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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether psilocybin, a compound in "magic mushrooms," can reduce symptoms of obsessive-compulsive disorder (OCD). The focus is on individuals with treatment-resistant OCD, who have not found success with other treatments. Participants will receive two doses of psilocybin, spaced two weeks apart, to determine if it safely and effectively improves OCD symptoms. Those who have not responded to at least two medications and one therapy method for OCD may be suitable candidates. As a Phase 1 trial, the research aims to understand how the treatment works in people, offering participants the opportunity to be among the first to receive this innovative treatment.

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.

Is there any evidence suggesting that this treatment is likely to be safe for humans?

Research has shown that psilocybin might be safely used for people with obsessive-compulsive disorder (OCD). In one study, researchers safely administered psilocybin to nine people with OCD, and it helped reduce their symptoms in a controlled setting. Another study found that a 10 mg dose of psilocybin was well-tolerated by people with OCD, as they did not experience severe side effects. These findings suggest that psilocybin, when administered carefully and in supportive environments, is generally safe. However, this research remains in the early stages, so more studies are needed to fully understand its safety. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for OCD?

Unlike the standard treatments for OCD, which typically involve SSRIs and cognitive-behavioral therapy, psilocybin offers a unique approach by targeting serotonin receptors in the brain differently. Psilocybin, the active ingredient, is a psychedelic compound that may help "reset" brain activity patterns linked to obsessive-compulsive behaviors. Researchers are excited about its potential to provide rapid and lasting effects after just a couple of doses, offering a promising alternative for those who haven't found relief with traditional therapies.

What evidence suggests that psilocybin might be an effective treatment for OCD?

Studies have shown that psilocybin, the active ingredient in "magic mushrooms," can help reduce symptoms in people with OCD. One study found a 10 mg dose of psilocybin to be safe and possibly effective for easing OCD symptoms. Since the 1960s, reports have indicated that people experience improvements in obsessive and compulsive behaviors when using psychedelics recreationally. In animal studies, a single dose of psilocybin led to significant long-term improvements in anxiety and related behaviors. These findings suggest that psilocybin may be a promising option for treating OCD. Participants in this trial will receive a 25 mg dose of psilocybin, administered twice throughout the trial, with two weeks between doses. ^{4 5 6 7 8}

Who Is on the Research Team?

Gwyneth Zai, MD, MSc, PhD

Principal Investigator

Centre for Addiction and Mental Health

Are You a Good Fit for This Trial?

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

I am willing to follow all the study's requirements.

Timeline for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

Citations

1. yalemedicine.org yalemedicine.org/clinical-trials/neural-correlates-of-the-effects-of-psilocybin-in-obsessive-compulsive-disorder

Efficacy of Psilocybin in OCD: a Double-Blind, Placebo- ... This study aims to investigate the effects of oral psilocybin on OCD symptomatology and provide the first evidence of the neural mechanism that may mediate ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S0010440X25000471

Single-dose (10 mg) psilocybin reduces symptoms in ... A 10 mg dose of oral psilocybin was found to be well-tolerated and potentially efficacious in patients with OCD.

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39611453/

Psychedelics for the Treatment of Obsessive-Compulsive ... Since the 1960s, case studies have reported improvements to obsessive and compulsive behaviors in patients taking psychedelics recreationally.

4. clinicaltrials.gov clinicaltrials.gov/study/NCT05546658

Effects of Psilocybin in Obsessive Compulsive Disorder This study will test the feasibility, safety, and evidence for efficacy of psilocybin administration in participants with obsessive compulsive disorder ...

5. nature.com nature.com/articles/s41380-024-02786-0

Striking long-term beneficial effects of single dose ... Secondary outcome measures such as head-body twitches and anxiety all showed a significant improvement over 21 days. Notably, in mice that ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/17196053/

Safety, tolerability, and efficacy of psilocybin in 9 patients ... Conclusions: In a controlled clinical environment, psilocybin was safely used in subjects with OCD and was associated with acute reductions in core OCD symptoms ...

7. frontiersin.org frontiersin.org/journals/psychiatry/articles/10.3389/fpsyt.2023.1278823/full

Safety, feasibility, tolerability, and clinical effects of ... This trial aims to evaluate the safety, feasibility, tolerability, and clinical effects of two doses of psilocybin paired with non-directive support in the ...

8. academic.oup.com academic.oup.com/ijnp/article/27/12/pyae057/7912598

Psychedelics for the Treatment of Obsessive–Compulsive ... Early case studies reported that patients with obsessive and/or compulsive behaviors had diminished symptoms after taking Psilocybe mushrooms (Savage et al., ...