A Phase 2a, Open-label, Pilot Study to Assess the Safety and Efficacy of Psilocybin Administration in Concert With Psychotherapy Among Adult Patients With Fibromyalgia
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 17
- 试验地点
- 1
- 主要终点
- Blood Pressure (BP) - First Dose (15 mg) - Systolic
研究概览
简要总结
The pressing need for effective fibromyalgia (FM) treatments, the known safety of psilocybin therapy, and the mechanistic plausibility for potential benefit provide a backdrop for investigating psilocybin therapy as a treatment for FM. The primary objective of this study is to evaluate the clinical benefit of oral psilocybin in concert with psychotherapy to treat chronic pain symptoms in patients with FM.
详细描述
Fibromyalgia is a chronic syndrome of widespread musculoskeletal pain that often manifests with a cluster of co-occurring symptoms, including sleep disturbances, fatigue, cognitive dysfunction, and mood problems including anxiety and depression. Recent studies have provided evidence of altered central pain pathways. Current management of FM typically takes a multidimensional approach including behavioral therapy, exercise, and medication. However, current medications provide only modest benefit and carry significant side effect burden, leading many people with FM to seek other alternatives.
Psilocybin therapy (psilocybin delivered in concert with psychotherapy) may be a potentially safe and effective treatment for symptoms associated with FM. Indeed, psilocybin therapy has shown positive effects in treating cancer-related psychiatric distress, depression and anxiety, treatment-resistant depression, and nicotine or alcohol addiction. The United States Food and Drug Administration (FDA) has granted a Breakthrough Therapy designation for psilocybin in treatment-resistant depression and major depressive disorder. Psilocybin therapy is generally safe and well-tolerated when conducted under controlled conditions. While no clinical studies have explored psychedelic effects among people with FM, a recent review outlined potential mechanisms through which psychedelics could alleviate chronic pain symptoms.
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
- 25 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Open Label Oral Psilocybin
This is an open-label study, and participants who meet the inclusion and exclusion criteria will be eligible and invited to enroll. Enrolled participants are planned to receive 2 doses of psilocybin: a 15 mg dose followed 2 weeks later by a 25 mg dose. The total planned duration of the study for an individual participant from screening to last follow-up is approximately 8 months.
干预措施: Psilocybin (Drug)
Open Label Oral Psilocybin
This is an open-label study, and participants who meet the inclusion and exclusion criteria will be eligible and invited to enroll. Enrolled participants are planned to receive 2 doses of psilocybin: a 15 mg dose followed 2 weeks later by a 25 mg dose. The total planned duration of the study for an individual participant from screening to last follow-up is approximately 8 months.
干预措施: Psychotherapy (Behavioral)
结局指标
主要结局
Blood Pressure (BP) - First Dose (15 mg) - Systolic
时间窗: Day 22 Pre-Dose (Baseline) and at 30, 60, 90, 120, 180, 240, 300, and 360 minutes post-dose
Systolic BP was measured in millimeters of mercury (mm Hg) before TRP-8802 capsule administration and at 30, 60, 90, 120, 180, 240, 300, and 360 minutes after capsule administration. Systolic BP greater than 200 for more than 15 minutes was considered to be an adverse event.
Blood Pressure (BP) - Second Dose (25 mg) - Systolic
时间窗: Day 36 Pre-Dose (Baseline) and at 30, 60, 90, 120, 180, 240, 300, and 360 minutes post-dose
BP was measured in millimeters of mercury (mm Hg) before TRP-8802 capsule administration and at 30, 60, 90, 120, 180, 240, 300, and 360 minutes after capsule administration. Systolic BP greater than 200 for more than 15 minutes was considered to be an adverse event.
Blood Pressure (BP) - First Dose (15 mg) - Diastolic
时间窗: Day 22 Pre-Dose (Baseline) and at 30, 60, 90, 120, 180, 240, 300, and 360 minutes post-dose
Diastolic BP was measured in millimeters of mercury (mm Hg) before TRP-8802 capsule administration and at 30, 60, 90, 120, 180, 240, 300, and 360 minutes after capsule administration. BP greater than 110 diastolic for more than 15 minutes was considered to be an adverse event.
Adverse Events (AE) Incidence
时间窗: Day 1 through Day 64
Results reflect the total number of all adverse events that occurred during the trial.
Heart Rate Beats Per Minute (BPM) - First Dose (15 mg)
时间窗: Day 22 Pre-Dose (Baseline) and at 30, 60, 90, 120, 180, 240, 300, and 360 minutes post-dose
BPM was measured before TRP-8802 capsule administration and at 30, 60, 90, 120, 180, 240, 300, and 360 minutes after capsule administration.
Heart Rate Beats Per Minute (BPM) - Second Dose (25 mg)
时间窗: Day 36 Pre-Dose (Baseline) and at 30, 60, 90, 120, 180, 240, 300, and 360 minutes post-dose
BPM was measured before TRP-8802 capsule administration and at 30, 60, 90, 120, 180, 240, 300, and 360 minutes after capsule administration.
Blood Pressure (BP) - Second Dose (25 mg) - Diastolic
时间窗: Day 36 Pre-Dose (Baseline) and at 30, 60, 90, 120, 180, 240, 300, and 360 minutes post-dose
Diastolic BP was measured in millimeters of mercury (mm Hg) before TRP-8802 capsule administration and at 30, 60, 90, 120, 180, 240, 300, and 360 minutes after capsule administration. BP greater than 110 diastolic for more than 15 minutes was considered to be an adverse event.
次要结局
- Sleep Disturbance(Day 1 and Day 64)
- Chronic Pain Acceptance(Day 1 and Day 64)
- Patient Global Impression of Change (PGI-C)(Day 64)
- Change in Pain Interference(Day 1 and Day 64)
- Chronic Pain Intensity Between Groups in the Study Period(Days 1-7 & Days 57-63)
研究者
Kevin Boehnke
Research Assistant Professor
University of Michigan