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Trial record 3 of 9 for:    mdma | Recruiting Studies

A Multi-Site Phase 3 Study of MDMA-Assisted Psychotherapy for PTSD

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ClinicalTrials.gov Identifier: NCT03537014
Recruitment Status : Recruiting
First Posted : May 25, 2018
Last Update Posted : May 16, 2019
Sponsor:
Information provided by (Responsible Party):
Multidisciplinary Association for Psychedelic Studies

Brief Summary:
This multi-site double-blind, placebo-controlled randomized Phase 3 study assesses the efficacy and safety of 3,4-methylenedioxymethamphetamine (MDMA)-assisted psychotherapy versus psychotherapy with placebo in participants diagnosed with at least severe posttraumatic stress disorder (PTSD). The study will be conducted in up to N ≈ 100 participants. Participants will be randomized to receive a flexible dose of MDMA or placebo, followed by a supplemental half-dose, unless contraindicated, during the Treatment Period with manualized psychotherapy in three monthly Experimental Sessions. This ~12-week Treatment Period is preceded by three Preparatory Sessions. During the Treatment Period, each Experimental Session is followed by three Integrative Sessions of non-drug psychotherapy. The Primary Outcome measure is change in Clinician Administered PTSD Scale for DSM 5 (CAPS-5) from Baseline. Exploratory measures will address specific symptoms or behavior that is sometimes related to PTSD. Drug safety will be assessed by measuring blood pressure, heart rate and body temperature during experimental sessions, collecting adverse events and measuring suicidal thoughts or behaviors with the Columbia Suicide Severity Rating Scale (CSSRS). This study will compare the effects of three manualized Experimental Sessions of psychotherapy assisted by flexible doses of MDMA versus placebo. Initial doses per Experimental Session include 80 mg or 120 mg of MDMA compounded with mannitol and magnesium stearate or placebo alone (mannitol and magnesium stearate), followed 1.5 to 2 hours later by a supplemental half-dose (40 or 60 mg). Total amounts of MDMA to be administered per Experimental Session range from 80 mg to 180 mg.

Condition or disease Intervention/treatment Phase
Posttraumatic Stress Disorder Behavioral: Psychotherapy Drug: MDMA Drug: Placebo Phase 3

Detailed Description:

PTSD is a serious debilitating disorder that negatively impacts a person's daily life. PTSD is a stress-related psychiatric condition that may occur following a traumatic event such as war, disaster, sexual abuse, violence, terrorism, and accidents. PTSD negatively impacts a person's daily life, resulting in relationship difficulties, difficulty in finding and maintaining a job, reduced cognitive and psychosocial functioning, substance abuse, high-cost healthcare use, and increased depression and suicide risk. Available PTSD treatments, including medications and therapy, effectively treat only a fraction of people who try them for adequate dose and duration. People with PTSD can be treated with psychotherapies and pharmacotherapies. In the past decade, there has been a growing amount of research into medications and other methods that may augment the effectiveness of psychotherapy for PTSD

3,4-methylenedioxymethamphetamine (MDMA) is a drug that releases serotonin, norepinephrine and dopamine in the brain and indirectly increases levels of the neurohormones oxytocin, arginine vasopressin and cortisol. The combined neurobiological effects of MDMA increase compassion, reduce defenses and fear of emotional injury, and enhance communication and introspection. MDMA produces anxiolytic and prosocial effects, which counteract avoidance and hyperarousal in the context of therapy. A combined treatment of MDMA and psychotherapy may be especially useful for treating PTSD.

This multi-site, double-blind, randomized Phase 3 study assesses the efficacy and safety of MDMA-assisted psychotherapy versus psychotherapy with placebo control in participants diagnosed with at least severe posttraumatic stress disorder (PTSD). The study will be conducted in N ≈ 100 participants. Participants will be enrolled in one of two groups at a 1:1 ratio. A flexible dose of MDMA or placebo, followed by a supplemental half-dose unless contraindicated, is administered during the Treatment Period with manualized psychotherapy in three monthly Experimental Sessions. This ~12-week Treatment Period is preceded by three Preparatory Sessions. During the Treatment Period, each Experimental Session is followed by three Integrative Sessions of non-drug psychotherapy. The Primary Outcome measure is change in Clinician Administered PTSD Scale for DSM 5 (CAPS-5) from Baseline. Exploratory measures will address specific symptoms, or behavior that is sometimes related to PTSD. Drug safety will be assessed by measuring blood pressure, heart rate and body temperature during experimental sessions, collecting adverse events and measuring suicidal thoughts or behaviors with the Columbia Suicide Severity Rating Scale (CSSRS). This study will compare the effects of three manualized Experimental Sessions of psychotherapy supported by assisted by flexible doses of MDMA versus placebo. Initial doses per Experimental Session include 80 mg or 120 mg of MDMA compounded with mannitol and magnesium stearate or placebo alone (mannitol and magnesium stearate), followed 1.5 to 2 hours later by a supplemental half-dose (40 or 60 mg). Total amounts of MDMA to be administered per Experimental Session range from 80 mg to 180


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized, double-blind between group comparison of change in PTSD symptoms
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Masking Description: Use of separate databases for outcome measures and safety data. Assessment made by pool of independent raters. Randomization will be managed via an Interactive Web Randomization System (IWRS) based on a centralized randomization schedule developed by an independent third-party vendor to maintain blinding.
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Placebo-Controlled, Multi-Site Phase 3 Study of the Efficacy and Safety of Manualized MDMA-Assisted Psychotherapy for the Treatment of Severe Posttraumatic Stress Disorder
Actual Study Start Date : November 5, 2018
Estimated Primary Completion Date : November 5, 2019
Estimated Study Completion Date : December 18, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: MDMA
Administration of 80 or 120 mg MDMA in combination with psychotherapy and a supplemental dose offered 1.5/2 hrs later of 40 or 60 mg MDMA respectively.
Behavioral: Psychotherapy
Standardized non-directive psychotherapy performed by therapist team
Other Name: Manualized MDMA-assisted psychotherapy

Drug: MDMA
Administration of 80 to 120 mg MDMA during three sessions of MDMA-assisted psychotherapy followed by a supplemental dose of 40 or 60 mg MDMA offered 1.5/2 hrs after the initial dose, respectively.
Other Name: 3,4-methylenedioxymethamphetamine

Placebo Comparator: Placebo
Administration of inactive placebo in combination with psychotherapy
Behavioral: Psychotherapy
Standardized non-directive psychotherapy performed by therapist team
Other Name: Manualized MDMA-assisted psychotherapy

Drug: Placebo
Administration of placebo during three sessions of MDMA-assisted psychotherapy
Other Name: Inactive placebo




Primary Outcome Measures :
  1. Change from Baseline in Clinician-Administered PTSD for DSM 5 [ Time Frame: 18 weeks post baseline post enrollment confirmation ]
    Global severity Scores on the CAPS-5, a measure of PTSD symptoms


Secondary Outcome Measures :
  1. Change from Baseline in Beck Depression Inventory II (BDI-II) [ Time Frame: 18 weeks post enrollment confirmation ]
    Assesses self-reported depression symptoms

  2. Systolic Blood pressure (SBP) [ Time Frame: 4 weeks after enrollment ]
    Systolic blood pressure assessed 1.5 to 2 hours after initial MDMA/placebo dose during first of three experimental sessions

  3. Systolic Blood pressure (SBP) [ Time Frame: 8 weeks after enrollment ]
    Systolic blood pressure assessed 1.5 to 2 hours after initial MDMA/placebo dose during second of three experimental sessions

  4. Systolic Blood pressure (SBP) [ Time Frame: 12 weeks after enrollment ]
    Systolic blood pressure assessed 1.5 to 2 hours after initial MDMA/placebo dose during third of three experimental sessions

  5. Diastolic blood pressure (DBP) [ Time Frame: 4 weeks after enrollment ]
    Diastolic blood pressure assessed 1.5 to 2 hours after initial MDMA dose during first of three experimental sessions

  6. Diastolic blood pressure (DBP) [ Time Frame: 8 weeks after enrollment ]
    Diastolic blood pressure assessed 1.5 to 2 hours after initial MDMA/placebo dose during second of three experimental sessions

  7. Diastolic blood pressure (DBP) [ Time Frame: 12 weeks after enrollment ]
    Diastolic blood pressure assessed 1.5 to 2 hours after initial MDMA/placebo dose during third of three experimental sessions

  8. Pulse [ Time Frame: 4 weeks after enrollment ]
    Pulse assessed 1.5 to 2 hours after initial dose of MDMA or placebo during first of three experimental sessions

  9. Pulse [ Time Frame: 8 weeks after enrollment ]
    Pulse assessed 1.5 to 2 hours after initial dose of MDMA or placebo during second of three experimental sessions

  10. Pulse [ Time Frame: 12 weeks after enrollment ]
    Pulse assessed 1.5 to 2 hours after initial dose of MDMA or placebo during third of three experimental sessions

  11. Body temperature (BT) [ Time Frame: 4 weeks after enrollment ]
    BT assessed 1.5 to 2 hours after initial dose of MDMA or placebo during first of three experimental sessions.

  12. Body temperature (BT) [ Time Frame: 8 weeks after enrollment ]
    BT assessed 1.5 to 2 hours after initial dose of MDMA or placebo during second of three experimental sessions.

  13. Body temperature (BT) [ Time Frame: 12 weeks after enrollment ]
    BT assessed 1.5 to 2 hours after initial dose of MDMA or placebo during third of three experimental sessions.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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, meet DSM-5 criteria for current severe PTSD

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

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): NCT03537014


Locations
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United States, California
New School Research LLT Recruiting
North Hollywood, California, United States, 91601
Contact: Study coordinator    818-643-5234    info@newschoolresearch.com   
San Francisco Insight and Integration Center Recruiting
San Francisco, California, United States, 94114
Contact: Study coordinator    415-400-5722    info@sfinsightcenter.com   
University of California San Francisco Recruiting
San Francisco, California, United States, 94122
Contact: Study coordinator    510-985-3522    mdma.research@ucsf.edu   
United States, Colorado
Aguazul-Blue Water Inc. Recruiting
Boulder, Colorado, United States, 80302
Contact: Study coordinator    720-892-8395    info.boulderstudy@comcast.net   
Wholeness Center Recruiting
Fort Collins, Colorado, United States, 80525
Contact: Study coordinator    970-825-6610    wcresearch@wholeness.com   
United States, Louisiana
Ray Worthy Psychiatry LLC Recruiting
New Orleans, Louisiana, United States, 70123
Contact: Study coordinator    504-689-6277    info.nolaresearch@gmail.com   
United States, Massachusetts
Trauma Research Foundation Recruiting
Boston, Massachusetts, United States, 02446
Contact: Study coordinator    617-651-2646    mdma.study.boston@gmail.com   
United States, New York
New York University Not yet recruiting
New York, New York, United States, 10016
Contact: Study coordinator    646-501-4206    MDMA.Research@nyumc.org   
Affective Care Recruiting
New York, New York, United States, 10024
Contact: Study coordinator    917-830-4948    info@mdma.nyc   
United States, South Carolina
Zen Therapeutic Solutions, LLC Recruiting
Mount Pleasant, South Carolina, United States, 29464
Contact: Study coordinator    843-882-5203    information.zts@gmail.com   
United States, Wisconsin
University of Wisconsin at Madison Recruiting
Madison, Wisconsin, United States, 53705
Contact: Study coordinator    608-265-8926    Maps.madison@mailplus.wisc.edu   
Canada, British Columbia
Providence Health Center Recruiting
Vancouver, British Columbia, Canada, V5R 5H3
Contact: Study coordinator    604-360-1850    maps.trial.bc@gmail.com   
Canada, Quebec
Dr. Simon Amar, Inc. Recruiting
Montreal, Quebec, Canada, H2W1Y9
Contact: Study coordinator    514-845-1814    mdmastudymtl@protonmail.com   
Israel
Assaf Harofeh Research Fund Recruiting
Be'er Ya'aqov, Israel
Contact: Study coordinator    +972-8-9258396    kmehkarim@gmail.com   
Contact    +972-8-9258474      
Sheba Fund for Health Services and Research Not yet recruiting
Tel HaShomer, Israel
Contact: Study coordinator    +972-3-5303773    Lee.gat@sheba.health.gov.il   
Sponsors and Collaborators
Multidisciplinary Association for Psychedelic Studies
Investigators
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Study Director: Michael Mithoefer, MD MAPS Public Benefit Corp.

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Responsible Party: Multidisciplinary Association for Psychedelic Studies
ClinicalTrials.gov Identifier: NCT03537014     History of Changes
Other Study ID Numbers: MAPP1
First Posted: May 25, 2018    Key Record Dates
Last Update Posted: May 16, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: We will share outcome data appearing in any published reports upon request.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Time Frame: Data and study-related documents will be available when the database has been locked and data has been unblinded.
Access Criteria: Interested persons should correspond with the central contact for the multisite study.

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Stress Disorders, Traumatic
Stress Disorders, Post-Traumatic
Trauma and Stressor Related Disorders
Mental Disorders
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