Post Traumatic Stress Disorder study: 3
Official title MDMA-Assisted Massed Exposure Therapy for PTSD
ClinicalTrials.gov ID: NCT07288151
What this study is testing
What is 3,4-Methylenedioxymethamphetamine (MDMA)?
This is an investigational medicine being studied to see if it helps treat post-traumatic stress disorder (PTSD) when used with a specific type of talk therapy. It is designed to change brain activity to help people feel less afraid and more able to process difficult memories during therapy.
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
- This study is testing whether MDMA plus talk therapy works better than a pretend pill. It also looks at how long the benefits last.
- Who it's for
- You may be able to join if you are an adult with PTSD.
- What's involved
- You would get ten talk therapy sessions over two weeks. You would also take either MDMA or a pretend pill.
- Time commitment
- The study lasts about two weeks for treatment, with a check-in one month later.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. 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
Ages 21 to 70
You may be able to join if
- PTSD diagnosis as assessed by Clinician-Administered Posttraumatic Stress Scale for DSM-5 - Revised (CAPS-5-R).
- Able to speak and read English (due to standardization of outcome measures).
- Willing to sign a release for the investigators to communicate with their primary care or mental health providers if indicated.
- Able to swallow pills.
- Agree to have study visits video and/or audio recorded, including Experimental Session, assessments, and non-drug therapy sessions.
You likely can't join if
- Are not able to give adequate informed consent.
- Have previously participated in a Multidisciplinary Association for Psychedelic Studies (MAPS) sponsored MDMA clinical trial.
- Have any current problem which, in the opinion of the investigator or study physician, might interfere with participation.
- Have hypersensitivity to any ingredient of the Investigational Medicinal Product (IMP).
- Upon review of medical or psychiatric history and psychiatric assessment, have any current or past diagnosis that would be considered a risk to...
- Requires ongoing psychiatric medication use with certain exceptions.
See the full eligibility criteria
- PTSD diagnosis as assessed by Clinician-Administered Posttraumatic Stress Scale for DSM-5 - Revised (CAPS-5-R).
- Able to speak and read English (due to standardization of outcome measures).
- Willing to sign a release for the investigators to communicate with their primary care or mental health providers if indicated.
- Able to swallow pills.
- Agree to have study visits video and/or audio recorded, including Experimental Session, assessments, and non-drug therapy sessions.
- Willing to provide a contact (relative, spouse, close friend, or another support person) who is willing and able to be contacted by the investigators.
- Agree to inform the investigators within 48 hours of any medical conditions and procedures.
- If able to become pregnant, must have a negative pregnancy test before study entry, at study entry, and before the Medicine Session.
- Agree to the following lifestyle modifications: comply with requirements for fasting and refraining from certain medications before the Medicine Session, and not participating in any other treatment clinical trials...
- Are not able to give adequate informed consent.
- Have previously participated in a Multidisciplinary Association for Psychedelic Studies (MAPS) sponsored MDMA clinical trial.
- Have any current problem which, in the opinion of the investigator or study physician, might interfere with participation.
- Have hypersensitivity to any ingredient of the Investigational Medicinal Product (IMP).
- Upon review of medical or psychiatric history and psychiatric assessment, have any current or past diagnosis that would be considered a risk to participating in the study
- Requires ongoing psychiatric medication use with certain exceptions. Individuals may decide to taper psychiatric medications under the guidance of their local provider.
- Have a history of any medical condition that could make receiving MDMA dangerous because of increases in blood pressure and heart rate or any medical condition the study physician believes would pose a safety risk or...
- Have any unstable medical condition that would interfere with participation.
- Have uncontrolled hypertension) documented on three separate occasions.
- Have Wolff-Parkinson-White syndrome or any other accessory pathway that has not been successfully eliminated by ablation.
- Have a history of ever having ventricular arrhythmia or any other abnormal heart rhythm that the study physician believes would pose a significant risk of participation.
- Have an abnormal finding on electrocardiogram
- Have a history of additional risk factors for Torsade de Pointes (e.g., heart failure, hypokalemia, family history of Long QT Syndrome).
- Require the use of concomitant medications that could impact the effects or safety of MDMA during the Medicine Session.
- Have symptomatic liver disease or significant liver enzyme elevations.
- Have a history of hyponatremia or hyperthermia.
- Weigh less than 48 kilograms (105 lbs.).
- Are pregnant or nursing
- Have engaged in ketamine-assisted therapy or used ketamine within 12 weeks of enrollment
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, 21 years to 70 years. 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.