RecruitingPhase 2interventionalRules rewrite

Phase 2: Psilocybin + MBCT therapy for Post Traumatic Stress Disorder

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, randomly assigned, controlled study in participants with PTSD.

Official registry: https://clinicaltrials.gov/study/NCT07104916 · Anthony P King · enrollment listed as 30

What this phase means

Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

If you join, the listed intervention(s) are Psilocybin + MBCT therapy, or Active Comparator: Psilocybin with Support Only. The registry lists allocation as randomized. The goal of this study is to learn how psilocybin delivered with mindfulness-based therapy may help symptoms of posttraumatic stress disorder (PTSD).

They plan to enroll about 30 people at Columbus. Taking part typically means study visits and measurements plus check-ins.

Official title (unrewritten)

A Pilot Mechanistic RCT of Psilocybin With Mindfulness-based Therapy vs Support for Posttraumatic Stress Disorder (PTSD)

Interventions: Psilocybin + MBCT therapy, Active Comparator: Psilocybin with Support Only

Primary outcome (registry wording): Changes in parameter estimate of regional brain activity measured by fMRI after one dose of psilocybin in participants with PTSD

Who it is for (from inclusion criteria)

Ages 21 Years to 65 Years
Participants meeting the following criteria will be included in the study:
Participant is assigned female or male at birth
Participant is aged between 21 to 65 years, inclusive, at Screening. This is to reduce variability in brain function and connectivity in this small pilot study that may be related to age / developmental factors in persons under 21 and over 65
Participant has a body-mass index (BMI) of 18 to 30 kg/m2, inclusive, at Screening
PTSD severity moderate to severe based on CAPS-5 score ≥25, and with moderate depression MADRS ≥20

Who the registry excludes

Participants with the following will be excluded from study participation:
Cardiovascular disease, including coronary artery disease (CAD) and congestive heart failure (CHF). This is an FDA requirement
Currently receiving a monoamine oxidase inhibitor, tricyclic antidepressant, other non-SSRI or non-SNRI antidepressants (e.g. bupropion, mirtazapine, etc), an antipsychotic or a mood stabilizer
Exposure to psilocybin, or any other psychedelics, such as ayahuasca, mescaline, LSD or peyote more than 10 times in the last 10 years, or any psychedelic use within 6 months prior to Screening
Family history of schizophrenia or schizoaffective disorder (first degree relatives), or bipolar disorder type 1 (first degree relatives)
Diagnosis of hypertension or arrhythmia
Presence of clinically significant ECG abnormalities at the Screening visit, as defined by medical judgement

Public study contact (from the registry)

Anthony King, PhD

614 688-9537

anthony.king@osumc.edu

Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.

Sites listed on ClinicalTrials.gov

1 listed

The Ohio State University Medical Center — Columbus, Ohio (recruiting)

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FAQ about this NCT record

Is NCT07104916 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT07104916?

Phase 2. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT07104916?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary