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

Study acronym: PAP-OCD
StatusCompleted
PhasePhase 1
Started2024-09-01
View on ClinicalTrials.gov ↗

Amendment history

2026-09-25
Trial completed
2026-07-27
Study Status v5
Trial status changed: Enrolling by Invitation → Active, Not Recruiting
Primary completion pushed: 2026-06 → 2026-09
Completion pushed: 2026-08 → 2026-09
2026-05-14
Study Status, Contacts/Locations v4
Trial status changed: Recruiting → Enrolling by Invitation
Study sitesdetails revised at 1 of 1 site
2026-03-24
Study Status, Study Description v3
Primary completion date2025-08→2026-06
Completion date2025-10→2026-08
Study description-540 characters
[...] tegrative therapy session with the trained study therapist. AtBetween Visit 5 (V5) and Visit 7 (V7), 2-weeks after the first psilocybin dose, participants will undergo the second psilocybin dosing session where they will receive an active dose (25mg) of psilocybin in conjunction with supportive therapy. On the day after the second dosing session (Visit 8, V8) and one-week after the second dosing se [...] during study Visit 96 (V9V6), the same neurophysiological measurements will be performe [...] ring Visit 3 (V3). Follow-up assessments will also occur at 3, 6, 9, and 12 weeks (Visit 117, 128, 9 and 1310) a [...]
2025-02-21
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v2
Trial statusNot Yet Recruiting→Recruiting
Primary completion date2025-06→2025-08
Completion date2025-07→2025-10
Start dateestimated 2024-09→confirmed 2024-09-01
Study sites0→1
2024-08-19
Study Status v1
Primary completion date2024-06→2025-06
Completion date2024-09→2025-07
Start date2024-04→2024-09
2024-02-29
Original filing
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.
Trial Details
NCT Number NCT06299319
Lead Sponsor Centre for Addiction and Mental Health
Conditions Obsessive-Compulsive Disorder
Enrollment 10 participants
Start Date 2024-09-01
Primary Completion 2026-09-04 (estimated)
Study Completion 2026-09-04 (estimated)
Updated on ClinicalTrials.gov 2026-09-24