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New treatment option for Post Traumatic Stress Disorder
Official title MDMA-Assisted Massed Exposure Therapy for PTSD
ClinicalTrials.gov ID: NCT07288151
What this study is testing
What is 3,4-Methylenedioxymethamphetamine (MDMA)?
3,4-Methylenedioxymethamphetamine (MDMA) is an investigational medicine, given as a pill taken by mouth, 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 goal of this clinical trial is to investigate the efficacy of 3,4-methylenedioxy-methamphetamine hydrochloride (MDMA) combined with Massed Prolonged Exposure (PE) therapy for the treatment of posttraumatic stress disorder (PTSD) in adult participants diagnosed with PTSD. This randomized, placebo-controlled trial will enroll 95 participants.
- 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. Individuals may decide to taper psychiatric medications under the guidance of...
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. Must agree to use adequate birth control for a month before the Medicine session and...
- 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's taking place
- 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 - 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?
Study sites include Atlanta, Georgia, 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.