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New treatment option for PTSD
Official title Group Psilocybin-Assisted Therapy for Post-Traumatic Stress Disorder
ClinicalTrials.gov ID: NCT07506395
What this study is testing
What is Psilocybin?
Psilocybin is an investigational medicine, being studied as a potential treatment for ptsd.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 89
You may be able to join if
- 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...
You likely can't join if
- Inability to achieve five days of abstinence from alcohol, non-prescribed opioids, methamphetamines, cocaine, benzodiazepines, or other illicit...
- Inability or unwillingness to remain abstinent from cannabis use for 24 hours prior to psilocybin dosing session and 12 hours after receiving the...
- 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...
- Uncontrolled hypertension, defined as \>140/90 mm Hg at screening or baseline or \>145/95 mm Hg on presentation for dosing day assessed on three...
- History of myocardial infarction, cardiac ischemia, congestive heart failure, clinically relevant valvular heart disease, or pulmonary hypertension...
See the full eligibility 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 terms of the study, including attending all trial visits (most of which will occur in a group setting), preparation and
- follow-up sessions, and completing all trial evaluations
- Ability and willingness to swallow capsules PTSD severity:
- Meet criteria for PTSD, as defined in the DSM-5
- At screening, symptoms of moderate to severe PTSD (PCL-5 score of 34 or greater) present for at least six months
- 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...
- Uncontrolled hypertension, defined as \>140/90 mm Hg at screening or baseline or \>145/95 mm Hg on presentation for dosing day assessed on three consecutive blood pressure measurements
- History of myocardial infarction, cardiac ischemia, congestive heart failure, clinically relevant valvular heart disease, or pulmonary hypertension; any other significant history of cardiovascular condition, based on...
- ECG: Clinically significant abnormality (e.g. atrial fibrillation based on judgement of trial physician including prolonged corrected QT interval (QTc\> 450 milliseconds (males) or \>470 milliseconds (females)
- Poorly controlled diabetes (HbA1c \>8.0%; clinically significant hypoglycemia in the past 6 months)
- Neurological conditions (e.g. epilepsy or other seizure disorder) or neurodegenerative disease (e.g., dementia, Parkinson's disease, Huntington's disease, amyotrophic lateral sclerosis.), or brain tumor that would...
- Severe hepatic impairment
- Severe renal impairment,
- Unstable existing thyroid disorder
- Any of the following psychiatric conditions:
- Active suicidal ideation; history of hospitalization for suicide attempt within the 12 months prior to screening, affirmative responses to C-SSRS questions 4 or 5
- Confirmed diagnosis of schizophrenia or other psychotic disorder, firstdegree relative with schizophrenia
- Axis-II diagnosis
- Use of psychedelics (e.g., psilocybin, mescaline, ayahuasca, DMT, LSD, MDMA, or ketamine) resulting in a discrete psychedelic experience in the past six months. Using daily dose of psilocybin mushrooms at dose \<0.2 mg...
- Returning to an unsafe environment and/or inadequate social support-Any other condition, physical or psychological symptom, medication, or other relevant finding prior to randomization that, based on the clinical...
- Participation in experimental treatment for PTSD or any research studies within 30 days of screening assessment
The study team makes the final eligibility decision.
Where it's taking place
- Albuquerque, New Mexico, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 89 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Albuquerque, New Mexico, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.