PTSDPhase 1GPATNCT07506395
Group Psilocybin-Assisted Therapy for Post-Traumatic Stress Disorder
A Phase 1 study testing Psilocybin in people with PTSD, run by University of New Mexico at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 89 years
- Conditions the study is for
- PTSD
- What is being tested?
- Psilocybin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2026to 1 May 2028
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Victoria Culkin contact
United States1 site, 1 recruiting
- Recruiting
Interdisciplinary Substance Use and Brain Injury (ISUBI)
Albuquerque, New Mexico, 87131
Victoria Culkin, MA, 505-272-1754, vculkin@salud.unm.edu
Victoria Culkin, MA, vculkin@salud.unm.edu
About this study
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.
Read the detailed description
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.
These will be assessed by the following outcome measures:
- Proportion of participants completing the study protocol
- 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
- Mean change in the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) and PTSD checklist for DSM-5 (PCL-5). The CAPS-5 and PCL-5 are based on the DSM-5 not the DSM-5-TR.
- Conditions
- PTSD
- Being tested
- Psilocybin
- Medical subject headings
- Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PsilocybinDrug
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
| Study group | Role | What they receive |
|---|---|---|
| GPAT-PTSD | Other | Not described Receives: Drug: Psilocybin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of study completion-feasabiity measure
Number of participants that completed the study.
Measured: 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.
Measured: 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
Measured: 18 weeks after baseline
Secondary outcomes (4)
Beck Depression Inventory-II
The Beck Depression Inventory-II is a 21-item, 4-point Likert scale (0-3) self-report questionnaire depression assessment with a minimum score of 0 and a maximum score of 63; higher scores indicate greater depression severity.
Measured: 12 weeks after second psilocybin administration
Hamilton Anxiety Scale
The Hamilton Anxiety Scale is a 14-item clinician-administered tool used to quantify the severity of anxiety symptoms. Each item is scored from 0 (not present) to 4 (very severe), with a total score range of a minimum score of 0 and a maximum score of 56. Higher scores indicate higher anxiety symptoms.
Measured: 12 weeks after second psilocybin administration
Sheehan Disability Scale
The Sheehan Disability Scale is a 3-item self-reported tool measuring functional impairment in work, social life, and family life, each rated from 0 (not at all) to 10 (extremely). Total scores range from a minimum score of 0 and a maximum score of 30; higher scores indicate greater impairment.
Measured: 12 weeks after second psilocybin administration
World Health Organization 5-Wellbeing Index
The World Health Organization 5-Wellbeing Index is a 5-item, self-reported questionnaire assessing subjective psychological well-being over the past two weeks. Respondents rate items from 0 ("at no time"), with total raw scores (0-25) multiplied by 4, to generate a final 0-100 score. A maximum score of 100 indicates the best well-being, while a minimum score of 0 indicates the worst.
Measured: 12 weeks after second psilocybin administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2026
- Study start1 May 2026
- Primary completion1 May 2027 (estimated)
- Study completion1 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PTSDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of New Mexico
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lawrence Leeman, University of New Mexico
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07506395
- Sponsor's protocol ID
- 25-570
- Acronym
- GPAT
- Status last verified
- May 2026
- First submitted
- 18 Mar 2026
- Last updated
- 22 May 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: no plans to share IPD
Publications
Leeman L, Armstrong M, Menashi D, Nayo-Washington H, Marseille E, Herrera J, Romero C, Page-Reeves J. Community engagement as a foundation for implementation research for group psilocybin assisted therapy in New Mexico. Front Public Health. 2026 Jun 17;14:1845943. doi: 10.3389/fpubh.2026.1845943. eCollection 2026.
PubMed 42395285
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Group Psilocybin-Assisted Therapy for Post-Traumatic Stress Disorder
- ClinicalTrials.gov ID
- NCT07506395
- Acronym / sponsor ID
- GPAT / 25-570
- Conditions
- PTSD
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- University of New MexicoUniversity, hospital or other
- Study start
- 1 May 2026 (actual)
- Primary completion
- 1 May 2027 (estimated)
- Study completion
- 1 May 2028 (estimated)
- First posted
- 1 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
These will be assessed by the following outcome measures:
- Proportion of participants completing the study protocol
- 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
- Mean change in the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) and PTSD checklist for DSM-5 (PCL-5). The CAPS-5 and PCL-5 are based on the DSM-5 not the DSM-5-TR.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| GPAT-PTSD | Other | Drug: Psilocybin |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- -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
Key exclusion criteria (22 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PsilocybinTwo 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 | Drug | GPAT-PTSD |
Primary outcome
Rate of study completion-feasabiity measure
Time frame: 18 weeks after baseline
Number of participants that completed the study.
Clinician-Administered PTSD Scale for DSM-5
Time frame: baseline 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.
Time frame: 18 weeks after baseline
adverse event assessment as safety measure
4 secondary outcomes
Beck Depression Inventory-II
Time frame: 12 weeks after second psilocybin administration
Hamilton Anxiety Scale
Time frame: 12 weeks after second psilocybin administration
Sheehan Disability Scale
Time frame: 12 weeks after second psilocybin administration
World Health Organization 5-Wellbeing Index
Time frame: 12 weeks after second psilocybin administration
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2026.
- Derived from this study: PubMed 42395285Leeman L, Armstrong M, Menashi D, Nayo-Washington H, Marseille E, Herrera J, Romero C, Page-Reeves J. Community engagement as a foundation for implementation research for group psilocybin assisted therapy in New Mexico. Front Public Health. 2026 Jun 17;14:1845943. doi: 10.3389/fpubh.2026.1845943. eCollection 2026.
- GAT Study website at UNM Academic Interest Group for Psychedelic Assisted TherapiesLink provided by the sponsor.
- Individual participant dataSharing planned: No. no plans to share IPD
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Victoria Culkin contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Psilocybin in people with PTSD, run by University of New Mexico at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Victoria Culkin (vculkin@salud.unm.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of study completion-feasabiity measure (time frame: 18 weeks after baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07506395, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2026.