Trauma-informed Psilocybin Assisted Psychotherapy (TiPAP) for Post-Traumatic Stress Disorder
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 13
- 试验地点
- 1
- 主要终点
- Number of Participants With One or More Treatment-Emergent Adverse Events
研究概览
简要总结
This is an open-label pilot study designed to evaluate the safety, tolerability, and preliminary clinical effects of psilocybin-enhanced trauma-focused psychotherapy in individuals with post-traumatic stress disorder (PTSD).
Participants will receive a structured therapeutic protocol that includes preparatory sessions, two psilocybin administration sessions (15 mg followed by 25 mg), and integration sessions based on a trauma-focused therapeutic approach.
The primary objective of the study is to assess the safety and tolerability of psilocybin administration in this clinical population. Secondary objectives include evaluating changes in PTSD symptom severity, as measured by the Clinician-Administered PTSD Scale (CAPS-5), at 30 days following treatment.
This pilot study will include 13 participants and is intended to inform the feasibility and design of a subsequent randomized controlled trial.
详细描述
This study is an open-label pilot clinical trial evaluating the safety, tolerability, and preliminary clinical effects of psilocybin-enhanced trauma-focused psychotherapy for the treatment of post-traumatic stress disorder (PTSD).
PTSD is a chronic and disabling condition characterized by intrusive symptoms, avoidance, negative alterations in cognition and mood, and hyperarousal. Despite the availability of evidence-based psychotherapies and pharmacological treatments, a substantial proportion of patients do not achieve sufficient symptom relief, highlighting the need for novel and rapid-acting interventions.
Psilocybin, a serotonergic psychedelic compound, has demonstrated potential therapeutic effects in a range of psychiatric conditions, including depression, anxiety, and trauma-related disorders. When administered in a controlled therapeutic setting, psilocybin may facilitate emotional processing, cognitive flexibility, and adaptive reorganization of trauma-related memories.
In this study, psilocybin administration is combined with an integrative trauma-focused psychotherapeutic framework based on principles of Acceptance and Commitment Therapy (ACT) and Narrative Exposure Therapy (NET). ACT emphasizes psychological flexibility, acceptance, self-as-context, and values-based action, supporting individuals in changing their relationship with trauma-related internal experiences. NET complements this approach by facilitating the structured integration of traumatic memories within a coherent autobiographical narrative, embedding the traumatic experience within the broader context of the individual's life story. Together, this framework is designed to support the processing of traumatic experiences within an expanded and flexible cognitive-emotional context, promoting adaptive meaning-making and reconnection with a broader sense of self.
Participants will undergo a structured treatment protocol consisting of preparatory sessions, two psilocybin administration sessions (15 mg for the first session and 25 mg for the second session), and post-session integration sessions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 21-65 years.
- •Diagnosis of post-traumatic stress disorder (PTSD) according to DSM-5 criteria, as assessed by CAPS-
- •At least 1 year since the traumatic event.
- •Moderate or greater PTSD severity (CAPS-5 score ≥ 25).
- •Ability to provide written informed consent.
- •Ability to read, write, speak, and understand Hebrew.
- •Prior trauma-focused psychotherapy.
- •Medically healthy at screening, as determined by a study physician, including:
- •No exclusionary medical conditions.
- •Resting blood pressure between 90/60 and 150/90 mmHg and heart rate between 45-100 bpm.
- •Normal laboratory results (including liver function, renal function, and electrolytes).
排除标准
- •Current or past diagnosis of psychotic disorders, bipolar disorder, schizoaffective disorder, dissociative identity disorder, or borderline personality disorder (as assessed by MINI or SCID-5-SPQ).
- •Current psychotic features.
- •First-degree relative with a history of a psychotic disorder.
- •History of antidepressant-induced mania or hypomania.
- •Significant suicidal risk as assessed by the Columbia Suicide Severity Rating Scale (C-SSRS), including active suicidal ideation with intent or plan, or suicidal behavior within the past 6 months.
- •Substance use disorder (excluding nicotine and caffeine); mild-to-moderate alcohol or cannabis use may be permitted under monitoring and PI approval.
- •Use of psychedelic substances within 3 months before enrollment
- •Participation in a clinical trial involving administration of a psychedelic substance within the past 12 months.
- •History of adverse psychological reaction to psychedelics requiring hospitalization.
- •Significant cardiovascular disease, including ischemic heart disease, uncontrolled hypertension, arrhythmia, or heart failure (NYHA class ≥3).
- •Dementia or suspected cognitive impairment.
- •Traumatic brain injury with loss of consciousness >24 hours or post-traumatic amnesia >7 days (unless cleared by neurological evaluation).
- •Pregnancy, breastfeeding, or positive pregnancy/drug test (excluding cannabis) on the day of dosing.
- •BMI <18 or >33
- •Abnormal liver or renal function tests.
- •Use of medications contraindicated with psilocybin.
- •Changes in psychiatric medication (dose or type) within one month before enrollment.
- •Needle phobia or inability to undergo blood testing.
结局指标
主要结局
Number of Participants With One or More Treatment-Emergent Adverse Events
时间窗: From the first psilocybin administration session through 30 days after completion of the therapeutic intervention.
Treatment-emergent adverse events (TEAEs) are defined as any medical or psychological adverse event that begins or worsens after the first psilocybin administration. The reported outcome will be the number of participants experiencing at least one TEAE from the first dosing session through the 30-day follow-up period. Treatment-emergent adverse events (TEAEs) will be identified through clinical assessments conducted by the study physician and psychologist, monitoring of vital signs (blood pressure and heart rate), participant self-reports, administration of the Columbia-Suicide Severity Rating Scale (C-SSRS) to assess suicidal ideation and behavior, and the Swiss Psychedelic Side Effects Inventory (SPSI) to systematically assess psychedelic-related side effects. Serious adverse events (SAEs) will be monitored, documented, and reported in accordance with the study safety reporting procedures.
Number of Participants Completing the Full Therapeutic Intervention
时间窗: From enrollment through completion of the 30-day follow-up assessment.
Feasibility and tolerability will be assessed by the number of participants who successfully complete the full therapeutic intervention, defined as completion of both psilocybin administration sessions and all protocol-required preparatory and integration psychotherapy sessions. Successful completion of the intervention reflects the feasibility of implementing the study protocol as planned and the tolerability of the intervention.
次要结局
- Change in PTSD Symptom Severity as Measured by CAPS-5(Baseline to 30 days after completion of the therapeutic intervention)