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Bruce Poulter

6 papers in the library · 1,316 citations · publishing 2018-2024

Papers

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The conceptual framework for the therapeutic approach used in phase 3 trials of MDMA-assisted therapy for PTSD.

Frontiers in Psychology 2024 Kelley C O'Donnell, Lauren Okano, Michael Alpert et al.

Results from multiple recent studies support further evaluation of 3,4-methylenedioxymethamphetamine (MDMA) in conjunction with psychotherapy (i.e., MDMA-Assisted Therapy) in the treatment of post-traumatic stress disorder (PTSD). In two Phase 3 trials, MDMA-Assisted Therapy comprised a short-term, intensive psychotherapy that included three sessions directly facilitated by MDMA (referred to as...

MDMA-Assisted Therapy for Severe PTSD: A Randomized, Double-Blind, Placebo-Controlled Phase 3 Study.

Focus (American Psychiatric Publishing) July 1, 2023 Jennifer Mitchell, Michael P. Bogenschutz, Alia Lilienstein et al. 97 citations

Post-traumatic stress disorder (PTSD) presents a major public health problem for which currently available treatments are modestly effective. We report the findings of a randomized, double-blind, placebo-controlled, multi-site phase 3 clinical trial (NCT03537014) to test the efficacy and safety of 3,4-methylenedioxymethamphetamine (MDMA)-assisted therapy for the treatment of patients with...

Scaling Up: Multisite Open-Label Clinical Trials of MDMA-Assisted Therapy for Severe Posttraumatic Stress Disorder

Journal of Humanistic Psychology June 23, 2021 Julie B. Wang, Jessica Lin, Leah Bedrosian et al. 22 citations

Background: Posttraumatic stress disorder (PTSD) is a debilitating mental health condition associated with serious adverse health outcomes and functional impairment. Previous MDMA–assisted therapy (MDMA-AT) studies have shown promising results in single site studies. Two open-label studies tested this modality in multisite clinical trials to assess the feasibility of scaling this manualized...

MDMA-assisted therapy for severe PTSD: a randomized, double-blind, placebo-controlled phase 3 study.

Nature Medicine June 1, 2021 Jennifer Mitchell, Michael P. Bogenschutz, Alia Lilienstein et al. 965 citations

Post-traumatic stress disorder (PTSD) presents a major public health problem for which currently available treatments are modestly effective. We report the findings of a randomized, double-blind, placebo-controlled, multi-site phase 3 clinical trial (NCT03537014) to test the efficacy and safety of 3,4-methylenedioxymethamphetamine (MDMA)-assisted therapy for the treatment of patients with...

3,4-Methylenedioxymethamphetamine-assisted psychotherapy for treatment of chronic posttraumatic stress disorder: A randomized phase 2 controlled trial.

Journal of psychopharmacology (Oxford, England) December 1, 2018 Marcela Ot'Alora G, Jim Grigsby, Bruce Poulter et al. 232 citations

Posttraumatic stress disorder often does not resolve after conventional psychotherapies or pharmacotherapies. Pilot studies have reported that 3,4-methylenedioxymethamphetamine (MDMA) combined with psychotherapy reduces posttraumatic stress disorder symptoms. This pilot dose response trial assessed efficacy and safety of MDMA-assisted psychotherapy across multiple therapy teams. Twenty-eight...

The Conceptual Framework for the Therapeutic Approach used in Phase 3 Trials of MDMA-AT for PTSD

Kelley C O'Donnell, Michael Alpert, Lauren Okano et al. preprint

Results from multiple recent studies support the use of 3,4-methylenedioxymethamphetamine (MDMA) in conjunction with psychotherapy (i.e., MDMA-Assisted Therapy) in the treatment of post-traumatic stress disorder (PTSD). In two Phase 3 trials, MDMA-Assisted Therapy comprised a short-term, intensive psychotherapy that included three sessions directly facilitated by MDMA (referred to as...