Clinical trial for PTSD
Official title Psilocybin-Assisted Therapy
ClinicalTrials.gov ID: NCT07332143
What this study is testing
What is psilocybin?
psilocybin is an investigational medicine, being studied as a potential treatment for ptsd.
Also referred to as 3-[2-(Dimethylamino)ethyl]-1H-indol-4-yl dihydrogen phosphate.
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 testing whether psilocybin plus talk therapy helps reduce PTSD symptoms. It also checks how safe and well-tolerated the treatment is.
- Who it's for
- You may be able to join if you have PTSD.
- What's involved
- You would get psilocybin (a medicine that changes how you feel) and talk therapy. You would be picked by chance to get one of two treatment plans.
- Time commitment
- The source text does not say how long the study lasts or how many visits are needed.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
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
You may be able to join if
- Eligible participants must be over the age of 18. They must self-identify as military veterans, reservists, National Guard members, or active-duty...
- Meet criteria for PTSD due to trauma occurring at least 3 months prior based on CAPS-5-R diagnostic scoring rules.
- Able to speak and read English (due to standardization of outcome measures).
- Willingness of participant to sign a release for the investigators to communicate with their primary care or mental health providers, if indicated
- Are 18 years and older.
You likely can't join if
- Are not able to give adequate informed consent.
- Have a family history bipolar disorder type 1 or a psychotic disorder in first degree relatives.
- Have any current problem which, in the opinion of the investigator or Medical Monitor, might interfere with participation.
- Have hypersensitivity to any ingredient of the IMP (Investigational Medicinal Product).
- Have a history of or current bipolar type 1 disorder, primary psychotic disorder (e.g., schizophrenia), or secondary psychotic features (i.e., Major...
- Have met criteria at any time during their life for amphetamine or cocaine substance use disorder or any drug of abuse the study physician determines...
See the full eligibility criteria
Who can join
- Eligible participants must be over the age of 18. They must self-identify as military veterans, reservists, National Guard members, or active-duty servicemembers.
- Meet criteria for PTSD due to trauma occurring at least 3 months prior based on CAPS-5-R diagnostic scoring rules.
- Able to speak and read English (due to standardization of outcome measures).
- Willingness of participant to sign a release for the investigators to communicate with their primary care or mental health providers, if indicated
- Are 18 years and older.
- Are able to swallow pills.
- Agree to have study visits video and/or audio recorded, including Medicine Session, Independent Rater assessments, and non-drug psychotherapy sessions.
- Must provide a contact (relative, spouse, close friend, or other support person) who is willing and able to be reached by the investigators in the event of a participant becoming suicidal or unreachable.
- Must agree to inform the investigators within 48 hours of any medical conditions and procedures.
- If able to become pregnant, participants must have a negative pregnancy test prior to study entry, at study entry, and prior to each Medicine Session.
- Agree to the following lifestyle modifications: comply with requirements for fasting and refraining from certain medications prior to Medicine Session, not participate in any other treatment clinical trials during the...
What rules you out
- Are not able to give adequate informed consent.
- Have a family history bipolar disorder type 1 or a psychotic disorder in first degree relatives.
- Have any current problem which, in the opinion of the investigator or Medical Monitor, might interfere with participation.
- Have hypersensitivity to any ingredient of the IMP (Investigational Medicinal Product).
- Have a history of or current bipolar type 1 disorder, primary psychotic disorder (e.g., schizophrenia), or secondary psychotic features (i.e., Major Depressive disorder with psychotic features.
- Have met criteria at any time during their life for amphetamine or cocaine substance use disorder or any drug of abuse the study physician determines to be unfit for the study.
- Meet criteria for current (past 3 months) moderate or severe substance use disorder, as defined by 4 or more DSM SUD criteria symptoms.
- Have a positive screen for any drug of abuse (amphetamines, etc.) on drug test administered in local community or on site unless being taken as prescribed by a physician.
- Any participant presenting current serious suicide risk, as determined through psychiatric interview and clinical judgment of the investigator will be excluded;
- Suicidal ideation score of 4 or greater within the last 6 months.
- Any suicidal behavior, including suicide attempts or preparatory acts, within the last 6 months of the assessment
- However, history of suicide attempts is not an exclusion.
- Require ongoing concomitant therapy with a psychiatric medication with exceptions described in protocol section on Concomitant Medications. Medical History
- Have a history of any medical condition that could make receiving a sympathomimetic drug harmful because of increases in blood pressure and heart rate, or any medical condition the study physician believes would pose a...
- This includes, but is not limited to, a history of myocardial infarction, cerebrovascular accident, or aneurysm.
- Participants with other stable chronic medical problems may be enrolled if the site physician believes would not significantly increase the risk of Psilocybin administration or be likely to produce significant symptoms...
- Have any unstable medical or central nervous system-related illness that would interfere with participation.
- Systolic blood pressure \>= 140 mmHg or diastolic blood pressure \>= 90 mmHg, measured in the supine position after at least five minutes at rest.
- Have a history of clinically significant arrhythmia, other than premature atrial contractions (PACs) or occasional PVCs in the absence of ischemic heart disease, within 12 months of screening. a.
- Have a marked Baseline prolongation of QT/QTc interval e.g., repeated demonstration of a QTc interval \> 450 milliseconds (ms) in males and \>470 ms in females.
- Have a history of additional risk factors for Torsade de pointes (e.g., heart failure, family history of Long QT Syndrome).
- Have significant liver enzyme elevations as evidenced by total bilirubin \>1.5mg/dL and/or ALT and AST (\>two times upper limit of normal [ULN]) per baseline laboratory test.
- Creatinine clearance: \<30 mL/min)
- Non-ambulatory or require two-person assistance with transfers (Fall risk)
- Body Mass Index (BMI) \<18
- Are pregnant or nursing
- fMRI Scan Exclusions Only: History of cranial surgery, metallic particles in the eye or head (exclusive of mouth), implanted cardiac pacemaker or any intra-cardiac lines, implanted neurostimulators, intra-cranial...
- NOTE: these ineligibility criteria preclude participants from undergoing a fmri scan but does not exclude them from the primary study participant and they may proceed without fMRI.
The study team makes the final eligibility decision.
Where it is enrolling
- Atlanta, Georgia, 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, but 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 and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Atlanta, Georgia, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.