Mindfulness-based Psilocybin Therapy for PTSD

Part of paid clinical trials in Columbus, Ohio.

Sponsor
Anthony P King
Study ID
NCT07104916
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

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

Interventions

  • Psilocybin + MBCT therapy — COMBINATION_PRODUCT
    The experimental arm has psilocybin with support and MBCT sessions.
  • Active Comparator: Psilocybin with Support Only — COMBINATION_PRODUCT
    The active comparator has psilocybin with support only.

Study Details

The goal of this study is to learn how psilocybin delivered with mindfulness-based therapy may help symptoms of posttraumatic stress disorder (PTSD). This is an assessor-blinded, randomized, controlled study in participants with PTSD. The study will investigate the changes in brain activity, connectivity, and microstructural neuroplasticity assessed using EEG/EMG and multimodal MRI measures after administration of one oral dose of psilocybin, accompanied either with standard "psychological support" only; or with standard support plus Mindfulness-based Cognitive Therapy (MBCT).

Key Dates

Start date
Jul 1, 2026
Status verified
Jun 2026
Primary completion
Sep 30, 2029
Completion
Dec 31, 2029

Study Design

Enrollment
30 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Psilocybin with support + MBCT
    Participants will receive one oral dose of psilocybin (capsule), with PAT psychological support and MBCT sessions before, during, and after the psilocybin administration
  • Active Comparator: Psilocybin with support only
    Participants will receive one oral dose of psilocybin (capsule), with PAT psychological support only sessions before, during, and after the psilocybin administration

Primary Outcome Measure

Changes in parameter estimate of regional brain activity measured by fMRI after one dose of psilocybin in participants with PTSD [ Time Frame: Between Baseline and Time point 24 hours and 28 days post-Investigational Product ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
The Ohio State University Medical CenterColumbusOhio43210
Anthony King, PhD
[email protected]
7347094744
Wenfei Yu, BS
[email protected]
614 688 9537
Anthony King, PhD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Columbus, OH

By condition
PTSD (post-traumatic stress disorder)
By specialty
PsychiatryMental healthBehavioral health
By research site
The Ohio State University Medical Center· Columbus, OH

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