Clinical trial NCT05274230: Sustaining Remission From PTSD Using Tuned Vibroacoustic Stimulation (TVS) Following MDMA-Assisted Psychotherapy
Official title: Sustaining Remission From Posttraumatic Stress Disorder (PTSD) Using Tuned Vibroacoustic Stimulation (TVS) Following MDMA-Assisted Psychotherapy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Stress Disorders, Post-Traumatic
Keywords: remission
PTSD
psychotherapy
MDMA
Lead sponsor: Apollo Neuroscience, Inc.
Sponsor class: INDUSTRY
Collaborators: name: The Board of Medicine
First posted: 2022-03-10
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: This is a single group study. All participants will receive identical instructions regarding the device and will complete the same survey measures.
Primary purpose: SUPPORTIVE_CARE

Brief 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

Detailed 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.

Eligibility 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

Primary outcomes:
measure: PTSD Checklist for DSM-5 (PCL-5)
timeFrame: Through study completion, an average of two years
measure: Beck Depression Inventory II (BDI-II)
timeFrame: Through study completion, an average of two years
Secondary outcomes:
measure: World Health Organization Health and Work Performance Questionnaire (HPQ Short form)
timeFrame: Through study completion, an average of two years
measure: Alcohol Use Disorders Identification Test (AUDIT)
timeFrame: Through study completion, an average of two years
measure: Drug Use Disorders Identification Test (DUDIT)
timeFrame: Through study completion, an average of two years
measure: Chronic Pain Grade Scale (CPGS)
timeFrame: Through study completion, an average of two years
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: Apollo Neuroscience, Inc.
state: Pennsylvania
Study officials:
affiliation: The Board of Medicine
name: Belinda Tan, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: