A Randomized Double-blinded Controlled Trial for the Treatment of Persisting Symptoms After Concussion With Psilocybin-assisted Therapy: A Safety and Feasibility Trial
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Study protocol feasibility
研究概览
简要总结
The goal of this randomized controlled trial is to evaluate the safety, feasibility, and efficacy of psilocybin assisted therapy as an intervention to reduce symptom burden in adult patients (aged 18-65) with persisting symptoms after concussion (PSaC).
This trail will test the following 2 aims:
AIM 1 : To test the safety and feasibility of an active psilocybin-assisted psychotherapy to an active control for patients with PSaC.
AIM 2: To evaluate the efficacy of an active psilocybin-assisted psychotherapy compared to an active control as a treatment for PSaC.
Participants will be asked to:
- Complete a 2-part screening process
- Attend a baseline assessment
- Complete a psychoeducation preparation session(s)
- Attend psilocybin administration session (receive high dose [25mg] or low dose psilocybin [1mg])
- Complete 5 weekly sessions of Acceptance and commitment therapy (ACT)
- Repeat outcome measures at 1-week, 4 weeks, 3 months, and 6 months post-psilocybin administration (online only at 6 months).
详细描述
The overall objective of this study is to evaluate the safety, feasibility, and efficacy of psilocybin assisted therapy administered with Acceptance and Commitment Therapy (ACT) as an intervention to reduce symptom burden in patients with persisting symptoms after concussion (PSaC).
This trail will test the following 2 aims:
AIM 1 : To test the safety and feasibility of an active/high dose (25mg) psilocybin-assisted psychotherapy to an active control (1mg) for adults with PSaC. Safety will be determined through the reporting of adverse events and response following psilocybin for each participant up to 6-months. Feasibility will be determined through recruitment, enrollment, and adherence rates.
AIM 2: To evaluate the efficacy of an active/high dose (25mg) psilocybin-assisted psychotherapy compared to an active control (1mg) as a treatment for PPCS at 1-week, 4 weeks, 3 months, and 6 months post-psilocybin administration. The primary efficacy outcome will be the change in PSaC burden (RPQ).
The secondary efficacy outcomes will include measures of headache, dizziness, mood, anxiety, post-traumatic stress, cognitive flexibility, emotional regulation, and quality of life.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
The group assignments to active (25mg) and control (1mg) psilocybin-assisted therapy will be based on a blocked randomization list (10 participants per block) using sealed envelopes created by an employee of the University of Calgary, who will not be involved in the conduct, or the analysis of the study.
The pharmacy administering the psilocybin will be responsible for maintaining the master randomization code list and only the technician preparing the samples will have access to the envelopes and code list.
When a new study ID is generated, the technician is to verify the randomization and prepare the participant's study intervention accordingly. Unblinding will only occur once the entire study is completed, and the database has been locked.
The trials active intervention and comparator will be provided by the manufactures and will be identical in shape, colour, and weight.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •In order to be eligible to participate in this study, an individual must meet all of the following criteria:
- •Individuals of all sexes, gender identities, and ethnicities
- •Ages 18 to 65 years at the time of screening
- •Diagnosis of concussion based on the 2024 ACRM criteria
- •Meet ICD-10 criteria for PSaC for at least 3-months to a maximum of 5 years
- •Have an overall RPQ score ≥ 13 with 3 or more symptoms scored ≥3
- •Limited lifetime use of serotonergic hallucinogens
- •Ability to read/write English
- •An individual who meets any of the following criteria will be excluded from participation in this study:
- •Severe or moderate substance use disorder other than nicotine in past 6 months
- •Lifetime diagnosis of schizophrenia or bipolar disorders (or first or second-degree relative)
- •Active suicidal ideation or serious attempt within the past 1 year.
- •Current pregnancy or nursing, trying to become pregnant
- •Any notable abnormality on ECG or routine medical blood laboratory test
- •Insulin-dependent diabetes; if taking oral hypoglycemic agent, then no history of hypoglycemia
- •Epilepsy with a history of seizures
- •Current or recent (within 12 weeks) participation in a clinical trial
- •Cognitive impairment (SLUMS score <20)
- •Suffered a moderate/severe TBI at least once in lifetime
- •Any other circumstances that, in the opinion of the investigators, compromises participant safety
排除标准
- 未提供
研究组 & 干预措施
High dose (25mg)
High Dose (25mg) PEX010 (Oral Psilocybin), 25mg; single dose (20 participants) administered 24hrs prior to first ACT session
干预措施: Psilocybin (Drug)
Low dose (1mg)
Low Dose (1mg) PEX010 (Oral Psilocybin), 1mg; single dose (20 participants)administered 24hrs prior to first ACT session
干预措施: Psilocybin (Drug)
结局指标
主要结局
Study protocol feasibility
时间窗: Screening, enrolment, intervention, and participation up to study end point (6-months)
The feasibility will be determined based on recruitment (greater than 30% of those screened eligible), attendance (70% intervention appointment attendance), retention (70% complete study protocol)
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
时间窗: Throughout study completion, an average of 6 months
Safety will be determined based on adverse reactions and symptom reporting (categorized as mild, moderate, and severe)
Study protocol efficacy
时间窗: Throughout study completion, an average of 6 months
The primary efficacy outcome is the Rivermead Post-Concussion Symptoms Questionnaire (RPQ).The RPQ assesses the severity of 16 commonly experienced PSaC symptoms using a scale of 0 ("not experienced") to 4 ("severe problem"), with higher scores indicating greater PSaC symptom burden.
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
时间窗: Throughout study completion, an average of 6 months
Safety will be determined based on adverse reactions and symptom reporting (categorized as mild, moderate, and severe)
Study protocol efficacy
时间窗: Throughout study completion, an average of 6 months
The primary efficacy outcome is the Rivermead Post-Concussion Symptoms Questionnaire (RPQ).The RPQ assesses the severity of 16 commonly experienced PSaC symptoms using a scale of 0 ("not experienced") to 4 ("severe problem"), with higher scores indicating greater PSaC symptom burden.
Study protocol feasibility
时间窗: Screening, enrolment, intervention, and participation up to study end point (6-months)
The feasibility will be determined based on recruitment (greater than 30% of those screened eligible), attendance (70% intervention appointment attendance), retention (70% complete study protocol)
次要结局
- Montgomery-Asberg Depression Rating Scale Self report (MADRS-S)(Throughout study completion, an average of 6 months [assessed at baseline, and 1-week, 4 weeks, 3 months, and 6 months post-dosing])
- Generalized Anxiety Disorder-7 (GAD-7).(Throughout study completion, an average of 6 months [assessed at baseline, and 1-week, 4 weeks, 3 months, and 6 months post-dosing])
- Sleep and Concussion Questionnaire (SCQ)(Throughout study completion, an average of 6 months [assessed at baseline, and 1-week, 4 weeks, 3 months, and 6 months post-dosing])
- Headache Impact Test (HIT-6).(Throughout study completion, an average of 6 months [assessed at baseline, and 1-week, 4 weeks, 3 months, and 6 months post-dosing])
- Dizziness Handicap Questionnaire (DHI)(Throughout study completion, an average of 6 months [assessed at baseline, and 1-week, 4 weeks, 3 months, and 6 months post-dosing])
- PTSD Checklist for DSM-5 (PCL-5)(Throughout study completion, an average of 6 months [assessed at baseline, and 1-week, 4 weeks, 3 months, and 6 months post-dosing])
- The Quality of Life after Brain Injury (QOLIBRI)(Throughout study completion, an average of 6 months [assessed at baseline, and 1-week, 4 weeks, 3 months, and 6 months post-dosing])
- Difficulties in Emotion Regulation Scale (DERS)(Throughout study completion, an average of 6 months [assessed at baseline, and 1-week, 4 weeks, 3 months, and 6 months post-dosing])
- Think Aloud Task(Throughout study completion, an average of 6 months [assessed at baseline, and 1-week, 4 weeks, and 3 months post-dosing])
- Probabilistic Reversal Learning Task(Throughout study completion, an average of 6 months [assessed at baseline, and 1-week, 4 weeks, and 3 months post-dosing])
- The Acceptance and Action Questionnaire II (AAQ-II)(Throughout study completion, an average of 6 months [assessed at baseline, and 1-week, 4 weeks, 3 months, and 6 months post-dosing])
- The Acceptance and Action after Brain Injury Questionnaire (AAQ-ABI)(Throughout study completion, an average of 6 months [assessed at baseline, and 1-week, 4 weeks, 3 months, and 6 months post-dosing])
- Cognitive Fusion Questionnaire (CFQ-7)(Throughout study completion, an average of 6 months [assessed at baseline, and 1-week, 4 weeks, 3 months, and 6 months post-dosing])
- Bergs Card Sorting Task(Throughout study completion, an average of 6 months [assessed at baseline, and 1-week, 4 weeks, and 3 months post-dosing])