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New treatment option for Post Traumatic Stress Disorder
Official title MDMA-Assisted Therapy for Veterans With PTSD and Alcohol Use Disorder
ClinicalTrials.gov ID: NCT07118839
What this study is testing
What is Full Dose MDMA?
Full Dose MDMA is an investigational medicine, given as a monthly pill taken by mouth, being studied as a potential treatment for 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
- The study investigators are conducting the first randomized placebo-controlled trial of MDMA-assisted therapy with a comorbid sample of military Veterans with a co-occurring diagnosis of Alcohol Use Disorder (AUD) and Post-Traumatic Stress Disorder (PTSD). This novel experimental treatment package consists of three once-monthly Experimental Sessions of therapy combined with a divided-dose of MDMA HCl, along with non-drug preparatory and integrative therapy.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug, 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
- Participants are eligible to be included in the study if all the following criteria apply: Age
- Are at least 18 years old at the time of signing the informed consent. Type of Participant and Disease Characteristics
- Are currently enrolled in VA care.
- Veterans must have initiated and discontinued (or completed) at least one first-line evidence-based treatment (EBT) for PTSD alone, for PTSD and AUD...
- Are fluent in speaking and reading English.
You likely can't join if
- Participants are excluded from the study if any of the following criteria apply: Medical Conditions
- Have symptomatic liver disease or have significant liver enzyme elevations.
- Alanine transaminase (ALT) or aspartate transaminase (AST) \> 3 x upper limit of normal (ULN).
- Total bilirubin \> 1.5 x ULN or direct bilirubin \< 35%.
- Current unstable liver or biliary disease per investigator assessment defined by the presence of ascites, encephalopathy, coagulopathy...
- Moderate or severe chronic kidney disease, defined as Estimated Glomerular Filtration Rate (eGFR)\<60 mL/min at screening or end stage renal disease...
See the full eligibility criteria
Who can join
- Participants are eligible to be included in the study if all the following criteria apply: Age
- Are at least 18 years old at the time of signing the informed consent. Type of Participant and Disease Characteristics
- Are currently enrolled in VA care.
- Veterans must have initiated and discontinued (or completed) at least one first-line evidence-based treatment (EBT) for PTSD alone, for PTSD and AUD together, or for a dual-diagnosis condition, as documented in CPRS.
- Are fluent in speaking and reading English.
- At Screening, Veterans must meet past 3-month criteria for Alcohol Use Disorder as measured by the SCID-5.
- Must have a desire to abstain or reduce alcohol use, per Veteran report.
- Able to safely abstain from alcohol for at least 48 hours without requiring medical detox.
- At Screening (V0) have a confirmed diagnosis of PTSD with symptom duration of at least 6 months and a total severity score of \>28 per the CAPS-5. a.At Baseline (V3) must continue to have a confirmed diagnosis of PTSD...
- Are able to swallow pills.
- Agree to have study visits recorded, including Experimental Sessions, assessments, and non-drug therapy sessions.
- Able to 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.
- Able to identify an appropriate support person to stay with the participant on the evenings of the Experimental Sessions. Weight
- Body Mass Index (BMI) in the range of 18-35. Sex and Contraceptive/ Barrier Requirements
- For participants assigned female sex at birth: -A participant is eligible to participate if not pregnant, not planning to become pregnant, or is not breastfeeding and one of the following conditions applies: oIs not...
- Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the ICF and in this protocol. Other Inclusions
- Agree to inform the investigators within 48 hours of any medical conditions and procedures.
- May have asymptomatic Hepatitis C virus (HCV) that has previously undergone evaluation and treatment as needed.
- May have a history of or current Diabetes Mellitus (Type 2) if additional screening measures of Hemoglobin A1c levels are less than 7, identifying that the Type 2 diabetes is well controlled, if the condition is judged...
- 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
- Participants are excluded from the study if any of the following criteria apply: Medical Conditions
- Have symptomatic liver disease or have significant liver enzyme elevations.
- Alanine transaminase (ALT) or aspartate transaminase (AST) \> 3 x upper limit of normal (ULN).
- Total bilirubin \> 1.5 x ULN or direct bilirubin \< 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...
- Moderate or severe chronic kidney disease, defined as Estimated Glomerular Filtration Rate (eGFR)\<60 mL/min at screening or end stage renal disease on dialysis.
- Have a history of seizures or delirium tremens.
- Significant alcohol withdrawal symptoms, defined as a Clinical Institute Withdrawal Assessment of alcohol scale, revised (CIWA-Ar) \>10.
- Have a recent history of clinically significant hyponatremia or hyperthermia.
- Have a marked Screening QTcF interval \>450 ms demonstrated on repeated ECG assessments. Participants whose QTcF exceeds this value during screening may be initially enrolled if a pre-study concomitant medication is...
- 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 physician and principal investigators agree the condition would not significantly increase the risk of MDMA administration or be...
- Examples of stable medical conditions that could be allowed include, but are not limited to, Diabetes Mellitus (Type 2), Human Immunodeficiency Virus (HIV) infection, Gastroesophageal Reflux Disease (GERD)...
- Acute Retention History (e.g., have needed a catheter in the last 6-12 months) or "Stage 4" BPH (kidney damage or chronic high residual urine) a.Note: BPH Stage 1-2 (Mild/Moderate) and BPH on Alpha Blockers could be...
- Have a diagnosis of uncontrolled hypertension, defined as repeated blood pressure readings of 140 millimeters of Mercury [mmHg] systolic or 90 mmHg diastolic. The diagnosis may be confirmed by repeated clinic...
- 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. a)Participants with a history of atrial...
- Have a history of additional risk factors for Torsade de pointes (e.g., heart failure, hypokalemia, family history of Long QT Syndrome). Psychiatric Conditions
- 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 currently prescribed antidepressant medication (antidepressant pharmacotherapy use considered if assessed by physician and titrated down to 5 half-lives + 1 week washout).
- Are currently prescribed antipsychotic medications. Note: off-label use of low dose quetiapine (\<100 mg) for insomnia is not exclusionary. Quetiapine should be replaced by other treatment to control insomnia such as...
- 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 directly 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 cannabis use disorder within the 12 months prior to enrollment...
- Have an active substance use disorder (other than cannabis) at any severity within 12 months prior to enrollment.
- Have used MDMA or Ecstasy (material represented as containing MDMA) more than 10 times within the last 10 years or at least once within 12 months of the first Experimental Session
- Any participant presenting current serious suicide risk, as determined through psychiatric interview, responses to C-SSRS, and clinical judgment of the investigator will be excluded; however, history of suicide attempts...
- Suicidal ideation score of 4 or greater within the last 6 months 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...
- Would present a serious risk to others as established through clinical interview and contact with treating providers. Prior/Concomitant Therapy
- Require ongoing concomitant therapy with a psychiatric medication with exceptions described in protocol section on Concomitant Medications (refer to Appendix 3: Permitted and Prohibited Medications).
- Current use of pharmacotherapies (i.e., naltrexone, acamprosate, or disulfiram) to treat alcohol use.
- Require use of concomitant medications that could prolong the QT interval during Experimental Sessions.
- Are currently engaged in trauma-focused psychotherapy or are currently in a treatment program for SUD (self-help programs are not an exclusion). Prior/Concurrent Clinical Study Experience
- Current enrollment in any other clinical study involving an investigational study treatment or any other type of medical research, unless approved by the study team. Diagnostic Assessments
- Have a history of or a current Schizophrenia Spectrum and other Psychotic Disorder according to the DSM-5, or a bipolar disorder type I or II, or DSM-5 category of Dissociative Identity Disorder, assessed via the DDIS...
- Have a current eating disorder with compensatory behaviors.
- Have current major depressive disorder with psychotic features.
- Have current Personality Disorders (Cluster A or Cluster B) assessed via the SCID-5-PD. Diagnoses will be confirmed by clinical interview. Other Exclusions
- Are not able to provide adequate informed consent.
- Sensitivity to any of the study interventions, or components thereof, or drug or other allergy that, in the opinion of the Principal Investigator or study physician, contraindicates participation in the study.
- Lack of social support or lack of a stable living situation since the inclusion of a support person to assist the participant following Experimental Sessions is important for ensuring participant safety. If a...
- Previous participation in a MAPS/Lykos-sponsored MDMA clinical trial.
- Employees (and their immediate family members) of MAPS, Lykos, or MAPS Europe B.V; or individuals in a personal relationship with the sponsor investigator.
- Have any current problem which, in the opinion of the Principal Investigator or study clinician, might interfere with study participation.
The study team makes the final eligibility decision.
Where it's taking place
- West Haven, Connecticut, United States
- Providence, Rhode Island, 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 and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include West Haven, Connecticut, United States; Providence, Rhode Island, 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.