RECRUITING

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

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PTSDveteranspsilocybintraumapsychedelic

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2025-01-30
Study Completion:2025-08-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06888128

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.

Ages Eligible for Study:21 Years to 64 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT
Inclusion CriteriaExclusion Criteria
  1. * Be a United States Military Veteran
  2. * Have at least a high-school level of education or equivalent (e.g. GED).
  3. * Have a current DSM-5 diagnosis of Post-traumatic Stress Disorder
  4. * Have a CAPS-5 total severity score of ≥23 at baseline
  5. * SSRIs will be allowable so long as participants are on a stable regimen for a period of 3 months.
  6. * 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.
  7. * 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
  8. * No use of hallucinogens in the past 3 months and no history of regular or frequent use of hallucinogens
  1. * General medical

Contacts and Locations

Study Contact

Lynnette A. Averill, Ph.D.
CONTACT
‪(832) 271-6615
emerging@bcm.edu

Study Locations (Sites)

Baylor College of Medicine
Houston, Texas, 77030
United States

Collaborators and Investigators

Sponsor: Baylor College of Medicine

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-01-30
Study Completion Date2025-08-31

Study Record Updates

Study Start Date2025-01-30
Study Completion Date2025-08-31

Terms related to this study

Keywords Provided by Researchers

  • PTSD
  • veterans
  • psilocybin
  • trauma
  • psychedelic

Additional Relevant MeSH Terms

  • PTSD