Clinical TrialPTSDMDMAEnrolling by invitation
MDMA Plus Exposure Therapy for PTSD
This Phase IV interventional trial (n=40) aims to investigate the efficacy and safety of MDMA (84-100mg) in combination with Prolonged Exposure therapy (PE) for individuals with posttraumatic stress disorder (PTSD).
Target Enrollment
40 participants
Study Type
Phase II interventional
Design
Non-randomized
Registry
Detailed Description
Open-label, single-group study of MDMA combined with massed Prolonged Exposure therapy in people meeting criteria for PTSD; a single Medicine Session with MDMA occurs on Day 2 of a 10-day PE programme.
Primary outcomes assess feasibility, safety and PTSD symptom change; exploratory psychophysiological and optional fMRI measures will probe mechanisms of treatment response. Participants are followed up at 1, 2 and 4 weeks and 6 months after treatment.
Study Protocol
Preparation
1 sessions
Dosing
1 sessions
Integration
sessions
Therapeutic Protocol
cbt
Study Arms & Interventions
MDMA + PE
experimentalOpen-label MDMA administered during a massed Prolonged Exposure (PE) programme; single-group, one Medicine Session on Day 2.
Interventions
- MDMA100 mgvia Oral• single dose• 1 doses total
MDMA HCl 100 mg (≈84 mg MDMA) given during Medicine Session (Day 2) in combination with PE.
Participants
Ages
21 – 70
Sexes
Male & Female
BMI
-
Psychosis History
-
Inclusion Criteria
- Inclusion Criteria:
- Meet criteria for PTSD
- Willingness of the participant to sign a release for the investigators to communicate with their primary care or mental health providers if indicated
- Are able to visually read and understand the English language and give written informed consent.
- Are able to swallow pills.
- Agree to have study visits and treatment sessions video and/or audio recorded,
- Must provide a contact (relative, spouse, close friend, or another support person) who is willing and able to be reached by the investigators.
- Must 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 prior to study entry, at study entry, and prior to the Medicine Session. Must agree to use adequate birth control for a month prior to the Medicine session and through 10 days after the Medicine session.
- Agree to the following lifestyle modifications: comply with requirements for fasting and refraining from certain medications prior to Medicine Session, and not participate in any other interventional clinical trials during the duration of the study and are driven home or to a hotel after the Medicine Session, and commit to medication dosing, therapy, and study procedures.
Exclusion Criteria
- Exclusion Criteria:
- 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 assessment, have any current or past diagnosis that would be considered a risk to participating in the study
- Current or past substance abuse that would be considered a risk for 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 interfere with the effects of the treatment. Any medical disorder judged by the investigator to significantly increase the risk of MDMA administration by any mechanism is exclusionary.
- 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.