A Multi-site Expanded Access Program for MDMA-assisted Psychotherapy for Patients With Treatment-resistant PTSD (EAMP1)
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|ClinicalTrials.gov Identifier: NCT04438512|
Expanded Access Status : Temporarily not available
First Posted : June 18, 2020
Last Update Posted : November 10, 2021
|First Submitted Date||February 25, 2020|
|First Posted Date||June 18, 2020|
|Last Update Posted Date||November 10, 2021|
|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.|
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|
|Publications *||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|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|
|Responsible Party||Multidisciplinary Association for Psychedelic Studies|
|Study Sponsor||Multidisciplinary Association for Psychedelic Studies|
|PRS Account||Multidisciplinary Association for Psychedelic Studies|
|Verification Date||November 2021|