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PTSDPhase 2NCT05876481

Evaluation of Psilocybin-assisted Psychotherapy (PaP) for the Treatment of Post-traumatic Stress Disorder (PTSD) in Military Veterans

A Phase 2 study testing Psilocybin in people with PTSD, run by Combat Stress at 1 site in United Kingdom.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial summary

Post-Traumatic Stress Disorder (PTSD) is a mental health condition that occurs as a result of a traumatic experience. Symptoms include feeling anxious, flashbacks, nightmares and difficulty sleeping. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
PTSD
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
8 participants
Where
1 siteUnited Kingdom
Study dates
Jun 2023to Aug 2025
Phase
Phase 2
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 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Aged 18-65 years
  • Fluent in English (reading and speaking)
  • Has internet access via computer or tablet
  • Is able to commit to the study visits and treatment length
  • Can provide a contact (relative, close friend, other support person) who is able to accompany the participant to dosing visits
  • Agrees to inform researchers within 48 hours of any medical treatments or procedures
Show all 11Show fewer
  • Can swallow pills
  • Agrees to lifestyle restrictions: not to consume alcohol within 24 hours prior to dosing, and to not consume more caffeine than usual
  • Agrees to not participate in any other clinical trials for the duration of the study
  • PCL-5 score ≥33
  • At least one unsuccessful evidence-based psychotherapy/pharmacotherapy for PTSD

Who cannot join

  • General exclusion criteria:
  • History of poor cooperation or unreliability
  • Engaged in compensation litigation whereby financial game would be achieved from prolonged symptoms of PTSD or any other psychiatric disorders
  • Any other current problems that may interfere with participation (e.g., availability, private space for sessions at home)
  • Has hearing impairment that could interfere with ability to participate in the study
  • Is unable to provide written informed consent
Show all 55Show fewer
  • Has known hypersensitivity or previous allergic reaction to any constituent of psilocybin
  • Pregnant or breastfeeding
  • BMI <18 or >35 or non-consent for metric to be measured during assessment visit
  • Has been diagnosed with, or has first degree relative with schizophrenia, psychotic disorder (unless substance induced or due to medical condition), or bipolar I disorder
  • Current alcohol or substance use disorder (other than caffeine or nicotine) requiring detox, or currently in withdrawal from such disorder. Exception for milder disorder if realistic plan (agreed by researcher, therapy team, and medical monitor) for successfully mitigating alcohol/substance use to prevent use from impacting participation, safety, and/or efficacy of the treatment.
  • Mental health exclusion:
  • Schizophrenia spectrum or other psychotic disorders or first degree relative with such disorders (incl. major depressive disorder with psychotic features, or Bipolar I or II disorders)
  • May present serious risk to others (established via clinical interview and contact with treating psychiatrist)
  • Is likely to be re-exposed to index trauma or other significant trauma, lack social support, or lack of stable living situation
  • Physical health exclusion:
  • History of myocardial infarction, angina, cerebrovascular accident, aneurysm, or pulmonary vascular disease
  • Has had Transient Ischemic Attack (TIA) within past 6 months
  • Has uncontrolled hypertension (140/90 mmHG or higher assessed on three separate occasions). Adequately controlled hypertension does not exclude participant
  • Has Wolff-Parkinson-White syndrome or other accessory pathway conditions that have not been successfully eliminated by ablation
  • History of arrhythmia, other than premature atrial contractions (PACs) or occasional premature ventricular contractions (PVCs) in the absence of ischemic heart disease, within past 12 month
  • History of risk factors for Torsade de pointes (e.g., heart failure, hypokalemia, Long QT Syndrome family history)
  • Requires use of concomitant medications that may prolong the QT/QTc interval during psilocybin dosing sessions
  • Marked Baseline prolongation of QT/corrected QT interval (QTc; e.g., repeated demonstration of a QTc interval >450ms and >460ms in females corrected by Bazett's formula). For transgender or non-binary subjects, QTc interval will be evaluated based on sex assigned at birth, unless the subject has been on hormonal treatment for five or more years.
  • History of medical condition that could make receiving a sympathomimetic drug harmful because of increased blood pressure and heart rate
  • Haptic enzymes alkaline phosphatase (ALP), alanine transaminase (ALT), Aspartate aminotransferase (AST) or Gamma-glutamyl Transferase (GGT) > three times upper limit of normal (ULN), or total bilirubin levels >2x ULN
  • Previous indication of liver or kidney damage
  • Current Hepatitis C virus (HCV) infection - Asymptomatic HCV permitted if previously undergone evaluation and treatment as needed
  • Current uncontrolled Type 2 diabetes mellitus
  • Current uncontrolled hypothyroidism
  • Current or historic glaucoma unless participation approved by an ophthalmologist
  • History of traumatic brain injury (TBI)/cognitive impairment limiting ability to engage in treatment (e.g., memory or concentration problems, impulsivity related to brain injury)
  • Current neurological illness including, but not limited to, seizure disorders, frequent migraines (or on prophylaxis for same), multiple sclerosis, movement disorders, history of significant head trauma, or central nervous system (CNS) tumour)
  • The presence of other severe acute or chronic medical condition, psychiatric condition or laboratory abnormality that may increase the risk associated with participation or may interfere with interpretation of trial results. Please note: mild, stable chronic medical problems (e.g., Type 1 or 2 Diabetes Mellitus, HIV infection, glaucoma, hypothyroidism, hepatitis C, hepatic or renal disease, etc.) may be enrolled if Investigator and research psychiatrist agree that condition(s) would not: significantly increase risk of psilocybin administration, or be likely to produce significant symptoms during the study that could interfere with participation, or be confused with side effects of Investigational Product
  • Previous use of psilocybin or other psychedelic substance (except cannabis) on more than 5 occasions and/or use of the same within the past 5 years
  • Previous use of psilocybin, methylenedioxymethamphetamine (MDMA), ketamine (or substances reportedly containing psilocybin, MDMA, or ketamine) with therapeutic aim for current PTSD diagnosis
  • Has received Electroconvulsive Therapy (ECT) within 12 weeks of enrolment
  • Requires ongoing concomitant therapy with a psychiatric medication (unless deemed acceptable by the research psychiatrist)
  • Exposure to other investigational drug/device within 30 days of enrolment
  • Medication exclusion criteria:
  • Over-the-counter products intended to affect mood/anxiety
  • Efavirenz
  • Lithium
  • "Rest-Category" Antidepressants (e.g., mirtazapine, trazodone, bupropion); Exception if ≤7.5mg mirtazapine, or ≤50mg trazodone as sleeping medication
  • Antipsychotics/Neuroleptics; Exception if ≤50mg quetiapine as sleeping medication
  • Stimulants
  • The following medications are permitted if the dose is hypnotic: selective serotonin reuptake inhibitor (SSRIs); Tricyclic antidepressants (TCAs); monoamine oxidase inhibitor (MAOIs)
  • The following medications are permitted if their use is unaltered during the study: Benzodiazepines "Z-drugs" (e.g., zolpidem); Anticonvulsants; Antihistamines
  • Medications which are permitted as determined case-by-case by research psychiatrist: non-psychiatric, but mind-altering medication (e.g., morphine, dexamethasone, etc.).
  • Not to be used 72hrs prior to psilocybin dosing session: Sildenafil (Viagra), tadalafil, or similar medications
  • Not to be used on dosing days and research psychiatrist discretion: Medical cannabis
  • Risk exclusion criteria:
  • Current suicidal ideation/intent/action
  • Previous (within previous 6 months) suicidal ideation/intent/action
  • Current and previous deliberate self-harm

Trial locations and contacts

1 site in 1 country.

Prof. Dominic Murphy contact

01372 587 017

dominic.murphy@combatstress.org.uk

United Kingdom1 site

  • Combat Stress

    Leatherhead, Surrey, KT22 0BX

Other trials in United Kingdom

About this study

Official title: Evaluation of the Acceptability, Safety, Feasibility, and Efficacy of Psilocybin-assisted Psychotherapy (PaP) for the Treatment of Post-traumatic Stress Disorder (PTSD) in Military Veterans

Post-Traumatic Stress Disorder (PTSD) is a mental health condition that occurs as a result of a traumatic experience. Symptoms include feeling anxious, flashbacks, nightmares and difficulty sleeping. Several studies indicate that psilocybin-assisted psychotherapy (PaP) may be an effective treatment for a number of mental health conditions. This has led to PaP being designated as a "breakthrough treatment" by the FDA in the US. Despite indications that PaP may hold benefits in treating individuals with posttraumatic stress disorder (PTSD), this remains to be investigated. As such, the present study aims to examine the acceptability, feasibility, safety, and efficacy of PaP (psilocybin administered with psychotherapy) in treating PTSD in military veterans.

Read the detailed description

Recent studies have shown that Psilocybin-Assisted Psychotherapy (PaP) for individuals with treatment-resistant depression can result in outcomes that exceed routine psychotherapy. Psilocybin may have a catalytic effect on the psychotherapeutic process, enhancing introspection and interoception. PaP may similarly benefit the treatment of posttraumatic stress disorder (PTSD). Research indicates high treatment drop-out rates (approximately 30%) among PTSD patients, and moderate remission rates (approximately 44%) 40 months after completing treatment. Furthermore, some veterans with PTSD have poorer treatment responses than members of the general public. This suggests that alternative treatment approaches may be required to support veterans who do not benefit from standard evidence-based approaches. This study aims to explore the acceptability, feasibility, safety and efficacy of PaP for veterans with PTSD. A total of eight military veterans will be recruited. The study involves two non-directive preparatory sessions, two dosing sessions of psilocybin, followed by 12 sessions of Cognitive Processing Therapy. It is hypothesised that PaP will result in a significant reduction in PTSD symptoms, as indicated by PTSD Checklist for Diagnostic and Statistical Manual of Mental Disorders (DSM-5; PCL-5) scores from baseline to one-month follow-up.

Conditions
PTSD
Being tested
Psilocybin
Keywords
PTSD, Veteran, Psilocybin-assisted Psychotherapy, Feasibility trial
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

    Product name: Psilocybin Pharmaceutical form: capsule, hard Dose number and units: 25 mg per day (8-hour dosing session) x 2 Route of administration: oral

Study groups in NCT05876481
Study groupRoleWhat they receive
Psilocybin-assisted PsychotherapyExperimentalAll participants will receive 25mg psilocybin (capsule, hard, oral administration) in two 8-hour psilocybin dosing sessions, followed by Cognitive Processing Therapy.
Receives: Drug: Psilocybin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Symptoms of PTSD measured using the Posttraumatic Stress Disorder Checklist For DSM-5 (PCL- PTSD symptoms

    Symptoms of PTSD measured using the Posttraumatic Stress Disorder Checklist For DSM-5 (PCL- 5). Scores range from 0-80, with a higher score indicated a worse outcome.

    Measured: Change from baseline PCL-5 score at one month follow up

Secondary outcomes (8)

  1. Core features of PTSD and complex PTSD measured using the International Trauma Questionnaire (ITQ)

    Scores range from 0 to 48 with a higher score indicating a worse outcome.

    Measured: Change from baseline ITQ score at one month follow up

  2. Difficulties with anger measured using the Dimensions of Anger Reactions (DAR-5)

    Scores range from 5-25, with a higher score indicating a worse outcome.

    Measured: Change from baseline DAR-5 score at one month follow up

  3. Depression symptoms measured using the Patient Health Questionnaire (PHQ-9)

    Scores range from 0-27, with a higher score indicating a worse outcome.

    Measured: Change from baseline PHQ-9 score at one month follow up

  4. General anxiety symptoms measured using the Generalised Anxiety Disorder (GAD-7)

    Scores range from 0-14, with a higher score indicating a worse outcome.

    Measured: Change from baseline GAD-7 score at one month follow up

  5. Mental wellbeing measured using the Short Warwick-Edinburgh Mental Wellbeing Scale (SWEMWBS)

    Scores range from 7-35, with a lower score indicating a worse outcome.

    Measured: Change from baseline SWEMWBS score at one month follow up

  6. Perceived social support measured using the Oslo Social Support Scale

    Scores range from 3-14, with a higher score indicating a worse outcome.

    Measured: Change from baseline OSS score at one month follow up

  7. Challenging aspects of experiences with psilocybin measured using the Challenging Experience Questionnaire

    Scores range from 5-25, with a higher score indicating a worse outcome.

    Measured: Administered at the end of dosing session one, week 4

  8. Challenging aspects of experiences with psilocybin measured using the Challenging Experience Questionnaire

    Measures a phenomenological profile of experiences with scores not indicative of more or less strongly challenging experiences.

    Measured: Administered at the end of dosing session two, week 5

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 May 2023
  2. Study startJun 2023 (estimated)
  3. Primary completionJul 2025 (estimated)
  4. Study completionAug 2025 (estimated)

Resources

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
8 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05876481
Sponsor's protocol ID
CS-2023-002
Status last verified
May 2023
First submitted
4 Apr 2023
Last updated
25 May 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Carhart-Harris R, Giribaldi B, Watts R, Baker-Jones M, Murphy-Beiner A, Murphy R, Martell J, Blemings A, Erritzoe D, Nutt DJ. Trial of Psilocybin versus Escitalopram for Depression. N Engl J Med. 2021 Apr 15;384(15):1402-1411. doi: 10.1056/NEJMoa2032994.

    PubMed 33852780

  • Davis AK, Barrett FS, May DG, Cosimano MP, Sepeda ND, Johnson MW, Finan PH, Griffiths RR. Effects of Psilocybin-Assisted Therapy on Major Depressive Disorder: A Randomized Clinical Trial. JAMA Psychiatry. 2021 May 1;78(5):481-489. doi: 10.1001/jamapsychiatry.2020.3285.

    PubMed 33146667

  • Dos Santos RG, Hallak JEC. Therapeutic use of serotoninergic hallucinogens: A review of the evidence and of the biological and psychological mechanisms. Neurosci Biobehav Rev. 2020 Jan;108:423-434. doi: 10.1016/j.neubiorev.2019.12.001. Epub 2019 Dec 3.

    PubMed 31809772

  • Nichols DE. Psychedelics. Pharmacol Rev. 2016 Apr;68(2):264-355. doi: 10.1124/pr.115.011478.

    PubMed 26841800

  • Cloitre M, Stolbach BC, Herman JL, van der Kolk B, Pynoos R, Wang J, Petkova E. A developmental approach to complex PTSD: childhood and adult cumulative trauma as predictors of symptom complexity. J Trauma Stress. 2009 Oct;22(5):399-408. doi: 10.1002/jts.20444. Epub 2009 Sep 30.

    PubMed 19795402

  • Morina N, Wicherts JM, Lobbrecht J, Priebe S. Remission from post-traumatic stress disorder in adults: a systematic review and meta-analysis of long term outcome studies. Clin Psychol Rev. 2014 Apr;34(3):249-55. doi: 10.1016/j.cpr.2014.03.002. Epub 2014 Mar 14.

    PubMed 24681171

  • Kitchiner NJ, Roberts NP, Wilcox D, Bisson JI. Systematic review and meta-analyses of psychosocial interventions for veterans of the military. Eur J Psychotraumatol. 2012;3. doi: 10.3402/ejpt.v3i0.19267. Epub 2012 Dec 5.

    PubMed 23233869

  • Straud CL, Siev J, Messer S, Zalta AK. Examining military population and trauma type as moderators of treatment outcome for first-line psychotherapies for PTSD: A meta-analysis. J Anxiety Disord. 2019 Oct;67:102133. doi: 10.1016/j.janxdis.2019.102133. Epub 2019 Aug 18.

    PubMed 31472332

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Psilocybin in people with PTSD, run by Combat Stress at 1 site in United Kingdom.

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 11 inclusion and 55 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: status not confirmed, as of the sponsor's last update on 25 May 2023. 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 Kingdom. 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Prof. Dominic Murphy (01372 587 017, dominic.murphy@combatstress.org.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Symptoms of PTSD measured using the Posttraumatic Stress Disorder Checklist For DSM-5 (PCL- PTSD symptoms (time frame: Change from baseline PCL-5 score at one month follow up). 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 NCT05876481, which also lists 8 linked publications.

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 25 May 2023.

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