Phase 3 PTSD Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• People who are at least 18 years old at the time of signing the consent form
• People who are currently receiving care through the VA (Veterans Affairs) system
• Veterans who have already tried and stopped (or finished) at least one recommended treatment for PTSD, for both PTSD and alcohol use disorder together, or for a dual diagnosis condition, as recorded in their VA medical records
• People who can speak and read English fluently
• People who have been diagnosed with Alcohol Use Disorder in the past 3 months, confirmed through a structured interview
• People who want to stop drinking or reduce how much they drink
• People who are able to safely go without alcohol for at least 48 hours without needing medical help for withdrawal
• People who have had a confirmed PTSD diagnosis with symptoms lasting at least 6 months and a symptom severity score above 28 on a clinical assessment, confirmed at the start of the screening process and again at the baseline visit
• People who are able to swallow pills
• People who agree to have study visits recorded, including therapy sessions and assessment appointments
• People who can provide the contact details of a trusted person (such as a family member, spouse, or close friend) who can be reached by the study team if needed
• People who can identify a support person who is able to stay with them on the evenings following the experimental sessions
• People whose Body Mass Index (BMI) is between 18 and 35
• People assigned female sex at birth who are not pregnant, not planning to become pregnant, and not breastfeeding — and who either cannot become pregnant or are using a highly effective form of contraception (with a failure rate of less than 1%); a negative pregnancy test is also required at study entry and before each experimental session
• People who are capable of giving informed consent and agreeing to follow the study requirements
• People who agree to inform the study team within 48 hours of any new medical conditions or procedures
• People who have had Hepatitis C that has already been assessed and treated as needed, and who currently have no active symptoms
• People with a history of or current well-controlled Type 2 Diabetes, where blood sugar control levels (HbA1c) are below 7, the condition is stable, and the study doctor approves participation
• People with an underactive thyroid (hypothyroidism) who are on a stable and adequate medication dose for this condition
• People with a history of or current glaucoma, if an eye specialist (ophthalmologist) has approved their participation

Who may not be able to join:

• People with active or symptomatic liver disease, or significantly elevated liver enzyme levels on blood tests
• People with an unstable liver or bile duct condition, such as fluid build-up in the abdomen, confusion caused by liver problems, problems with blood clotting, low protein levels, swollen veins in the oesophagus or stomach, persistent yellowing of the skin, or cirrhosis
• People with moderate or severe chronic kidney disease (based on a specific kidney function test result), or those receiving dialysis
• People with a history of seizures or severe alcohol withdrawal (delirium tremens)
• People currently showing significant alcohol withdrawal symptoms based on a clinical assessment score
• People who have recently had a clinically significant drop in blood sodium levels or a dangerous rise in body temperature
• People with a specific heart measurement (QTcF interval) above 450 milliseconds on repeated heart tracing (ECG) tests, unless a current medication is thought to be the cause (confirm with trial site)
• People with a history of any medical condition that could make it harmful to receive a drug that raises blood pressure and heart rate — including heart attack, stroke, heart failure, severe coronary artery disease, or aneurysm
• People with a history of needing a urinary catheter in the last 6 to 12 months, or with an advanced stage of an enlarged prostate causing kidney damage or chronic high urine retention
• People with uncontrolled high blood pressure, defined as repeated readings of 140 mmHg systolic or 90 mmHg diastolic or above
• People with a history of a type of irregular heartbeat called ventricular arrhythmia (other than occasional minor irregularities without heart disease)
• People with a heart condition called Wolff-Parkinson-White syndrome, or any similar condition involving an extra electrical pathway in the heart that has not been successfully treated
• People with a history of certain types of irregular heartbeat within the 12 months before screening, unless successfully treated and stable for at least a year (confirm with trial site)
• People with additional risk factors for a specific dangerous heart rhythm condition called Torsade de Pointes — for example, heart failure, low potassium levels, or a family history of Long QT Syndrome
• People who have started a new type of mental health treatment within 12 weeks before enrolling, including electroconvulsive therapy (ECT) or ketamine-assisted therapy
• People who are currently taking antidepressant medication (though the study doctor may assess whether a gradual taper and washout period could allow participation — confirm with trial site)
• People who are currently taking antipsychotic medications (low-dose quetiapine of less than 100 mg taken for sleep problems may be an exception — confirm with trial site)
• People who, in the study team's opinion, are likely to be exposed to the traumatic event or another significant trauma during the study period
• People with a current moderate or severe cannabis use disorder that is not in early remission in the past 3 months (mild cannabis use disorder or moderate cannabis use disorder in early remission for 3 months may be acceptable — confirm with trial site)
• People with any other active substance use disorder (other than cannabis) at any level of severity within the 12 months before enrolling
• People who have used MDMA or Ecstasy more than 10 times in the past 10 years, or at least once in the 12 months before the first experimental session
• People who are currently assessed as presenting a serious suicide risk, or who are likely to need hospitalisation due to suicidal thoughts or behaviour — specific thresholds apply based on a standardised assessment tool (confirm with trial site); a past history of suicide attempts alone is not an exclusion
• People who are assessed as presenting a serious risk of harm to others
• People who currently require ongoing psychiatric medication (with some exceptions outlined in the study protocol — confirm with trial site)
• People currently using naltrexone, acamprosate, or disulfiram to treat alcohol use
• People who require medications that could affect a specific heart measurement (QT interval) during experimental sessions
• People currently engaged in trauma-focused psychotherapy or currently enrolled in a substance use disorder treatment programme (self-help programmes are not excluded)
• People currently enrolled in another clinical research study involving an investigational treatment, unless the study team approves
• People with a history of or current schizophrenia or other psychotic disorders, Bipolar Disorder Type I or II, or Dissociative Identity Disorder, as assessed by standardised clinical tools
• People with a current eating disorder that involves compensatory behaviours (such as purging)
• People with a current major depressive episode that includes psychotic features
• People with current Cluster A or Cluster B personality disorders, confirmed through clinical interview
• People who are not able to provide informed consent
• People with a known sensitivity or allergy to the study drug or its components, where the study doctor considers this a reason not to participate
• People who do not have a stable living situation or cannot identify a support person for after experimental sessions
• People who have previously taken part in an MDMA clinical trial sponsored by MAPS or Lykos
• Employees of MAPS, Lykos, or MAPS Europe B.V., or their immediate family members, or people in a personal relationship with the study's sponsor investigator
• People with any other current issue that, in the study team's judgement, could interfere with their participation

Important: Always verify eligibility with the trial site directly before applying.