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PTSDPhase 2NCT07332143

Psilocybin-Assisted Therapy

A Phase 2 study testing psilocybin, Supportive Therapy and Prolonged Exposure Therapy in people with PTSD, run by Emory University at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

This pilot study will examine the safety, tolerability, acceptability, and efficacy of combination psilocybin + psychotherapy to decrease PTSD symptoms. Participants will be randomized into two different treatment groups, allowing the investigators to directly compare PE augmented with psilocybin and… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
PTSD
What is being tested?
psilocybin, Supportive Therapy and Prolonged Exposure Therapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
150 participants
Where
1 siteUnited States
Study dates
8 Jun 2026to Mar 2027
Phase
Phase 2
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Meet criteria for PTSD due to trauma occurring at least 3 months prior based on CAPS-5-R diagnostic scoring rules.
  • Able to speak and read English (due to standardization of outcome measures).
  • Willingness of participant to sign a release for the investigators to communicate with their primary care or mental health providers, if indicated
  • Are 18 years and older.
  • Are able to swallow pills.
  • Agree to have study visits video and/or audio recorded, including Medicine Session, Independent Rater assessments, and non-drug psychotherapy sessions.
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  • Must provide a contact (relative, spouse, close friend, or other support person) who is willing and able to be reached by the investigators in the event of a participant becoming suicidal or unreachable.
  • Must agree to inform the investigators within 48 hours of any medical conditions and procedures.
  • If able to become pregnant, participants must have a negative pregnancy test prior to study entry, at study entry, and prior to each Medicine Session. They must agree to use highly effective birth control for a month prior to the Medicine session and through 10 days after the Medicine session.
  • Agree to the following lifestyle modifications: comply with requirements for fasting and refraining from certain medications prior to Medicine Session, not participate in any other interventional clinical trials during the duration of the treatment, and agree not to operate their vehicles (or heavy machinery) up to 24 hours after Medicine Session, and commit to medication dosing, therapy, and study procedures.

Who cannot join

  • Are not able to give adequate informed consent.
  • Have a family history bipolar disorder type 1 or a psychotic disorder in first degree relatives.
  • Have any current problem which, in the opinion of the investigator or Medical Monitor, might interfere with participation.
  • Have hypersensitivity to any ingredient of the IMP (Investigational Medicinal Product).
  • Have a history of or current bipolar type 1 disorder, primary psychotic disorder (e.g., schizophrenia), or secondary psychotic features (i.e., Major Depressive disorder with psychotic features.
  • Have met criteria at any time during their life for amphetamine or cocaine substance use disorder or any drug of abuse the study physician determines to be unfit for the study.
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  • Meet criteria for current (past 3 months) moderate or severe substance use disorder, as defined by 4 or more DSM SUD criteria symptoms.
  • Have a positive screen for any drug of abuse (amphetamines, etc.) on drug test administered in local community or on site unless being taken as prescribed by a physician.
  • Any participant presenting current serious suicide risk, as determined through psychiatric interview and clinical judgment of the investigator will be excluded;
  • Suicidal ideation score of 4 or greater within the last 6 months.
  • Any suicidal behavior, including suicide attempts or preparatory acts, within the last 6 months of the assessment
  • However, history of suicide attempts is not an exclusion.
  • Require ongoing concomitant therapy with a psychiatric medication with exceptions described in protocol section on Concomitant Medications.
  • Medical History
  • Have a history of any medical condition that could make receiving a sympathomimetic drug harmful because of increases in blood pressure and heart rate, or any medical condition the study physician believes would pose a safety risk or interfere with the effects of the treatment.
  • This includes, but is not limited to, a history of myocardial infarction, cerebrovascular accident, or aneurysm.
  • Participants with other stable chronic medical problems may be enrolled if the site physician believes would not significantly increase the risk of Psilocybin administration or be likely to produce significant symptoms during the study that could interfere with study participation or be confused with side effects of the IMP.
  • Have any unstable medical or central nervous system-related illness that would interfere with participation.
  • Systolic blood pressure >= 140 mmHg or diastolic blood pressure >= 90 mmHg, measured in the supine position after at least five minutes at rest. If the initial blood pressure is >= 140/90 mmHg, up to three additional attempts before dosing visit are permitted. The study physician will manage blood pressure monitoring from baseline through 10 days after drug administration.
  • Have a history of clinically significant arrhythmia, other than premature atrial contractions (PACs) or occasional PVCs in the absence of ischemic heart disease, within 12 months of screening.
  • Participants with a history of atrial fibrillation, atrial tachycardia, atrial flutter or paroxysmal supraventricular tachycardia or any other arrhythmia associated with a bypass tract may be enrolled only if they have been successfully treated with ablation and have not had recurrent arrhythmia for at least one year off all antiarrhythmic drugs and confirmed by a cardiologist.
  • Have a marked Baseline prolongation of QT/QTc interval e.g., repeated demonstration of a QTc interval > 450 milliseconds (ms) in males and >470 ms in females. For transgender or non-binary participants, QTc interval will be evaluated based on sex assigned at birth.
  • Have a history of additional risk factors for Torsade de pointes (e.g., heart failure, family history of Long QT Syndrome).
  • Have significant liver enzyme elevations as evidenced by total bilirubin >1.5mg/dL and/or ALT and AST (>two times upper limit of normal [ULN]) per baseline laboratory test.
  • Creatinine clearance: <30 mL/min)
  • Non-ambulatory or require two-person assistance with transfers (Fall risk)
  • Body Mass Index (BMI) <18
  • Are pregnant or nursing
  • fMRI Scan Exclusions Only: History of cranial surgery, metallic particles in the eye or head (exclusive of mouth), implanted cardiac pacemaker or any intra-cardiac lines, implanted neurostimulators, intra-cranial implants (e.g., aneurysm clips, shunts, stimulators, cochlear implants, or electrodes) or implanted medical pumps.
  • NOTE: these ineligibility criteria preclude participants from undergoing a fmri scan but does not exclude them from the primary study participant and they may proceed without fMRI.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Anna Wise, PhD contact

404-712-1035

patstudy@emory.edu

Jessica Maples-Keller, PhD contact

404-778-2075

jmaple2@emory.edu

United States1 site, 1 recruiting

  • Emory University Hospital

    Atlanta, Georgia, 30322

    Anna Wise, PhD, 404-712-1035, patstudy@emory.edu

    Jessica Maples-Keller, PhD, 404-778-2075, jmaple2@emory.edu

    Recruiting

Other trials in United States

About this study

Official title: The Safety and Acceptability of Psilocybin With Support and With Massed Prolonged Exposure Therapy for PTSD

This pilot study will examine the safety, tolerability, acceptability, and efficacy of combination psilocybin + psychotherapy to decrease PTSD symptoms. Participants will be randomized into two different treatment groups, allowing the investigators to directly compare PE augmented with psilocybin and psilocybin-assisted psychotherapy.

Read the detailed description

The Primary objective is to pilot and investigate tolerability, safety, and acceptability of psilocybin-assisted supportive therapy and psilocybin-assisted massed prolonged exposure (PE) therapy and conduct exploratory analyses related to comparative effectiveness of these treatments, including preliminary outcomes from pre-treatment to 1-month follow-up on post-traumatic stress disorder (PTSD) symptoms. Safety and tolerability of the treatment will be assessed and evaluated using the Swiss Psychedelic Side Effects Inventory (SPSI), Psychedelic-assisted Therapy After Effects (PATAE), and the Accessibility Questionnaire (AQ).

The study will also evaluate the effect of psilocybin and massed exposure therapy using Subjective Units of Distress (SUDS) during imaginal exposure sessions; to assess self-reported PTSD and depression symptoms across treatment and investigate effect on fear extinction learning and fear extinction recall as assessed via fear potentiated startle. Given that this is a pilot study with small sample, analyses will be preliminary.

Conditions
PTSD
Being tested
psilocybin, Supportive Therapy, Prolonged Exposure Therapy
Keywords
Psilocybin, PTSD, Supportive therapy, PE therapy
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

    Also called 3-[2-(Dimethylamino)ethyl]-1H-indol-4-yl dihydrogen phosphate

    25 mg

  • Supportive TherapyBehavioural

    Treatment includes non-directive psychological support across the preparatory, dosing, and integration sessions. Preparatory sessions include psychoeducation regarding psilocybin's subjective effects and establish strategies for psilocybin related support, including boundaries around physical touch. Therapists encourage setting intention for dosing day, and practicing experiential exercises. Integration sessions include processing the participant's experience of their psilocybin administration session. Therapists will support participants in identifying activities for ongoing integration outside of sessions. The standard care for supportive therapy will be modeled in this study.

  • Prolonged Exposure TherapyBehavioural

    Prolonged Exposure (PE) Therapy will be conducted for 10 sessions. They will consist of repeated exposures to trauma memories (imaginal exposure) consistent with the manualized protocol for massed exposure therapy. Also consistent with this treatment manual, participants will listen to imaginal exposures and conduct in real life exposures outside of PE sessions for "homework". The standard care for PE therapy will be modeled in this study.

Study groups in NCT07332143
Study groupRoleWhat they receive
Group 1: Psilocybin combined with supportive therapyExperimentalAll participants will receive a single 25 mg dose of psilocybin during the experimental session, which occurs during to their respective therapy model. Then, participants will receive 2 support (integrative) therapy sessions that will be 1 week apart. In between these sessions, subjects will complete a series of online surveys to track treatment progress.
Receives: Drug: psilocybin; Behavioral: Supportive Therapy
Group 2: Psilocybin combined with massed prolonged exposure (PE) therapyExperimentalAll participants will receive a single 25 mg dose of psilocybin during the experimental session, followed by 10 prolonged exposure (PE) therapy sessions for 10 days. In between these sessions, participants will complete a series of online surveys to track treatment progress.
Receives: Drug: psilocybin; Behavioral: Prolonged Exposure Therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in PTSD symptoms based on CAPS-5-R total severity score

    PTSD symptoms will be evaluated using the Revised Clinician-Administered PTSD Scale for DSM-5, that refers to 20 core symptoms as CAPS-5, each rated on a 0-4 severity scale (0 = absent to 4 = extremely severe), combining frequency and intensity. Total possible score range is 0 to 80 with higher scores correlating with worse outcome.

    Measured: Baseline, 1-month post-intervention

  2. Change in PCL-5 score

    The PCL-5 is a 20-item self-report measure of DSM-5 PTSD symptoms. Scores on the PCL range from 0 to 80, with higher scores indicating higher symptom severity, and a cutoff of 33 indicating clinical levels of PTSD symptoms.

    Measured: Baseline, 1, 6 and 12 months post-intervention

  3. Depression symptoms (PHQ-9)

    The PHQ-9 is a 9-item self-report measure of depressive symptoms. A score of 10 or above indicative of a possible major depressive episode, and it provides a measure of severity of these symptoms. Total possible score range is 0-29, higher score correlates with worse outcome.

    Measured: Baseline, 1, 6 and 12 months post-intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Jan 2026
  2. Study start8 Jun 2026
  3. Primary completionMar 2027 (estimated)
  4. Study completionMar 2027 (estimated)

Resources

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
150 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07332143
Sponsor's protocol ID
2025P013649
Status last verified
Sep 2026
First submitted
8 Jan 2026
Last updated
1 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing psilocybin, Supportive Therapy and Prolonged Exposure Therapy in people with PTSD, run by Emory University 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 10 inclusion and 30 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 1 Oct 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 Anna Wise, PhD (404-712-1035, patstudy@emory.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in PTSD symptoms based on CAPS-5-R total severity score (time frame: Baseline, 1-month post-intervention). 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 NCT07332143.

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 1 Oct 2026.

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