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Group MDMA-therapy for Veterans With PTSD (Group-MVP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05961527
Recruitment Status : Recruiting
First Posted : July 27, 2023
Last Update Posted : November 18, 2023
Sponsor:
Collaborator:
Steven & Alexandra Cohen Foundation
Information provided by (Responsible Party):
Christopher Stauffer, Oregon Health and Science University

Study Description
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Brief Summary:
This Phase 2a, open-label, non-randomized, 3-cohort study assesses the feasibility and safety of MDMA-assisted group therapy for the treatment of PTSD in veterans. The study will be conducted in up to N=18 participants, recruited in three cohorts of six participants each and receive therapy sessions throughout their participation in these group cohorts.

Condition or disease Intervention/treatment Phase
PTSD Drug: MDMA Behavioral: Group Therapy Phase 1 Phase 2

Detailed Description:
To assess the feasibility and safety of MDMA-assisted group therapy for participants with at least moderate PTSD, the sponsor-investigator is conducting a phase 2, open-label, non-randomized, 3-cohort study. This novel treatment package consists of two once-monthly open-label MDMA Sessions combined with non-drug preparatory and integrative therapy administered in both individual and group sessions. The Primary Clinical Outcome measure, the Clinician Administered PTSD Scale (CAPS-5), evaluates changes in PTSD symptom severity and is assessed by a blinded centralized Independent Rater (IR) pool. The therapeutic approach will combine manualized MDMA-assisted therapy for PTSD with group therapy components.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 18 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Open-label study examining safety and feasibility of MDMA-assisted group therapy
Masking: None (Open Label)
Masking Description: Independent raters for the primary clinical outcome will be blinded to study design and timepoint.
Primary Purpose: Treatment
Official Title: An Open-Label Feasibility and Safety Study of MDMA-Assisted Group Therapy for the Treatment of Posttraumatic Stress Disorder in Veterans
Actual Study Start Date : October 1, 2023
Estimated Primary Completion Date : July 31, 2025
Estimated Study Completion Date : September 30, 2025
Arms and Interventions
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Arm Intervention/treatment
Experimental: MDMA-assisted group therapy
Four Preparatory Sessions, two MDMA Sessions, and four Integrative Sessions following each MDMA Session.
 Drug: MDMA
Initial dose of 120 mg MDMA HCL and optional supplemental dose of 60 mg MDMA HCL at 1.5 to 2 hours after first dose
Other Name: 3,4-methylenedioxymethamphetamine

Behavioral: Group Therapy
Standardized group psychotherapy performed by therapist team in combination with non-directive MDMA therapy


Outcome Measures
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Primary Outcome Measures :
  1. Change in CAPS-5 Total Severity Score [ Time Frame: Baseline - 3 months from first Experimental Session ]
    The CAPS-5 is a semi-structured interview that assesses index history of DSM-5-defined traumatic event exposure, including the most distressing event, time since exposure, to produce a diagnostic score (presence vs. absence) and a PTSD Total Severity score. The CAPS-5 rates intrusion symptoms (intrusive thoughts or memories), avoidance, cognitive and mood symptoms, arousal and reactivity symptoms, duration and degree of distress and dissociation. 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.


Secondary Outcome Measures :
  1. Change in Sheehan Disability Scale (SDS) [ Time Frame: Baseline - 3 months from first Experimental Session ]
    Sheehan Disability Scale (SDS) total score, a measure of clinician-rated functional impairment. The first three items indicate degree of impairment in the domains of work/school, social life, and home life, with response options based on an eleven-point scale (0=not at all to 10=extremely), and five verbal tags (not at all, mildly, moderately, markedly, extremely). The remaining two items assess Days Lost and Days Unproductive during the reporting period.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Are at least 18 years old.
  • Are a U.S. Military Veteran
  • Are fluent in speaking and reading the predominantly used or recognized language of the study site.
  • Are able to swallow pills.
  • Agree to have study visits recorded, including MDMA Sessions, outcome assessments, and non-drug psychotherapy sessions.
  • Must provide a contact who is willing and able to be reached by the investigators in the event of a participant becoming suicidal or unreachable.
  • 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 at study entry and prior to each Experimental Session, and must agree to use adequate contraception through 10 days after the last Experimental Session.
  • Must not participate in any other interventional clinical trials during the duration of the study.
  • Must commit to medication dosing, therapy, and study procedures.
  • Have a current PTSD diagnosis at the time of screening.

Exclusion Criteria:

  • Are not able to give adequate informed consent.
  • Have uncontrolled hypertension.
  • Have a marked baseline QTcF interval >450 milliseconds [ms] demonstrated on repeated ECG assessments.
  • Have a history of additional risk factors for Torsade de pointes (e.g., heart failure, hypokalemia, family history of Long QT Syndrome).
  • Have evidence or history of significant medical disorders.
  • Have symptomatic liver or biliary disease.
  • Have history of hyponatremia or hyperthermia.
  • Weigh less than 48 kilograms (kg).
  • Are pregnant or nursing, or are able to become pregnant and are not practicing an effective means of birth control.
  • Are abusing illegal drugs or alcohol.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05961527


Contacts
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Contact: Kevin Rothstein-Kightly, MS 360-450-9349 Kevin.Rothstein-Kightly@va.gov

Locations
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United States, Washington
Portland-Vancouver VA Recruiting
Vancouver, Washington, United States, 98661
Sponsors and Collaborators
Portland VA Research Foundation, Inc
Steven & Alexandra Cohen Foundation
More Information
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Responsible Party: Christopher Stauffer, Associate Professor of Psychiatry, Oregon Health and Science University
ClinicalTrials.gov Identifier: NCT05961527    
Other Study ID Numbers: 02
First Posted: July 27, 2023    Key Record Dates
Last Update Posted: November 18, 2023
Last Verified: November 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Christopher Stauffer, Oregon Health and Science University:
MDMA
PTSD
Veterans
Group Therapy
Additional relevant MeSH terms:
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N-Methyl-3,4-methylenedioxyamphetamine
Hallucinogens
Physiological Effects of Drugs
Psychotropic Drugs
Serotonin Agents
Neurotransmitter Agents
 Molecular Mechanisms of Pharmacological Action
Adrenergic Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Adrenergic Agents