assessment System in Palliative Care Patients”. Journal of Pain and Symptom Management. Elsevier BV. doi:10.1016/j.jpainsymman.2010.04.020.

Annals of Internal MedicineJournal

Clarifying Confusion: The Confusion Assessment Method

Inouye, Sharon K.. 1990. “Clarifying Confusion: The Confusion Assessment Method”. Annals of Internal Medicine. American College of Physicians. doi:10.7326/0003-4819-113-12-941.

Journal of Affective DisordersJournal