Dose Optimization of MDMA-Assisted Therapy for PTSD
ConditionPosttraumatic Stress Disorder
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorBronx VA Medical Center
About this trial
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. Participants will complete from one to five cycles of MDMA-AT.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Single group
Treatments tested in this trial
Midomafetamine
DrugOne to five MDMA-assisted therapy sessions, each followed by three non-drug psychotherapy sessions (see behavioral intervention below)
Psychotherapy
BehavioralStandardized psychotherapy performed by therapy team
Treatment groups
60 Participants
are divided into 1 treatment groupGroup A: Treatment ArmExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
PTSD Checklist for DSM-5 (PCL-5)
The PCL-5 is a 20-item self-report questionnaire in which respondents indicate the presence and severity of PTSD symptoms per DSM-5. Participants indicate how much distress they have experienced due to each symptom on a five-point Likert-type scale (1=Not at all to 5=Extremely).
Time frame
From Baseline to Outcome Site Visit (up to ~27 weeks for participants who complete all five treatment cycles)Secondary outcomes
1
Clinician-Administered PTSD Scale for DSM-5 (CAPS-5)
The last month CAPS-5 is a semi-structured interview that assesses index history of DSM-5-defined traumatic event exposure and past-month symptom severity to produce a diagnostic score (presence vs. absence) and a PTSD Total Severity score. The CAPS-5 rates intrusion symptoms (intrusive thoughts or memories), avoidance, cognitive and mood symptoms, arousal and reactivity symptoms, duration and degree of distress and dissociation.
Time frame
From Pre-treatment Psychological Evaluation to Post-treatment Psychological Evaluation (up to ~28 weeks for participants who complete all five treatment cycles)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov