Study protocol of an open-label proof-of-concept trial examining the safety and clinical efficacy of psilocybin-assisted therapy for veterans with PTSD
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 treatmen...
| Main Authors: | , , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
BMJ Publishing Group
2023-05-01
|
| Series: | BMJ Open |
| Online Access: | https://bmjopen.bmj.com/content/13/5/e068884.full |
| _version_ | 1797833274437926912 |
|---|---|
| author | Alan K Davis Adam W Levin Paul B Nagib Stacey B Armstrong Rafaelle L Lancelotta |
| author_facet | Alan K Davis Adam W Levin Paul B Nagib Stacey B Armstrong Rafaelle L Lancelotta |
| author_sort | Alan K Davis |
| collection | DOAJ |
| description | 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. |
| first_indexed | 2024-04-09T14:20:36Z |
| format | Article |
| id | doaj.art-5804e96957654668a0086cb49112522b |
| institution | Directory Open Access Journal |
| issn | 2044-6055 |
| language | English |
| last_indexed | 2024-04-09T14:20:36Z |
| publishDate | 2023-05-01 |
| publisher | BMJ Publishing Group |
| record_format | Article |
| series | BMJ Open |
| spelling | doaj.art-5804e96957654668a0086cb49112522b2023-05-04T19:30:07ZengBMJ Publishing GroupBMJ Open2044-60552023-05-0113510.1136/bmjopen-2022-068884Study protocol of an open-label proof-of-concept trial examining the safety and clinical efficacy of psilocybin-assisted therapy for veterans with PTSDAlan K Davis0Adam W Levin1Paul B Nagib2Stacey B Armstrong3Rafaelle L Lancelotta4US University of MichiganCenter for Psychedelic Drug Research and Education, The Ohio State University College of Social Work, Columbus, Ohio, USACenter for Psychedelic Drug Research and Education, The Ohio State University College of Social Work, Columbus, Ohio, USACenter for Psychedelic Drug Research and Education, The Ohio State University College of Social Work, Columbus, Ohio, USACenter for Psychedelic Drug Research and Education, The Ohio State University College of Social Work, Columbus, Ohio, USAIntroduction 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.https://bmjopen.bmj.com/content/13/5/e068884.full |
| spellingShingle | Alan K Davis Adam W Levin Paul B Nagib Stacey B Armstrong Rafaelle L Lancelotta Study protocol of an open-label proof-of-concept trial examining the safety and clinical efficacy of psilocybin-assisted therapy for veterans with PTSD BMJ Open |
| title | Study protocol of an open-label proof-of-concept trial examining the safety and clinical efficacy of psilocybin-assisted therapy for veterans with PTSD |
| title_full | Study protocol of an open-label proof-of-concept trial examining the safety and clinical efficacy of psilocybin-assisted therapy for veterans with PTSD |
| title_fullStr | Study protocol of an open-label proof-of-concept trial examining the safety and clinical efficacy of psilocybin-assisted therapy for veterans with PTSD |
| title_full_unstemmed | Study protocol of an open-label proof-of-concept trial examining the safety and clinical efficacy of psilocybin-assisted therapy for veterans with PTSD |
| title_short | Study protocol of an open-label proof-of-concept trial examining the safety and clinical efficacy of psilocybin-assisted therapy for veterans with PTSD |
| title_sort | study protocol of an open label proof of concept trial examining the safety and clinical efficacy of psilocybin assisted therapy for veterans with ptsd |
| url | https://bmjopen.bmj.com/content/13/5/e068884.full |
| work_keys_str_mv | AT alankdavis studyprotocolofanopenlabelproofofconcepttrialexaminingthesafetyandclinicalefficacyofpsilocybinassistedtherapyforveteranswithptsd AT adamwlevin studyprotocolofanopenlabelproofofconcepttrialexaminingthesafetyandclinicalefficacyofpsilocybinassistedtherapyforveteranswithptsd AT paulbnagib studyprotocolofanopenlabelproofofconcepttrialexaminingthesafetyandclinicalefficacyofpsilocybinassistedtherapyforveteranswithptsd AT staceybarmstrong studyprotocolofanopenlabelproofofconcepttrialexaminingthesafetyandclinicalefficacyofpsilocybinassistedtherapyforveteranswithptsd AT rafaellellancelotta studyprotocolofanopenlabelproofofconcepttrialexaminingthesafetyandclinicalefficacyofpsilocybinassistedtherapyforveteranswithptsd |