Psilocybin-Assisted Therapy for PTSD

Overseen By Anna Wise, PhD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Emory University

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: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Who Is on the Research Team?

Anna Wise, PhD

Principal Investigator

Emory University

Are You a Good Fit for This Trial?

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

What Are the Treatments Tested in This Trial?

Interventions

• Psilocybin

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