Group psilocybin-assisted therapy for PTSD

Group Psilocybin-Assisted Therapy for Post-Traumatic Stress Disorder

This trial will try group psilocybin-assisted therapy to see if it helps adults with moderate to severe PTSD, including veterans, first responders, female survivors of sexual violence, and Indigenous people.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 36 (estimated)
• Ages: 18 Years to 89 Years
• Sex: All
• Sponsor: University of New Mexico (Academic / other)
• Locations: 1 site (Albuquerque, New Mexico)
• Trial ID: NCT07506395 on ClinicalTrials.gov

What this trial studies

This is an open-label, community-informed phase 1 trial testing a group-format psilocybin-assisted therapy (GPAT) program for people with PTSD. The study is pragmatic and based at a single site in Albuquerque, New Mexico, with most visits delivered in a group setting including preparation, dosing, and follow-up sessions. Primary outcomes focus on safety and feasibility, including completion rates and adverse events recorded using CTCAE v5.0, with preliminary symptom effects measured by CAPS-5 and PCL-5 scores. The protocol targets cohorts defined by lived experience (veterans/first responders, female survivors of sexual violence, Indigenous participants) and requires ability to attend group visits and meet medication and pregnancy-related safety criteria.

Who should consider this trial

Good fit: Adults with moderate to severe PTSD (PCL-5 ≥34) who identify as a veteran or first responder, a female survivor of sexual violence, or an Indigenous person, who can attend group visits, are willing to follow medication and birth-control requirements, and can consent in English.

Not a fit: People with only mild PTSD, unstable medical or psychiatric conditions, those who cannot discontinue interfering medications, pregnant or breastfeeding individuals, or those unable to participate in English-language group sessions may not benefit from or be eligible for this program.

Why it matters

Potential benefit: If successful, this approach could reduce PTSD symptoms while offering a more scalable, group-based option for care.

How similar studies have performed: Individual psilocybin-assisted therapy has shown promising results in small trials for depression and PTSD symptoms, but group-format psilocybin therapy for PTSD is largely novel and largely untested in formal trials.

Eligibility criteria

Inclusion Criteria:

General:

-T+H years of age and \<89 years of age

Identify as a member of one of the cohorts to be studied:

* 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

PTSD severity:

* 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 Criteria:

* 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

Cardiovascular conditions:

* 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.

Using daily dose of psilocybin mushrooms at dose \<0.2 mg or LSD at \<20 mcg per day for \<30 days in a year ("microdosing") will not be an exclusion criterion.

However, participants must agree to no further use of psychedelics during this study starting at screening.

* 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

Where this trial is running

Albuquerque, New Mexico

• Interdisciplinary Substance Use and Brain Injury (ISUBI) — Albuquerque, New Mexico, United States (Recruiting)

Study contacts

• Study coordinator: Lawrence M Leeman, MD

Conditions PTSD