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New treatment option for Borderline Personality Disorder
Official title MDMA in Borderline Personality Disorder
ClinicalTrials.gov ID: NCT06683014
What this study is testing
What is MDMA?
MDMA is an investigational medicine, being studied as a potential treatment for borderline personality disorder.
Also referred to as 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
- The purpose of this study is to test the effects of MDMA (3,4-methylenedioxymethamphetamine) on social cognition in adults with Borderline Personality Disorder.
- 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 to 60
You may be able to join if
- Adults between the ages of 18-60 years
- Body weight between 110 and 210 pounds. Minimum body mass index (BMI) 16.5.
- Able to swallow pills.
- Must provide a contact (relative, spouse, close friend or other support person) who is willing and able to be reached by the investigators in the...
- People of childbearing potential must agree to utilize a highly effective method of birth control (including the following, in accordance with...
You likely can't join if
- History of bipolar disorder, schizophrenia or schizoaffective disorder or currently exhibiting psychotic features as determined by the Structured...
- Lifetime diagnosis of autism.
- Serious suicide risk in the past 6 months, as assessed by Columbia Suicide Severity Rating Scale (CSSRS) type 4 or 5 ideation, or suicidal behavior...
- Any current substance use disorder (in the last 1 month) per SCID interview for alcohol or non-alcohol substances; or a positive pre-study...
- Any severe substance use disorder during the last 6 months.
- Any significant history of serious medical or neurological illness (including history of stroke, myocardial infarction, heart failure, cardiac...
See the full eligibility criteria
- Adults between the ages of 18-60 years
- Body weight between 110 and 210 pounds. Minimum body mass index (BMI) 16.5.
- Able to swallow pills.
- Must 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 suicidal or unreachable and must sign...
- People of childbearing potential must agree to utilize a highly effective method of birth control (including the following, in accordance with Clinical Trials Facilitation and Coordination Group (CTFG) guidelines...
- Able to provide written informed consent according to Yale IRB guidelines.
- Able to read and write English proficiently.
- Diagnosis of BPD, as determined by the Diagnostic Interview for Personality Disorders BPD questions (DIPD), including endorsement of the criteria for abandonment fears and for stormy relationships.
- No exposure to MDMA in the last 6 months, and no more than 10 lifetime uses of ecstasy.
- Agree not to drive a motor vehicle for 24 hours after the treatment day. Agree to identify a support person to accompany them home after the medication day.
- Are willing to remain overnight at the study site after each experimental session until the next morning if recommended by the study physician
- Currently not taking contraindicated medications (antidepressants, antipsychotics, mood stabilizers, stimulants).
- Medications not on the contraindicated list must be reviewed and approved by the study PI
- For people in mental health care, signs releases for the study investigators to communicate with their mental healthcare provider and medical doctor(s) about their medical and mental health history and their mental and...
- For people not in mental health care acknowledges receipt of local resources for mental healthcare.
- For all participants, acknowledges receipt of local emergency resources
- History of bipolar disorder, schizophrenia or schizoaffective disorder or currently exhibiting psychotic features as determined by the Structured Clinical Interview for DSM5 (SCID-5) and/or clinician assessment.
- Lifetime diagnosis of autism.
- Serious suicide risk in the past 6 months, as assessed by Columbia Suicide Severity Rating Scale (CSSRS) type 4 or 5 ideation, or suicidal behavior (CSSRS item) or preparatory acts (CSSRS item).
- Any current substance use disorder (in the last 1 month) per SCID interview for alcohol or non-alcohol substances; or a positive pre-study (screening) urine drug screen.
- Any severe substance use disorder during the last 6 months.
- Any significant history of serious medical or neurological illness (including history of stroke, myocardial infarction, heart failure, cardiac arrhythmia, diabetes, family history of long-QT syndrome, etc.)
- Any signs of major medical or neurological illness on examination, ECG screening, or laboratory tests. For QTc, we would exclude for QTcf \>450. For liver function tests (AST, ALT), we will exclude for values more than...
- History of valvulopathy or pulmonary hypertension (due to evidence of 5HT2B receptor agonism by MDMA)
- History of uncontrolled hypertension with baseline blood pressure above 130 mmHg (systolic) and over 90 mmHg (diastolic). Any history of syncope and/or study baseline blood pressure below 90 mmHg (systolic).
- History of tachycardia with baseline heart rate above 90 beats per minute.
- Current pregnancy or breastfeeding as assessed by patient report or by urine pregnancy test.
- Taking any contraindicated medications: antidepressants, mood stabilizers, antipsychotics, stimulants. No patient will be encouraged to discontinue medications for the study. We will allow people to participate who...
- Hypersensitivity to non-MDMA ingredients of the investigational medicine product (IMP), namely mannitol, magnesium stearate, and hydroxypropylmethylcellulose.
- Herbal and dietary supplements will be reviewed on a case-by-case basis by the sponsor-PI for decision about safety.
The study team makes the final eligibility decision.
Where it's taking place
- New Haven, Connecticut, United States
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
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 to 60 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include New Haven, Connecticut, 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.