The primary aim of this study is to assess the safety and efficacy of psilocybin-assisted therapy in the treatment of post-traumatic stress disorder in the United States military Veterans.
Topic PTSD
Compound Psilocybin
Country United States of America
Visit trial
Status
Not yet recruiting
Results Published
Start date
01 January 2023
End date
31 January 2025
Chance of happening
89%
Phase
Phase II
Design
Open
Type
Interventional
Generation
First
Participants
15
Sex
All
Age
21- 64
Therapy
Yes
Trial Details
The objective of this study is to determine the safety and efficacy of psilocybin assisted psychotherapy in the treatment of Veterans with PTSD. This study will recruit 15 United States Military Veterans, age 21 to 64, primarily from the Columbus and Central Ohio Region who meet the criteria for PTSD. After enrollment and informed consent, participants will receive two separate doses of psilocybin in conjunction with preparatory and post-psilocybin therapy sessions. Each psilocybin session will last approximately 8 hours and will be facilitated by two trained session facilitators. Before the first psilocybin session, participants will meet with one or both of the session facilitators for a total of 6-8 hours of contact time (or up to 4 meetings) before the first psilocybin session day. Two post psilocybin therapy session visits will follow Psilocybin Sessions 1 and 2. Psilocybin Sessions 1 and 2 will occur about two weeks apart. Follow-up visits will occur 1 and 2 weeks and 1, 3, and 6 months after the final psilocybin session, with additional contact hours scheduled as needed. Thus, the intervention and follow-up requires at least 13 visits over a period of about 8-10 months.NCT Number NCT05554094
Sponsors & Collaborators
Ohio State UniversityThe Center for Psychedelic Drug Research & Education (CPDRE) at the College of Social Work at Ohio State University aims to explore and advance the research about psychedelic drugs and their effects, and to disseminate the knowledge about psychedelics.