Post-Traumatic Stress DisorderPhase 1NCT05562973
Safety and Tolerability of Psilocybin in Post-Traumatic Stress Disorder
A Phase 1 study testing Psilocybin in people with Post-Traumatic Stress Disorder, run by Johns Hopkins University.
Trial summary
The purpose of this study is to evaluate the safety, tolerability, and potential efficacy of psilocybin-assisted psychotherapy to reduce post-traumatic stress disorder (PTSD) severity in a sample of individuals with PTSD. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Post-Traumatic Stress Disorder
- What is being tested?
- Psilocybin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jan 2025to Dec 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 to 80 years old. Participants up to 80 years old who otherwise meet safety criteria will be included to ensure generalizability to the broader clinical population of people with PTSD. Prior work (Griffiths et al. 2016) by our research team administering psilocybin to older cancer patients using the same upper age limit in the inclusion/exclusion criteria (i.e., 80 years old) found a comparable risk profile for psilocybin to research conducted with younger patients. Although it is possible that older patients experience diminished serotonin 2A (5-HT2A) receptor expression resulting in a lower/less intense response to psilocybin, this information will be important to gather in this Phase I context.
- Have given written informed consent
- Read, write, and speak English
- At Screening, meet Diagnostic and Statistical Manual-5th edition (DSM-5) criteria for current PTSD with a symptom duration of 6 months or longer according to the Clinician-Administered PTSD Scale for DSM-5
- Able to complete the study measures
- Previously sought treatment for PTSD (e.g., prolonged exposure therapy, cognitive processing therapy, sertraline, paroxetine)
- Be otherwise medically stable as determined by screening for medical problems via a personal interview, a medical questionnaire, a physical examination, an electrocardiogram (ECG), and routine medical blood and urinalysis laboratory tests (Complete Blood Count, Comprehensive Metabolic Panel, urine beta-human chorionic gonadotropin, urine toxicology screen).
Who cannot join
- Current physical dependence (as evidenced by self-reported withdrawal symptoms) on a drug other than caffeine or nicotine
- Seizure disorder
- Receiving current treatment for PTSD
- Cardiovascular conditions: angina, a clinically significant ECG abnormality (e.g. atrial fibrillation or corrected QT interval >450msec), transient ischemic attack (TIA) in the last 6 months, stroke, or uncontrolled hypertension with resting blood pressure systolic >150 or diastolic >95.
- Recent (<1year) intracranial or subarachnoid hemorrhage, ischemic stroke, TIA
- Pulmonary disease: chronic obstructive pulmonary disease, active asthma (inhaler use in last 6 months)
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- Diabetes mellitus treated with insulin or oral hypoglycemic agents
- Current suicidal ideation or suicidality
- Current engagement in evidence-based PTSD therapy/treatment (prior to psilocybin session)
- Women: Pregnancy (pregnancy tests will be conducted for women during screen and prior to experimental sessions).
- Current or past history of meeting DSM-5 criteria for Schizophrenia, Psychotic Disorder (unless substance-induced or due to a medical condition), or Bipolar I Disorder.
- Currently taking efavirenz or serotonin-acting dietary supplements (e.g., 5-hydroxy- tryptophan, St. John's wort).
- Currently taking antidepressants of any drug class, antipsychotics, or monoamine oxidase inhibitors.
- Recent (within past 12 months) or extensive history of hallucinogen use (>20 lifetime uses).
- Moderate or severe DSM-5 Substance Use Disorder in the past five years (excluding tobacco and caffeine)
- Family (i.e., 1st degree relative) history of Schizophrenia, Psychotic Disorder (unless substance-induced or due to a medical condition), or Bipolar I Disorder.
- For the final (5th) dose sequence (35, 40, and 45 mg) participants that weigh less than 50 kg
About this study
The purpose of this study is to evaluate the safety, tolerability, and potential efficacy of psilocybin-assisted psychotherapy to reduce post-traumatic stress disorder (PTSD) severity in a sample of individuals with PTSD.
Read the detailed description
The proposed Phase I study aims to evaluate the safety, tolerability, and potential efficacy of psilocybin-assisted psychotherapy to reduce PTSD severity in a sample of individuals with PTSD. A sample of up to 30 individuals with PTSD will be recruited. All participants will receive the intervention, which will consist of three psilocybin sessions with an interval of approximately 2 weeks between each session. A 3+3 Phase I trial design will be used to evaluate a range of possible dose sequences with doses ranging from 15 mg up to 45 mg. Safety, tolerability, and efficacy endpoints will be evaluated 2 weeks following each psilocybin session and at 1-month, 3-month, and 6-month follow-ups.
- Conditions
- Post-Traumatic Stress Disorder
- Being tested
- Psilocybin
- Medical subject headings
- Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PsilocybinDrug
Participants will receive three psilocybin sessions, at least two weeks apart.
| Study group | Role | What they receive |
|---|---|---|
| Dose Sequence 1 (15, 20, 25) | Experimental | Psilocybin dose sequence
Session 1: 15 mg Session 2: 20 mg Session 3: 25 mg Receives: Drug: Psilocybin |
| Dose Sequence 2 (20, 25, 30) | Experimental | Psilocybin dose sequence
Session 1: 20 mg Session 2: 25 mg Session 3: 30 mg Receives: Drug: Psilocybin |
| Dose Sequence 3 (25, 30, 35) | Experimental | Psilocybin dose sequence
Session 1: 25 mg Session 2: 30 mg Session 3: 35 mg Receives: Drug: Psilocybin |
| Dose Sequence 4 (30, 35, 40) | Experimental | Psilocybin dose sequence
Session 1: 30 mg Session 2: 35 mg Session 3: 40 mg Receives: Drug: Psilocybin |
| Dose Sequence 5 (35, 40, 45) | Experimental | Psilocybin dose sequence
Session 1: 35 mg Session 2: 40 mg Session 3: 45 mg Receives: Drug: Psilocybin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Peak Post-Administration Blood Pressure
Blood pressure will be monitored at 30, 60, 90, 120, 180, 240, 300, and 360 minutes after capsule administration. Mean peak blood pressure across the 3 psilocybin sessions will be used as the outcome measure.
Measured: Approximately 1.5 - 2 months
Mean Peak Post-Administration Heart Rate
Heart rate will be monitored at 30, 60, 90, 120, 180, 240, 300, and 360 minutes after capsule administration. The mean peak heart rate across the 3 psilocybin sessions will be used as the outcome measure.
Measured: Approximately 1.5 - 2 months
Mean Pre-Administration Suicide Ideation Scores (Columbia Suicide Severity Rating Scale - Severity Factor)
The Columbia Suicide Severity Rating Scale will be used to assess baseline severity of suicide ideation. Scores on the Severity subscale range from 1 - 5, where 1= "wish to be dead"; 2 = "nonspecific active suicidal thoughts"; 3 = "suicidal thoughts with methods"; 4 = "suicidal intent"; and 5 = "suicidal intent with plan". The mean of the Severity subscale scores from the 3 preparation visits will be used as the outcome measure.
Measured: Approximately 3 weeks
Mean Change in Suicide Ideation Scores (Columbia Suicide Severity Rating Scale - Severity Factor)
The Columbia Suicide Severity Rating Scale will be used to assess post-administration severity of suicide ideation. Scores on the Severity subscale range from 1 - 5, where 1= "wish to be dead"; 2 = "nonspecific active suicidal thoughts"; 3 = "suicidal thoughts with methods"; 4 = "suicidal intent"; and 5 = "suicidal intent with plan". The mean change in Severity subscale scores between the preparation visits and the integration visits will be used as the outcome measure.
Measured: Approximately 3 weeks pre-administration; approximately 1.5 - 2 months post-administration
Secondary outcomes (2)
Mean Change in Clinician-Administered PTSD Scale for DSM-5 scores
The Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) is a semi-structured interview that assesses history of DSM-5-defined traumatic event exposure, including the most distressing event, time since exposure, to produce a diagnostic score (presence vs. absence) and a PTSD Total Severity score. The mean of the Total Severity scores from the 3 integration visits will be used as the outcome measure.
Measured: Approximately 3 weeks pre-administration; approximately 1.5 - 2 months post-administration
Mean Change in PTSD Checklist Scores
The PTSD Checklist (PCL-5) is a 20-item self-report questionnaire in which respondents indicate the presence and severity of PTSD symptoms according to diagnostics in the DSM-5. Participants indicate how much distress they have experienced due to symptoms such as "Trouble remembering important parts of a stressful experience from the past" and "Feeling irritable or having angry outbursts" on a five-point Likert-type scale (1=Not at all to 5=Extremely). The mean of the PCL-5 scores from the 3 integration visits will be used as the outcome measure.
Measured: Approximately 3 weeks pre-administration; approximately 1.5 - 2 months post-administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2022
- Study startJan 2025 (estimated)
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
Why it stopped: The principal investigator will be at a new institution.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Post-Traumatic Stress DisorderStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe 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 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Matthew W Johnson, Ph.D., Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05562973
- Sponsor's protocol ID
- IRB00288303
- Status last verified
- Jan 2024
- First submitted
- 28 Sep 2022
- Last updated
- 5 Jan 2024
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Griffiths RR, Johnson MW, Carducci MA, Umbricht A, Richards WA, Richards BD, Cosimano MP, Klinedinst MA. Psilocybin produces substantial and sustained decreases in depression and anxiety in patients with life-threatening cancer: A randomized double-blind trial. J Psychopharmacol. 2016 Dec;30(12):1181-1197. doi: 10.1177/0269881116675513.
PubMed 27909165
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Tolerability of Psilocybin in Post-Traumatic Stress Disorder
- ClinicalTrials.gov ID
- NCT05562973
- Acronym / sponsor ID
- IRB00288303
- Conditions
- Post-Traumatic Stress Disorder
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The principal investigator will be at a new institution.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Study start
- Jan 2025 (estimated)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 3 Oct 2022 (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 purpose of this study is to evaluate the safety, tolerability, and potential efficacy of psilocybin-assisted psychotherapy to reduce post-traumatic stress disorder (PTSD) severity in a sample of individuals with PTSD.
Detailed description
The proposed Phase I study aims to evaluate the safety, tolerability, and potential efficacy of psilocybin-assisted psychotherapy to reduce PTSD severity in a sample of individuals with PTSD. A sample of up to 30 individuals with PTSD will be recruited. All participants will receive the intervention, which will consist of three psilocybin sessions with an interval of approximately 2 weeks between each session. A 3+3 Phase I trial design will be used to evaluate a range of possible dose sequences with doses ranging from 15 mg up to 45 mg. Safety, tolerability, and efficacy endpoints will be evaluated 2 weeks following each psilocybin session and at 1-month, 3-month, and 6-month follow-ups.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Dose Sequence 1 (15, 20, 25) | Experimental | Drug: PsilocybinPsilocybin dose sequence Session 1: 15 mg Session 2: 20 mg Session 3: 25 mg |
| Dose Sequence 2 (20, 25, 30) | Experimental | Drug: PsilocybinPsilocybin dose sequence Session 1: 20 mg Session 2: 25 mg Session 3: 30 mg |
| Dose Sequence 3 (25, 30, 35) | Experimental | Drug: PsilocybinPsilocybin dose sequence Session 1: 25 mg Session 2: 30 mg Session 3: 35 mg |
| Dose Sequence 4 (30, 35, 40) | Experimental | Drug: PsilocybinPsilocybin dose sequence Session 1: 30 mg Session 2: 35 mg Session 3: 40 mg |
| Dose Sequence 5 (35, 40, 45) | Experimental | Drug: PsilocybinPsilocybin dose sequence Session 1: 35 mg Session 2: 40 mg Session 3: 45 mg |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 18 to 80 years old. Participants up to 80 years old who otherwise meet safety criteria will be included to ensure generalizability to the broader clinical population of people with PTSD. Prior work (Griffiths et al. 2016) by our research team administering psilocybin to older cancer patients using the same upper age limit in the inclusion/exclusion criteria (i.e., 80 years old) found a comparable risk profile for psilocybin to research conducted with younger patients. Although it is possible that older patients experience diminished serotonin 2A (5-HT2A) receptor expression resulting in a lower/less intense response to psilocybin, this information will be important to gather in this Phase I context.
- Have given written informed consent
- Read, write, and speak English
- At Screening, meet Diagnostic and Statistical Manual-5th edition (DSM-5) criteria for current PTSD with a symptom duration of 6 months or longer according to the Clinician-Administered PTSD Scale for DSM-5
- Able to complete the study measures
Key exclusion criteria (17 listed)
- Current physical dependence (as evidenced by self-reported withdrawal symptoms) on a drug other than caffeine or nicotine
- Seizure disorder
- Receiving current treatment for PTSD
- Cardiovascular conditions: angina, a clinically significant ECG abnormality (e.g. atrial fibrillation or corrected QT interval >450msec), transient ischemic attack (TIA) in the last 6 months, stroke, or uncontrolled hypertension with resting blood pressure systolic >150 or diastolic >95.
- Recent (<1year) intracranial or subarachnoid hemorrhage, ischemic stroke, TIA
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 |
|---|---|---|
| PsilocybinParticipants will receive three psilocybin sessions, at least two weeks apart. | Drug | Dose Sequence 1 (15, 20, 25), Dose Sequence 2 (20, 25, 30), Dose Sequence 3 (25, 30, 35), Dose Sequence 4 (30, 35, 40), Dose Sequence 5 (35, 40, 45) |
Primary outcome
Mean Peak Post-Administration Blood Pressure
Time frame: Approximately 1.5 - 2 months
Blood pressure will be monitored at 30, 60, 90, 120, 180, 240, 300, and 360 minutes after capsule administration. Mean peak blood pressure across the 3 psilocybin sessions will be used as the outcome measure.
Mean Peak Post-Administration Heart Rate
Time frame: Approximately 1.5 - 2 months
Heart rate will be monitored at 30, 60, 90, 120, 180, 240, 300, and 360 minutes after capsule administration. The mean peak heart rate across the 3 psilocybin sessions will be used as the outcome measure.
Mean Pre-Administration Suicide Ideation Scores (Columbia Suicide Severity Rating Scale - Severity Factor)
Time frame: Approximately 3 weeks
The Columbia Suicide Severity Rating Scale will be used to assess baseline severity of suicide ideation. Scores on the Severity subscale range from 1 - 5, where 1= "wish to be dead"; 2 = "nonspecific active suicidal thoughts"; 3 = "suicidal thoughts with methods"; 4 = "suicidal intent"; and 5 = "suicidal intent with plan". The mean of the Severity subscale scores from the 3 preparation visits will be used as the outcome measure.
Mean Change in Suicide Ideation Scores (Columbia Suicide Severity Rating Scale - Severity Factor)
Time frame: Approximately 3 weeks pre-administration; approximately 1.5 - 2 months post-administration
The Columbia Suicide Severity Rating Scale will be used to assess post-administration severity of suicide ideation. Scores on the Severity subscale range from 1 - 5, where 1= "wish to be dead"; 2 = "nonspecific active suicidal thoughts"; 3 = "suicidal thoughts with methods"; 4 = "suicidal intent"; and 5 = "suicidal intent with plan". The mean change in Severity subscale scores between the preparation visits and the integration visits will be used as the outcome measure.
2 secondary outcomes
Mean Change in Clinician-Administered PTSD Scale for DSM-5 scores
Time frame: Approximately 3 weeks pre-administration; approximately 1.5 - 2 months post-administration
Mean Change in PTSD Checklist Scores
Time frame: Approximately 3 weeks pre-administration; approximately 1.5 - 2 months post-administration
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2024.
- Background: PubMed 27909165Griffiths RR, Johnson MW, Carducci MA, Umbricht A, Richards WA, Richards BD, Cosimano MP, Klinedinst MA. Psilocybin produces substantial and sustained decreases in depression and anxiety in patients with life-threatening cancer: A randomized double-blind trial. J Psychopharmacol. 2016 Dec;30(12):1181-1197. doi: 10.1177/0269881116675513.
- 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.
Matthew W Johnson, Ph.D. principal investigator
Johns Hopkins University
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Psilocybin in people with Post-Traumatic Stress Disorder, run by Johns Hopkins University.
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 17 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: withdrawn, as of the sponsor's last update on 5 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Mean Peak Post-Administration Blood Pressure (time frame: Approximately 1.5 - 2 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05562973, which also lists 1 linked publication.
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 5 Jan 2024.