Actively Recruiting
Group Psilocybin-Assisted Therapy for Post-Traumatic Stress Disorder
Led by University of New Mexico · Updated on 2026-05-07
36
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Group Psilocybin-Assisted Therapy for Post-Traumatic Stress Disorder
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Between 18 and 89 years old
- Identify as a veteran, first responder, female survivor of sexual violence, or Indigenous person
- Not pregnant, breastfeeding, or planning pregnancy and willing to use reliable birth control if able to become pregnant
- Able and willing to taper and stop medications that interfere with psilocybin if needed
- Able to read, speak, and understand English
- Willing and able to consent, attend all study visits including group sessions, preparation, and follow-up
- Able and willing to swallow capsules
- Meet DSM-5 criteria for PTSD
- Have moderate to severe PTSD symptoms (PCL-5 score of 34 or greater) lasting at least six months
You will not qualify if you...
- Unable to abstain from alcohol, non-prescribed opioids, methamphetamines, cocaine, benzodiazepines, or other illicit substances for five days
- Unable or unwilling to remain abstinent from cannabis 24 hours before and 12 hours after psilocybin dosing
- At risk of dangerous acute withdrawal from any substance on dosing day
- Any medical condition that makes participation unsafe, including pregnancy or breastfeeding
- Uncontrolled hypertension or significant cardiovascular conditions
- Clinically significant abnormal ECG findings
- Poorly controlled diabetes or recent severe hypoglycemia
- Neurological or neurodegenerative diseases impacting participation
- Severe liver, kidney, or unstable thyroid disorders
- Active suicidal thoughts or recent suicide attempt
- Diagnosis of schizophrenia, psychotic disorders, or certain personality disorders
- Use of psychedelics causing a psychedelic experience in the past six months (microdosing allowed if within limits), with agreement to avoid psychedelics during the study
- Returning to unsafe environment or inadequate social support
- Any other condition deemed unsuitable by clinical trial staff
- Participation in experimental PTSD treatment or research within 30 days before screening
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Interdisciplinary Substance Use and Brain Injury (ISUBI)
Albuquerque, New Mexico, United States, 87131
Actively Recruiting
Research Team
L
Lawrence M Leeman, MD
CONTACT
V
Victoria Culkin
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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