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New treatment option for PTSD, Post Traumatic Stress Disorder
Official title Examining 3,4-methylenedioxymethamphetamine (MDMA) Effects on Psychological, Relational and Hyperarousal-Related Neural Reactivity Mechanisms in Veterans With PTSD and Moral Injury
ClinicalTrials.gov ID: NCT06394284
What this study is testing
What is MDMA-AT?
MDMA-AT is an investigational medicine, being studied as a potential treatment for ptsd, post traumatic stress disorder.
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
- Despite being exposed to a high level of potentially traumatic experiences due to exposure to combat, military veterans have poor response rates to traditional PTSD treatments, in some reports, just 1/3 of veterans recover using traditional treatments. In recent years 3,4-methylenedioxymethamphetamine (MDMA), a psychedelic drug has demonstrated a significant treatment potential for severe and treatment resistant PTSD though not specifically in a veteran population.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Adults, men only
You may be able to join if
- 1\. Were assigned male sex at birth and currently identify as a male (e.g. are not transgender nor taking hormone replacement therapy) 2. Are...
- 7\. Agree to have study visits recorded, including Experimental Sessions, Independent Rater assessments, and non-drug therapy sessions.
- 8\. 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...
- 8\. Must agree to inform the investigators within 48 hours of any medical conditions and procedures.
- 9\. Agree to the following lifestyle modifications: comply with requirements for fasting and refraining from certain medications prior to...
You likely can't join if
- \- Medical Conditions
- Alanine transaminase (ALT) [or aspartate transaminase (AST)]higher than 2 x upper limit of normal (ULN).
- Total bilirubin higher than 1.5 x ULN (isolated bilirubin higher than; 1.5 x ULN is acceptable if total bilirubin is fractionated and direct...
- Current unstable liver or biliary disease per investigator assessment defined by the presence of ascites, encephalopathy, coagulopathy...
- Note: Stable chronic liver disease (including Gilbert's syndrome, asymptomatic gallstones, and chronic stable hepatitis B (e.g., the presence of...
- Have a recent history of clinically significant hyponatremia or hyperthermia.
See the full eligibility criteria
Who can join
- 1\. Were assigned male sex at birth and currently identify as a male (e.g. are not transgender nor taking hormone replacement therapy) 2. Are veterans of the Israeli military 3. Are at least 18 years old. 4. Are fluent...
- 7\. Agree to have study visits recorded, including Experimental Sessions, Independent Rater assessments, and non-drug therapy sessions.
- 8\. 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 unwell or unreachable.
- 8\. Must agree to inform the investigators within 48 hours of any medical conditions and procedures.
- 9\. Agree to the following lifestyle modifications: comply with requirements for fasting and refraining from certain medications prior to experimental sessions, not enroll in any other treatment clinical trials during...
- Medical History
- 10\. At Screening, meet diagnostic criteria (Diagnostic Statisticians Manual, 5th version, DSM-5) for current military-based PTSD with a symptom duration of 6 months or longer with a history of at least one attempt at...
- 11\. At Screening, have a PCL-5 total score of 33 or greater and at Screening/Baseline a confirmed diagnosis of PTSD per CAPS-5 and a total severity score of 28 or greater.
- 12\. Have a body weight of at least 45 kilograms. Participants with a body weight of 45 to 48 kg must also have a body mass index (BMI) within the range of 18 to 30 kg/m2.
- 13\. Capable of giving signed informed consent.
What rules you out
- \- Medical Conditions
- Alanine transaminase (ALT) [or aspartate transaminase (AST)]higher than 2 x upper limit of normal (ULN).
- Total bilirubin higher than 1.5 x ULN (isolated bilirubin higher than; 1.5 x ULN is acceptable if total bilirubin is fractionated and direct bilirubin less than; 35%).
- Current unstable liver or biliary disease per investigator assessment defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal or gastric varices, persistent jaundice, or cirrhosis.
- Note: Stable chronic liver disease (including Gilbert's syndrome, asymptomatic gallstones, and chronic stable hepatitis B (e.g., the presence of hepatitis B surface antigen or positive hepatitis C antibody test result...
- Have a recent history of clinically significant hyponatremia or hyperthermia.
- Have a marked baseline QTcF (QT interval corrected for heart rate ) interval higher than 450 ms demonstrated on repeated ECG (electrocardiogram) assessments. Participants whose QTcF exceeds this value during screening...
- Note: The QTcF is the QT interval corrected for heart rate according to Fridericia's formula. It is either machine-read or manually over-read.
- 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...
- Participants with other mild, stable chronic medical problems may be enrolled if the study clinician and Sponsor Investigator (S-I) agree the condition would not significantly increase the risk of MDMA administration or...
- Examples of stable medical conditions that could be allowed include but are not limited to human immunodeficiency virus (HIV) infection, gastroesophageal reflux disease (GERD), hypothyroidism (if taking adequate and...
- Have a diagnosis of uncontrolled hypertension, defined as repeated blood pressure readings of ≥140 mmHg systolic or ≥90 mmHg diastolic. The diagnosis may be confirmed by repeated clinic measurements or home blood...
- Participants with well-controlled hypertension that has been successfully treated with anti-hypertensive medicines may be enrolled if they pass a risk assessment and potentially additional screening to rule out...
- 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 fibrillation, atrial tachycardia, atrial flutter or paroxysmal supraventricular tachycardia or any other arrhythmia associated with a bypass tract may be enrolled only if they have...
- Have a history of additional risk factors for Torsade de pointes (e.g., heart failure, hypokalemia, family history of Long QT Syndrome). Psychiatric Conditions (for MDMA-AT and somatic-based arms)
- Have engaged in a new form of psychiatric or mental health care within 12 weeks of enrollment, including Electroconvulsive Therapy (ECT), and ketamine-assisted therapy.
- Are likely, in the investigator's opinion and via observation during the Preparatory Period, to be re-exposed to their index trauma or other significant trauma during the study.
- Have a current moderate (not in early remission in the 3 months prior to enrollment and meets at least 5 of 11 diagnostic criteria per DSM-5) or severe alcohol or cannabis use disorder within the 12 months prior to...
- May have current mild alcohol or cannabis use disorder (meets 3 of 11 diagnostic criteria per DSM-5) or moderate alcohol or cannabis use disorder in early remission for the 3 months prior to enrollment (meets 4 or 5 of...
- Have an active illicit drug (other than cannabis) or prescription drug substance use disorder at any severity within 12 months prior to enrollment.
- Any participant presenting current serious suicide risk, as determined through psychiatric interview, responses to Columbia Suicide Severity Rating Scale (C-SSRS), and clinical judgment of the investigator will be...
- Suicidal ideation score of 4 or greater within the last month of the assessment at a frequency of once a week or more.
- Suicidal ideation score of 5 within the last 6 months of the assessment.
- 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...
- Unable or unwilling to safely taper-off prohibited psychiatric medication with exceptions described in section on Concomitant Medications in study protocol or require use of prohibited medications during experimental...
- Require use of concomitant medications that could prolong the QT interval during Experimental Sessions.
- Have used Ecstasy (unregulated material represented as containing MDMA) more than 10 times within the last 10 years, or at least once within 6 months of the first Experimental Session. Prior/Concurrent Clinical Study...
- Current enrollment in any other clinical study involving an investigational study treatment or any other type of medical research, unless approved by the study clinician. Diagnostic Assessments
- Have current Personality Disorders assessed via psychiatric assessment (by consultant psychiatrist).
- Have a current eating disorder with compensatory behaviors
- Have current major depressive disorder with psychotic features
- Have a history of, or a current primary psychotic disorder, bipolar affective disorder type 1 or dissociative identity disorder. Other Exclusions
- Sensitivity to any of the study interventions, or components thereof, or drug or other allergy that, in the opinion of the sponsor-investigator or study clinician, contraindicates participation in the study.
- Are currently engaged in compensation litigation whereby financial gain would be achieved from prolonged symptoms of PTSD or any other psychiatric disorders.
- Lack social support or lack a stable living situation.
- Previous participation in a MAPS-sponsored MDMA clinical trial.
- Employees (and their immediate family members) of MAPS, MAPS Public Benefit Corporation, or MAPS Europe B.V; or individuals in a personal relationship with the site investigator.
- Have any current problem which, in the opinion of the sponsor-investigator or study clinician, might interfere with study participation. Security Criteria The current study dealing with intensive treatment of military...
- The research will be carried out in Jerusalem and long sessions will not take place when there is a high risk of rocket attack or sirens during the previous day/night.
- The participants in the study will be military veterans who do not participate or have taken an operational part in the war in the three months prior to the start of their participation in the study.
- The participants in the study do not have first degree relatives or a partner who are actively serving in a war zone at the time of their participation in the study.
- The participants live in a permanent and safe place and are not expected to change their place of residence during their participation in the study.
The study team makes the final eligibility decision.
Where it's taking place
- Jerusalem, Israel
Compensation & support
Compensation likely.
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 male, not specified. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Jerusalem, Israel. 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.