Psilocybin for OCD

(PAP-OCD Trial)

Overseen By Ezmond Cheung, BPsySci

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Centre for Addiction and Mental Health

Must not be taking: Anticonvulsants, Benzodiazepines

Disqualifiers: Pregnancy, Substance use disorder, Schizophrenia, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 11

10 Participants Needed

Trial Summary

What is the purpose of this trial?

Psilocybin, the chemical component of "magic mushrooms", has been administered with psychotherapy in several randomized clinical trials (RCTs) showing large and sustained antidepressant effects. There is interest to see if similar effects may be provided in those with obsessive compulsive disorder (OCD). The purpose of this study is to evaluate the safety, feasibility, and clinical effects of psilocybin administration in those with OCD. Ten participants with treatment-resistant OCD will receive two doses of 25mg of psilocybin under supportive conditions, two weeks apart. The investigators hypothesize that two sessions of psilocybin 25mg administered under supportive conditions to participants with treatment-resistant OCD will lead to significant reductions in OCD symptoms.

Will I have to stop taking my current medications?

Yes, you will need to taper off your current OCD medications and certain enzyme inhibitors at least two weeks before starting the trial, and your doctor must confirm it's safe for you to do so.

What data supports the effectiveness of the drug psilocybin for treating OCD?

Research suggests that psilocybin may help reduce OCD symptoms, as seen in a case where a patient experienced significant improvement after taking psilocybin. Additionally, early studies and anecdotal reports indicate potential benefits, but more research is needed to confirm these findings. ^{1 2 3 4 5}

Is psilocybin safe for humans?

Psilocybin has been studied for its safety and tolerability in people with obsessive-compulsive disorder (OCD), and early research suggests it may be safe when used under medical supervision. However, more research is needed to fully understand its long-term safety. ^{1 2 3 4 5}

How does the drug psilocybin differ from other treatments for OCD?

Psilocybin is unique because it is a psychedelic drug that acts on the brain's serotonin system, potentially offering relief for OCD symptoms where traditional treatments may not be effective. Unlike standard medications, psilocybin is administered in a single dose and has shown promise in improving symptoms and quality of life in some patients with OCD. ^{1 2 3 4 5}

Research Team

Gwyneth Zai, MD, MSc, PhD

Principal Investigator

Centre for Addiction and Mental Health

Eligibility Criteria

This trial is for adults aged 18-65 with treatment-resistant OCD, which means they haven't improved after trying at least two medications and one type of therapy called CBT. Participants must be able to understand English well enough to consent and follow study procedures, have normal blood work results, and a certain level of kidney function.

Inclusion Criteria

I can take pills by mouth.

I am between 18 and 65 years old.

I understand the details of the clinical trial and can make decisions about my health.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Washout

Participants undergo a washout period where they are tapered off concomitant medications

2-4 weeks

Weekly check-ins (virtual)

Baseline and Preparatory Therapy

Participants complete baseline assessments and preparatory therapy sessions

1 week

Multiple visits (in-person)

Psilocybin Dosing Session 1

Participants receive the first 25mg dose of psilocybin with supportive therapy

1 day

1 visit (in-person)

Post-Dosing Integration 1

Participants complete questionnaires and undergo integrative therapy sessions

2 weeks

2 visits (in-person)

Psilocybin Dosing Session 2

Participants receive the second 25mg dose of psilocybin with supportive therapy

1 day

1 visit (in-person)

Post-Dosing Integration 2

Participants complete questionnaires and undergo integrative therapy sessions

3 weeks

3 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

10 weeks

3 visits (in-person)

Treatment Details

Interventions

• Psilocybin

Trial Overview The trial tests if psilocybin-assisted psychotherapy can help people with severe OCD who haven't gotten better with other treatments. It involves giving participants two doses of psilocybin (25mg each) in supportive conditions over two sessions spaced two weeks apart.

Participant Groups

Group I: Experimental: Psilocybin 25 mg Experimental Treatment 1 Intervention

Participants will receive a 25 mg dose of psilocybin, twice throughout the trial, with two weeks in between doses.

Who Is Running the Clinical Trial?

Centre for Addiction and Mental Health

Lead Sponsor

Trials

388

Recruited

84,200+

Findings from Research

In a study involving 9 patients with obsessive-compulsive disorder (OCD), psilocybin was administered in varying doses, and it was found to be safe with only one instance of transient hypertension, indicating a good safety profile.

All subjects experienced significant reductions in OCD symptoms, with decreases in Yale-Brown Obsessive Compulsive Scale (YBOCS) scores ranging from 23% to 100%, suggesting that psilocybin may be an effective treatment for OCD in a controlled setting.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety, tolerability, and efficacy of psilocybin in 9 patients with obsessive-compulsive disorder. Moreno, FA., Wiegand, CB., Taitano, EK., et al.[2022]

Psilocybin may offer a promising and safe treatment option for obsessive-compulsive disorder (OCD), which is often inadequately addressed by current therapies.

The chapter discusses the mechanisms of action of psilocybin and its potential efficacy in treating OCD, highlighting the need for further research in this area.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Psilocybin for the Treatment of Obsessive-Compulsive Disorders. Ehrmann, K., Allen, JJB., Moreno, FA.[2022]

This study is the first randomized controlled trial investigating the safety and efficacy of psilocybin for treating obsessive-compulsive disorder (OCD) in 30 adult participants who have not responded to standard treatments.

Participants will receive either a single dose of psilocybin or a placebo, with outcomes measured through OCD symptom scales and neuroimaging, aiming to uncover both clinical effects and the underlying neural mechanisms of psilocybin's action.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety, tolerability, and clinical and neural effects of single-dose psilocybin in obsessive-compulsive disorder: protocol for a randomized, double-blind, placebo-controlled, non-crossover trial. Ching, THW., Grazioplene, R., Bohner, C., et al.[2023]

A case study of a male adult with Obsessive Compulsive Disorder (OCD) demonstrated a significant reduction in symptoms after consuming psilocybin-containing mushrooms, suggesting potential therapeutic benefits.

This case adds to the growing evidence that psilocybin may be an effective treatment option for OCD, highlighting the need for further research to assess its safety and efficacy in larger populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term Amelioration of OCD Symptoms in a Patient with Chronic Consumption of Psilocybin-containing Mushrooms. Lugo-Radillo, A., Cortes-Lopez, JL.[2022]

A case study of a patient with refractory obsessive-compulsive disorder (OCD) showed significant improvement in symptoms after treatment with psilocybin, with the Yale-Brown Obsessive Compulsive Scale (YBOCS) score decreasing from 24 to 0-2 over a year.

The treatment not only reduced OCD symptoms but also led to positive changes in the patient's emotional well-being, social interactions, and overall quality of life, highlighting the potential of psilocybin as a therapeutic option for OCD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Single-dose psilocybin for treatment-resistant obsessive-compulsive disorder: A case report. Kelmendi, B., Kichuk, SA., DePalmer, G., et al.[2023]

References

1. United States pubmed.ncbi.nlm.nih.gov

Safety, tolerability, and efficacy of psilocybin in 9 patients with obsessive-compulsive disorder. [2022]

2. Germany pubmed.ncbi.nlm.nih.gov

Psilocybin for the Treatment of Obsessive-Compulsive Disorders. [2022]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Safety, tolerability, and clinical and neural effects of single-dose psilocybin in obsessive-compulsive disorder: protocol for a randomized, double-blind, placebo-controlled, non-crossover trial. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Long-term Amelioration of OCD Symptoms in a Patient with Chronic Consumption of Psilocybin-containing Mushrooms. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Single-dose psilocybin for treatment-resistant obsessive-compulsive disorder: A case report. [2023]