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

Официальное название

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

Обзор

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.

Вмешательства

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

Первичные конечные точки

• Safety of psilocybin-assisted therapy for PTSD [Срок оценки: Baseline to 6-month follow up]
• Safety of psilocybin-assisted therapy for PTSD [Срок оценки: Baseline to 6-month follow up]
• Efficacy of psilocybin-assisted therapy for PTSD [Срок оценки: Baseline to 6-month follow up]

Вторичные конечные точки (3)

• Self-reported clinical efficacy of psilocybin-assisted therapy for PTSD symptoms [Срок оценки: Baseline to 6-month follow up]
• Self-reported clinical efficacy of psilocybin-assisted therapy for depressive symptoms [Срок оценки: Baseline to 6-month follow up]
• Self-reported clinical efficacy of psilocybin-assisted therapy for anxiety symptoms [Срок оценки: Baseline to 6-month follow up]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 1 центр

• Baylor College of Medicine — Houston

Идентификаторы

NCT: NCT06888128 · H-50300

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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