PTSD Clinical Trial
Official title:
Examining the Safety and Clinical Efficacy of Psilocybin Therapy for Veterans With PTSD: An Open-Label Proof-of-Concept Trial
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 United States military Veterans.
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. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Active, not recruiting |
NCT03962504 -
Written Exposure Therapy Versus Prolonged Exposure: a Non-inferiority Trial
|
N/A | |
| Completed |
NCT01995123 -
Behavioral Activation for Smoking Cessation in PTSD
|
N/A | |
| Not yet recruiting |
NCT06278922 -
Evaluating Signs of Safety: A Deaf-Accessible Therapy Toolkit for AUD and Trauma
|
N/A | |
| Completed |
NCT04597450 -
Lu AG06466 in Participants With Post Traumatic Stress Disorder (PTSD)
|
Phase 1 | |
| Completed |
NCT03593772 -
Mission Reconnect- Delivering a Mobile and Web Based Self Directed Complementary And Integrative Health Program to Veterans and Their Partners to Manage Pain and PTSD
|
N/A | |
| Completed |
NCT03429166 -
Connecting Women to Care: Home-based Psychotherapy for Women With MST Living in Rural Areas
|
N/A | |
| Recruiting |
NCT04317820 -
Deep Brain Reorienting in Post-traumatic Stress Disorder
|
N/A | |
| Active, not recruiting |
NCT04588883 -
Strengthening Families Living With HIV in Kenya
|
N/A | |
| Completed |
NCT03504722 -
Evaluating the Feasibility of RESCUE: An Adjunctive HAI-Based Intervention for Veterans With PTSD
|
N/A | |
| Completed |
NCT04305353 -
Intensive Care Unit (ICU) Diary Project
|
N/A | |
| Completed |
NCT03113890 -
McLean and Genomind Prospective Study
|
N/A | |
| Withdrawn |
NCT05173831 -
Study of Feasibility and Safety of MDMA-Assisted Group Therapy for the Treatment of PTSD in Veterans
|
Phase 2 | |
| Not yet recruiting |
NCT04056767 -
Changes in Digital Phenotype During PE Therapy
|
||
| Withdrawn |
NCT03924297 -
Chilipad for Sleep and Symptoms of PTSD
|
N/A | |
| Completed |
NCT03343028 -
Biomarker Establishment for Superior Treatment of PTSD
|
||
| Completed |
NCT03158558 -
Intensive Weekend Retreat Multi-Couple Group Therapy for PTSD
|
N/A | |
| Withdrawn |
NCT03216356 -
Effect of D-cycloserine on a Short Imagery Rescripting Intervention for Subclinical PTSD
|
Phase 2/Phase 3 | |
| Completed |
NCT02370173 -
A Non-Pharmacological Method for Enhancing Sleep in PTSD
|
N/A | |
| Completed |
NCT01955538 -
The Effect of BAT Versus Mixed Physical Activity as add-on Treatment for Traumatised Refugees.
|
Phase 3 | |
| Completed |
NCT01911585 -
Efficacy of 60-minute Versus 90-minute Sessions in Treating PTSD Using Prolonged Exposure
|
N/A |