A Phase 2 Single-site, Double-blind, Placebo-controlled, Randomized Clinical Trial With an Open-label Extension Phase to Examine the Safety, Subjective Experiences, Acute Effects, and Suitability of Psilocybin Combined With Psychological Support (Psi-PS) for Military Veterans and First Responders With Co-occurring Alcohol Use Disorder (AUD) and Posttraumatic Stress Disorder (PTSD)
Nathan Brashares Sackett
Summary
This study is a phase 2 single-site, double-blind, placebo-controlled, randomized clinical trial with an open-label extension phase to examine the safety of psilocybin (25 mg) combined with psychological support (Psi-PS) for treatment of approximately 40 military veterans and first responders (ages 21-65) with co-occurring alcohol use disorder (AUD) and posttraumatic stress disorder (PTSD). Psychological support is defined as providing safety, reassurance, active listening, and empathetic presence during the drug administration session in a nondirective manner. We hypothesize that Psi-PS may provide a safe treatment for participants. The primary objective of study is to characterize the safety of psilocybin combined with psychological support (Psi-PS) for individuals with co-occurring alcohol use disorder (AUD) and PTSD.
Description
There is growing evidence suggesting that psychedelic drugs, when paired with therapy, may constitute a safe and effective form of treating a diverse range of psychopathological issues such as alcohol use disorder (AUD) and PTSD (Bogenschutz et al., 2015, 2022; Dakwar et al., 2020; Grabski et al., 2022; Mitchell et al., 2021, 2023). However, to date, no studies have explored any form of psychedelic-assisted therapy in the treatment of patients with co-occurring AUD and PTSD, despite high rates of comorbidity. This study will be the first of its kind to evaluate the safety of psilocybin paired…