deltatrials
Not Yet Recruiting INTERVENTIONAL NCT07332143

Psilocybin-Assisted Therapy

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

Sponsor: Emory University

Conditions PTSD
Interventions Prolonged Exposure Therapy Supportive Therapy psilocybin
Updated 2 times since 2026 Last updated: Apr 22, 2026 Started: May 1, 2026 Primary completion: Mar 1, 2027 Completion: Mar 1, 2027
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Listed as NCT07332143, this observational or N/A phase trial focuses on PTSD and remains actively recruiting participants. Sponsored by Emory University, it has been updated 2 times since 2026, reflecting limited change activity. This study adds to the evidence base for this therapeutic area through structured, versioned documentation.

Study Description(click to expand)

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.

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.

Status Flow

~Feb 2026 – ~Apr 2026 · 3 months · monthly snapshotNot Yet RecruitingApr 28, 2026 – present · 2 months · daily APINot Yet Recruiting

Change History

2 versions recorded

  1. Apr 28, 2026 — Present [daily]

    Not Yet Recruiting

    Phase: PHASE2 → None

  2. Feb 2026 — Apr 2026 [monthly]

    Not Yet Recruiting PHASE2

    First recorded

Eligibility 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 psilocybin-assisted psychotherapy.

Contact Information

Sponsor contact:
  • Emory University
  • Georgia Department of Veterans Services
Data source: ClinicalTrials.gov

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations