Group Psilocybin-Assisted Therapy for Post-Traumatic Stress Disorder
ConditionPTSD
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-89
SponsorUniversity of New Mexico
About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
Inability to achieve five days of abstinence from alcohol, non-prescribed opioids, methamphetamines, cocaine, benzodiazepines, or other illicit substances
Inability or unwillingness to remain abstinent from cannabis use for 24 hours prior to psilocybin dosing session and 12 hours after receiving the dose of psilocybin
Risk for clinically significant acute withdrawal from any substance that would cause safety concern on the day of dosing
Any medical condition that would preclude safe participation in the study, including the following, as determined by medical history review, physical examination, electrocardiogram (ECG), and clinical laboratory tests: Pregnancy/breastfeeding
Trial design
Treatments tested in this trial
- Psilocybin
Treatment groups
36 Participants
are divided into 1 treatment groupLocations
1Interdisciplinary Substance Use and Brain Injury (ISUBI)87131, AlbuquerqueNew Mexico, United States
Sponsors and collaborators
University of New Mexico
Lead sponsor
Source ClinicalTrials.gov