Post Traumatic Stress Disorder PTSDPhase 2PsiPTSDNCT06885996
Psilocybin-assisted Therapy for Post-Traumatic Stress Disorder in Survivors of Intimate Partner Violence
A Phase 2 study testing Psilocybin in people with Post Traumatic Stress Disorder PTSD and Intimate Partner Violence (IPV), run by University of Calgary at 2 sites in Canada.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Post Traumatic Stress Disorder PTSD, Intimate Partner Violence (IPV)
- What is being tested?
- Psilocybin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 2 sitesCanada
- Study dates
- 1 Oct 2026to 1 Aug 2029
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Canada2 sites
University of Calgary
Calgary, Alberta, T2N 2T9
Chantel T Debert, (403) 944-4500, cdebert@ucalgary.ca
Christina Campbell, 403-944-8649, christina.campbel1@ucalgary.ca
The University of British Columbia - Okanagan Campus
Kelowna, British Columbia, V1V 1V7
Zachary Walsh, zachary.walsh@ubc.ca
Zachary Walsh
About this study
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:
Read more
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.
Read the detailed description
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.
- Being tested
- Psilocybin
- Keywords
- Psychotherapy, Psilocybin, Acceptance and Commitment Therapy
- Medical subject headings
- Combat Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PsilocybinDrug
See treatment arm description.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: Psilocybin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Change from baseline to 1-week, 4 weeks, and 3 months, and 6 months post-dosing
Secondary outcomes (13)
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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: Change from baseline to 1-week, 4 weeks, and 6 months post-dosing
The Trail-Making Test (TMT)
- 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
Measured: 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.
Measured: 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).
Measured: 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.
Measured: Change from baseline to 1-week, 4 weeks, and 6 months post-dosing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2025
- Study start1 Oct 2026 (estimated)
- Primary completion1 Aug 2028 (estimated)
- Study completion1 Aug 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Traumatic Stress Disorder PTSDStudies of the same condition, open and under way.
- More trials run by University of CalgaryThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Double-blinded randomized controlled trial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 76 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Calgary
- Sponsor type
- University, hospital or other
- Collaborators
- Vancouver Island University, University of British Columbia
- Responsible party
- Sponsor
- Investigators
- Sandy Shultz, PhD, Principal investigator, The Institute on Aging & Lifelong Health, Faculty of Health, University of VictoriaLeah Mayo, PhD, Principal investigator, Parker Psychedelics Research Chair and Assistant Professor, Department of Psychiatry, University of Calgary, Cumming School of MedicinePamela Kryskow, MD, CCFP, Principal investigator, Medical Lead, Psychedelic-assisted Therapy Graduate Program, Vancouver Island University, Medical Director, Roots to Thrive SocietyZachary Walsh, PhD, Principal investigator, Professor, Department of Psychology, University of British ColumbiaPaul van Donkelaar, PhD, Principal investigator, Professor, Faculty of Health and Social Development, School of Health and Exercise Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06885996
- Sponsor's protocol ID
- REB25-0065
- Acronym
- PsiPTSD
- Status last verified
- Sep 2026
- First submitted
- 13 Mar 2025
- Last updated
- 8 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Psilocybin-assisted Therapy for Post-Traumatic Stress Disorder in Survivors of Intimate Partner Violence
- ClinicalTrials.gov ID
- NCT06885996
- Acronym / sponsor ID
- PsiPTSD / REB25-0065
- Keywords
- Psychotherapy, Psilocybin, Acceptance and Commitment Therapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 76 participants (estimated)
- Lead sponsor
- University of CalgaryUniversity, hospital or other
- Collaborators
- Vancouver Island University, University of British Columbia
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 1 Aug 2028 (estimated)
- Study completion
- 1 Aug 2029 (estimated)
- First posted
- 20 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Double-blinded randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| 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 | Drug: PsilocybinLow Dose (5mg) PEX010 (Oral Psilocybin), 5mg; single dose (20 participants) administered 24hrs prior to first ACT session |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PsilocybinSee treatment arm description. | Drug | Low Dose |
Primary outcome
Clinician-Administered PTSD Scale for DSM-5 (CAPS-5)
Time frame: 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)
Time frame: 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.
13 secondary outcomes
Montgomery-Åsberg Depression Rating Scale, Self-Reported (MADRS-S)
Time frame: Change from baseline to 1-week, 4 weeks, 3 months, and 6 months post-dosing
Generalized Anxiety Disorder-7 (GAD-7)
Time frame: Change from baseline to 1-week, 4 weeks, and 3 months, and 6 months post-dosing
Rivermead Post-Concussion Symptoms Questionnaire (RPQ)
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)
Time frame: Change from baseline to 1-week, 4 weeks, and 6 months post-dosing
Cognitive Fusion Questionnaire (CFQ-7)
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)
Time frame: Change from baseline to 1-week, 4 weeks, and 6 months post-dosing
9. EuroQol-5D (EQ-5D-5L)
Time frame: Change from baseline to 1-week, 4 weeks, and 6 months post-dosing
Cognitive Flexibility Scale (CFS)
Time frame: Change from baseline to 1-week, 4 weeks, and 6 months post-dosing
The Pittsburgh Sleep Quality Index (PSI)
Time frame: Change from baseline to 1-week, 4 weeks, and 6 months post-dosing
The Trail-Making Test (TMT)
Time frame: Change from baseline to 1-week, 4 weeks, and 6 months post-dosing
The Digit Span Task (DS)
Time frame: Change from baseline to 1-week, 4 weeks, and 6 months post-dosing
The Berg's Card Sorting Task (BCST)
Time frame: Change from baseline to 1-week, 4 weeks, and 6 months post-dosing
The Choice Reaction Time (CRT)
Time frame: Change from baseline to 1-week, 4 weeks, and 6 months post-dosing
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sandy Shultz, PhD principal investigator
The Institute on Aging & Lifelong Health, Faculty of Health, University of Victoria
Leah Mayo, PhD principal investigator
Parker Psychedelics Research Chair and Assistant Professor, Department of Psychiatry, University of Calgary, Cumming School of Medicine
Pamela Kryskow, MD, CCFP principal investigator
Medical Lead, Psychedelic-assisted Therapy Graduate Program, Vancouver Island University, Medical Director, Roots to Thrive Society
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Psilocybin in people with Post Traumatic Stress Disorder PTSD and Intimate Partner Violence (IPV), run by University of Calgary at 2 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 8 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Chantel T Debert, MD MSc FRCPC (403) 944-4500, cdebert@ucalgary.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) (time frame: Change from baseline to 1-week, 4 weeks, and 6 months post-dosing). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2026.