Clinical trial NCT06888128: State-Funded Trial Assessing Recovery and Long-Term Impact of Guided Psilocybin for Healing Trauma
Official title: The STARLIGHT Protocol: State-Funded Trial Assessing Recovery and Long-Term Impact of Guided Psilocybin for Healing Trauma
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: PTSD
Keywords: PTSD
veterans
psilocybin
trauma
psychedelic
Lead sponsor: Baylor College of Medicine
Sponsor class: OTHER
Collaborators: name: Texas Department of State Health Services
name: Usona Institute
name: AIM Youth Mental Health
First posted: 2025-03-21
Enrollment: 15
Sex: ALL
Minimum age (years): 21
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion 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

Exclusion Criteria:

* General medical exclusion criteria:

  * 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
* Psychiatric Exclusion Criteria:

  * 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

Primary outcomes:
measure: Safety of psilocybin-assisted therapy for PTSD
timeFrame: Baseline to 6-month follow up
measure: Safety of psilocybin-assisted therapy for PTSD
timeFrame: Baseline to 6-month follow up
measure: Efficacy of psilocybin-assisted therapy for PTSD
timeFrame: Baseline to 6-month follow up
Secondary outcomes:
measure: Self-reported clinical efficacy of psilocybin-assisted therapy for PTSD symptoms
timeFrame: Baseline to 6-month follow up
measure: Self-reported clinical efficacy of psilocybin-assisted therapy for depressive symptoms
timeFrame: Baseline to 6-month follow up
measure: Self-reported clinical efficacy of psilocybin-assisted therapy for anxiety symptoms
timeFrame: Baseline to 6-month follow up
Other outcomes:
measure: Changes in Resting-State Functional Connectivity
timeFrame: Baseline to 6-month follow up
Locations:
city: Houston
country: United States
facility: Baylor College of Medicine
state: Texas
Study officials:
References: