Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04438512
Expanded Access Status : Temporarily not available
First Posted : June 18, 2020
Last Update Posted : November 10, 2021
Sponsor:
Information provided by (Responsible Party):
Multidisciplinary Association for Psychedelic Studies

Tracking Information
First Submitted Date February 25, 2020
First Posted Date June 18, 2020
Last Update Posted Date November 10, 2021
 
Descriptive Information
Brief Title A Multi-site Expanded Access Program for MDMA-assisted Psychotherapy for Patients With Treatment-resistant PTSD
Brief Summary This is an open-labeled, expanded access protocol for eligible patients with treatment resistant PTSD. This protocol is designed to provide access to MDMA-assisted psychotherapy to patients who are not eligible for participation in another ongoing MDMA-assisted psychotherapy clinical trial.
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 psychotherapy 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-labeled, expanded access protocol with the primary purpose of providing MDMA-assisted psychotherapy to patients with treatment-resistant PTSD, who are not eligible for participation in another ongoing MDMA-assisted psychotherapy clinical trial. In addition, this study will provide supportive data on safety and tolerability of MDMA-assisted psychotherapy in treatment-resistant patients with PTSD. The study will enroll up to 50 patients. A flexible dose of MDMA, followed by a supplemental half-dose unless contraindicated, is administered duringthe Treatment Period with manualized psychotherapy 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-minuteIntegrative Sessions of non-drug psychotherapy. Experimental Sessions will be followed by an overnight stay.

Study Type Expanded Access
Expanded Access Type Intermediate-size Population, Treatment IND/Protocol
Intervention
  • 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Expanded Access Status Temporarily not available
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT04438512
Responsible Party Multidisciplinary Association for Psychedelic Studies
Study Sponsor Multidisciplinary Association for Psychedelic Studies
Collaborators Not Provided
Investigators
Study Director: Corine de Boer, MD MAPS Public Benefit Corp.
PRS Account Multidisciplinary Association for Psychedelic Studies
Verification Date November 2021