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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
Psilocybin
DrugTwo 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
Treatment groups
36 Participants
are divided into 1 treatment groupGroup A: GPAT-PTSDOther 1 intervention
Trial outcomes
Primary outcomes
1
Rate of study completion-feasabiity measure
Number of participants that completed the study.
Time frame
18 weeks after baseline2
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 weeks3
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 baselineSecondary outcomes
1
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 administration2
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 administration3
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 administration4
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 administrationSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov