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

This is an open-labelled, 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.

Trial Details

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-labelled, 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 the safety and tolerability of MDMA-assisted psychotherapy in treatment-resistant patients with PTSD. The study will enrol up to 50 patients. A flexible-dose of MDMA, followed by a supplemental half-dose unless contraindicated, is administered during the 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-minute integrative Sessions of non-drug psychotherapy. Experimental Sessions will be followed by an overnight stay.

NCT Number NCT04438512

Data attribution

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