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MPLONG: Long-Term Safety and Effectiveness of Manualized MDMA-Assisted Therapy for the Treatment of Posttraumatic Stress Disorder

Sponsor
Multidisciplinary Association for Psychedelic Studies (Other)
Overall Status
Enrolling by invitation
CT.gov ID
NCT05066282
Collaborator
(none)
400
Enrollment
1
Location
48
Anticipated Duration (Months)
8.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Data from a series of Phase 2 and 3 studies of MDMA-assisted therapy conducted by the sponsor provide preliminary evidence that chronic Posttraumatic Stress Disorder (PTSD), independent of cause, is treatable with up to three sessions of MDMA-assisted therapy. This non-interventional study will serve as the long-term follow-up (LTFU) protocol for MDMA-assisted therapy clinical trials and will measure persistence of effectiveness using the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) as a measure of PTSD symptom severity. Additionally, this study will gather data to support health economics and cost effectiveness analyses of this treatment. Participants who have received at least one dose of Investigational Medicinal Product (IMP) in the main study will be eligible to participate in this study.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    The Multidisciplinary Association for Psychedelic Studies (MAPS) is a non-profit research and education organization working as a clinical trial sponsor to obtain approval for the prescription use of 3,4-methylenedioxymethamphetamine (MDMA) as an adjunct to therapy for treatment of posttraumatic stress disorder (PTSD). Data from a series of Phase 2 and 3 studies of MDMA-assisted therapy conducted by the sponsor provide preliminary evidence that chronic PTSD, independent of cause, is treatable with up to three sessions of MDMA-assisted therapy. This non-interventional study will serve as the long-term follow-up (LTFU) protocol for MDMA-assisted therapy clinical trials and will measure persistence of effectiveness using the CAPS-5 as a measure of PTSD symptom severity. The primary objective of this study is to evaluate the long-term effectiveness of MDMA-assisted therapy for treatment of PTSD as measured by the change in CAPS-5 Total Severity Score (actual or imputed) from the main study Baseline and Study Termination to LTFU IR Assessments (Visit 1). Additionally, this study will gather data to support health economics and cost effectiveness analyses of this treatment. Participants who have received at least one dose of Investigational Medicinal Product (IMP) in the main study will be eligible to participate in this study.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    400 participants
    Observational Model:
    Cohort
    Time Perspective:
    Retrospective
    Official Title:
    Long-Term Safety and Persistence of Effectiveness of Manualized MDMA-Assisted Therapy for the Treatment of Posttraumatic Stress Disorder
    Actual Study Start Date :
    Mar 1, 2021
    Anticipated Primary Completion Date :
    Mar 1, 2025
    Anticipated Study Completion Date :
    Mar 1, 2025

    Arms and Interventions

    Arm Intervention/Treatment
    Participants with past PTSD who received IMP in the main study

    Outcome Measures

    Primary Outcome Measures

    1. Clinician Administered PTSD Scale for DSM-V (CAPS-5) Total Severity Score (actual or imputed) from the main study Baseline and Study Termination to assessment in the current LTFU study [LTFU IR Assessments at Least 6 Months Since Last Experimental Session in Main Study (Visit 1)]

      The Clinician-Administered PTSD Scale for DSM-V (CAPS-5) is a clinician administered and scored assessment of PTSD symptoms via structured interview based upon PTSD diagnosis in DSM-5. The total severity score is a sum of symptom frequency and intensity scores for the subscales B (re-experiencing), C (avoidance) and D (hypervigilance) and ranges from 0 to 136, with higher scores indicating greater severity of PTSD symptoms.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    1. Enrolled in a MAPS-sponsored study of MDMA-assisted therapy for the treatment of PTSD

    2. Have received Investigational Medicinal Product (IMP) in at least one Experimental Session in the main study

    3. Agree to be contacted by study team at least six months after the last Experimental Session in the main study to schedule and participate in LTFU visits

    Exclusion Criteria:

    1. Are not able to give adequate informed consent

    2. Have any current problem which, in the opinion of the investigator or Medical Monitor, might interfere with participation

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 USCF San Francisco California United States 94158

    Sponsors and Collaborators

    • Multidisciplinary Association for Psychedelic Studies

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Multidisciplinary Association for Psychedelic Studies
    ClinicalTrials.gov Identifier:
    NCT05066282
    Other Study ID Numbers:
    • MPLONG
    First Posted:
    Oct 4, 2021
    Last Update Posted:
    Oct 4, 2021
    Last Verified:
    Sep 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Stress Disorders, Post-Traumatic

    Study Results

    No Results Posted as of Oct 4, 2021