Post-Traumatic Stress Disorder, PTSDEarly Phase 1TiPAP-PTSDNCT07737054
Trauma-informed Psilocybin Assisted Psychotherapy (TiPAP) for PTSD
A Early Phase 1 study testing Psilocybin (drug) and Trauma-Focused Psychotherapy in people with Post-Traumatic Stress Disorder, PTSD, run by Tel-Aviv Sourasky Medical Center at 1 site in Israel.
Trial summary
This is an open-label pilot study designed to evaluate the safety, tolerability, and preliminary clinical effects of psilocybin-enhanced trauma-focused psychotherapy in individuals with post-traumatic stress disorder (PTSD). Read more about this study
- Who is it for?
- Ages 21 to 65 years
- Conditions the study is for
- Post-Traumatic Stress Disorder, PTSD
- What is being tested?
- Psilocybin (drug) and Trauma-Focused Psychotherapy
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteIsrael
- Study dates
- 22 Jul 2025to 31 Dec 2026
- Phase
- Early Phase 1
- 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
- Age 21-65 years.
- Diagnosis of post-traumatic stress disorder (PTSD) according to DSM-5 criteria, as assessed by CAPS-5.
- At least 1 year since the traumatic event.
- Moderate or greater PTSD severity (CAPS-5 score ≥ 25).
- Ability to provide written informed consent.
- Ability to read, write, speak, and understand Hebrew.
Show all 11Show fewer
- Prior trauma-focused psychotherapy.
- Medically healthy at screening, as determined by a study physician, including:
- No exclusionary medical conditions.
- Resting blood pressure between 90/60 and 150/90 mmHg and heart rate between 45-100 bpm.
- Normal laboratory results (including liver function, renal function, and electrolytes).
Who cannot join
- Current or past diagnosis of psychotic disorders, bipolar disorder, schizoaffective disorder, dissociative identity disorder, or borderline personality disorder (as assessed by MINI or SCID-5-SPQ).
- Current psychotic features.
- First-degree relative with a history of a psychotic disorder.
- History of antidepressant-induced mania or hypomania.
- Significant suicidal risk as assessed by the Columbia Suicide Severity Rating Scale (C-SSRS), including active suicidal ideation with intent or plan, or suicidal behavior within the past 6 months.
- Substance use disorder (excluding nicotine and caffeine); mild-to-moderate alcohol or cannabis use may be permitted under monitoring and PI approval.
Show all 18Show fewer
- Use of psychedelic substances within 3 months before enrollment
- Participation in a clinical trial involving administration of a psychedelic substance within the past 12 months.
- History of adverse psychological reaction to psychedelics requiring hospitalization.
- Significant cardiovascular disease, including ischemic heart disease, uncontrolled hypertension, arrhythmia, or heart failure (NYHA class ≥3).
- Dementia or suspected cognitive impairment.
- Traumatic brain injury with loss of consciousness >24 hours or post-traumatic amnesia >7 days (unless cleared by neurological evaluation).
- Pregnancy, breastfeeding, or positive pregnancy/drug test (excluding cannabis) on the day of dosing.
- BMI <18 or >33
- Abnormal liver or renal function tests.
- Use of medications contraindicated with psilocybin.
- Changes in psychiatric medication (dose or type) within one month before enrollment.
- Needle phobia or inability to undergo blood testing.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Israel1 site, 1 recruiting
- Recruiting
Tel Aviv Sourasky Medical Center
Tel Aviv, 6423906
About this study
Official title: Trauma-informed Psilocybin Assisted Psychotherapy (TiPAP) for Post-Traumatic Stress Disorder
This is an open-label pilot study designed to evaluate the safety, tolerability, and preliminary clinical effects of psilocybin-enhanced trauma-focused psychotherapy in individuals with post-traumatic stress disorder (PTSD).
Participants will receive a structured therapeutic protocol that includes preparatory sessions, two psilocybin administration sessions (15 mg followed by 25 mg), and integration sessions based on a trauma-focused therapeutic approach.
Read more
The primary objective of the study is to assess the safety and tolerability of psilocybin administration in this clinical population. Secondary objectives include evaluating changes in PTSD symptom severity, as measured by the Clinician-Administered PTSD Scale (CAPS-5), at 30 days following treatment.
This pilot study will include 13 participants and is intended to inform the feasibility and design of a subsequent randomized controlled trial.
Read the detailed description
This study is an open-label pilot clinical trial evaluating the safety, tolerability, and preliminary clinical effects of psilocybin-enhanced trauma-focused psychotherapy for the treatment of post-traumatic stress disorder (PTSD).
PTSD is a chronic and disabling condition characterized by intrusive symptoms, avoidance, negative alterations in cognition and mood, and hyperarousal. Despite the availability of evidence-based psychotherapies and pharmacological treatments, a substantial proportion of patients do not achieve sufficient symptom relief, highlighting the need for novel and rapid-acting interventions.
Psilocybin, a serotonergic psychedelic compound, has demonstrated potential therapeutic effects in a range of psychiatric conditions, including depression, anxiety, and trauma-related disorders. When administered in a controlled therapeutic setting, psilocybin may facilitate emotional processing, cognitive flexibility, and adaptive reorganization of trauma-related memories.
In this study, psilocybin administration is combined with an integrative trauma-focused psychotherapeutic framework based on principles of Acceptance and Commitment Therapy (ACT) and Narrative Exposure Therapy (NET). ACT emphasizes psychological flexibility, acceptance, self-as-context, and values-based action, supporting individuals in changing their relationship with trauma-related internal experiences. NET complements this approach by facilitating the structured integration of traumatic memories within a coherent autobiographical narrative, embedding the traumatic experience within the broader context of the individual's life story. Together, this framework is designed to support the processing of traumatic experiences within an expanded and flexible cognitive-emotional context, promoting adaptive meaning-making and reconnection with a broader sense of self.
Participants will undergo a structured treatment protocol consisting of preparatory sessions, two psilocybin administration sessions (15 mg for the first session and 25 mg for the second session), and post-session integration sessions.
The study physician retains clinical authority to discontinue a dosing session or withdraw a participant at any time, including in the event of sustained cardiovascular distress, severe psychological distress unresponsive to support, or acute psychiatric decompensation.
The primary objective of the study is to evaluate the safety and tolerability of psilocybin administration in individuals with PTSD. Safety will be assessed through monitoring of adverse events and clinical observations throughout the study.
Secondary objectives include assessing changes in PTSD symptom severity using the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) at 30 days following the intervention.
This pilot study will enroll 13 participants and is intended to provide preliminary data on feasibility, safety, and potential clinical effects to inform the design of a future randomized controlled trial.
- Conditions
- Post-Traumatic Stress Disorder, PTSD
- Being tested
- Psilocybin (drug), Trauma-Focused Psychotherapy
- Keywords
- Psilocybin, Psychedelic-Assisted Therapy, Trauma-Focused Therapy, Acceptance and Commitment Therapy, PTSD, ACT, Rapid-Acting Treatment, Psychotherapy, Pilot Study
- Medical subject headings
- Combat Disorders, Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Psilocybin (drug)Drug
Psilocybin is a naturally occurring psychedelic compound and a prodrug of psilocin, which exerts its effects primarily through serotonergic receptor activity.
In this study, psilocybin is administered orally in two dosing sessions (15 mg followed by 25 mg) in a controlled clinical setting, with a minimum interval of one week between sessions. Administration is performed by a study physician, who provides medical oversight, monitors vital signs, and evaluates acute responses. Participants are prepared through preparatory psychotherapy sessions and remain in the clinic during the acute drug effects. Each session lasts approximately six hours, after which participants are discharged following physician evaluation. Integration psychotherapy sessions follow each dosing session. After each dosing session, participants are accompanied home by a designated escort or transported by taxi to their care. The first integration psychotherapy session is held the following morning.
Trauma-Focused PsychotherapyBehavioural
The psychotherapy intervention is based on an integrative trauma-focused framework combining Acceptance and Commitment Therapy (ACT) and Narrative Exposure Therapy (NET). Psilocybin-assisted psychotherapy aims to facilitate emotional processing, psychological flexibility, and contextual integration of traumatic memories within a coherent autobiographical narrative. The intervention is delivered by a licensed therapist and includes two preparatory sessions, two psilocybin dosing sessions, and three integration sessions following each dosing session (six in total). Preparation focuses on therapeutic alliance and readiness for the psychedelic experience. Integration sessions support trauma processing, meaning-making, and incorporation of insights into daily functioning. The approach emphasizes flexible re-engagement with trauma-related memories while fostering a broader and more adaptive sense of self.
| Study group | Role | What they receive |
|---|---|---|
| Psilocybin-Assisted Trauma-Focused Psychotherapy | Experimental | Participants receive a structured clinical intervention combining preparatory psychotherapy sessions, two psilocybin dosing sessions (15 mg and 25 mg), and integration psychotherapy sessions within a trauma-focused therapeutic framework. Receives: Drug: Psilocybin (drug); Behavioral: Trauma-Focused Psychotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With One or More Treatment-Emergent Adverse Events
Treatment-emergent adverse events (TEAEs) are defined as any medical or psychological adverse event that begins or worsens after the first psilocybin administration. The reported outcome will be the number of participants experiencing at least one TEAE from the first dosing session through the 30-day follow-up period.
Treatment-emergent adverse events (TEAEs) will be identified through clinical assessments conducted by the study physician and psychologist, monitoring of vital signs (blood pressure and heart rate), participant self-reports, administration of the Columbia-Suicide Severity Rating Scale (C-SSRS) to assess suicidal ideation and behavior, and the Swiss Psychedelic Side Effects Inventory (SPSI) to systematically assess psychedelic-related side effects. Serious adverse events (SAEs) will be monitored, documented, and reported in accordance with the study safety reporting procedures.
Measured: From the first psilocybin administration session through 30 days after completion of the therapeutic intervention.
Number of Participants Completing the Full Therapeutic Intervention
Feasibility and tolerability will be assessed by the number of participants who successfully complete the full therapeutic intervention, defined as completion of both psilocybin administration sessions and all protocol-required preparatory and integration psychotherapy sessions. Successful completion of the intervention reflects the feasibility of implementing the study protocol as planned and the tolerability of the intervention.
Measured: From enrollment through completion of the 30-day follow-up assessment.
Secondary outcomes (1)
Change in PTSD Symptom Severity as Measured by CAPS-5
PTSD symptom severity will be assessed using the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5). The outcome measure will reflect the change in CAPS-5 total score from baseline to 30 days after completion of the therapeutic intervention.
Measured: Baseline to 30 days after completion of the therapeutic intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2026
- Study start22 Jul 2025
- Primary completion1 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Post-Traumatic Stress Disorder, PTSDStudies 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This is an open-label, single-group pilot study in which all participants receive the same intervention. The study follows a structured clinical protocol combining trauma-focused psychotherapy with psilocybin administration. The protocol includes a baseline clinical assessment conducted remotely, followed by two preparatory psychotherapy sessions. Participants then undergo two psilocybin dosing sessions (15 mg and 25 mg), each followed by a series of integration psychotherapy sessions. The study protocol comprises a total of ten in-person study sessions. Clinical assessments include baseline evaluation using self-report questionnaires and the Clinician-Administered PTSD Scale (CAPS-5). An immediate post-treatment assessment is conducted using self-report questionnaires, followed by a clinical assessment using CAPS-5 at 30 days post-intervention.
- Masking
- None (open label)
- Enrolment
- 13 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tel-Aviv Sourasky Medical Center
- Sponsor type
- Other government
- Collaborators
- Tel Aviv University Sagol School of Neuroscience
- Responsible party
- Sponsor
- Investigators
- Talma Hendler, Prof., Principal investigator, Tel Aviv University and Tel Aviv Sourasky Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07737054
- Sponsor's protocol ID
- 0101-24-PILOT
- Other IDs
- Internal Study ID
- Acronym
- TiPAP-PTSD
- Status last verified
- Jul 2026
- First submitted
- 14 Jul 2026
- Last updated
- 30 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Data sharing plans are currently under consideration. Given the pilot nature of the study, small sample size, and the sensitive nature of the data, individual participant data may be shared in a de-identified form upon reasonable request, subject to ethical approval and institutional policies.
Publications
Neisewander B, Moreau C. Trauma-Focused ACT: A Practitioner's Guide to Working With Mind, Body, and Emotion Using Acceptance and Commitment Therapy. Am J Psychother. 2024 Dec 12;77(4):215-216. doi: 10.1176/appi.psychotherapy.20240018. Epub 2024 Nov 6. No abstract available.
PubMed 39504448Mitchell JM, Ot'alora G M, van der Kolk B, Shannon S, Bogenschutz M, Gelfand Y, Paleos C, Nicholas CR, Quevedo S, Balliett B, Hamilton S, Mithoefer M, Kleiman S, Parker-Guilbert K, Tzarfaty K, Harrison C, de Boer A, Doblin R, Yazar-Klosinski B; MAPP2 Study Collaborator Group. MDMA-assisted therapy for moderate to severe PTSD: a randomized, placebo-controlled phase 3 trial. Nat Med. 2023 Oct;29(10):2473-2480. doi: 10.1038/s41591-023-02565-4. Epub 2023 Sep 14.
PubMed 37709999Goodwin GM, Aaronson ST, Alvarez O, Arden PC, Baker A, Bennett JC, Bird C, Blom RE, Brennan C, Brusch D, Burke L, Campbell-Coker K, Carhart-Harris R, Cattell J, Daniel A, DeBattista C, Dunlop BW, Eisen K, Feifel D, Forbes M, Haumann HM, Hellerstein DJ, Hoppe AI, Husain MI, Jelen LA, Kamphuis J, Kawasaki J, Kelly JR, Key RE, Kishon R, Knatz Peck S, Knight G, Koolen MHB, Lean M, Licht RW, Maples-Keller JL, Mars J, Marwood L, McElhiney MC, Miller TL, Mirow A, Mistry S, Mletzko-Crowe T, Modlin LN, Nielsen RE, Nielson EM, Offerhaus SR, O'Keane V, Palenicek T, Printz D, Rademaker MC, van Reemst A, Reinholdt F, Repantis D, Rucker J, Rudow S, Ruffell S, Rush AJ, Schoevers RA, Seynaeve M, Shao S, Soares JC, Somers M, Stansfield SC, Sterling D, Strockis A, Tsai J, Visser L, Wahba M, Williams S, Young AH, Ywema P, Zisook S, Malievskaia E. Single-Dose Psilocybin for a Treatment-Resistant Episode of Major Depression. N Engl J Med. 2022 Nov 3;387(18):1637-1648. doi: 10.1056/NEJMoa2206443.
PubMed 36322843Reiff CM, Richman EE, Nemeroff CB, Carpenter LL, Widge AS, Rodriguez CI, Kalin NH, McDonald WM; the Work Group on Biomarkers and Novel Treatments, a Division of the American Psychiatric Association Council of Research. Psychedelics and Psychedelic-Assisted Psychotherapy. Am J Psychiatry. 2020 May 1;177(5):391-410. doi: 10.1176/appi.ajp.2019.19010035. Epub 2020 Feb 26.
PubMed 32098487Johnson MW, Griffiths RR. Potential Therapeutic Effects of Psilocybin. Neurotherapeutics. 2017 Jul;14(3):734-740. doi: 10.1007/s13311-017-0542-y.
PubMed 28585222Steenkamp MM, Litz BT, Hoge CW, Marmar CR. Psychotherapy for Military-Related PTSD: A Review of Randomized Clinical Trials. JAMA. 2015 Aug 4;314(5):489-500. doi: 10.1001/jama.2015.8370.
PubMed 26241600
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Trauma-informed Psilocybin Assisted Psychotherapy (TiPAP) for Post-Traumatic Stress Disorder
- ClinicalTrials.gov ID
- NCT07737054
- Acronym / sponsor ID
- TiPAP-PTSD / 0101-24-PILOT
- Conditions
- Post-Traumatic Stress Disorder, PTSD
- Keywords
- Psilocybin, Psychedelic-Assisted Therapy, Trauma-Focused Therapy, Acceptance and Commitment Therapy, PTSD, ACT, Rapid-Acting Treatment, Psychotherapy
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 13 participants (estimated)
- Lead sponsor
- Tel-Aviv Sourasky Medical CenterOther government
- Collaborators
- Tel Aviv University Sagol School of Neuroscience
- Study start
- 22 Jul 2025 (actual)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 30 Jul 2026 (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 is an open-label pilot study designed to evaluate the safety, tolerability, and preliminary clinical effects of psilocybin-enhanced trauma-focused psychotherapy in individuals with post-traumatic stress disorder (PTSD).
Participants will receive a structured therapeutic protocol that includes preparatory sessions, two psilocybin administration sessions (15 mg followed by 25 mg), and integration sessions based on a trauma-focused therapeutic approach.
The primary objective of the study is to assess the safety and tolerability of psilocybin administration in this clinical population. Secondary objectives include evaluating changes in PTSD symptom severity, as measured by the Clinician-Administered PTSD Scale (CAPS-5), at 30 days following treatment.
This pilot study will include 13 participants and is intended to inform the feasibility and design of a subsequent randomized controlled trial.
Detailed description
This study is an open-label pilot clinical trial evaluating the safety, tolerability, and preliminary clinical effects of psilocybin-enhanced trauma-focused psychotherapy for the treatment of post-traumatic stress disorder (PTSD).
PTSD is a chronic and disabling condition characterized by intrusive symptoms, avoidance, negative alterations in cognition and mood, and hyperarousal. Despite the availability of evidence-based psychotherapies and pharmacological treatments, a substantial proportion of patients do not achieve sufficient symptom relief, highlighting the need for novel and rapid-acting interventions.
Psilocybin, a serotonergic psychedelic compound, has demonstrated potential therapeutic effects in a range of psychiatric conditions, including depression, anxiety, and trauma-related disorders. When administered in a controlled therapeutic setting, psilocybin may facilitate emotional processing, cognitive flexibility, and adaptive reorganization of trauma-related memories.
In this study, psilocybin administration is combined with an integrative trauma-focused psychotherapeutic framework based on principles of Acceptance and Commitment Therapy (ACT) and Narrative Exposure Therapy (NET). ACT emphasizes psychological flexibility, acceptance, self-as-context, and values-based action, supporting individuals in changing their relationship with trauma-related internal experiences. NET complements this approach by facilitating the structured integration of traumatic memories within a coherent autobiographical narrative, embedding the traumatic experience within the broader context of the individual's life story. Together, this framework is designed to support the processing of traumatic experiences within an expanded and flexible cognitive-emotional context, promoting adaptive meaning-making and reconnection with a broader sense of self.
Participants will undergo a structured treatment protocol consisting of preparatory sessions, two psilocybin administration sessions (15 mg for the first session and 25 mg for the second session), and post-session integration sessions.
The study physician retains clinical authority to discontinue a dosing session or withdraw a participant at any time, including in the event of sustained cardiovascular distress, severe psychological distress unresponsive to support, or acute psychiatric decompensation.
The primary objective of the study is to evaluate the safety and tolerability of psilocybin administration in individuals with PTSD. Safety will be assessed through monitoring of adverse events and clinical observations throughout the study.
Secondary objectives include assessing changes in PTSD symptom severity using the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) at 30 days following the intervention.
This pilot study will enroll 13 participants and is intended to provide preliminary data on feasibility, safety, and potential clinical effects to inform the design of a future randomized controlled trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is an open-label, single-group pilot study in which all participants receive the same intervention. The study follows a structured clinical protocol combining trauma-focused psychotherapy with psilocybin administration. The protocol includes a baseline clinical assessment conducted remotely, followed by two preparatory psychotherapy sessions. Participants then undergo two psilocybin dosing sessions (15 mg and 25 mg), each followed by a series of integration psychotherapy sessions. The study protocol comprises a total of ten in-person study sessions. Clinical assessments include baseline evaluation using self-report questionnaires and the Clinician-Administered PTSD Scale (CAPS-5). An immediate post-treatment assessment is conducted using self-report questionnaires, followed by a clinical assessment using CAPS-5 at 30 days post-intervention.
| Arm | Type | Receives |
|---|---|---|
| Psilocybin-Assisted Trauma-Focused Psychotherapy | Experimental | Drug: Psilocybin (drug), Behavioral: Trauma-Focused PsychotherapyParticipants receive a structured clinical intervention combining preparatory psychotherapy sessions, two psilocybin dosing sessions (15 mg and 25 mg), and integration psychotherapy sessions within a trauma-focused therapeutic framework. |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Age 21-65 years.
- Diagnosis of post-traumatic stress disorder (PTSD) according to DSM-5 criteria, as assessed by CAPS-5.
- At least 1 year since the traumatic event.
- Moderate or greater PTSD severity (CAPS-5 score ≥ 25).
- Ability to provide written informed consent.
Key exclusion criteria (18 listed)
- Current or past diagnosis of psychotic disorders, bipolar disorder, schizoaffective disorder, dissociative identity disorder, or borderline personality disorder (as assessed by MINI or SCID-5-SPQ).
- Current psychotic features.
- First-degree relative with a history of a psychotic disorder.
- History of antidepressant-induced mania or hypomania.
- Significant suicidal risk as assessed by the Columbia Suicide Severity Rating Scale (C-SSRS), including active suicidal ideation with intent or plan, or suicidal behavior within the past 6 months.
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 (drug)Psilocybin is a naturally occurring psychedelic compound and a prodrug of psilocin, which exerts its effects primarily through serotonergic receptor activity. In this study, psilocybin is administered orally in two dosing sessions (15 mg followed by 25 mg) in a controlled clinical setting, with a minimum interval of one week between sessions. Administration is performed by a study physician, who provides medical oversight, monitors vital signs, and evaluates acute responses. Participants are prepared through preparatory psychotherapy sessions and remain in the clinic during the acute drug effects. Each session lasts approximately six hours, after which participants are discharged following physician evaluation. Integration psychotherapy sessions follow each dosing session. After each dosing session, participants are accompanied home by a designated escort or transported by taxi to their care. The first integration psychotherapy session is held the following morning. | Drug | Psilocybin-Assisted Trauma-Focused Psychotherapy |
| Trauma-Focused PsychotherapyThe psychotherapy intervention is based on an integrative trauma-focused framework combining Acceptance and Commitment Therapy (ACT) and Narrative Exposure Therapy (NET). Psilocybin-assisted psychotherapy aims to facilitate emotional processing, psychological flexibility, and contextual integration of traumatic memories within a coherent autobiographical narrative. The intervention is delivered by a licensed therapist and includes two preparatory sessions, two psilocybin dosing sessions, and three integration sessions following each dosing session (six in total). Preparation focuses on therapeutic alliance and readiness for the psychedelic experience. Integration sessions support trauma processing, meaning-making, and incorporation of insights into daily functioning. The approach emphasizes flexible re-engagement with trauma-related memories while fostering a broader and more adaptive sense of self. | Behavioural | Psilocybin-Assisted Trauma-Focused Psychotherapy |
Primary outcome
Number of Participants With One or More Treatment-Emergent Adverse Events
Time frame: From the first psilocybin administration session through 30 days after completion of the therapeutic intervention.
Treatment-emergent adverse events (TEAEs) are defined as any medical or psychological adverse event that begins or worsens after the first psilocybin administration. The reported outcome will be the number of participants experiencing at least one TEAE from the first dosing session through the 30-day follow-up period. Treatment-emergent adverse events (TEAEs) will be identified through clinical assessments conducted by the study physician and psychologist, monitoring of vital signs (blood pressure and heart rate), participant self-reports, administration of the Columbia-Suicide Severity Rating Scale (C-SSRS) to assess suicidal ideation and behavior, and the Swiss Psychedelic Side Effects Inventory (SPSI) to systematically assess psychedelic-related side effects. Serious adverse events (SAEs) will be monitored, documented, and reported in accordance with the study safety reporting procedures.
Number of Participants Completing the Full Therapeutic Intervention
Time frame: From enrollment through completion of the 30-day follow-up assessment.
Feasibility and tolerability will be assessed by the number of participants who successfully complete the full therapeutic intervention, defined as completion of both psilocybin administration sessions and all protocol-required preparatory and integration psychotherapy sessions. Successful completion of the intervention reflects the feasibility of implementing the study protocol as planned and the tolerability of the intervention.
1 secondary outcome
Change in PTSD Symptom Severity as Measured by CAPS-5
Time frame: Baseline to 30 days after completion of the therapeutic intervention
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 30 Jul 2026.
- Background: PubMed 39504448Neisewander B, Moreau C. Trauma-Focused ACT: A Practitioner's Guide to Working With Mind, Body, and Emotion Using Acceptance and Commitment Therapy. Am J Psychother. 2024 Dec 12;77(4):215-216. doi: 10.1176/appi.psychotherapy.20240018. Epub 2024 Nov 6. No abstract available.
- Background: PubMed 37709999Mitchell JM, Ot'alora G M, van der Kolk B, Shannon S, Bogenschutz M, Gelfand Y, Paleos C, Nicholas CR, Quevedo S, Balliett B, Hamilton S, Mithoefer M, Kleiman S, Parker-Guilbert K, Tzarfaty K, Harrison C, de Boer A, Doblin R, Yazar-Klosinski B; MAPP2 Study Collaborator Group. MDMA-assisted therapy for moderate to severe PTSD: a randomized, placebo-controlled phase 3 trial. Nat Med. 2023 Oct;29(10):2473-2480. doi: 10.1038/s41591-023-02565-4. Epub 2023 Sep 14.
- Background: PubMed 36322843Goodwin GM, Aaronson ST, Alvarez O, Arden PC, Baker A, Bennett JC, Bird C, Blom RE, Brennan C, Brusch D, Burke L, Campbell-Coker K, Carhart-Harris R, Cattell J, Daniel A, DeBattista C, Dunlop BW, Eisen K, Feifel D, Forbes M, Haumann HM, Hellerstein DJ, Hoppe AI, Husain MI, Jelen LA, Kamphuis J, Kawasaki J, Kelly JR, Key RE, Kishon R, Knatz Peck S, Knight G, Koolen MHB, Lean M, Licht RW, Maples-Keller JL, Mars J, Marwood L, McElhiney MC, Miller TL, Mirow A, Mistry S, Mletzko-Crowe T, Modlin LN, Nielsen RE, Nielson EM, Offerhaus SR, O'Keane V, Palenicek T, Printz D, Rademaker MC, van Reemst A, Reinholdt F, Repantis D, Rucker J, Rudow S, Ruffell S, Rush AJ, Schoevers RA, Seynaeve M, Shao S, Soares JC, Somers M, Stansfield SC, Sterling D, Strockis A, Tsai J, Visser L, Wahba M, Williams S, Young AH, Ywema P, Zisook S, Malievskaia E. Single-Dose Psilocybin for a Treatment-Resistant Episode of Major Depression. N Engl J Med. 2022 Nov 3;387(18):1637-1648. doi: 10.1056/NEJMoa2206443.
- Background: PubMed 32098487Reiff CM, Richman EE, Nemeroff CB, Carpenter LL, Widge AS, Rodriguez CI, Kalin NH, McDonald WM; the Work Group on Biomarkers and Novel Treatments, a Division of the American Psychiatric Association Council of Research. Psychedelics and Psychedelic-Assisted Psychotherapy. Am J Psychiatry. 2020 May 1;177(5):391-410. doi: 10.1176/appi.ajp.2019.19010035. Epub 2020 Feb 26.
- Background: PubMed 28585222Johnson MW, Griffiths RR. Potential Therapeutic Effects of Psilocybin. Neurotherapeutics. 2017 Jul;14(3):734-740. doi: 10.1007/s13311-017-0542-y.
- Background: PubMed 26241600Steenkamp MM, Litz BT, Hoge CW, Marmar CR. Psychotherapy for Military-Related PTSD: A Review of Randomized Clinical Trials. JAMA. 2015 Aug 4;314(5):489-500. doi: 10.1001/jama.2015.8370.
- Individual participant dataSharing planned: Undecided. Data sharing plans are currently under consideration. Given the pilot nature of the study, small sample size, and the sensitive nature of the data, individual participant data may be shared in a de-identified form upon reasonable request, subject to ethical approval and institutional policies.
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Written Exposure Therapy, Breathing Techniques
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.
Talma Hendler, Prof. principal investigator
Tel Aviv University and Tel Aviv Sourasky Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Psilocybin (drug) and Trauma-Focused Psychotherapy in people with Post-Traumatic Stress Disorder, PTSD, run by Tel-Aviv Sourasky Medical Center at 1 site in Israel.
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 18 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: looking for participants now, as of the sponsor's last update on 30 Jul 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 Israel. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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 Ayelet Or-Borichev, PhD (+972507941243, ayeletorb@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With One or More Treatment-Emergent Adverse Events (time frame: From the first psilocybin administration session through 30 days after completion of the therapeutic intervention.). 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?
On the ClinicalTrials.gov record for NCT07737054, which also lists 6 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 30 Jul 2026.