Group Psilocybin-Assisted Therapy for Post-Traumatic Stress Disorder
University of New Mexico
Summary
This study is a community-informed, pragmatic, open-label, phase 1 clinical trial of group-format psilocybin-assisted therapy (GPAT) for individuals with post-traumatic stress disorder (PTSD). The primary objectives of this phase 1 study are to assess the safety and feasibility of (GPAT) for individuals with (PTSD) and to evaluate preliminary effects on PTSD severity.
Description
This study is a community-informed, pragmatic, open-label, phase 1 clinical trial of group-format psilocybin-assisted therapy (GPAT) for individuals with post-traumatic stress disorder (PTSD). The primary objectives of this phase 1 study are to assess the safety and feasibility of (GPAT) for individuals with (PTSD) and to evaluate preliminary effects on PTSD severity. These will be assessed by the following outcome measures: * Proportion of participants completing the study protocol * Incidence of adverse events (AEs), serious adverse events (SAEs) and AEs of special interest using the Natio…
Eligibility
- Age range
- 18–89 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: General: -T+H years of age and \<89 years of age Identify as a member of one of the cohorts to be studied: * Veteran or first responder * Female survivor of sexual violence * Indigenous person * Not pregnant, planning to become pregnant, or breastfeeding; if able to become pregnant, willing to use reliable form of birth control for the duration of the study * If needed, ability and willingness to taper and discontinue medications that may interfere with the action of psilocybin * Ability to read, speak, and understand English * Ability and willingness to consent to the…
Interventions
- DrugPsilocybin
Two group-format dosing sessions, scheduled 4 weeks apart, will be held at the ISUBI Center at UNM or a site outside of UNM with DEA approval for psilocybin storage
Location
- Interdisciplinary Substance Use and Brain Injury (ISUBI)Albuquerque, New Mexico