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 17, 2020
|Condition or disease||Intervention/treatment|
|Post Traumatic Stress Disorder||Drug: MDMA Behavioral: Psychotherapy|
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|
|Official Title:||An Intermediate-size Multi-site Expanded Access Program for MDMA-assisted Psychotherapy for Patients With Treatment-resistant PTSD|
- 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 respectivelyOther Name: 3,4-methylenedioxymethamphetamine
- Behavioral: Psychotherapy
Standardized non-directive psychotherapy performed by therapist team
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
|Study Director:||Corine de Boer, MD||MAPS Public Benefit Corp.|