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Group Psilocybin-Assisted Therapy for PTSD

This study is looking at a new way to treat Post-Traumatic Stress Disorder (PTSD) using group psilocybin-assisted therapy (GPAT). Researchers want to see if this treatment, which involves two group sessions with psilocybin (a psychedelic drug) four weeks apart, is safe and possible to do. They also want to see if it helps reduce PTSD symptoms. You might be able to join if you are between 18 and 89 years old and identify as a veteran or first responder, a female survivor of sexual violence, or an Indigenous person. This is a Phase 1 study, meaning it's an early step to understand safety and how well the treatment works. The study aims to enroll 36 participants, but its current status is unclear.

Study design
This is an open-label Phase 1 study, meaning everyone knows what treatment they are receiving. It plans to include 36 participants.
What's involved
You would participate in two group psilocybin dosing sessions, scheduled four weeks apart, and have your PTSD symptoms and any side effects checked for 18 weeks after the start of the study.
Compensation
Not stated in the trial record.
Follow-up
Your progress and any side effects will be monitored for 18 weeks after the start of the study.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07506395

Group Psilocybin-Assisted Therapy for Post-Traumatic Stress Disorder

Recruiting
PHASE1Ages 18–89InterventionalTreatment
University of New Mexico
~36 participants
Updated 2026-05-22 on ClinicalTrials.gov
What's tested:Psilocybin

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Rate of study completion-feasabiity measure
Measured over 18 weeks after baseline
+2 more outcomes measured

Conditions

PTSD

Explore related trials

Post-Traumatic Stress Disorder

Where it's being run

1 sites across 1 states
New Mexico1

Who to contact

Victoria Culkin
[email protected]
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

T+H years of age and \<89 years of age
Veteran or first responder
Female survivor of sexual violence
Indigenous person
Not pregnant, planning to become pregnant, or breastfeeding; if able to become pregnant, willing to use reliable form of birth control for the duration of the study
If needed, ability and willingness to taper and discontinue medications that may interfere with the action of psilocybin
Ability to read, speak, and understand English
Ability and willingness to consent to the terms of the study, including attending all trial visits (most of which will occur in a group setting), preparation and
follow-up sessions, and completing all trial evaluations
Ability and willingness to swallow capsules
Meet criteria for PTSD, as defined in the DSM-5
At screening, symptoms of moderate to severe PTSD (PCL-5 score of 34 or greater) present for at least six months

Exclusion

Inability to achieve five days of abstinence from alcohol, non-prescribed opioids, methamphetamines, cocaine, benzodiazepines, or other illicit substances
Inability or unwillingness to remain abstinent from cannabis use for 24 hours prior to psilocybin dosing session and 12 hours after receiving the dose of psilocybin
Risk for clinically significant acute withdrawal from any substance that would cause safety concern on the day of dosing
Any medical condition that would preclude safe participation in the study, including the following, as determined by medical history review, physical examination, electrocardiogram (ECG), and clinical laboratory tests: Pregnancy/breastfeeding
Uncontrolled hypertension, defined as \>140/90 mm Hg at screening or baseline or \>145/95 mm Hg on presentation for dosing day assessed on three consecutive blood pressure measurements
History of myocardial infarction, cardiac ischemia, congestive heart failure, clinically relevant valvular heart disease, or pulmonary hypertension; any other significant history of cardiovascular condition, based on the clinical judgment of the Trial Physician, which would make a participant unsuitable for the trial
ECG: Clinically significant abnormality (e.g. atrial fibrillation based on judgement of trial physician including prolonged corrected QT interval (QTc\> 450 milliseconds (males) or \>470 milliseconds (females)
Poorly controlled diabetes (HbA1c \>8.0%; clinically significant hypoglycemia in the past 6 months)
Neurological conditions (e.g. epilepsy or other seizure disorder) or neurodegenerative disease (e.g., dementia, Parkinson's disease, Huntington's disease, amyotrophic lateral sclerosis.), or brain tumor that would impact participation in the trial Serious abnormalities of complete blood count or chemistry
Severe hepatic impairment
Severe renal impairment,
Unstable existing thyroid disorder
Any of the following psychiatric conditions:
Active suicidal ideation; history of hospitalization for suicide attempt within the 12 months prior to screening, affirmative responses to C-SSRS questions 4 or 5
Confirmed diagnosis of schizophrenia or other psychotic disorder, firstdegree relative with schizophrenia
Axis-II diagnosis
Use of psychedelics (e.g., psilocybin, mescaline, ayahuasca, DMT, LSD, MDMA, or ketamine) resulting in a discrete psychedelic experience in the past six months.
Returning to an unsafe environment and/or inadequate social support-Any other condition, physical or psychological symptom, medication, or other relevant finding prior to randomization that, based on the clinical judgment of trial personnel, would make a participant unsuitable for the trial.-
Participation in experimental treatment for PTSD or any research studies within 30 days of screening assessment

What this trial measures

  • Rate of study completion-feasabiity measure18 weeks after baseline

    Number of participants that completed the study.

  • Clinician-Administered PTSD Scale for DSM-5baseline and 18 weeks

    The Clinician-Administered PTSD Scale for DSM-5 is a 30-item structured interview that determines a PTSD diagnosis and severity by assessing the frequency and intensity of 20 DSM-5 symptoms. Each symptom is rated on a 0-4 scale (0=absent, 4=extreme), with a total severity score calculated by summing individual item scores. Total Range: 0-80 (sum of 20 items) total scores indicate severity, with higher ratings indicating worse PTSD symptoms.

  • Incidence of adverse events (AEs), serious adverse events (SAEs) and AEs of special interest using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.18 weeks after baseline

    adverse event assessment as safety measure