Using a wearable device to improve PTSD remission after MDMA therapy
Sustaining Remission From Posttraumatic Stress Disorder (PTSD) Using Tuned Vibroacoustic Stimulation (TVS) Following MDMA-Assisted Psychotherapy
This study tests if using a wearable device that gives gentle vibrations can help people with PTSD who have had MDMA therapy feel better for a longer time.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Apollo Neuroscience, Inc. Industry-sponsored |
| Locations | 1 site (Pittsburgh, Pennsylvania) |
| Trial ID | NCT05274230 on ClinicalTrials.gov |
What this trial studies
This research investigates the impact of a wearable device called Apollo, which emits gentle vibrations, on individuals who have undergone MDMA-assisted psychotherapy for PTSD. The study aims to determine if regular use of the Apollo device can enhance the rates of sustained symptom remission over a two-year period. Participants will receive the device by mail and will complete monthly online questionnaires to assess their progress. The study does not modify the existing MDMA-assisted psychotherapy protocol but focuses on the additional benefits of the wearable device.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and over who have completed the MAPS MDMA-Assisted Psychotherapy for PTSD clinical trial.
Not a fit: Patients who are unable to provide informed consent or have current issues that may interfere with participation may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a novel method to enhance and sustain remission from PTSD symptoms following MDMA-assisted psychotherapy.
How similar studies have performed: While the use of wearable devices for mental health is an emerging field, this specific approach combining vibroacoustic stimulation with MDMA-assisted psychotherapy is novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age 18 or over * Completion of the MAPS MDMA-Assisted Psychotherapy for PTSD clinical trial (treatment cohort) * completion of the MAPS MDMA-Assisted Psychotherapy for PTSD clinical trial (placebo cohort) * enrolled in the MAPS MDMA-Assisted Psychotherapy for PTSD clinical trial, but dropped out Exclusion Criteria: * Unable to give adequate informed consent * Have any current problem which, in the opinion of the investigator might interfere with participation * Are unable to complete questionnaires written in English
Where this trial is running
Pittsburgh, Pennsylvania
- Apollo Neuroscience, Inc. — Pittsburgh, Pennsylvania, United States (Recruiting)
Study contacts
- Principal investigator: Belinda Tan, MD PhD — The Board of Medicine
- Study coordinator: Nicole Grinsell, MS
- Email: nicole@apolloneuro.com
- Phone: 8559220057
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.