Evaluation of Psilocybin-assisted Psychotherapy (PaP) for the Treatment of Post-traumatic Stress Disorder (PTSD) in Military Veterans

This interventional trial (n=8) investigates the acceptability, feasibility, safety, and efficacy of Psilocybin-Assisted Psychotherapy (PAP/PAT) in treating Post-Traumatic Stress Disorder (PTSD) in military veterans.

Psilocybin, administered with psychotherapy, is examined as a potential breakthrough treatment for PTSD. Eight military veterans, aged 18-65, fluent in English, with internet access, and a PCL-5 score ≥33, will participate. The study involves two preparatory sessions, two psilocybin dosing sessions, and 12 sessions of Cognitive Processing Therapy.

The primary outcome measure is the reduction in PTSD symptoms, assessed by PCL-5 scores from baseline to one-month follow-up. The study is conducted in Surrey, United Kingdom, by Combat Stress, with Prof. Dominic Murphy as the principal investigator. The estimated study start is June 2023, with an estimated completion in August 2025.

Topic PTSD
Compound Psilocybin
Country United Kingdom
Visit trial
Status Not yet recruiting
Results Published No
Start date 01 June 2023
End date 31 August 2025
Phase Phase II
Design Open
Type Interventional
Generation First
Participants 8
Sex All
Age 16- 65
Therapy Yes

Trial Details

Post-Traumatic Stress Disorder (PTSD) is a mental health condition that occurs as a result of a traumatic experience. Symptoms include feeling anxious, flashbacks, nightmares and difficulty sleeping. Several studies indicate that psilocybin-assisted psychotherapy (PaP) may be an effective treatment for a number of mental health conditions. This has led to PaP being designated as a "breakthrough treatment" by the FDA in the US. Despite indications that PaP may hold benefits in treating individuals with posttraumatic stress disorder (PTSD), this remains to be investigated. As such, the present study aims to examine the acceptability, feasibility, safety, and efficacy of PaP (psilocybin administered with psychotherapy) in treating PTSD in military veterans.

NCT Number NCT05876481

Data attribution

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