Your browser doesn't support javascript.
loading
Study protocol of an open-label proof-of-concept trial examining the safety and clinical efficacy of psilocybin-assisted therapy for veterans with PTSD.
Davis, Alan K; Levin, Adam W; Nagib, Paul B; Armstrong, Stacey B; Lancelotta, Rafaelle L.
Afiliación
  • Davis AK; Center for Psychedelic Drug Research and Education, The Ohio State University College of Social Work, Columbus, Ohio, USA davis.5996@osu.edu.
  • Levin AW; Center for Psychedelic and Consciousness Research, Department of Psychiatry and Behavioral Sciences, Johns Hopkins University, Baltimore, Maryland, USA.
  • Nagib PB; The Ohio State University College of Medicine, Columbus, Ohio, USA.
  • Armstrong SB; Center for Psychedelic Drug Research and Education, The Ohio State University College of Social Work, Columbus, Ohio, USA.
  • Lancelotta RL; The Ohio State University College of Medicine, Columbus, Ohio, USA.
BMJ Open ; 13(5): e068884, 2023 05 04.
Article en En | MEDLINE | ID: mdl-37142308
INTRODUCTION: Psilocybin-assisted therapy has shown significant promise in treating the cluster of mood and anxiety symptoms that comprise post-traumatic stress disorder (PTSD) but has yet to be tested specifically in this condition. Furthermore, current pharmacological and psychotherapeutic treatments for PTSD are difficult to tolerate and limited in efficacy, especially in the US Military Veteran (USMV) population. This open-label pilot study will examine the safety and efficacy of two psilocybin administration sessions (15 mg and 25 mg), combined with psychotherapy, among USMVs with severe, treatment resistant PTSD. METHODS AND ANALYSIS: We will recruit 15 USMVs with severe, treatment resistant PTSD. Participants will receive one low dose (15 mg) and one moderate/high dose (25 mg) of psilocybin in conjunction with preparatory and post-psilocybin therapy sessions. The primary safety outcome will be the type, severity and frequency of adverse events and suicidal ideation/behaviour, as measured by the Columbia Suicide Severity Rating Scale. The primary outcome measure for PTSD will be the Clinician Administered PTSD Scale-5. The primary endpoint will be 1 month following the second psilocybin administration session, and the total follow-up time will be 6 months. ETHICS AND DISSEMINATION: All participants will be required to provide written informed consent. The trial has been authorised by the Ohio State University Institutional Review Board (study number: 2022H0280). Dissemination of results will occur via a peer-reviewed publication and other relevant media. TRIAL REGISTRATION NUMBER: NCT05554094.
Asunto(s)
Palabras clave
Texto completo
Añadir a Mi BVS
Imprimir
XML
PubMed Links
Buscar en Google

Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Trastornos por Estrés Postraumático / Veteranos Tipo de estudio: Guideline Aspecto: Ethics Límite: Humans Idioma: En Revista: BMJ Open Año: 2023 Tipo del documento: Article País de afiliación: Estados Unidos Pais de publicación: Reino Unido
Texto completo
Añadir a Mi BVS
Imprimir
XML
PubMed Links
Buscar en Google

Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Trastornos por Estrés Postraumático / Veteranos Tipo de estudio: Guideline Aspecto: Ethics Límite: Humans Idioma: En Revista: BMJ Open Año: 2023 Tipo del documento: Article País de afiliación: Estados Unidos Pais de publicación: Reino Unido