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Open Label Multi-Site Study of Safety and Effects of MDMA-assisted Psychotherapy for Treatment of PTSD

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ClinicalTrials.gov Identifier: NCT03282123
Recruitment Status : Recruiting
First Posted : September 13, 2017
Last Update Posted : June 12, 2018
Sponsor:
Information provided by (Responsible Party):
Multidisciplinary Association for Psychedelic Studies

Brief Summary:
This multi-site, open-label, Phase 2, lead-in study assesses the safety and effect of 3,4-methylenedioxymethamphetamine (MDMA)-assisted psychotherapy in participants diagnosed with at least severe posttraumatic stress disorder (PTSD). Therapy teams that have been identified and trained to work on the sponsor's planned Phase 3 studies will treat at least one open-label participant in this study. The study will be conducted in up to N=60 participants. A flexible dose of MDMA, followed by a supplemental half-dose unless contraindicated, is administered during the Treatment Period with manualized psychotherapy in three open-label 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, the 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 open-label manualized Experimental Sessions of psychotherapy assisted by flexible doses of MDMA. Initial doses per Experimental Session include 80 mg or 120 mg of MDMA compounded with lactose, followed 1.5 to 2 hours later by a supplemental half-dose (40 mg 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
PTSD Drug: MDMA Behavioral: Psychotherapy Phase 2

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 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, open-label, Phase 2, lead-in study assesses the safety and effect of 3,4-methylenedioxymethamphetamine (MDMA)-assisted psychotherapy in participants diagnosed with at least severe posttraumatic stress disorder (PTSD). Therapy teams that have been identified and trained to work on the sponsor's planned Phase 3 studies will treat at least one open-label participant in this study. The study will be conducted in up to N=60 participants. A flexible dose of MDMA, followed by a supplemental half-dose unless contraindicated, is administered during the Treatment Period with manualized psychotherapy in three open-label 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, the 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 open-label manualized Experimental Sessions of psychotherapy assisted by flexible doses of MDMA. Initial doses per Experimental Session include 80 mg or 120 mg of MDMA compounded with lactose, followed 1.5 to 2 hours later by a supplemental half-dose (40 mg or 60 mg). Total amounts of MDMA to be administered per Experimental Session range from 80 mg to 180 mg.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Examining safety and effects of three sessions of MDMA-assisted psychotherapy, with Clinician-Administered PTSD Scale for DSM 5 (CAPS-5) severity after treatment compared with baseline
Masking: None (Open Label)
Masking Description: This study will be open label
Primary Purpose: Treatment
Official Title: An Open-Label, Multi-Site Phase 2 Study of the Safety and Effect of Manualized MDMA-Assisted Psychotherapy for the Treatment of Severe Posttraumatic Stress Disorder
Actual Study Start Date : October 24, 2017
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : January 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Club Drugs

Arm Intervention/treatment
Experimental: MDMA-assisted psychotherapy
Three sessions of MDMA-assisted psychotherapy with flexible dose of MDMA from 80 to 120 mg and optional supplemental dose half that of initial dose 1.5 to 2 hours later
Drug: MDMA
80 to 120 mg MDMA
Other Name: 3,4-methylenedioxymethamphetamine

Behavioral: Psychotherapy
Non-directive psychotherapy conducted during MDMA-assisted psychotherapy session




Primary Outcome Measures :
  1. Change from Baseline in Clinician Administered PTSD Scale for DSM-5 [ Time Frame: 18 weeks post-enrollment ]
    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 ]
    Assesses self-reported depression symptoms

  2. Systolic blood pressure (SBP) [ Time Frame: Seven weeks after enrollment ]
    Systolic blood pressure assessed 1.5 to 2 hours after initial MDMA dose

  3. Systolic blood pressure (SBP) [ Time Frame: 11 weeks after enrollment ]
    Systolic blood pressure assessed 1.5 to 2 hours after initial MDMA dose

  4. Systolic blood pressure (SBP) [ Time Frame: 15 weeks after enrollment ]
    Systolic blood pressure assessed 1.5 to 2 hours after initial MDMA dose

  5. Diastolic blood pressure (DBP) [ Time Frame: Seven weeks after enrollment ]
    Diastolic blood pressure assessed 1.5 to 2 hours after initial MDMA dose

  6. Diastolic blood pressure (DBP) [ Time Frame: 11 weeks after enrollment ]
    Diastolic blood pressure assessed 1.5 to 2 hours after initial MDMA dose

  7. Diastolic blood pressure (DBP) [ Time Frame: 15 weeks after enrollment ]
    Diastolic blood pressure assessed 1.5 to 2 hours after initial MDMA dose

  8. Pulse [ Time Frame: Seven weeks after enrollment ]
    Pulse assessed 1.5 to 2 hours after initial MDMA dose

  9. Pulse [ Time Frame: 11 weeks after enrollment ]
    Pulse assessed 1.5 to 2 hours after initial MDMA dose

  10. Pulse [ Time Frame: 15 weeks after enrollment ]
    Pulse assessed 1.5 to 2 hours after initial MDMA dose

  11. Body temperature (BT) [ Time Frame: Seven weeks after enrollment ]
    BT assessed 1.5 to 2 hours after initial MDMA dose

  12. Body temperature (BT) [ Time Frame: 11 weeks after enrollment ]
    BT assessed 1.5 to 2 hours after initial MDMA dose

  13. Body temperature (BT) [ Time Frame: 15 weeks after enrollment ]
    BT assessed 1.5 to 2 hours after initial MDMA dose



Information from the National Library of Medicine

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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
  • 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
  • Meet DSM-5 Criteria for 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): NCT03282123


Contacts
Contact: B

Locations
United States, California
New School Research LLC 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    720-263-0190    info.boulderstudy@comcast.net   
Wholeness Center Active, not recruiting
Fort Collins, Colorado, United States, 80525
United States, Connecticut
University of Connecticut Recruiting
Farmington, Connecticut, United States, 06030
Contact: Study coordinator    860-679-2631    ptsdstudy@uconn.edu   
United States, Louisiana
Ray Worthy Psychiatry LLC Active, not recruiting
New Orleans, Louisiana, United States, 70123
United States, Massachusetts
Trauma Research Foundation Not yet recruiting
Brookline, Massachusetts, United States, 02446
Contact: Study coordinator         
United States, New York
New York University Recruiting
New York, New York, United States, 10016
Contact: Study coordinator    848-389-3850    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 Not yet recruiting
Madison, Wisconsin, United States, 53705
Contact: Study coordinator         
Sponsors and Collaborators
Multidisciplinary Association for Psychedelic Studies
Investigators
Study Director: Michael C Mithoefer, MD MAPS Public Benefit Corp.

Responsible Party: Multidisciplinary Association for Psychedelic Studies
ClinicalTrials.gov Identifier: NCT03282123     History of Changes
Other Study ID Numbers: MP-16
First Posted: September 13, 2017    Key Record Dates
Last Update Posted: June 12, 2018
Last Verified: March 2018
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 wehn all participants have completed the study
Access Criteria: Interested persons should correspond with the central contact for the multi-site study.
URL: http://

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

Keywords provided by Multidisciplinary Association for Psychedelic Studies:
MDMA
methylenedioxymethamphetamine
psychotherapy

Additional relevant MeSH terms:
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