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Study of Safety and Effects of MDMA-assisted Psychotherapy for Treatment of PTSD (Canada)

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ClinicalTrials.gov Identifier: NCT03485287
Recruitment Status : Completed
First Posted : April 2, 2018
Results First Posted : July 1, 2021
Last Update Posted : July 1, 2021
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. A flexible dose of MDMA (100 to 125 mg), followed by a supplemental half-dose, unless contraindicated, is administered during the Treatment Period with manualized therapy 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 is the change in the Clinician Administered PTSD Scale for DSM 5 (CAPS-5) total severity scores from Baseline to Visit 19. The secondary outcome measure is the change in the Sheehan Disability Scale (adapted SDS) total scores from Baseline to Visit 19.

Condition or disease Intervention/treatment Phase
Posttraumatic Stress Disorder Drug: MDMA Behavioral: Therapy Phase 2

Detailed Description:

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. A flexible dose of MDMA (100 to 125 mg), followed by a supplemental half-dose, unless contraindicated, is administered during the Treatment Period with manualized therapy 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 is the change in the Clinician Administered PTSD Scale for DSM 5 (CAPS-5) total severity scores from Baseline to Visit 19. The secondary outcome measure is the change in the Sheehan Disability Scale (adapted SDS) total scores from Baseline to Visit 19.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 4 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Open-label multi-site study axamining 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)
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 (Canada)
Actual Study Start Date : April 10, 2018
Actual Primary Completion Date : June 4, 2019
Actual Study Completion Date : June 4, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: MDMA and Psychotherapy
Three sessions of MDMA-assisted psychotherapy with flexible dose of MDMA from 100 to 125 mg and optional supplemental dose half that of initial dose 1.5 to 2 hours later
Drug: MDMA
Three sessions of MDMA-assisted therapy with flexible dose of MDMA from 100 to 125 mg and optional supplemental dose half that of initial dose 1.5 to 2 hours later
Other Name: 3,4-methylenedioxymethamphetamine

Behavioral: Therapy
Non-directive therapy
Other Name: MDMA-assisted therapy




Primary Outcome Measures :
  1. Change From Baseline to Primary Endpoint in Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) Total Severity Score [ Time Frame: Baseline (Visit 3) to Primary Endpoint (Visit 19,18 weeks post enrollment) ]
    The Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) is a clinician administered and scored assessment of PTSD symptoms via structured interview based upon PTSD diagnosis in DSM-5. It contains symptom subscales, a CAPS-5 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.

  2. Baseline Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) Total Severity Scores [ Time Frame: Baseline (Visit 3) ]
    The Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) is a clinician administered and scored assessment of PTSD symptoms via structured interview based upon PTSD diagnosis in DSM-5. It contains symptom subscales, a CAPS-5 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.

  3. Primary Endpoint Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) Total Severity Score [ Time Frame: Visit 19 (18 weeks post-enrollment) ]
    The Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) is a clinician administered and scored assessment of PTSD symptoms via structured interview based upon PTSD diagnosis in DSM-5. It contains symptom subscales, a CAPS-5 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.


Secondary Outcome Measures :
  1. Change From Baseline to Primary Endpoint in Sheehan Disability Scale (Adapted SDS) Total Score [ Time Frame: Baseline (Visit 3) to Primary Endpoint (Visit 19, 18 weeks post-enrollment) ]
    The Sheehan Disability Scale (adapted SDS) is a self-report assessment of functional impairment. The reporting period for the adapted SDS refers to the past month. 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), with higher scores indicating greater functional impairment.

  2. Baseline Sheehan Disability Scale (Adapted SDS) Total Score [ Time Frame: Baseline (Visit 3) ]
    The Sheehan Disability Scale (adapted SDS) is a self-report assessment of functional impairment. The reporting period for the adapted SDS refers to the past month. 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), with higher scores indicating greater functional impairment.

  3. Primary Endpoint Sheehan Disability Scale (Adapted SDS) Total Score [ Time Frame: Visit 19 (18 weeks post-enrollment) ]
    The Sheehan Disability Scale (adapted SDS) is a self-report assessment of functional impairment. The reporting period for the adapted SDS refers to the past month. 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), with higher scores indicating greater functional impairment.



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
  • 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

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.
  • Must not be 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): NCT03485287


Locations
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Canada, British Columbia
British Columbia Centre on Substance Abuse
Vancouver, British Columbia, Canada, V64 1H
Canada, Quebec
Dr. Simon Amar, LLC
Montréal, Quebec, Canada, H2W 1Y9
Sponsors and Collaborators
Multidisciplinary Association for Psychedelic Studies
Investigators
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Study Director: Michael Mithoefer MAPS Public Benefit Corp.
  Study Documents (Full-Text)

Documents provided by Multidisciplinary Association for Psychedelic Studies:
Study Protocol  [PDF] April 2, 2018
Statistical Analysis Plan  [PDF] August 7, 2017

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Responsible Party: Multidisciplinary Association for Psychedelic Studies
ClinicalTrials.gov Identifier: NCT03485287    
Other Study ID Numbers: MP-17
First Posted: April 2, 2018    Key Record Dates
Results First Posted: July 1, 2021
Last Update Posted: July 1, 2021
Last Verified: May 2021
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 study.

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Multidisciplinary Association for Psychedelic Studies:
PTSD
MDMA
Therapy
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