Obsessive-Compulsive Disorder > Psilocybin

Psilocybin for OCD

(PAP-OCD Trial)

Recruiting in Palo Alto (17 mi)

Overseen By Gwyneth Zai, MD, MSc, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Recruiting

Sponsor: Centre for Addiction and Mental Health

Must not be taking: Anticonvulsants, Benzodiazepines

Disqualifiers: Pregnancy, Substance use disorder, Schizophrenia, others

No Placebo Group

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.

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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.

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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.

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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.

Trial 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)

Participant Groups

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.

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.

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Centre for Addiction and Mental Health Toronto, Canada

Who Is Running the Clinical Trial?

Centre for Addiction and Mental Health Lead Sponsor

References

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

Safety, tolerability, and efficacy of psilocybin in 9 patients with obsessive-compulsive disorder. [2022] Anecdotal reports suggest that psychedelic agents may relieve symptoms of obsessive-compulsive disorder (OCD). This modified double-blind study investigated the safety, tolerability, and clinical effects of psilocybin, a potent 5-HT(1A) and 5-HT(2A/2C) agonist, in patients with OCD.

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

Psilocybin for the Treatment of Obsessive-Compulsive Disorders. [2022] Obsessive-compulsive disorder (OCD) is a highly prevalent and disabling condition for which currently available treatments are insufficiently effective and alternatives merit priority attention. Psilocybin may represent a safe and effective avenue for treatment of individuals affected by this condition. In this chapter we briefly introduce OCD symptoms, epidemiology, as well as relevant hypotheses on the mechanism of disease that may inform treatment interventions. We briefly describe currently available treatments, mechanisms of action, and efficacy limitations, as preamble to the potential use of psilocybin and perhaps similar compounds in the treatment of OCD and related conditions. Although much is reviewed throughout this book about the mechanisms of action of psychedelic agents, a focused discussion of psilocybin effects as they pertain to OCD is also included. Our experience with incidental observation, prospective research, and current explorations of psilocybin in OCD are also described.

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] Psilocybin may help treat obsessive-compulsive disorder (OCD). To date, only one open-label study of psilocybin for OCD exists, necessitating further investigation with a randomized controlled design. The neural correlates of psilocybin's effects on OCD have also not been studied.

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] Obsessive Compulsive Disorder (OCD) is a chronic neuropsychiatric condition, characterized by obsessions and compulsions, which is usually disabling for the suffering individual. The first-line treatment is not effective in all patients. There is evidence showing the effectiveness of psilocybin and psilocybin-containing mushrooms in the treatment of OCD symptoms. We present the case of a male adult with OCD who showed a clinically meaningful reduction of his OCD symptomatology after the consumption of psilocybin-containing mushrooms. Future research will determine if psilocybin and other psychoactive compounds of psilocybin-containing mushrooms are effective and safe for the treatment of OCD.

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

Single-dose psilocybin for treatment-resistant obsessive-compulsive disorder: A case report. [2023] Classic psychedelics, such as psilocybin, act on the brain's serotonin system and produce striking psychological effects. Early work in the 1950s and 1960s and more recent controlled studies suggest benefit from psychedelic treatment in a number of conditions. A few case reports in recreational users and a single experimental study suggest benefit in patients with obsessive-compulsive disorder (OCD), but careful clinical data and long-term follow-up have been lacking. Here we describe a case of a patient with refractory OCD treated with psilocybin and followed prospectively for a year, with marked symptomatic improvement. We provide qualitative and quantitative detail of his experience during and after treatment. Improvement in OCD symptoms (YBOCS declined from 24 to 0-2) was accompanied by broader changes in his relationship to his emotions, social and work function, and quality of life. This individual was an early participant in an ongoing controlled study of psilocybin in the treatment of OCD (NCT03356483). These results are preliminary but promising, motivating ongoing investigations of the therapeutic potential of appropriately monitored and supported psychedelic treatment in the treatment of patients with obsessions and compulsions.