Alcohol Use Disorder (AUD)Phase 2Psi-PSNCT06853912
PsiloStudy: Psilocybin With Psychological Support (Psi-PS) for Military Veterans and First Responders With Co-occurring PTSD & Alcohol Use Disorder (AUD)
A Phase 2 study testing Psilocybin 25 mg in people with Alcohol Use Disorder (AUD) and PTSD, run by Nathan Brashares Sackett at 1 site in United States.
Trial summary
This study is a phase 2 single-site, double-blind, placebo-controlled, randomized clinical trial with an open-label extension phase to examine the safety of psilocybin (25 mg) combined with psychological support (Psi-PS) for treatment of approximately 40 military veterans and first responders (ages 21-65) with… Read more about this study
- Who is it for?
- Ages 21 to 65 years
- Conditions the study is for
- Alcohol Use Disorder (AUD), PTSD
- What is being tested?
- Psilocybin 25 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2025to 1 Jun 2027
- 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 21 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged 21-65 who meet criteria for current DSM-5 diagnosis of AUD and PTSD as determined by the Alcohol System Checklist and CAPS-5.
- Are either a US military Veteran or are currently employed as a first responder, including EMT, paramedic, firefighter, or law enforcement officer.
- Report wanting to stop or decrease drinking and are willing to abstain from alcohol for the week prior to receiving any study drug.
- Are English-speaking.
- Must be willing to use contraception throughout the duration of the study. This applies to anyone, regardless of biological sex, who can cause pregnancy or become pregnant themselves.
- Have a friend or family member who can pick them up and stay with them overnight after the DAS and who agrees to share contact information with the research team.
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- Have a primary care provider.
- Have access to stable internet and either smart phone or computer.
- Are willing to disclose medication use, supplement use, and interventions they are currently enrolled in; and commit to all study-related activities and follow-up sessions.
- For the drug administration session, participants must be willing to reduce alcohol intake to be alcohol-free for 24 hours before DAS, fast after midnight before DAS, avoid caffeine and nicotine 2 hours before and 6-8 hours after DAS, and avoid driving for 24 hours post-DAS.
- Must be locally accessible to the University of Washington for multiple in-person study visits.
- Must have a friend or someone else the participant trusts to stay with them overnight for the evening following the DAS.
Who cannot join
- A reported history of known medical conditions that would preclude safe participation in the trial, including the following:
- seizure disorder,
- coronary artery disease,
- history of arrhythmia or known valvopathy,
- heart failure,
- cerebrovascular accident,
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- severe asthma
- pulmonary hypertension,
- hyperthyroidism,
- stenosing peptic ulcer,
- pyloroduodenal obstruction,
- symptomatic prostatic hypertrophy,
- bladder-neck obstruction.
- Clinical findings on screening, including:
- significantly impaired liver function found in labs in prior 45-days or at screening
- uncontrolled hypertension (above 165/95 mmHg at screening)
- Serious ECG abnormalities measured at or within 45-days of screening (e.g., evidence of ischemia, myocardial infarction, QTc prolongation (QTc > 0.45 seconds for men, QTc > 0.47 seconds for women).
- Reported history or findings on SCID-CT of known exclusionary psychiatric conditions, including schizophrenia, schizoaffective disorder, bipolar disorder type I or type II.
- A reported history of a serious suicide attempt (SSA) in previous 12-months.
- A reported history of a personality disorder at time of screening.
- A reported family history of schizophrenia or schizoaffective disorder (first- or second-degree relatives), or bipolar disorder type 1 (first degree relatives).
- Currently using SSRIs, SNRIs, MAOIs, TCAs, antipsychotics, lithium, stimulants, or other psychedelics.
- Currently engaged in CBT, DBT, EMDR, psychoanalytic/psychodynamic therapy, MBSR, or unapproved group therapies, except for peer support groups.
- Cognitive impairment (Folstein Mini Mental State Exam score < 26).
- A reported lifetime history of hallucinogen use disorder (per DSM-5).
- A reported history of cocaine, psychostimulant, or opioid use disorder defined by DSM-5 in the past 12 months, or currently utilizing full-agonist (methadone) or partial-agonist (buprenorphine) for OUD.
- Current or historical abuse of psychedelic/hallucinogenic substances (e.g. LSD, mushrooms/psilocybin, mescaline/peyote, MDMA, ketamine, ayahuasca, ibogaine, DMT, etc.) endorsed by participant or suspected by the Lead Investigator's clinical judgement.
- Reported current non-medical use of cocaine, psychostimulants, psilocybin, or opioids (past 30 days).
- A reported history of significant alcohol withdrawal (CIWA-Ar score greater than 7) or a history of severe alcohol withdrawal, including delirium tremens, withdrawal seizures or any acute hospitalization related to alcohol withdrawal. Participants presenting at screening in withdrawal may be referred for detoxification and reassessed within 30 days.
- Serious abnormalities of complete blood count (CBC) or chemistries found at or within 45-days of screening.
- Currently enrolled in another clinical trial of any kind.
- Active legal problems with the potential to result in incarceration.
- Pregnancy or lactation; or intention to become pregnant or cause pregnancy
- Need to take medication with significant potential to interact with study medications (e.g., antidepressants, antipsychotics, psychostimulants, treatments for addictions, other dopaminergic or serotonergic agents, lithium, anticonvulsants) as determined by Study Physician or Lead Investigator.
- Allergy or hypersensitivity to psilocybin.
- High risk of adverse emotional or behavioral reaction based on investigator's clinical evaluation (e.g., evidence of serious personality disorder, antisocial behavior, serious current stressors, lack of meaningful social support), or deemed not suitable for other reasons stipulated by the research team.
- A previous diagnosis of Hallucination Perceptual Persisting Disorder (HPPD).
- Received an investigational drug (including investigational vaccines) or used an invasive investigational medical device within 3 months or 5 half-lives before enrollment or is currently enrolled in the treatment stage of an investigational study.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Washington Center for Novel Therapeutics in Addiction Psychiatry
Seattle, Washington, 98195
About this study
Official title: PsiloStudy: A Phase 2 Single-site, Double-blind, Placebo-controlled, Randomized Clinical Trial With an Open-label Extension Phase to Examine the Safety, Subjective Experiences, Acute Effects, and Suitability of Psilocybin Combined With Psychological Support (Psi-PS) for Military Veterans and First Responders With Co-occurring Alcohol Use Disorder (AUD) and Posttraumatic Stress Disorder (PTSD)
This study is a phase 2 single-site, double-blind, placebo-controlled, randomized clinical trial with an open-label extension phase to examine the safety of psilocybin (25 mg) combined with psychological support (Psi-PS) for treatment of approximately 40 military veterans and first responders (ages 21-65) with co-occurring alcohol use disorder (AUD) and posttraumatic stress disorder (PTSD). Psychological support is defined as providing safety, reassurance, active listening, and empathetic presence during the drug administration session in a nondirective manner. We hypothesize that Psi-PS may provide a safe treatment for participants. The primary objective of study is to characterize the safety of psilocybin combined with psychological support (Psi-PS) for individuals with co-occurring alcohol use disorder (AUD) and PTSD.
Read the detailed description
There is growing evidence suggesting that psychedelic drugs, when paired with therapy, may constitute a safe and effective form of treating a diverse range of psychopathological issues such as alcohol use disorder (AUD) and PTSD (Bogenschutz et al., 2015, 2022; Dakwar et al., 2020; Grabski et al., 2022; Mitchell et al., 2021, 2023). However, to date, no studies have explored any form of psychedelic-assisted therapy in the treatment of patients with co-occurring AUD and PTSD, despite high rates of comorbidity. This study will be the first of its kind to evaluate the safety of psilocybin paired with therapy to target symptoms of comorbid AUD and PTSD. Data derived from this clinical trial will help shed light on whether Psi-PS may be safe for those suffering from both PTSD and AUD.
Taken together, we propose the following primary, secondary, and exploratory objectives:
- Primary Objective: Characterize the safety of psilocybin combined with psychological support (Psi-PS) for participants during the drug administration session (DAS) while the drug's acute effects are ongoing, approximately 24 hours after the DAS when the drug's acute effects have subsided, and approximately one-week post-DAS.
- Exploratory Objective: (1) Explore the subjective experiences of Psi-PS within approximately 24 hours following the DAS, i.e., when the drug's acute effects have subsided, approximately one-week following the DAS, and at follow-up at approximately three-months. (2) Assess acute effects of Psi-PS on a range of variables at baseline and weeks 1, 2, 4, 12, and 24 post-DAS; (3) Further, assess suitability at baseline and approximately 4-weeks post-DAS.
This study is a single-site, double-blinded, placebo-controlled, randomized clinical trial with an open-label extension phase assessing safety in two conditions: 1. Psi-PS (psilocybin combined with psychological support); and 2. placebo and nondirective psychological support. The study will last approximately 26-32 weeks and is composed of two preparation sessions; one Drug Administration Session (DAS), where 25 mg of oral psilocybin (PEX010) or inert placebo (PCB2) is administered in a clinical setting with two facilitators present; and three integration sessions. Placebo conditions will receive the same psychological support but will receive an inert placebo. 4-weeks after DAS, the study will be unblinded and those who received placebo will be offered Psi-PS for the open-label extension phase, following the same procedures. The intended sample size for the study is approximately 40 military veterans and first responders (ages 21-65) with co-occurring alcohol use disorder (AUD) and posttraumatic stress disorder (PTSD). Study drug shipments will arrive on-site pre randomized by the manufacturer, and double-blinding will be maintained throughout the study by using a placebo that is designed to have similar physical characteristics as the study drug. All participants will then be followed for a total of 6 months (24 weeks) following the DAS to assess durability of potential effects.
- Conditions
- Alcohol Use Disorder (AUD), PTSD
- Being tested
- Psilocybin 25 mg, Maltodextrin (Placebo)
- Keywords
- Psilocybin, Psychological Support, PTSD, AUD, Military Veterans and First Responders, Psychedelics, Vet, Veteran, Post-Traumatic Stress Disorder, Alcohol, Alcohol Use Disorder, Post Traumatic Stress Disorder, Military, Military Veterans, First Responders, Healthcare Workers
- Medical subject headings
- Alcoholism, Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Psilocybin 25 mgDrug
Also called PEX010, PYEX
Botanical drug product PEX010(25) contains the drug substance, PYEX, which is primarily composed of psilocybin (delivered in a capsule)
Maltodextrin (Placebo)Drug
25 mg of Maltodextrin (delivered in a capsule)
| Study group | Role | What they receive |
|---|---|---|
| Psilocybin + Nondirective Psychological Support | Experimental | The intervention is composed of two 60-minute telehealth preparation sessions (Prep 1 and Prep 2) with two facilitators; one 6-8-hour drug administration session (25 mg of oral psilocybin) in a clinical setting with the same two facilitators present; and three 60-minute telehealth integration sessions (Integration 1-3) with the same two facilitators. Ideally the entire intervention will be delivered over 6 weeks allowing for some flexibility based on schedules and logistics. Receives: Drug: Psilocybin 25 mg |
| Placebo + Nondirective Psychological Support | Placebo comparator | The arm is composed of two 60-minute telehealth preparation sessions (Prep 1 and Prep 2) with two facilitators; inert placebo (25 mg of Maltodextrin) administered in a clinical setting with the same two facilitators present; and three 60-minute telehealth integration sessions (Integration 1-3) with the same two facilitators. Ideally the entire intervention will be delivered over 6 weeks allowing for some flexibility based on schedules and logistics. Receives: Drug: Maltodextrin (Placebo) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of Psi-PS
Safety of Psi-PS will be measured through the assessment of adverse events (AEs), serious adverse events (SAEs), and acute suicidality using the Columbia Suicide Severity Rating Scale (C-SSRS).
Measured: Within approximately 24 hours post-DAS, i.e., when the drug's acute effects have subsided, and approximately one-week post-DAS.
Secondary outcomes (1)
Subjective Experiences
Describe the subjective experiences of psilocybin combined with psychological support (Psi-PS) for individuals with alcohol use disorder (AUD) and PTSD with qualitative data analyses.
Measured: On the day of the DAS, 1-week post-DAS, and 3-months post-DAS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2025
- Study start1 Jun 2025
- Primary completion1 Nov 2026 (estimated)
- Study completion1 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcohol Use Disorder (AUD)Studies of the same condition, open and under way.
- 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
- A single-site, double-blinded, placebo-controlled, randomized clinical trial with an open-label extension phase assessing safety in two conditions: (1) 25 mg of psilocybin combined with nondirective psychological support (Psi-PS); and (2) placebo and nondirective psychological support.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nathan Brashares Sackett
- Sponsor type
- University, hospital or other
- Collaborators
- Washington State Legislation
- Responsible party
- Sponsor-investigator, Nathan Brashares Sackett, University of Washington
- Investigators
- Nathan B Sackett, MD, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06853912
- Sponsor's protocol ID
- STUDY00021194
- Acronym
- Psi-PS
- Status last verified
- Aug 2026
- First submitted
- 11 Dec 2024
- Last updated
- 13 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PsiloStudy: A Phase 2 Single-site, Double-blind, Placebo-controlled, Randomized Clinical Trial With an Open-label Extension Phase to Examine the Safety, Subjective Experiences, Acute Effects, and Suitability of Psilocybin Combined With Psychological Support (Psi-PS) for Military Veterans and First Responders With Co-occurring Alcohol Use Disorder (AUD) and Posttraumatic Stress Disorder (PTSD)
- ClinicalTrials.gov ID
- NCT06853912
- Acronym / sponsor ID
- Psi-PS / STUDY00021194
- Conditions
- Alcohol Use Disorder (AUD), PTSD
- Keywords
- Psilocybin, Psychological Support, PTSD, AUD, Military Veterans and First Responders, Psychedelics, Vet, Veteran
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Nathan Brashares SackettUniversity, hospital or other
- Collaborators
- Washington State Legislation
- Study start
- 1 Jun 2025 (actual)
- Primary completion
- 1 Nov 2026 (estimated)
- Study completion
- 1 Jun 2027 (estimated)
- First posted
- 3 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.
This study is a phase 2 single-site, double-blind, placebo-controlled, randomized clinical trial with an open-label extension phase to examine the safety of psilocybin (25 mg) combined with psychological support (Psi-PS) for treatment of approximately 40 military veterans and first responders (ages 21-65) with co-occurring alcohol use disorder (AUD) and posttraumatic stress disorder (PTSD). Psychological support is defined as providing safety, reassurance, active listening, and empathetic presence during the drug administration session in a nondirective manner. We hypothesize that Psi-PS may provide a safe treatment for participants. The primary objective of study is to characterize the safety of psilocybin combined with psychological support (Psi-PS) for individuals with co-occurring alcohol use disorder (AUD) and PTSD.
Detailed description
There is growing evidence suggesting that psychedelic drugs, when paired with therapy, may constitute a safe and effective form of treating a diverse range of psychopathological issues such as alcohol use disorder (AUD) and PTSD (Bogenschutz et al., 2015, 2022; Dakwar et al., 2020; Grabski et al., 2022; Mitchell et al., 2021, 2023). However, to date, no studies have explored any form of psychedelic-assisted therapy in the treatment of patients with co-occurring AUD and PTSD, despite high rates of comorbidity. This study will be the first of its kind to evaluate the safety of psilocybin paired with therapy to target symptoms of comorbid AUD and PTSD. Data derived from this clinical trial will help shed light on whether Psi-PS may be safe for those suffering from both PTSD and AUD.
Taken together, we propose the following primary, secondary, and exploratory objectives:
- Primary Objective: Characterize the safety of psilocybin combined with psychological support (Psi-PS) for participants during the drug administration session (DAS) while the drug's acute effects are ongoing, approximately 24 hours after the DAS when the drug's acute effects have subsided, and approximately one-week post-DAS.
- Exploratory Objective: (1) Explore the subjective experiences of Psi-PS within approximately 24 hours following the DAS, i.e., when the drug's acute effects have subsided, approximately one-week following the DAS, and at follow-up at approximately three-months. (2) Assess acute effects of Psi-PS on a range of variables at baseline and weeks 1, 2, 4, 12, and 24 post-DAS; (3) Further, assess suitability at baseline and approximately 4-weeks post-DAS.
This study is a single-site, double-blinded, placebo-controlled, randomized clinical trial with an open-label extension phase assessing safety in two conditions: 1. Psi-PS (psilocybin combined with psychological support); and 2. placebo and nondirective psychological support. The study will last approximately 26-32 weeks and is composed of two preparation sessions; one Drug Administration Session (DAS), where 25 mg of oral psilocybin (PEX010) or inert placebo (PCB2) is administered in a clinical setting with two facilitators present; and three integration sessions. Placebo conditions will receive the same psychological support but will receive an inert placebo. 4-weeks after DAS, the study will be unblinded and those who received placebo will be offered Psi-PS for the open-label extension phase, following the same procedures. The intended sample size for the study is approximately 40 military veterans and first responders (ages 21-65) with co-occurring alcohol use disorder (AUD) and posttraumatic stress disorder (PTSD). Study drug shipments will arrive on-site pre randomized by the manufacturer, and double-blinding will be maintained throughout the study by using a placebo that is designed to have similar physical characteristics as the study drug. All participants will then be followed for a total of 6 months (24 weeks) following the DAS to assess durability of potential effects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- A single-site, double-blinded, placebo-controlled, randomized clinical trial with an open-label extension phase assessing safety in two conditions: (1) 25 mg of psilocybin combined with nondirective psychological support (Psi-PS); and (2) placebo and nondirective psychological support.
| Arm | Type | Receives |
|---|---|---|
| Psilocybin + Nondirective Psychological Support | Experimental | Drug: Psilocybin 25 mgThe intervention is composed of two 60-minute telehealth preparation sessions (Prep 1 and Prep 2) with two facilitators; one 6-8-hour drug administration session (25 mg of oral psilocybin) in a clinical setting with the same two facilitators present; and three 60-minute telehealth integration sessions (Integration 1-3) with the same two facilitators. Ideally the entire intervention will be delivered over 6 weeks allowing for some flexibility based on schedules and logistics. |
| Placebo + Nondirective Psychological Support | Placebo comparator | Drug: Maltodextrin (Placebo)The arm is composed of two 60-minute telehealth preparation sessions (Prep 1 and Prep 2) with two facilitators; inert placebo (25 mg of Maltodextrin) administered in a clinical setting with the same two facilitators present; and three 60-minute telehealth integration sessions (Integration 1-3) with the same two facilitators. Ideally the entire intervention will be delivered over 6 weeks allowing for some flexibility based on schedules and logistics. |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Adults aged 21-65 who meet criteria for current DSM-5 diagnosis of AUD and PTSD as determined by the Alcohol System Checklist and CAPS-5.
- Are either a US military Veteran or are currently employed as a first responder, including EMT, paramedic, firefighter, or law enforcement officer.
- Report wanting to stop or decrease drinking and are willing to abstain from alcohol for the week prior to receiving any study drug.
- Are English-speaking.
- Must be willing to use contraception throughout the duration of the study. This applies to anyone, regardless of biological sex, who can cause pregnancy or become pregnant themselves.
Key exclusion criteria (38 listed)
- A reported history of known medical conditions that would preclude safe participation in the trial, including the following:
- Clinical findings on screening, including:
- Reported history or findings on SCID-CT of known exclusionary psychiatric conditions, including schizophrenia, schizoaffective disorder, bipolar disorder type I or type II.
- A reported history of a serious suicide attempt (SSA) in previous 12-months.
- A reported history of a personality disorder at time of screening.
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 |
|---|---|---|
| Psilocybin 25 mgAlso: PEX010, PYEXBotanical drug product PEX010(25) contains the drug substance, PYEX, which is primarily composed of psilocybin (delivered in a capsule) | Drug | Psilocybin + Nondirective Psychological Support |
| Maltodextrin (Placebo)25 mg of Maltodextrin (delivered in a capsule) | Drug | Placebo + Nondirective Psychological Support |
Primary outcome
Safety of Psi-PS
Time frame: Within approximately 24 hours post-DAS, i.e., when the drug's acute effects have subsided, and approximately one-week post-DAS.
Safety of Psi-PS will be measured through the assessment of adverse events (AEs), serious adverse events (SAEs), and acute suicidality using the Columbia Suicide Severity Rating Scale (C-SSRS).
1 secondary outcome
Subjective Experiences
Time frame: On the day of the DAS, 1-week post-DAS, and 3-months post-DAS
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 13 Aug 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. This study is not recruiting at the moment.
Nathan B Sackett, MD principal investigator
University of Washington
1 site 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 25 mg in people with Alcohol Use Disorder (AUD) and PTSD, run by Nathan Brashares Sackett at 1 site in United States.
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 12 inclusion and 38 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: under way, not looking for participants, as of the sponsor's last update on 13 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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. Some participants in this study may receive a placebo. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety of Psi-PS (time frame: Within approximately 24 hours post-DAS, i.e., when the drug's acute effects have subsided, and approximately one-week post-DAS.). 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 13 Aug 2026.