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

Description

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

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Study Overview

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Study Details

Study overview

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.

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

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

Condition
PTSD
Intervention / Treatment

-

Contacts and Locations

Houston

Baylor College of Medicine, Houston, Texas, United States, 77030

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * 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
  • * General medical

Ages Eligible for Study

21 Years to 64 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Baylor College of Medicine,

Study Record Dates

2025-08-31