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.
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 National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 * Mean change in the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) and PTSD checklist for DSM-5 (PCL-5). The CAPS-5 and PCL-5 are based on the DSM-5 not the DSM-5-TR.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
36
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
Interdisciplinary Substance Use and Brain Injury (ISUBI)
Albuquerque, New Mexico, United States
RECRUITINGRate of study completion-feasabiity measure
Number of participants that completed the study.
Time frame: 18 weeks after baseline
Clinician-Administered PTSD Scale for DSM-5
The Clinician-Administered PTSD Scale for DSM-5 is a 30-item structured interview that determines a PTSD diagnosis and severity by assessing the frequency and intensity of 20 DSM-5 symptoms. Each symptom is rated on a 0-4 scale (0=absent, 4=extreme), with a total severity score calculated by summing individual item scores. Total Range: 0-80 (sum of 20 items) total scores indicate severity, with higher ratings indicating worse PTSD symptoms.
Time frame: baseline and 18 weeks
Incidence of adverse events (AEs), serious adverse events (SAEs) and AEs of special interest using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
adverse event assessment as safety measure
Time frame: 18 weeks after baseline
Beck Depression Inventory-II
The Beck Depression Inventory-II is a 21-item, 4-point Likert scale (0-3) self-report questionnaire depression assessment with a minimum score of 0 and a maximum score of 63; higher scores indicate greater depression severity.
Time frame: 12 weeks after second psilocybin administration
Hamilton Anxiety Scale
The Hamilton Anxiety Scale is a 14-item clinician-administered tool used to quantify the severity of anxiety symptoms. Each item is scored from 0 (not present) to 4 (very severe), with a total score range of a minimum score of 0 and a maximum score of 56. Higher scores indicate higher anxiety symptoms.
Time frame: 12 weeks after second psilocybin administration
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Sheehan Disability Scale
The Sheehan Disability Scale is a 3-item self-reported tool measuring functional impairment in work, social life, and family life, each rated from 0 (not at all) to 10 (extremely). Total scores range from a minimum score of 0 and a maximum score of 30; higher scores indicate greater impairment.
Time frame: 12 weeks after second psilocybin administration
World Health Organization 5-Wellbeing Index
The World Health Organization 5-Wellbeing Index is a 5-item, self-reported questionnaire assessing subjective psychological well-being over the past two weeks. Respondents rate items from 0 ("at no time"), with total raw scores (0-25) multiplied by 4, to generate a final 0-100 score. A maximum score of 100 indicates the best well-being, while a minimum score of 0 indicates the worst.
Time frame: 12 weeks after second psilocybin administration