MDMA combined with exposure therapy for treating PTSD
A Pilot Study of MDMA-Assisted Massed Exposure Therapy for PTSD (MDMA PE)
This study is testing if taking MDMA along with exposure therapy can help people with PTSD feel better.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 21 Years to 70 Years |
| Sex | All |
| Sponsor | Emory University Academic / other |
| Locations | 1 site (Atlanta, Georgia) |
| Trial ID | NCT05746572 on ClinicalTrials.gov |
What this trial studies
This study investigates the effects of MDMA in conjunction with Prolonged Exposure therapy, a recognized treatment for PTSD. Participants will undergo a 10-day therapy program, receiving MDMA on the second day along with daily therapy sessions. The trial aims to assess the efficacy of this combined approach in alleviating PTSD symptoms, while also collecting psychophysiological data for further analysis. Recruitment will occur through community advertising and mental health referrals, with a thorough screening process to ensure participant eligibility.
Who should consider this trial
Good fit: Ideal candidates are individuals diagnosed with PTSD who are willing to participate in a structured therapy program and meet the study's eligibility criteria.
Not a fit: Patients who do not meet the PTSD criteria or those who are unable to participate in the required therapy sessions may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve treatment outcomes for patients suffering from PTSD.
How similar studies have performed: Previous studies combining MDMA with psychotherapy have shown promising results, indicating potential for success in this novel approach.
Eligibility criteria
Show full inclusion / exclusion 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: * 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.
Where this trial is running
Atlanta, Georgia
- Emory Brain Health Center — Atlanta, Georgia, United States (Recruiting)
Study contacts
- Principal investigator: Jessica Maples-Keller, PhD — Emory University
- Study coordinator: Jessica Maples-Keller, PhD
- Email: mdmapestudy@emory.edu
- Phone: (404)778-2431
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.