BridgeMD
New treatment option for Post-Traumatic Stress Disorder
Official title MDMA-assisted Massed Prolonged Exposure for PTSD
ClinicalTrials.gov ID: NCT06117306
What this study is testing
What is 3,4 Methylenedioxymethamphetamine?
3,4 Methylenedioxymethamphetamine is an investigational medicine, given as an once-daily, being studied as a potential treatment for post-traumatic stress disorder.
Also referred to as MDMA.
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
- The overall objective of this study is to pilot the VASDHS-adapted Emory MDMA-PE Protocol (aE-MDMA-PE) and assess the effect on clinician-rated PTSD symptoms in veterans who receive different doses of MDMA.
- Phase 3: a large, late-stage study
- 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 to 64
You may be able to join if
- Be a veteran (age 18-64 years old) who meets criteria for PTSD on the CAPS-5 (severity ≥ 25).
- Be fluent in speaking and reading English.
- Are willing to commit to medication dosing, therapy sessions, follow-up sessions, completing evaluation instruments, and all necessary telephone...
- Be able to swallow pills.
- Agree to have study visits audio and/or video recorded, including MDMA session, assessments, and PE sessions, and aware that Independent Rater...
You likely can't join if
- Are not able to give adequate, written informed consent.
- Are currently engaged in compensation and pension (C\&P) litigation whereby financial gain would be achieved from prolonged symptoms of PTSD or any...
- Are likely, in the investigator's opinion and via assessment period, to be re- exposed to their index trauma or other significant trauma, lack social...
- Have used Ecstasy (material represented as containing MDMA) or have participated in an MDMA clinical trial.
- Have a positive screen for amphetamine or cocaine.
- Have any current problem which, in the clinical opinion of the investigator and study physician, might interfere with participation due to it...
See the full eligibility criteria
Who can join
- Be a veteran (age 18-64 years old) who meets criteria for PTSD on the CAPS-5 (severity ≥ 25).
- Be fluent in speaking and reading English.
- Are willing to commit to medication dosing, therapy sessions, follow-up sessions, completing evaluation instruments, and all necessary telephone contact
- Be able to swallow pills.
- Agree to have study visits audio and/or video recorded, including MDMA session, assessments, and PE sessions, and aware that Independent Rater assessments for PE sessions will occur.
- Have a contact able to drive the participant home after the MDMA session.
- 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.
- Agree to inform the investigators within 48 hours of any new medical conditions or procedures.
- If able to become pregnant (i.e., assigned female at birth, fertile, following menarche and until becoming post-menopausal unless permanently sterile), must have a highly sensitive negative pregnancy test at study entry...
- Agree to the following lifestyle modifications (described in more detail in Section 3.3 Lifestyle Modifications): comply with requirements for fasting and refraining from certain medications prior to and following the...
- Agree not to participate in other PTSD psychotherapy during study treatment.
- Not enroll in any other treatment clinical trials during the duration of the study, and commit to medication dosing, therapy, and study procedures.
- At Pre-Screening, have at least moderate PTSD symptoms in the last month based on PCL-5 total score of 40 or greater (index).
- May have well-controlled hypertension that has been successfully treated with anti- hypertensive medicines if they pass additional screening to rule out underlying cardiovascular disease.
- 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 investigator, therapy team, and study physician, to reduce use of alcohol...
- 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.
- May have a history of, or current, glaucoma if approval for study participation is received from an ophthalmologist.
What rules you out
- Are not able to give adequate, written informed consent.
- Are currently engaged in compensation and pension (C\&P) litigation whereby financial gain would be achieved from prolonged symptoms of PTSD or any other psychiatric disorders.
- Are likely, in the investigator's opinion and via assessment period, to be re- exposed to their index trauma or other significant trauma, lack social support, or lack a stable living situation.
- Have used Ecstasy (material represented as containing MDMA) or have participated in an MDMA clinical trial.
- Have a positive screen for amphetamine or cocaine.
- Have any current problem which, in the clinical opinion of the investigator and study physician, might interfere with participation due to it impacting the patient's safety and/or ability to participate in the protocol.
- Have hypersensitivity to any ingredient of the IMP (Investigational Medicinal Product).
- Have received Electroconvulsive Therapy (ECT) within 12 weeks of enrollment.
- Have dementia.
- Have a history of or a current primary psychotic disorder assessed via the DIAMOND and clinical interview.
- Have a history of or current Bipolar 1 disorder, Bipolar 2 disorder, or manic episode assessed via the DIAMOND and clinical interview.
- Have a current eating disorder with active purging assessed via DIAMOND and clinical interview.
- Have current major depressive disorder with psychotic features assessed via DIAMOND.
- Have a current panic disorder assessed via the DIAMOND
- Have a history of amphetamine or cocaine substance use disorder
- Have a current alcohol or substance use disorder other than caffeine or nicotine that the investigators, therapy team, and/or study physician judge to be a safety concern for enrollment in the study or that could...
- Present with current serious suicide risk, as determined through psychiatric interview, responses to C-SSRS (scores of four or greater), and clinical judgment of the investigator; however, history of suicide attempts is...
- Suicidal ideation score of 4 or greater within the last 6 months of the assessment at a frequency of once a week or more.
- Any suicidal behavior, including suicide attempts or preparatory acts, within the last 6 months of the assessment. Participants with non-suicidal self- injurious behavior may be included if approved by the study...
- Would present a serious risk to others as established through clinical interview and if necessary, discussion with treating psychiatrist.
- Require ongoing concomitant therapy with a psychiatric medication other than the exceptions described in protocol section on Concomitant Medications.
- Have a history of any medical condition that could make receiving a sympathomimetic drug harmful because of increases in blood pressure and heart rate. This includes, but is not limited to, a history of myocardial...
- Have a diagnosis of uncontrolled hypertension defined by the American Heart Association as repeated readings of ≥ 140 millimeters of Mercury [mmHg] systolic or ≥ 90 mmHg diastolic.
- Have a history of ventricular arrhythmia at any time, other than occasional premature ventricular contractions (PVCs) in the absence of ischemic heart disease.
- Have Wolff-Parkinson-White syndrome or any other accessory pathway that has not been successfully eliminated by ablation.
- Have a history of arrhythmia, other than premature atrial contractions (PACs) or occasional PVCs in the absence of ischemic heart disease, within 12 months of screening. Participants with a history of atrial...
- Have a marked Baseline prolongation of QT/QTc interval. For purposes of eligibility, this is defined as repeated demonstration of a QT interval corrected using Fridericia's formula [QTcF] \>450 milliseconds [ms].
- Have a history of additional risk factors for Torsade de pointes (e.g., heart failure, hypokalemia, family history of Long QT Syndrome).
- Require use of concomitant medications that prolong the QT/QTc interval during Sessions. Refer to protocol section on Concomitant Therapy.
- Have symptomatic liver disease or have repeated significant liver enzyme elevations on labs.
- Have history of hyponatremia or hyperthermia.
- Have a BMI of 18.5 or less.
- Are pregnant or nursing or are able to become pregnant and are not willing/able to practice an effective means of birth control.
- Have engaged in ketamine-assisted therapy or used ketamine within 12 weeks of enrollment.
- Have any preexisting condition affecting renal functioning.
The study team makes the final eligibility decision.
Where it's taking place
- San Diego, California, United States
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
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 64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include San Diego, California, 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.