Psilocybin-Assisted Therapy for PTSD

Overseen By Anna Wise, PhD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Emory University

Must not be taking: Psychiatric medications

Disqualifiers: Bipolar, Psychotic disorders, Substance use, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 1

Duration: 2 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether combining psilocybin (a compound found in certain mushrooms) with therapy can help reduce PTSD symptoms in military veterans and service members. Participants will be randomly assigned to one of two groups: one will receive psilocybin with supportive therapy, and the other with prolonged exposure therapy. The study aims to assess the safety and effectiveness of these combinations for treating PTSD. Individuals who have experienced trauma-related PTSD for at least six months and are seeking treatment may be suitable candidates. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

Do I have to stop taking my current medications for the trial?

The trial requires participants to refrain from certain medications before the psilocybin session, but it doesn't specify which ones. It's best to discuss your current medications with the trial investigators to see if any adjustments are needed.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that psilocybin, the treatment under study, is generally safe and well-tolerated. In one study, participants who took a single 25 mg dose of psilocybin reported no serious side effects, suggesting safety for most individuals. Another study found psilocybin safe when combined with therapy for treating post-traumatic stress disorder (PTSD).

While these results are encouraging, individual responses can vary. Some people might experience mild side effects, such as temporary changes in mood or perception. Overall, research indicates that psilocybin is safe for use in controlled settings. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Unlike the standard treatments for PTSD, which typically involve medications like SSRIs or SNRIs and various forms of talk therapy, psilocybin offers a novel approach by acting on the brain's serotonin receptors, potentially fostering new neural connections and emotional breakthroughs. Researchers are excited about psilocybin-assisted therapy because it combines the psychedelic effects of psilocybin with supportive therapy and exposure therapy, which could lead to faster and more profound healing experiences. This treatment might show benefits in just a few sessions, offering a quicker path to relief compared to traditional treatments that can take weeks or months to show results.

What evidence suggests that this trial's treatments could be effective for PTSD?

Research has shown that psilocybin, when used with supportive therapy, may help reduce PTSD symptoms. In this trial, participants in Group 1 will receive psilocybin combined with supportive therapy, while those in Group 2 will receive psilocybin combined with massed prolonged exposure (PE) therapy. Early data suggests that even one dose of psilocybin, combined with therapy, can lessen PTSD symptoms. Psilocybin has also proven helpful for depression, which often accompanies PTSD. Studies have found that psilocybin-assisted therapy can improve mood and mental health. While more research is needed, these early results offer promise for those considering this treatment. ^{3 6 7 8 9}

Who Is on the Research Team?

Anna Wise, PhD

Principal Investigator

Emory University

Are You a Good Fit for This Trial?

This trial is for Georgia military veterans, reservists, National Guard members, or active-duty service members over 18 seeking PTSD treatment. They must be able to swallow pills, consent to recordings of sessions, and have a contact person in case of emergencies. Women who can become pregnant need a negative pregnancy test and agree to birth control use. Participants should not have certain psychiatric disorders or substance abuse issues.

Inclusion Criteria

Participants must be willing to sign a release for the investigators to communicate with their primary care or mental health providers

Participants must be able to visually read and understand the English language and give written informed consent

Participants must be able to swallow pills

Exclusion Criteria

Participants meeting other medical exclusion criteria specified in the protocol

Participants currently engaged in compensation litigation for financial gain from prolonged symptoms of PTSD or any other psychiatric disorders

Participants likely to be re-exposed to trauma, lack social support, or lack a stable living situation

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a single 25 mg dose of psilocybin followed by therapy sessions. Group 1 receives 2 supportive therapy sessions 1 week apart, and Group 2 receives 10 prolonged exposure therapy sessions over 10 days.

2 weeks

1 visit (in-person) for psilocybin session, multiple therapy sessions

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments at 1, 6, and 12 months post-intervention.

12 months

Multiple assessments (virtual)

What Are the Treatments Tested in This Trial?

Interventions

• Psilocybin

Trial Overview

The study compares two treatments for PTSD: one group receives psilocybin with psychotherapy while the other undergoes Prolonged Exposure Therapy augmented with psilocybin. The goal is to see which method better reduces PTSD symptoms by randomly assigning participants into these groups.

How Is the Trial Designed?

Group I: Group 2: Psilocybin combined with massed prolonged exposure (PE) therapy Experimental Treatment 2 Interventions

All 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.

Group II: Group 1: Psilocybin combined with supportive therapy Experimental Treatment 2 Interventions

All 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.

Who Is Running the Clinical Trial?

Emory University

Lead Sponsor

Trials

1,735

Recruited

2,605,000+

Georgia Department of Veterans Services

Collaborator

Citations

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ptsd.va.gov/professional/treat/txessentials/psychedelics_assisted_therapy.asp

Psychedelic-Assisted Therapy for PTSD

Finally, preliminary data suggests that a single administration of psilocybin along with group psychotherapy can decrease symptoms of PTSD in older long-term ...

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thelancet.com

thelancet.com/journals/eclinm/article/PIIS2589-5370(25)00626-1/fulltext

Investigational psilocybin treatment for post-traumatic ...

Psilocybin has shown promise in treating depression, a condition that is often comorbid with PTSD.

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clinicaltrials.gov

clinicaltrials.gov/study/NCT07332143

NCT07332143 | Psilocybin-Assisted Randomized Therapy

This pilot study will examine the safety, tolerability, acceptability, and efficacy of combination psilocybin + psychotherapy to decrease ...

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pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10845102/

The Psychedelic Future of Post-Traumatic Stress Disorder ...

While data thus far suggest that psychedelic-assisted psychotherapy (PAP) has the potential to be a successful treatment for PTSD, several features of these ...

5.

ccjm.org

ccjm.org/content/92/3/171

Psychedelic-assisted therapy: An overview for the internist

The pooled response rate at primary end point (which, across included trials, ranged from 1 to 7 weeks after psilocybin administration) was 57% ...

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pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/40883964/

A nonrandomized open-label clinical trial

Investigating the safety and tolerability of single-dose psilocybin for post-traumatic stress disorder: A nonrandomized open-label clinical ...

7.

clinicaltrials.gov

clinicaltrials.gov/study/NCT05562973

Safety and Tolerability of Psilocybin in Post-Traumatic ...

The purpose of this study is to evaluate the safety, tolerability, and potential efficacy of psilocybin-assisted psychotherapy to reduce post-traumatic stress ...

8.

ir.compasspathways.com

ir.compasspathways.com/News--Events-/news/news-details/2025/Compass-Pathways-Announces-Publication-of-Results-from-Phase-2-Study-of-COMP360-Psilocybin-for-Post-Traumatic-Stress-Disorder/default.aspx

News Details

Open-label Phase 2 study shows a single 25 mg COMP360 psilocybin dose was well tolerated, with no serious adverse events observed, ...

9.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S0165032724016227

Single-dose psilocybin for U.S. military Veterans with ...

This is the first study to evaluate the efficacy and safety of psilocybin in Veterans with severe treatment-resistant depression (TRD).