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Study Comparing Two Versus Three Active MDMA-assisted Sessions in U.S. Military Veterans With Chronic PTSD (MPVA6)

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: NCT04784143
Recruitment Status : Recruiting
First Posted : March 5, 2021
Last Update Posted : September 15, 2022
Sponsor:
Information provided by (Responsible Party):
Multidisciplinary Association for Psychedelic Studies

Tracking Information
First Submitted Date  ICMJE March 2, 2021
First Posted Date  ICMJE March 5, 2021
Last Update Posted Date September 15, 2022
Actual Study Start Date  ICMJE November 8, 2021
Estimated Primary Completion Date July 2025   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 10, 2021)
  • Change in CAPS-5 Total Severity Score from Baseline to Visit 12 for 2 Session Group [ Time Frame: Baseline - 3 months from enrollment ]
    The Clinician-Administered PTSD Scale for DSM-IV (CAPS-IV) is a clinician administered and scored assessment of PTSD symptoms via structured interview based upon PTSD diagnosis in DSM-IV. It contains symptom subscales, a CAPS-IV total severity score, and a diagnostic score. 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. The dichotomous diagnostic score is based upon meeting each of five criteria, including index trauma, presence or absence of Criteria B, C, D described above, duration of symptoms and distress and is scored as meeting versus not meeting criteria for diagnosis.
  • Change in CAPS-5 Total Severity Score from Baseline to Visit 16 for 3 Session Group [ Time Frame: Baseline - 4 months from enrollment ]
    The Clinician-Administered PTSD Scale for DSM-IV (CAPS-IV) is a clinician administered and scored assessment of PTSD symptoms via structured interview based upon PTSD diagnosis in DSM-IV. It contains symptom subscales, a CAPS-IV total severity score, and a diagnostic score. 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. The dichotomous diagnostic score is based upon meeting each of five criteria, including index trauma, presence or absence of Criteria B, C, D described above, duration of symptoms and distress and is scored as meeting versus not meeting criteria for diagnosis.
Original Primary Outcome Measures  ICMJE
 (submitted: March 2, 2021)
  • Change in CAPS-5 Total Severity Score from Baseline to Visit 12 for 2 Session Group [ Time Frame: Baseline - 3 months from enrollment ]
    Clinician-administered and scored assessment of posttraumatic stress disorder (PTSD) following diagnostic criteria found in DSM IV.It produces a global score, a dichotomous diagnostic scale, and subscales
  • Change in CAPS-5 Total Severity Score from Baseline to Visit 16 for 3 Session Group [ Time Frame: Baseline - 4 months from enrollment ]
    Clinician-administered and scored assessment of posttraumatic stress disorder (PTSD) following diagnostic criteria found in DSM IV.It produces a global score, a dichotomous diagnostic scale, and subscales
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 10, 2021)
  • Change in Sheehan Disability Scale (SDS) from Baseline to Visit 12 for 2 Session Group [ Time Frame: Baseline - 3 months from enrollment ]
    Sheehan Disability Scale (SDS) total score, a measure of clinician-rated functional impairment. The 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).
  • Change in Sheehan Disability Scale (SDS) from Baseline to Visit 16 for 3 Session Group [ Time Frame: Baseline - 4 months from enrollment ]
    Sheehan Disability Scale (SDS) total score, a measure of clinician-rated functional impairment. The 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).
Original Secondary Outcome Measures  ICMJE
 (submitted: March 2, 2021)
  • Change in Sheehan Disability Scale (SDS) from Baseline to Visit 12 for 2 Session Group [ Time Frame: Baseline - 3 months from enrollment ]
    Sheehan Disability Scale (SDS) total score, a measure of clinician-rated functional impairment
  • Change in Sheehan Disability Scale (SDS) from Baseline to Visit 16 for 3 Session Group [ Time Frame: Baseline - 4 months from enrollment ]
    Sheehan Disability Scale (SDS) total score, a measure of clinician-rated functional impairment
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study Comparing Two Versus Three Active MDMA-assisted Sessions in U.S. Military Veterans With Chronic PTSD
Official Title  ICMJE A Phase 2, Open-Label, Randomized Comparative Effectiveness Study for MDMA-Assisted Psychotherapy in U.S. Veterans With Chronic PTSD
Brief Summary This open-label, randomized study will assess the comparative effectiveness of two versus three active MDMA-assisted sessions in U.S. military veterans with at least moderate chronic PTSD treated in an outpatient VA treatment clinic.
Detailed Description This open-label, randomized study will assess the comparative effectiveness of two versus three active MDMA-assisted therapy sessions in U.S. military veterans with at least moderate chronic PTSD treated in an outpatient VA treatment clinic. The study will be conducted in up to 60 participants. Prior to the randomized portion of the study, each therapist pair team will treat one participant under the 3-session model, and one participant under the 2-session model. In total, 8 participants will be treated under this proof of principle therapist training lead-in. A 120 mg dose of MDMA, followed by a supplemental dose (60 mg) unless contraindicated, is administered during the treatment period with manualized psychotherapy in 2 or 3 open-label monthly Experimental Sessions. This ~ 8-12-week Treatment Period includes three Preparatory Sessions prior to the first MDMA-assisted session. During the treatment period, each Experimental Session is followed by three Integrative Sessions of non-drug therapy. The Primary Outcome measure, the change in CAPS-5 from Baseline, is assessed by a centralized, blinded Independent Rater (IR) pool at post-treatment for each group.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE PTSD
Intervention  ICMJE
  • Drug: MDMA
    3,4-methylenedioxymethamphetamine
  • Behavioral: Psychotherapy
    Standardized non-directive psychotherapy performed by therapist team
Study Arms  ICMJE
  • Active Comparator: Two MDMA-assisted Psychotherapy Sessions
    Two Experimental Sessions of MDMA-assisted Psychotherapy
    Interventions:
    • Drug: MDMA
    • Behavioral: Psychotherapy
  • Active Comparator: Three MDMA-assisted Psychotherapy Sessions
    Three Experimental Sessions of MDMA-assisted Psychotherapy
    Interventions:
    • Drug: MDMA
    • Behavioral: Psychotherapy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: March 2, 2021)
60
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 2025
Estimated Primary Completion Date July 2025   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Are at least 18 years old.
  • 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 Experimental Sessions, Independent Rater assessments, and non-drug psychotherapy sessions.
  • Must provide a contact (relative, spouse, close friend or other caregiver) 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 of childbearing potential, must have a negative pregnancy test at study entry and prior to each Experimental Session, and must agree to use adequate birth control through 10 days after the last Experimental Session.
  • Must not participate in any other interventional clinical trials during the duration of the study.
  • Must be willing to remain overnight at the study site after each Experimental Session and be driven home after, and commit to medication dosing, therapy, and study procedures.
  • At baseline, have moderate PTSD diagnosis.

Exclusion Criteria:

  • Are not able to give adequate informed consent.
  • Have uncontrolled hypertension.
  • Have a marked baseline prolongation of QT/QTc interval (e.g., repeated demonstration of a QTc interval >450 milliseconds [ms] corrected by Bazett's formula).
  • 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 disease.
  • Have history of hyponatremia or hyperthermia.
  • Weigh less than 48 kilograms (kg).
  • Are pregnant or nursing, or are of childbearing potential and are not practicing an effective means of birth control.
  • Are abusing illegal drugs.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Rachel Yehuda, PhD 718-741-4000 ext 6964 rachel.yehuda@va.gov
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04784143
Other Study ID Numbers  ICMJE MPVA6
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Multidisciplinary Association for Psychedelic Studies
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Multidisciplinary Association for Psychedelic Studies
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Multidisciplinary Association for Psychedelic Studies
Verification Date July 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP