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

NCT06888128 | Recruiting Phase 2 FDA Drug

• 1 other identifier: H-50300
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief 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

PTSD

Keywords

PTSD; veterans; psilocybin; trauma; psychedelic

Outcome Measures

Primary Outcomes (3)

• Safety of psilocybin-assisted therapy for PTSD

  Safety as measured by Adverse Event Reporting

  Baseline to 6-month follow up

• Safety of psilocybin-assisted therapy for PTSD

  Safety as measured by changes in suicidal ideation on the Columbia Suicide Safety Rating Scale (CSSRS). This section of the measure is assessed on a scale of 0 to 25, with higher scores indicating greater intensity of suicidal ideation.

  Baseline to 6-month follow up

• Efficacy of psilocybin-assisted therapy for PTSD

  Change in Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) score. This measure is assessed on a scale of 0 to 80, with higher scores reflecting increased severity of PTSD symptoms.

  Baseline to 6-month follow up

Secondary Outcomes (3)

• Self-reported clinical efficacy of psilocybin-assisted therapy for PTSD symptoms

  Baseline to 6-month follow up

• Self-reported clinical efficacy of psilocybin-assisted therapy for depressive symptoms

  Baseline to 6-month follow up

• Self-reported clinical efficacy of psilocybin-assisted therapy for anxiety symptoms

  Baseline to 6-month follow up

Other Outcomes (1)

• Changes in Resting-State Functional Connectivity

  Baseline to 6-month follow up

Study Arms (1)

Psilocybin-assisted therapy

EXPERIMENTAL

Participants will enter a 5-week participation phase, which includes 3 preparatory sessions, 2 dosing days, and 4 integration sessions.

Drug: Psilocybin 15mg; Drug: Psilocybin 25mg

Interventions

Psilocybin 25mg DRUG

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

Psilocybin-assisted therapy

Psilocybin 15mg DRUG

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.

Psilocybin-assisted therapy

Eligibility Criteria

• Age: 21 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Be a United States Military Veteran
• Have at least a high-school level of education or equivalent (e.g. GED).
• Have a current DSM-5 diagnosis of Post-traumatic Stress Disorder
• Have a CAPS-5 total severity score of ≥23 at baseline
• SSRIs will be allowable so long as participants are on a stable regimen for a period of 3 months.
• Concurrent psychotherapy is allowed if the type and frequency of the therapy has been stable for at least 2 months prior to screening and is expected to remain stable during participation in the study.
• Be medically stable as determined by screening for medical problems via a personal interview, a medical questionnaire, a physical examination, an electrocardiogram (ECG), and routine medical blood and urinalysis laboratory tests
• No use of hallucinogens in the past 3 months and no history of regular or frequent use of hallucinogens

You may not qualify if:

• Individuals who are pregnant or nursing; individuals who are of child-bearing potential and sexually active who are not practicing a highly effective means of birth control
• Individuals with partners of childbearing potential who are sexually active and not practicing a highly effective means of contraception
• Cardiovascular conditions: coronary artery disease, stroke, angina, uncontrolled hypertension, a clinically significant ECG abnormality (e.g., atrial fibrilation), prolonged QTc interval (i.e., QTc \> 450 msec), artificial heart valve, or TIA in the past year • Systolic blood pressure (SBP) \> 139 mm HG; diastolic blood pressure (DBP) \> 89 mm HG; heart rate (HR) \> 90 bpm.
• Epilepsy with history of seizures
• Insulin-dependent diabetes; if taking oral hypoglycemic agent, then no history of symptoms of hypoglycemia
• Current or past history of meeting DSM-5 criteria for schizophrenia spectrum or other psychotic disorders (except substance/medication-induced or due to another medical condition), or Bipolar I or II Disorder
• Current or history within six months of meeting DSM-5 criteria for a moderate or severe alcohol, tobacco, caffeine, or other drug use disorder; if a regular smoker, they must agree to use a nicotine patch on the day of dosing as smoking will not be allowed on these sessions
• Have a first degree relative with schizophrenia spectrum or other psychotic disorders including substance/medication-induced or due to another medical condition
• Risk for acute suicidality as determined by clinician judgment (C-SSRS)
• Has a psychiatric condition which precludes the establishment of therapeutic rapport as evidenced by long-term patterns of unstable relationships, history of significant stress-related paranoia, and identity disturbances
• History of a medically significant suicide attempt
• Current MAOI antidepressant use

Sponsors & Collaborators

• Baylor College of Medicine: lead
• Texas Department of State Health Services: collaborator
• Usona Institute: collaborator
• AIM Youth Mental Health: collaborator

Study Sites (1)

Baylor College of Medicine

Houston, Texas, 77030, United States

RECRUITING

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic; Wounds and Injuries

Interventions

Psilocybin

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Indole Alkaloids; Alkaloids; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Tryptamines; Indolizidines; Indolizines

Central Study Contacts

Lynnette A. Averill, Ph.D.

CONTACT

‪(832) 271-6615; emerging@bcm.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: February 21, 2025
• First Posted: March 21, 2025
• Study Start: January 30, 2025
• Primary Completion (Estimated): December 15, 2026
• Study Completion (Estimated): December 15, 2026
• Last Updated: January 22, 2026

Record last verified: 2026-01

Locations

US (1)