Sustaining Remission From PTSD Using Tuned Vibroacoustic Stimulation (TVS) Following MDMA-Assisted Psychotherapy

Last updated: January 31, 2023
Sponsor: Apollo Neuroscience, Inc.
Overall Status: Active - Recruiting

Phase

N/A

Condition

Post-traumatic Stress Disorders

Treatment

N/A

Clinical Study ID

NCT05274230
AN006
20214600
  • Ages > 18
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

The purpose of this research is to examine a wearable device called Apollo that emits gentle vibrations found to benefit mood, energy, and focus. We want to understand how it affects outcomes related to MDMA-assisted psychotherapy for PTSD including depression, anxiety and emotion regulation.

This study will test whether regular use of the Apollo wearable improves rates of sustained symptom remission in PTSD following MDMA-assisted psychotherapy over the course of two years

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Age 18 or over
  • Completion of the MAPS MDMA-Assisted Psychotherapy for PTSD clinical trial (treatmentcohort)
  • completion of the MAPS MDMA-Assisted Psychotherapy for PTSD clinical trial (placebocohort)
  • enrolled in the MAPS MDMA-Assisted Psychotherapy for PTSD clinical trial, but droppedout

Exclusion

Exclusion Criteria:

  • Unable to give adequate informed consent
  • Have any current problem which, in the opinion of the investigator might interferewith participation
  • Are unable to complete questionnaires written in English

Study Design

Total Participants: 200
Study Start date:
December 08, 2021
Estimated Completion Date:
December 31, 2025

Study Description

The study examines the effect of the Apollo wearable on its users after undergoing MDMA-assisted psychotherapy. There will be no study specific modification to the MDMA-assisted psychotherapy that participants receive. All study participants will have previously consented to MAPS MDMA-assisted psychotherapy for PTSD clinical trial before enrolling in this protocol. Once they have been identified as people who have been consented to the MAPS trial regardless of this research, they will be approached about the study, and screened/consented/enrolled accordingly.

Participants will receive the Apollo wearable device via mail upon consenting to participate in this study. They will be provided an instruction manual with guidelines on how to best use the device and will be asked to continue to use the Apollo device in their everyday life following MDMA-assisted psychotherapy.

Participants in the study will be asked to complete monthly online questionnaires for the duration of the two year study.

Please note: this study is not affiliated with the MAPS organization who is running the MDMA-assisted psychotherapy research study.

Connect with a study center

  • Apollo Neuroscience, Inc.

    Pittsburgh, Pennsylvania 15219
    United States

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.