RecruitingPhase 1NCT06299319

Feasibility, Clinical Effects, and Safety of Psilocybin-assisted Psychotherapy for Treatment-resistant OCD

Evaluating the Feasibility, Clinical Effects, and Safety of Psilocybin-assisted Psychotherapy for Treatment-resistant Obsessive-compulsive Disorder: An Open-label Clinical Trial


Sponsor

Centre for Addiction and Mental Health

Enrollment

10 participants

Start Date

Sep 1, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether psilocybin-assisted psychotherapy (a structured therapy session guided by a therapist, combined with a controlled dose of psilocybin, the compound in psychedelic mushrooms) is feasible and safe for people with treatment-resistant OCD — meaning OCD that has not responded to standard medications and therapy. **You may be eligible if...** - You are 18–65 years old with a confirmed diagnosis of OCD - Your OCD symptoms are moderate to severe and have not improved after trying at least 2 different medications and at least one course of cognitive behavioural therapy (CBT) - You can read and communicate in English - You are an outpatient and able to give informed consent - You are willing to use effective contraception if you could become pregnant **You may NOT be eligible if...** - You have a personal or family history of psychosis, bipolar disorder type 1, or schizophrenia - You are currently pregnant or breastfeeding - You have significant kidney impairment - You have abnormal blood test results at screening Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGPsilocybin

The psilocybin used in this study meets quality specifications suitable for human research use. The active drug is encapsulated using a hydroxypropyl methylcellulose (HPMC) capsule and contains 25 mg of psilocybin. The psilocybin will be administered twice during the trial, in conjunction with supportive therapy.


Locations(1)

Centre for Addiction and Mental Health

Toronto, Ontario, Canada

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NCT06299319


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