Psilocybin-Assisted Psychotherapy for Veterans With PTSD (PsiVet)
Psilocybin-Assisted Psychotherapy for Posttraumatic Stress Disorder in Military Veterans: A Pilot Feasibility Study
調査の概要
詳細な説明
Posttraumatic stress disorder (PTSD) is a severe and debilitating mental health condition that significantly impacts patients' lives, leading to functional impairments, strained relationships, and high healthcare costs. About half of the patients with PTSD do not benefit from current evidence-based psychotherapy and available pharmacological treatments offer only limited benefits. Therefore, there is a high need for novel therapeutic approaches in the treatment of PTSD.
Psilocybin-assisted psychotherapy is a promising approach combining the pharmacological effects of psilocybin, a serotonergic psychedelic, with psychotherapy. Psilocybin-assisted psychotherapy has shown promising effects in several phase 2 studies in the treatment of mental health conditions such as depression and end-of-life anxiety, with two phase 3 studies underway for treatment-resistant depression. Building on these initial promising results, psilocybin-assisted psychotherapy is increasingly being studied for other psychiatric indications, including PTSD.
Many of psilocybin's potential therapeutic mechanisms appear to be transdiagnostic in nature. For example, studies suggest that psilocybin can enhance introspection, emotional processing, and psychological flexibility, all of which could facilitate psychotherapeutic processes. Psilocybin has also been shown to reduce avoidance and promote neural plasticity and cognitive reappraisal, which could be particularly relevant for addressing core symptoms of PTSD, such as persistent avoidance and rigid negative thought patterns. Furthermore, its ability to foster a sense of connectedness aligns well with the therapeutic need of individuals with PTSD who face challenges related to social isolation.
Preliminary findings from an initial Phase 2 trial suggest that psilocybin-assisted psychotherapy may be safe and associated with clinically meaningful improvements in PTSD symptoms. However, this study differed from the present study in several important aspects. Participants were not required to have had previous unsuccessful evidence-based psychotherapies for PTSD, and psilocybin administration was not embedded within psychotherapeutic treatment. The current open-label pilot study will focus on veterans with treatment-refractory PTSD, a patient population that frequently shows partial or no response to standard evidence-based PTSD treatment. In addition, psilocybin administration will be part of an extensive psychotherapeutic treatment protocol. This study aims to collect data on the feasibility, preliminary efficacy and safety of psilocybin-assisted psychotherapy in this population, to inform a potential future randomized controlled trial.
研究の種類
入学 (推定)
段階
- フェーズ2
連絡先と場所
研究連絡先
- 名前：Annika Wirsching, MSc
- 電話番号：+31 088 330 5699
- メール：a.wirsching@arq.org
研究場所
-
-
-
Oegstgeest、オランダ、2342 EG
- ARQ National Psychotrauma Centre / ARQ Centrum'45
-
-
参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
Inclusion Criteria:
- Are between 18 and 70 years old.
- Able to provide written informed consent.
- Fluent in speaking and reading Dutch.
- Is a veteran of the Dutch Armed Forces.
- Able to swallow pills.
- Have a body mass index (kg/m2) of >18.0.
- Meet DSM-5 criteria for current PTSD.
- Meet criteria for treatment-refractory PTSD.
- Agree to have study visits audiovisually recorded.
- Able to provide a contact (relative, spouse, close friend, or other support person) who is willing and able to be reached by the investigators in the event of the participant becoming unwell or unreachable.
Exclusion Criteria:
- Has a history of any medical condition that could make receiving psilocybin harmful because of temporary increases in blood pressure and heart rate.
- Has a medical or psychiatric condition that could interfere with study participation or pose a risk to the participant's safety or well-being.
- Has uncontrolled hypertension.
- Unable or unwilling to safely taper-off prohibited psychiatric medication.
- Has been exposed to electroconvulsive therapy (ECT) within 12 weeks of enrollment.
- Has any current problem which, in the opinion of the investigator, might interfere with study participation.
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：なし
- 介入モデル：単一グループの割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：Psilocybin-assisted psychotherapy
|
Two psilocybin sessions (15 mg psilocybin in the first session; 25 mg psilocybin in the second session) embedded in a psychotherapeutic framework with three preparatory sessions and six integrative sessions.
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Clinician-Administered PTSD Scale for DSM-5 Revised (CAPS-5-R)
時間枠：From Baseline to 1 month after final integrative psychotherapy session
|
The last month CAPS-5-R is a semi-structured interview that assesses index history of DSM-5-defined traumatic event exposure, including the most distressing event and time since exposure, and rates intrusion symptoms (intrusive thoughts or memories), avoidance, cognitive and mood symptoms, arousal and reactivity symptoms, duration and degree of distress and dissociation.
The CAPS-5-R will be administered by a study independent CAPS-5-R rater.
|
From Baseline to 1 month after final integrative psychotherapy session
|
|
Semi-structured interview
時間枠：One month after final integrative psychotherapy session
|
Comprehensive qualitative information about participants' evaluation of the feasibility, acceptability and efficacy of psilocybin-assisted psychotherapy for PTSD will be collected through a semi-structured interview.
|
One month after final integrative psychotherapy session
|
|
Treatment Acceptability/Adherence Scale Modified (TAAS-M)
時間枠：One month after final integrative psychotherapy session
|
A modified 10-item version of the Treatment Acceptability and Adherence Scale (TAAS-M) will be used to describe acceptability and adherence to psilocybin-assisted psychotherapy.
|
One month after final integrative psychotherapy session
|
|
Feasibility of participant screening and study retention
時間枠：From screening until one month after the final integrative psychotherapy session.
|
The feasibility of participant screening and study retention will be assessed by documenting the number and proportion of participants who fail screening, the number and proportion of enrolled participants who discontinue the intervention, and the reasons for screen failure and discontinuation.
All measures will be summarized descriptively.
|
From screening until one month after the final integrative psychotherapy session.
|
|
Concomitant medication use
時間枠：From screening until one month after the final integrative psychotherapy session.
|
Concomitant medication use during study participation will be recorded.
|
From screening until one month after the final integrative psychotherapy session.
|
|
Columbia Suicide Severity Rating Scale (C-SSRS)
時間枠：Measured at several timepoints from screening to one month after the final integrative psychotherapy session.
|
The C-SSRS is a clinician-administered measure of suicidal behavior devised to detect potential suicidal thoughts or behaviors during a clinical trial.
|
Measured at several timepoints from screening to one month after the final integrative psychotherapy session.
|
|
Adverse events
時間枠：From screening until one month after the final integrative psychotherapy session.
|
Severity, incidence and frequency of AEs and serious adverse events (SAEs).
|
From screening until one month after the final integrative psychotherapy session.
|
|
Blood pressure
時間枠：At several timepoints between screening and one month after the final integrative psychotherapy session, including during psilocybin administration.
|
Systiloc and diastolic blood pressure (mmHg) will be monitored.
|
At several timepoints between screening and one month after the final integrative psychotherapy session, including during psilocybin administration.
|
|
Heart rate
時間枠：At several timepoints between screening and one month after the final integrative psychotherapy session, including during psilocybin administration.
|
Heart rate (beats per minute) will be monitored.
|
At several timepoints between screening and one month after the final integrative psychotherapy session, including during psilocybin administration.
|
|
Body temperature
時間枠：At several timepoints between screening and one month after the final integrative psychotherapy session, including during psilocybin administration.
|
Body temperature (°C) will be monitored.
|
At several timepoints between screening and one month after the final integrative psychotherapy session, including during psilocybin administration.
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Sheehan Disability Scale
時間枠：Change from Baseline to one month after final integrative psychotherapy session
|
The Sheehan Disability Scale is a 3-item assessment of functional impairment.
|
Change from Baseline to one month after final integrative psychotherapy session
|
|
Beck Depression Inventory-II (BDI-II)
時間枠：Change from baseline to one month after final integrative psychotherapy session
|
The BDI-II is a 21-item self-report measure for depression symptom severity.
|
Change from baseline to one month after final integrative psychotherapy session
|
協力者と研究者
協力者
捜査官
- 主任研究者：Eric Vermetten, MD, PhD、Leiden University Medical Center
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- 2025-521488-11-00
- 2025 (米国 NIH グラント/契約：Faculty of Social Sciences Scientific Grant at the University of Gdańsk)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。