Psilocybin-assisted Therapy for Post-Traumatic Stress Disorder in Survivors of Intimate Partner Violence
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 76
- 试验地点
- 5
- 主要终点
- Clinician-Administered PTSD Scale for DSM-5 (CAPS-5)
研究概览
简要总结
The goal of this randomized controlled trial is to evaluate the efficacy of psilocybin administered with Acceptance and Commitment Therapy (ACT) as an intervention to reduce post-traumatic stress disorder (PTSD) symptom burden in adult (aged 18-65) survivors of intimate partner violence (IPV).
This trail will test the following 2 aims:
AIM 1 : To compare the efficacy of a therapeutic psilocybin dose at improving outcomes on the PCL-5 and CAPS-5 as compared to an active control psilocybin dose in IPV survivors with chronic PTSD.
AIM 2: To evaluate the efficacy of psilocybin on quality of life, cognitive function, motor ability, depression, anxiety, and cognitive flexibility.
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 5-6 weekly sessions of ACT
- Repeat outcome measures at 1-week, 4 weeks, 3 months (online questionnaires only), and 6 months post-psilocybin administration.
详细描述
The overall objective of this study is to evaluate the efficacy of psilocybin administered with Acceptance and Commitment Therapy (ACT) as an intervention to reduce post-traumatic stress disorder (PTSD) symptom burden in survivors of intimate partner violence (IPV).
This trail will test the following 2 aims:
AIM 1 : To compare the efficacy of a therapeutic psilocybin dose (25mg) at improving outcomes on the PCL-5 and CAPS-5 as compared to an active control psilocybin dose (1mg) (allocation ratio 1:1) in IPV survivors with chronic PTSD. Mean baseline scores will be compared to scores at each follow-up timepoint (1-week, 4 weeks, 3 months (PCL-5 only), and 6 months post-psilocybin administration).
AIM 2: to evaluate the efficacy of psilocybin on quality of life, cognitive function, motor ability, depression, anxiety, and cognitive flexibility. Mean baseline scores will be compared to scores at each follow-up timepoint (1-week, 4 weeks, 3 months (online only), and 6 months post-psilocybin administration).
The secondary efficacy outcomes will include measures of 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 (high dose) and control (low dose) 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 pharmacies 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
- •Individuals of all sexes, gender identities, and ethnicities
- •Ages 19 to 65 years at the time of screening
- •At least 6 months since last IPV incident
- •A score of 1 on the Composite Abuse Scale with repetition of abusive events
- •Minimum PCL-5 score of ≥ 33
- •Limited lifetime use of serotonergic hallucinogens
- •Ability to read/write English
排除标准
- •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
- •Suffered a mild TBI within the last 6 months
- •Any other circumstances that, in the opinion of the investigators, compromises participant safety
- •Not compelled to enter treatment to avoid legal consequences
研究组 & 干预措施
Low Dose
Low Dose (5mg) PEX010 (Oral Psilocybin), 5mg; single dose (20 participants) administered 24hrs prior to first ACT session
干预措施: Psilocybin (Drug)
High Dose
High Dose (25mg) PEX010 (Oral Psilocybin), 25mg; single dose (38 participants) administered 24hrs prior to first ACT session
结局指标
主要结局
Clinician-Administered PTSD Scale for DSM-5 (CAPS-5)
时间窗: Change from baseline to 1-week, 4 weeks, and 6 months post-dosing
A clinician-administered, 30-item structured interview to diagnose and assess severity of PTSD symptoms in patients. It is widely used and validated, and is considered the gold standard PTSD diagnostic tool.
PTSD Checklist for DSM-5 (PCL-5)
时间窗: Change from baseline to 1-week, 4 weeks, and 3 months, and 6 months post-dosing
A 20-item self-report measure that assesses the 20 DSM-5 symptoms of PTSD.
次要结局
- Montgomery-Åsberg Depression Rating Scale, Self-Reported (MADRS-S)(Change from baseline to 1-week, 4 weeks, 3 months, and 6 months post-dosing)
- Generalized Anxiety Disorder-7 (GAD-7)(Change from baseline to 1-week, 4 weeks, and 3 months, and 6 months post-dosing)
- Rivermead Post-Concussion Symptoms Questionnaire (RPQ)(Change from baseline to 1-week, 4 weeks, and 3 months, and 6 months post-dosing)
- The Acceptance and Action Questionnaire II (AAQ-II)(Change from baseline to 1-week, 4 weeks, and 6 months post-dosing)
- Cognitive Fusion Questionnaire (CFQ-7)(Change from baseline to 1-week, 4 weeks, and 6 months post-dosing)
- The Sheehan Disability Scale (SDS)(Change from baseline to 1-week, 4 weeks, and 6 months post-dosing)
- 9. EuroQol-5D (EQ-5D-5L)(Change from baseline to 1-week, 4 weeks, and 6 months post-dosing)
- Cognitive Flexibility Scale (CFS)(Change from baseline to 1-week, 4 weeks, and 6 months post-dosing)
- The Trail-Making Test 'B' (TMT-B)(Change from baseline to 1-week, 4 weeks, and 6 months post-dosing)
- The Digit Span Task (DS)(Change from baseline to 1-week, 4 weeks, and 6 months post-dosing)
- The Rey Auditory Verbal Learning Test (RAVLT)(Change from baseline to 1-week, 4 weeks, and 6 months post-dosing)
- Symbol Digit Modalities Test (SDMT)(Change from baseline to 1-week, 4 weeks, and 6 months post-dosing)
- The World Health Organization Disability Assessment Schedule 2.0 12-item survey (WHODAS)(Change from baseline to 1-week, 4 weeks, and 6 months post-dosing)
- The Pittsburgh Sleep Quality Index (PSI)(Change from baseline to 1-week, 4 weeks, and 6 months post-dosing)
- The Trail-Making Test (TMT)(Change from baseline to 1-week, 4 weeks, and 6 months post-dosing)
- The Berg's Card Sorting Task (BCST)(Change from baseline to 1-week, 4 weeks, and 6 months post-dosing)
- The Choice Reaction Time (CRT)(Change from baseline to 1-week, 4 weeks, and 6 months post-dosing)