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

Sponsor
Centre for Addiction and Mental Health
Study ID
NCT06299319
Phase
PHASE1
Status
Enrolling By Invitation

Conditions

  • Obsessive-Compulsive Disorder

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Psilocybin — DRUG
    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.

Study Details

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.

Key Dates

First listed
Mar 7, 2024
Start date
Sep 1, 2024
Status verified
Mar 2026
Primary completion
Jun 30, 2026
Completion
Aug 31, 2026

Study Design

Enrollment
10 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

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

Primary Outcome Measure

Feasibility of administering psilocybin (25 mg) in adults with treatment-resistant OCD [ Time Frame: Screening Period, Intervention (2 weeks), Follow-up after 2nd dosing session (up to 10 weeks after 2nd dose) ]

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