A Pilot Mechanistic RCT of Psilocybin With Mindfulness-based Therapy vs Support for Posttraumatic Stress Disorder (PTSD)
Anthony P King
Summary
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).
Description
Many patients with PTSD do not respond or have an incomplete response to treatment with currently available medications that are FDA-approved for PTSD, and/or do not respond to psychotherapies for PTSD. The use of psychedelics (e.g. psilocybin) is being investigated as a new approach to improve symptoms in patients with PTSD and depression, however their mechanism of action is still not well understood. Furthermore, while psychedelics are usually administered in the context of psychological support ("psychedelic assisted therapy", PAT) the kinds of support therapy used and possible interaction…
Eligibility
- Age range
- 21–65 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Participant is assigned female or male at birth. 2. Participant is aged between 21 to 65 years, inclusive, at Screening. 3. Participant has a BMI of 18 to 35 kg/m2, inclusive, at Screening. 4. Participant is ≥60 kg. 5. Participant has a diagnosis of PTSD (as defined in the Diagnostic and Statistical Manual of Mental Disorders, 5th edition \[DSM-5\] established through a clinician interview that includes the Mini-International Neuropsychiatric Interview \[MINI\]) and CAPS-5. 6. PTSD severity moderate to severe based on CAPS score ≥24. 7. Depression severity moderate to s…
Interventions
- Combination ProductPsilocybin + MBCT therapy
The experimental arm has psilocybin with support and MBCT sessions.
- Combination ProductActive Comparator: Psilocybin with Support Only
The active comparator has psilocybin with support only.
Location
- The Ohio State University Medical CenterColumbus, Ohio