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New treatment option for Posttraumatic Stress Disorder
Official title Dose Optimization of MDMA-Assisted Therapy for PTSD
ClinicalTrials.gov ID: NCT06418178
What this study is testing
What is Midomafetamine?
Midomafetamine is an investigational medicine, being studied as a potential treatment for posttraumatic stress disorder.
Also referred to as MDMA, 3,4-methylenedioxymethamphetamine.
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 open label, within-subjects dose optimization trial will investigate the optimal number of MDMA-Assisted Therapy treatment cycles (i.e., one MDMA session and three integration sessions) in a sample of U.S. veterans with PTSD.
- Phase 2: a mid-size study of how well it works
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
- Are a U.S. military veteran at least 18 years old.
- Are able to provide written, informed consent.
- Are able to swallow pills.
- Agree to have study visits recorded, including Experimental Sessions, psychological assessments, and non-drug therapy sessions.
- Must provide a contact who is willing and able to be reached by the investigators in the event of a participant becoming unwell or unreachable.
You likely can't join if
- Are not able to give adequate informed consent.
- Have a history of any medical condition, or any significant clinical finding on screening tests, that could make receiving a sympathomimetic drug...
- Have uncontrolled hypertension.
- Have evidence or history of significant medical or psychiatric disorders.
- Have symptomatic liver disease.
- Have history of hyponatremia or hyperthermia.
See the full eligibility criteria
- Are a U.S. military veteran at least 18 years old.
- Are able to provide written, informed consent.
- Are able to swallow pills.
- Agree to have study visits recorded, including Experimental Sessions, psychological assessments, and non-drug therapy sessions.
- Must provide a contact who is willing and able to be reached by the investigators in the event of a participant becoming unwell or unreachable.
- If able to become pregnant, must have a negative pregnancy test at study entry and prior to each Experimental Session, and must agree to use adequate contraceptive methods.
- Must have a current PTSD diagnosis at screening and baseline.
- Must not participate in any other treatment clinical trials for the duration of the study.
- Must commit to medication dosing, therapy, and all study procedures.
- Are not able to give adequate informed consent.
- Have a history of any medical condition, or any significant clinical finding on screening tests, that could make receiving a sympathomimetic drug harmful.
- Have uncontrolled hypertension.
- Have evidence or history of significant medical or psychiatric disorders.
- Have symptomatic liver disease.
- Have history of hyponatremia or hyperthermia.
- Weigh less than 48 kilograms (kg).
- Unable or unwilling to safely taper off prohibited psychiatric medication.
- Abusing illegal drugs or alcohol.
- Have received Electroconvulsive Therapy (ECT) or ketamine therapy within 12 weeks of enrollment.
- Are pregnant or nursing or are able to become pregnant and are not practicing an effective means of contraception.
The study team makes the final eligibility decision.
Where it's taking place
- The Bronx, New York, 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 The Bronx, New York, 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.