Group Psilocybin-Assisted Therapy for Post-Traumatic Stress Disorder

NCT07506395 | Recruiting Phase 1 FDA Drug

• 1 other identifier: 25-570
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

This study is a community-informed, pragmatic, open-label, phase 1 clinical trial of group-format psilocybin-assisted therapy (GPAT) for individuals with post-traumatic stress disorder (PTSD). The primary objectives of this phase 1 study are to assess the safety and feasibility of (GPAT) for individuals with (PTSD) and to evaluate preliminary effects on PTSD severity.

Conditions

PTSD

Outcome Measures

Primary Outcomes (3)

• Rate of study completion-feasabiity measure

  Number of participants that completed the study.

  18 weeks after baseline

• Clinician-Administered PTSD Scale for DSM-5

  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.

  baseline and 18 weeks

• 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.

  adverse event assessment as safety measure

  18 weeks after baseline

Secondary Outcomes (4)

• Beck Depression Inventory-II

  12 weeks after second psilocybin administration

• Hamilton Anxiety Scale

  12 weeks after second psilocybin administration

• Sheehan Disability Scale

  12 weeks after second psilocybin administration

• World Health Organization 5-Wellbeing Index

  12 weeks after second psilocybin administration

Study Arms (1)

GPAT-PTSD

OTHER

Drug: Psilocybin

Interventions

Psilocybin DRUG

Two group-format dosing sessions, scheduled 4 weeks apart, will be held at the ISUBI Center at UNM or a site outside of UNM with DEA approval for psilocybin storage

GPAT-PTSD

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of New Mexico: lead

Study Sites (1)

Interdisciplinary Substance Use and Brain Injury (ISUBI)

Albuquerque, New Mexico, 87131, United States

RECRUITING

Related Links

• GAT Study website at UNM Academic Interest Group for Psychedelic Assisted Therapies

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Interventions

Psilocybin

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Indole Alkaloids; Alkaloids; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Tryptamines; Indolizidines; Indolizines

Central Study Contacts

Victoria Culkin

CONTACT

vculkin@salud.unm.edu

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 18, 2026
• First Posted: April 1, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): May 1, 2028
• Last Updated: May 22, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)