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Trial record 3 of 3 for:    mdma | Netherlands

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

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: NCT04030169
Recruitment Status : Recruiting
First Posted : July 23, 2019
Last Update Posted : September 17, 2020
Sponsor:
Collaborator:
Multidisciplinary Association for Psychedelic Studies
Information provided by (Responsible Party):
MAPS Europe B.V.

Brief Summary:
This open-label, lead-in Phase 2 study is intended to gather supportive data on the safety and effectiveness of manualized MDMA-assisted psychotherapy as a treatment for PTSD. This will be the first study of MDMA-assisted psychotherapy in Europe using the CAPS-5 as a primary outcome measure to confirm assumptions made for statistical power calculations using the Clinician-Administered PTSD Scale for DSM-4 (CAPS-4) which support planned Phase 3 clinical trials. This study will gather supportive data on the safety and effectiveness of manualized MDMA-assisted psychotherapy as a treatment for PTSD and provide clinical supervision to planned Phase 3 therapy teams. This study will also be the first multi-site study of MDMA-assisted psychotherapy for PTSD in Europe and will explore reproducibility of findings from FDA-regulated trials in a multi-site format to further confirm the Phase 3 study design. This study will compare the effects of two 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 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 multicenter, open-label, lead-in study assesses the safety and effectiveness of MDMA- assisted psychotherapy in participants diagnosed with at least severe PTSD. All safety data will be included in the global safety database for MDMA maintained by MAPS. Some sites will participate in the imaging sub-study. A flexible dose of MDMA, followed by a supplemental half-dose unless contraindicated, is administered during the Treatment Period with manualized psychotherapy in two open-label Experimental Sessions spaced approximately a month apart. This 8-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. 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 two 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.

This study will be the first multi-site study of MDMA-assisted psychotherapy for PTSD in Europe and will explore reproducibility of findings from FDA-regulated trials in a multi-site format to further confirm the Phase 3 study design.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Examining safety and effects of two 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, Phase 2, Multicenter Feasibility Study of Manualized MDMA-Assisted Psychotherapy With an Optional fMRI Sub-Study Assessing Changes in Brain Activity in Subjects With Posttraumatic Stress Disorder
Actual Study Start Date : June 24, 2020
Estimated Primary Completion Date : May 2021
Estimated Study Completion Date : June 2021

Arm Intervention/treatment
Experimental: Experimental: MDMA-assisted psychotherapy
Two 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
Non-directive psychotherapy conducted during MDMA-assisted psychotherapy session
Other Name: 3,4-methylenedioxymethamphetamine




Primary Outcome Measures :
  1. Change in CAPS-5 Total Severity Score [ Time Frame: 13 weeks post-enrollment ]
    The primary objective of this study is to evaluate the effectiveness of MDMA-assisted psychotherapy for treatment of PTSD, as measured by the estimand of change in CAPS-5 Total Severity Score


Secondary Outcome Measures :
  1. Change in Sheehan Disability Scale (SDS) item scores [ Time Frame: 13 weeks post-enrollment ]
    The secondary objective is to evaluate the effectiveness of MDMA-assisted psychotherapy for PTSD in clinician-rated functional impairment, as measured by the mean change in Sheehan Disability Scale (SDS) item scores.



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:

  1. Are at least 18 years old
  2. Are fluent in speaking and reading the predominantly used or recognized language of the study site
  3. Are able to swallow pills
  4. Agree to have study visits video-recorded, including Experimental Sessions, Independent Rater assessments, and non-drug psychotherapy sessions
  5. Must provide a contact (relative, spouse, close friend or other support person) who is willing and able to be reached by the investigators in the event of a participant becoming suicidal or unreachable
  6. Must agree to inform the investigators within 48 hours of any medical treatments and procedures
  7. 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. Adequate birth control methods include intrauterine device (IUD), injected or implanted hormonal methods, abstinence, oral hormones plus a barrier contraception, vasectomized sole partner or double barrier contraception. Two forms of contraception are required with any barrier method or oral hormones (i.e. condom plus diaphragm, condom or diaphragm plus spermicide, oral hormonal contraceptives plus spermicide or condom). Not of childbearing potential is defined as permanent sterilization, postmenopausal, or assigned male at birth.
  8. Agree to the following lifestyle modifications: comply with requirements for fasting and refraining from certain medications prior to Experimental Sessions, not participate in any other interventional clinical trials during the duration of the study, remain overnight at the study site after each Experimental Session and be driven home after, and commit to medication dosing, therapy, and study procedures
  9. At Screening, meet DSM-5 criteria for current PTSD
  10. At Screening, may have well-controlled hypertension that has been successfully treated with anti-hypertensive medicines, if they pass additional screening to rule out underlying cardiovascular disease
  11. At Screening, may have asymptomatic Hepatitis C virus (HCV) that has previously undergone evaluation and treatment as needed

Exclusion Criteria:

  1. Are not able to give adequate informed consent
  2. Have any current problem which, in the opinion of the investigator or Medical Monitor, might interfere with participation
  3. Would present a serious risk to others as established through clinical interview and contact with treating psychiatrist
  4. Require ongoing concomitant therapy with a psychiatric medication with exceptions described in Section 11.0: Concomitant Medications.
  5. Weigh less than 48 kilograms (kg)
  6. Are pregnant or nursing or are of childbearing potential and are not practicing an effective means of birth control.

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): NCT04030169


Contacts
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Contact: Fabiana da Silva Alves askmapseu@mapseurope.eu

Locations
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Czechia
NUDZ - National Institute of Mental Health Recruiting
Klecany, Středočeský Kraj, Czechia, 250 67
Contact: Michaela Victorinova    +420283088258    michaela.viktorinova@nudz.cz   
Netherlands
Maastricht University, Dept of Neuropsychology and Psychopharmacology Not yet recruiting
Maastricht, Limburg, Netherlands, 6229 ER
Contact: Kim Kuypers    +31433881902    k.kuypers@maastrichtuniversity.nl   
Stichting Centrum '45/Arq Recruiting
Oegstgeest, Noord Holand, Netherlands, 2342 AX
Contact: Viyan Bedawi    +31715191500    V.Bedawi@centrum45.nl   
Norway
Sykehuset Østfold Hf, DPS Norder Not yet recruiting
Moss, Norway, 1535
Contact: Study Team General    +47 69 86 97 61    psykforsk@so-hf.no   
Portugal
Fundação de Anna de Sommer Champalimaud Not yet recruiting
Lisbon, Portugal, 1400-038
United Kingdom
University Hospital of Wales - Research Facility Not yet recruiting
Cardiff, United Kingdom, CF14 4XW
Contact: Mathew Hoskins       hoskinsmd1@cardiff.ac.uk   
Sponsors and Collaborators
MAPS Europe B.V.
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: MAPS Europe B.V.
ClinicalTrials.gov Identifier: NCT04030169    
Other Study ID Numbers: MP18
First Posted: July 23, 2019    Key Record Dates
Last Update Posted: September 17, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: We will share outcome data appearing in any published reports upn request.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Time Frame: Data and study-related documents will be available when all participants have completed the study.
Access Criteria: Interested persons should correspond with the central contact for the multi-site study.

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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 MAPS Europe B.V.:
MDMA
methylenedioxymethamphetamine
psychotherapy
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