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A Multi-site Expanded Access Program for MDMA-assisted Psychotherapy for Patients With Treatment-resistant PTSD (EAMP1)

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: NCT04438512
Expanded Access Status : Available
First Posted : June 18, 2020
Last Update Posted : May 15, 2023
Sponsor:
Information provided by (Responsible Party):
Multidisciplinary Association for Psychedelic Studies

Study Description
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Brief Summary:
This is an open-label, expanded access protocol for eligible patients with treatment-resistant posttraumatic stress disorder (PTSD). This protocol is designed to provide access to MDMA-assisted therapy for patients who are not eligible for participation in another ongoing MDMA-assisted therapy clinical trial.

Condition or disease Intervention/treatment
Post Traumatic Stress Disorder Drug: MDMA Behavioral: Psychotherapy

Detailed Description:

PTSD is a serious debilitating disorder that negatively impacts a person's daily life, and can result in diminished cognitive and psychosocial functioning, fractured relationships, inability to maintain employment, substance abuse, high-cost healthcare utilization, increased depression, and suicide risk. People who suffer from PTSD relive their traumatic experience(s) through nightmares and flashbacks, have difficulty sleeping, and feel detached or estranged. Symptoms can be severe and long lasting.

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 therapy may be especially useful for treating PTSD. The subjective effects of MDMA create a productive psychological state that enhances the therapeutic process.

This is an open-label, expanded access protocol for eligible patients with treatment-resistant PTSD. This protocol is designed to provide access to MDMA-assisted therapy for patients who are not eligible for participation in another ongoing MDMA-assisted therapy clinical trial. In addition, this study will provide supportive data on safety and tolerability of MDMA-assisted therapy in treatment-resistant patients with PTSD. The study will treat up to 50 patients. A flexible dose of MDMA, followed by a supplemental dose unless contraindicated, is administered during the Treatment Period with manualized therapy in up to three open-label Experimental Sessions. During the Treatment Period, each Experimental Session is preceded by three 90-minute Preparatory Sessions and followed by three 90-minute Integrative Sessions of non-drug therapy. Experimental Sessions will be followed by an overnight stay.

Study Design
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Study Type : Expanded Access
Expanded Access Type : Intermediate-size Population, Treatment IND/Protocol
Official Title: An Intermediate-size Multi-site Expanded Access Program for MDMA-assisted Psychotherapy for Patients With Treatment-resistant PTSD

Resource links provided by the National Library of Medicine


Interventions
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Intervention Details:
  • Drug: 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
    Other Name: 3,4-methylenedioxymethamphetamine
  • Behavioral: Psychotherapy
    Standardized non-directive psychotherapy performed by therapist team
Eligibility Criteria
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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
Criteria

Inclusion Criteria:

  • At Screening, meet criteria for PTSD diagnosis according to medical history and clinical interview and have at least moderate PTSD symptoms in the last month.
  • Have had at least two unsuccessful attempts at treatment for PTSD. Treatment attempts can consist of adequate dose and duration of medication treatment (at least 3 months of Paroxetine or Sertraline or other SSRI at dosages recommended in the package insert) or adequate duration of therapy treatment (at least 12 sessions of psychotherapy) or any combination of these two categories.
  • Are at least 18 years old.
  • Are fluent in speaking and reading a recognized language of the expanded access site.
  • Are able to swallow pills.
  • Agree to have study visits recorded, if applicable, including Experimental Sessions and non-drug therapy sessions.
  • 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 patient becoming suicidal or unreachable.
  • Must agree to inform the investigators within 48 hours of any medical conditions and procedures.
  • If a patient has the ability to become pregnant, they must have a negative pregnancy test at program entry and prior to each Experimental Session, and must agree to use adequate contraception through 10 days after the last Experimental Session.
  • 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 protocol without prior approval of the medical monitor, remain overnight at the site, or nearby location, after each Experimental Session and be driven home on the following day, and commit to medication dosing, therapy, and program procedures.
  • May have well-controlled hypertension that has been successfully treated with anti-hypertensive medicines, if they pass additional screening within the past year to rule out underlying cardiovascular disease.
  • May have asymptomatic Hepatitis C virus (HCV) that has previously undergone evaluation and treatment as needed.
  • May have current alcohol or substance use disorder if patient meets criteria for early remission prior to enrollment.
  • May have a history of or current Diabetes Mellitus (Type 1 or Type 2), if the patient passes additional screening to rule out underlying cardiovascular disease
  • May have hypothyroidism if taking adequate and stable thyroid replacement medication.
  • May have a history of, or current glaucoma, if approval for program participation is received from an ophthalmologist.

Exclusion Criteria:

  • Are not able to give adequate informed consent.
  • Have any current problem which, in the opinion of the investigator or medical monitor, might interfere with participation.
  • In the investigator's opinion, lack a stable living situation or supportive family/network.
  • Have evidence or history of significant medical and psychiatric disorders.
  • Any patient presenting current serious suicide risk.
  • Would present a serious risk to others as established through clinical interview and contact with treating psychiatrist.
  • Have evidence or history of significant hematological, endocrine, cerebrovascular, cardiovascular, coronary, pulmonary, renal, gastrointestinal, immunocompromising, or neurological disease, including seizure disorder, or any other medical disorder judged by the investigator to significantly increase the risk of MDMA.
  • Have a history of ventricular arrhythmia, other than occasional PVCs in the absence of ischemic heart disease, at any time or with a history of supraventricular arrhythmia within the past year.
  • Have a diagnosis of uncontrolled hypertension using the standard criteria of the American Heart Association for Stage 2 hypertension (values of 140/90 milligrams of Mercury [mmHg] or higher assessed on three separate occasions).
  • Have a marked baseline prolongation of QT/QTc interval (e.g., repeated demonstration of a QTc interval >450 milliseconds [ms] corrected by Fridericia's formula).
  • Have a history of additional risk factors for Torsade de pointes (e.g., heart failure, hypokalemia, family history of Long QT Syndrome).
  • Require use of concomitant medications that prolong the QT/QTc interval during Experimental Sessions.
  • Have symptomatic liver disease or have significant liver enzyme elevation.
  • Have a history of HCV that has not been evaluated and treated successfully if treatment is indicated.
  • Have history of hyponatremia or hyperthermia.
  • Are pregnant or nursing, or able to become pregnant and are not practicing an effective means of contraception.
Contacts and Locations
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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): NCT04438512


Contacts
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Contact: Recruitment Officer (831) 471-5091 eamp1inquiries@mapsbcorp.com

Locations
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United States, California
Sage Integrative Health Available
Berkeley, California, United States, 94705
Contact: Research Assistant    510-694-4253    ea@sageintegrativehealth.org   
Principal Investigator: James Henry         
Luminous Healing Center Available
Santa Cruz, California, United States, 95060
Contact: Research Assistant    831-454-8870    info@luminoushealingcenter.com   
Principal Investigator: Elizabeth Esalen         
Principal Investigator: Robert Grant         
United States, Maine
Riverbird Clinic Available
Portland, Maine, United States, 04102
Contact: Study Coordinator    207-370-1831    research@riverbirdclinic.com   
Principal Investigator: Selma Holden         
United States, Maryland
Sunstone Medical, PC Available
Rockville, Maryland, United States, 20850
Contact: Research Assistant    301-750-3401    research@sunstonetherapies.com   
Principal Investigator: Paul Thambi         
United States, North Carolina
Pearl Psychedelic Institute Available
Waynesville, North Carolina, United States, 28786
Contact: Study Coordinator    828-400-1029    program1@pearlpsychedelicinstitute.org   
Principal Investigator: Raymond Turpin         
Principal Investigator: Tiffany Sauls         
Sponsors and Collaborators
Multidisciplinary Association for Psychedelic Studies
Investigators
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Study Director: Linda Iovanni MAPS PBC
More Information
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Responsible Party: Multidisciplinary Association for Psychedelic Studies
ClinicalTrials.gov Identifier: NCT04438512    
Other Study ID Numbers: EA
First Posted: June 18, 2020    Key Record Dates
Last Update Posted: May 15, 2023
Last Verified: May 2023
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