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| Name | Class |
|---|---|
| Vancouver Island University | UNKNOWN |
| University of British Columbia | OTHER |
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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:
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.
Exploratory Aim: Exploratory objectives of this study include evaluating blood biomarkers reflective of inflammation, growth factors, brain injury, and oxidative stress relevant to PTSD and psilocybin's mechanisms of action.
A total of 76 male and female patients between the ages of 18-65 with the last incident of IPV greater than 6 months prior with a score of 1 on the Composite Abuse Scale with repetition of abusive events, meeting DSM-5 criteria for PTSD and a minimum PCL-5 score of 33.
All patients will undergo a thorough, 2-part screening procedure. Eligible participants will be randomly allocated 1:1 to either the high dose (38 participants) or low dose (38 participants) psilocybin groups. All participants will be asked to attend a baseline session consisting of clinical and behavioural outcome measures followed by a pre-dosing psychoeducation session. Following the single dosing session, participants will complete 5-6 weekly ACT sessions. Outcome measure assessments will be repeated at 1-week, 4 weeks, 3 months (online only), and 6 months post-dosing.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High Dose | Experimental | High Dose (25mg) PEX010 (Oral Psilocybin), 25mg; single dose (38 participants) administered 24hrs prior to first ACT session | |
| Low Dose | Active Comparator | Low Dose (5mg) PEX010 (Oral Psilocybin), 5mg; single dose (20 participants) administered 24hrs prior to first ACT session |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Psilocybin | Drug | See treatment arm description. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) | 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. | Change from baseline to 1-week, 4 weeks, and 6 months post-dosing |
| PTSD Checklist for DSM-5 (PCL-5) | A 20-item self-report measure that assesses the 20 DSM-5 symptoms of PTSD. | Change from baseline to 1-week, 4 weeks, and 3 months, and 6 months post-dosing |
| Measure | Description | Time Frame |
|---|---|---|
| Montgomery-Ã…sberg Depression Rating Scale, Self-Reported (MADRS-S) | A self-reported, 9-item assessment of depressive symptoms using a recall period of the past 7 days. This tool elicits a total score ranging from 0-54, with higher scores indicating greater depression. | Change from baseline to 1-week, 4 weeks, 3 months, and 6 months post-dosing |
| Measure | Description | Time Frame |
|---|---|---|
| Blood biomarkers | To explore blood biomarkers related to PTSD, brain injury, inflammation, oxidative stress, and growth factors following psilocybin-assisted therapy | Change from baseline to 1-week, 4 weeks, and 6 months post-dosing |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Chantel T Debert, MD MSc FRCPC | Contact | 403) 944-4500 | cdebert@ucalgary.ca | |
| Christina Campbell, MSc | Contact | 403-944-8649 | christina.campbel1@ucalgary.ca |
| Name | Affiliation | Role |
|---|---|---|
| Sandy Shultz, PhD | The Institute on Aging & Lifelong Health, Faculty of Health, University of Victoria | Principal Investigator |
| Leah Mayo, PhD | Parker Psychedelics Research Chair and Assistant Professor, Department of Psychiatry, University of Calgary, Cumming School of Medicine |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Calgary | Calgary | Alberta | T2N 2T9 | Canada |
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| ID | Term |
|---|---|
| D003130 | Combat Disorders |
| ID | Term |
|---|---|
| D040921 | Stress Disorders, Traumatic |
| D000068099 | Trauma and Stressor Related Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D011562 | Psilocybin |
| ID | Term |
|---|---|
| D026121 | Indole Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D007211 | Indoles |
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Double-blinded randomized controlled trial
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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.
| Generalized Anxiety Disorder-7 (GAD-7) | A 7-item self-reported questionnaire for measuring the severity of generalized anxiety disorder. Individuals rate how often they have been bothered by seven listed problems and score their responses from 0 ("not at all") to 3 ("nearly every day"). Total scores for anxiety severity are: 0-4: minimal anxiety; 5-9: mild; 10-14: moderate; 15-21: severe anxiety | Change from baseline to 1-week, 4 weeks, and 3 months, and 6 months post-dosing |
| Rivermead Post-Concussion Symptoms Questionnaire (RPQ) | A self-reported, 16-item questionnaire used to assess severity of 16 commonly experienced PPCS symptoms using a scale of 0 ("not experienced") to 4 ("severe problem"), with higher scores indicating greater PPCS symptom burden. | Change from baseline to 1-week, 4 weeks, and 3 months, and 6 months post-dosing |
| The Acceptance and Action Questionnaire II (AAQ-II) | A 7-item questionnaire measuring psychological flexibility. Scores range from 0 to 49 with higher scores indicating greater psychological flexibility. | Change from baseline to 1-week, 4 weeks, and 6 months post-dosing |
| Cognitive Fusion Questionnaire (CFQ-7) | A 7-point Likert scale measuring cognitive fusion. Scores range from 0 to 49 with higher scores indicating greater fusion with one's thoughts. | 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) | A 12-item self-administered scale of disability across different diseases, countries, and cultures with higher scores indicating greater disability. | Change from baseline to 1-week, 4 weeks, and 6 months post-dosing |
| 9. EuroQol-5D (EQ-5D-5L) | A self-report measure of 5 key life dimensions, designed to measure health-related quality of life. | Change from baseline to 1-week, 4 weeks, and 6 months post-dosing |
| Cognitive Flexibility Scale (CFS) | A 12-item Likert-scale designed to assess the ability to identify options and alternatives to a situation, flexibility in behaviour, and confidence in the flexible behaviour. | Change from baseline to 1-week, 4 weeks, and 6 months post-dosing |
| The Pittsburgh Sleep Quality Index (PSI) | A 19-item self-reported questionnaire which measures sleep patterns and quality. Items are scored 0 (no difficulty) to 3 (severe difficulty) with higher overall scores indicating poorer sleep quality | Change from baseline to 1-week, 4 weeks, and 6 months post-dosing |
| The Trail-Making Test (TMT) | 2. The Trail-Making Test (TMT) is a test of general cognitive function, designed to assess working memory, visual processing, visuospatial skills, selective and divided attention, processing speed, and psychomotor coordination. The measure for this 3 to 4-min task is the time required for accurate completion | Change from baseline to 1-week, 4 weeks, and 6 months post-dosing |
| The Digit Span Task (DS) | The Digit Span Task (DS)is a measure of verbal short term and working memory designed to measure simple attention. This 1 to 3-min task required participants to repeat a series of digits increasing in length and is measured through direction of the task, longest sequence successfully complete, and total number of attempts. | Change from baseline to 1-week, 4 weeks, and 6 months post-dosing |
| The Berg's Card Sorting Task (BCST) | The Berg's Card Sorting Task (BCST) is a set-shifting measure of cognitive flexibility modeled after the Wisconsin Card Sorting task.82 Participants must select the stimulus that is different from others based on feedback and adapt their responses once the criteria for correct choice switches. Perseverative errors are defined as the number of instances in which three incorrect responses are made based on a previous rule, and they are thought to reflect less cognitive flexibility (or cognitive rigidity). | Change from baseline to 1-week, 4 weeks, and 6 months post-dosing |
| The Choice Reaction Time (CRT) | The Choice Reaction Time (CRT) Test is a computerized cognitive task that measures attention, processing speed, and motor response by requiring participants to respond quickly and accurately to one of several possible stimuli. Changes in CRT performance may reflect improvements in attention and processing efficiency, key domains often affected by traumatic brain injury. | Change from baseline to 1-week, 4 weeks, and 6 months post-dosing |
| Principal Investigator |
| Pamela Kryskow, MD, CCFP | Medical Lead, Psychedelic-assisted Therapy Graduate Program, Vancouver Island University, Medical Director, Roots to Thrive Society | Principal Investigator |
| Zachary Walsh, PhD | Professor, Department of Psychology, University of British Columbia | Principal Investigator |
| Paul van Donkelaar, PhD | Professor, Faculty of Health and Social Development, School of Health and Exercise Sciences | Principal Investigator |
| The University of British Columbia - Okanagan Campus | Kelowna | British Columbia | V1V 1V7 | Canada |
|
| D006574 |
| Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D014363 | Tryptamines |
| D054836 | Indolizidines |
| D007212 | Indolizines |