A Phase 2 interventional study of Psilocybin in Post Traumatic Stress Disorder PTSD and Intimate Partner Violence (IPV), sponsored by University of Calgary. Not yet recruiting at 2 sites in Canada. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-09-08.
Sponsored by University of Calgary · Phase 2, Interventional, and Treatment
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.
200 studies on the registry are indexed under Combat Disorders; 90 are open to participants now.
This study's planned enrollment of 76 is close to the median of 72 across 167 interventional studies indexed under Combat Disorders.
Browse Combat Disorders studies →University of Calgary is the lead sponsor of 703 studies on the registry; 196 are open to participants now.
Of its 10 completed or terminated interventional studies of FDA-regulated products, 2 (20%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
High Dose (25mg) PEX010 (Oral Psilocybin), 25mg; single dose (38 participants) administered 24hrs prior to first ACT session
Low Dose (5mg) PEX010 (Oral Psilocybin), 5mg; single dose (20 participants) administered 24hrs prior to first ACT session
Drug: Psilocybin
See treatment arm description.
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.
Time frame: 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.
Time frame: Change from baseline to 1-week, 4 weeks, and 3 months, and 6 months post-dosing
Montgomery-Åsberg 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.
Time frame: Change from baseline to 1-week, 4 weeks, 3 months, and 6 months post-dosing
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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: Change from baseline to 1-week, 4 weeks, and 6 months post-dosing
Blood biomarkers
To explore blood biomarkers related to PTSD, brain injury, inflammation, oxidative stress, and growth factors following psilocybin-assisted therapy
Time frame: Change from baseline to 1-week, 4 weeks, and 6 months post-dosing
Plan to share: No
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