MDMA in Borderline Personality Disorder
ConditionBorderline Personality Disorder
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-60
SponsorYale University
About this trial
The purpose of this study is to test the effects of MDMA (3,4-methylenedioxymethamphetamine) on social cognition in adults with Borderline Personality Disorder.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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 release of information for this contact person.
Disqualifiers
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.
Trial design
Design model
Single group
Treatments tested in this trial
MDMA
DrugParticipants will receive one dose of open-label 3,4-methylenedioxymethamphetamine (MDMA).
Treatment groups
10 Participants
are divided into 1 treatment groupGroup A: Open-Label MDMAExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Change in Self-Reported Social Cognition After 1 Dose of MDMA.
Defined as sociability visual-analogue scale (VAS) score. Total score range is 0-100, higher scores indicating more sociability.
Time frame
From baseline (immediately before drug dose) to 2 hours after drug dose on the same day.Secondary outcomes
1
Change from baseline in emotion appraisal on facial emotion recognition task score, on same day after drug administration.
The facial-emotion recognition task is a computer-based cognitive task for measuring ability to recognize facial emotions, that yields accuracy scores for positive and negative emotions. Possible scores range from 0 (poor facial emotion recognition) to 100% (excellent facial emotion recognition).
Time frame
From baseline (immediately before drug dose) to 2 hours after drug dose on the same day.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Yale University
Lead sponsor
Connecticut Mental Health Center
Collaborator
Source ClinicalTrials.gov