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State-Funded Trial Assessing Recovery and Long-Term Impact of Guided Psilocybin for Healing Trauma

NCT06888128 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2026-01-22

No results posted yet for this study

Summary

The principal investigator for this study plans to build upon the psilocybin-assisted therapy intervention used in prior completed trials to conduct an open-label trial of two psilocybin administration sessions combined with psychotherapy to investigate the safety, tolerability, and clinical efficacy of psilocybin-assisted therapy for the treatment of PTSD in US Veterans.

Conditions

Interventions

DRUG

Psilocybin 15mg

Each participant will have a low dose (15 mg) psilocybin session to establish basic skills with session format, psilocybin effects, and continue to build rapport with session facilitators. Given the potential intensity of the psilocybin and the reality of experiencing significant trauma memories, the purpose of the first psilocybin session is to familiarize participants with the drug effects that may be encountered at a higher dose of psilocybin. The first psilocybin session will also allow for assessment of both the suitability of each participant to the study procedures and drug effects, and the safety of administering a higher dose to each participant.

DRUG

Psilocybin 25mg

The second psilocybin session will utilize a high dose (25mg) and take place approximately 2 weeks after the first psilocybin session.

Sponsors & Collaborators

  • Texas Department of State Health Services

    collaborator OTHER

  • Usona Institute

    collaborator OTHER

  • AIM Youth Mental Health

    collaborator UNKNOWN

  • Baylor College of Medicine

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
21 Years
Max Age
64 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-01-30
Primary Completion
2026-12-15
Completion
2026-12-15
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06888128 on ClinicalTrials.gov