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New treatment option for Post Traumatic Stress Disorder
Official title Psilocybin-Assisted Therapy for Sexual Assault-Related PTSD
ClinicalTrials.gov ID: NCT06902974
What this study is testing
What is Psilocybin 25 mg?
Psilocybin 25 mg is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for post traumatic stress disorder.
Also referred to as Psilocybin-assisted therapy.
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
- A Phase 2, Open-Label Study to explore the efficacy, safety, and tolerability of psilocybin-assisted therapy in women with sexual assault-related Posttraumatic Stress Disorder (PTSD).
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, women only
You may be able to join if
- Cisgender women who are at least 18 years old.
- Meet Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria for current PTSD secondary to sexual assault (i.e., index...
- CAPS-5 score of 25 or higher at Baseline.
- Are able to swallow pills.
- Are willing to be driven home after the Dosing Session with a family member or caregiver or trusted transportation.
You likely can't join if
- Male
- Condition impairing oral intake or digestive absorption.
- Are not able to give adequate informed consent.
- Significant suicide risk as defined by suicidal ideation with intend and a plan as endorsed on items 5 on the C-SSRS within the past 3 months
- Have any current problem which, in the opinion of the principal investigator or designated physician, might interfere with participation.
- Would present a serious risk to others as established through clinical interview and contact with treating therapist.
See the full eligibility criteria
Who can join
- Cisgender women who are at least 18 years old.
- Meet Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria for current PTSD secondary to sexual assault (i.e., index trauma is sexual assault that occurred 6 or more months in the past).
- CAPS-5 score of 25 or higher at Baseline.
- Are able to swallow pills.
- Are willing to be driven home after the Dosing Session with a family member or caregiver or trusted transportation.
- Are able to complete all protocol-required assessment tools without any assistance or alteration to the copyrighted assessments, and to comply with all study visits.
- If able to become pregnant (i.e., with uterus and associated reproductive organs, fertile, following menarche and until becoming post-menopausal unless permanently sterile), must have a highly sensitive negative...
- Must agree to inform the clinical investigators within 48 hours of any medical conditions and procedures.
- Are proficient in speaking and reading English.
- Agree to have all clinic visit sessions recorded to audio and/or video. Participants may opt out of the data analysis of the recordings.
- Agree to the following lifestyle modifications: a light breakfast 2 to 3 hours before dosing is permitted, however, participants will refrain from caffeine and nicotine 2 hours prior to dosing sessions and at least 6...
- Agree to refrain from beginning new medication and/or psychotherapy treatment.
- Continued treatment with SSRIs will be permitted if participants have been on a stable dose for 3 months or longer prior to enrollment. However, participants must be tapered off of monoamine oxidase inhibitors (MAOIs)...
- May have well-controlled hypertension that has been successfully treated with anti-hypertensive medicines.
- May have asymptomatic Hepatitis C virus (HCV) that has previously undergone evaluation and treatment as needed.
- May have alcohol or substance use disorder if participant is not in withdrawal or requiring detox. Participants must have a plan, agreed upon by the principal investigator or designated physician, to reduce use of...
- May have a history of or current Diabetes Mellitus (Type 2) if additional screening measures rule out underlying cardiovascular disease, if the condition is judged to be stable on effective management, and with approval...
- May have hypothyroidism if taking adequate and stable thyroid replacement medication.
What rules you out
- Male
- Condition impairing oral intake or digestive absorption.
- Are not able to give adequate informed consent.
- Significant suicide risk as defined by suicidal ideation with intend and a plan as endorsed on items 5 on the C-SSRS within the past 3 months
- Have any current problem which, in the opinion of the principal investigator or designated physician, might interfere with participation.
- Would present a serious risk to others as established through clinical interview and contact with treating therapist.
- Have a history of, or a current primary, schizophrenia, schizoaffective disorder or any form of psychotic disorder, major depressive disorder with psychotic features, bipolar affective disorder type 1, or personality...
- Require ongoing concomitant therapy with a psychiatric medication with exceptions described below (see Section 6.6).
- Have received Electroconvulsive Therapy (ECT) within 12 weeks of enrollment.
- Have evidence or history of recent stroke (\< 6 months from signing of ICF), recent myocardial infarction (\< 6 months from signing of ICF), or clinically significant arrhythmia within 1 year of signing the ICF.
- Have evidence or history of significant (controlled or uncontrolled) hematological, endocrine, cerebrovascular, cardiovascular, coronary, pulmonary, renal, gastrointestinal, immunocompromising, or neurological disease...
- Have uncontrolled hypertension using the standard criteria of the American Heart Association (values of 140/90 milligrams of Mercury [mmHg] or higher).
- Abnormal and clinically significant results on vital signs, ECG, or laboratory tests at screening and baseline
- Have symptomatic liver disease.
- Are pregnant, nursing, or able to become pregnant and are not practicing an effective means of birth control if sexually active with a biologically male partner.
- Have hypersensitivity to any ingredient of the study drug.
- Positive urine drug screen for illicit drugs or drugs of abuse prior to the Dosing Session. Any positive urine drug test will be reviewed with participants to determine the pattern of use and eligibility will be...
- Current enrollment in any investigational drug or device study or participation in such within 30 days of screening.
- Other personal circumstances and behavior judged to be incompatible with establishment of rapport or safe exposure to psilocybin or completion of clinical study procedures (e.g., active participation in legal...
The study team makes the final eligibility decision.
Where it's taking place
- Rockville, Maryland, 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 female, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Rockville, Maryland, 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.