MDMA-assisted psychotherapy for treatment of anxiety and other psychological distress related to life-threatening illnesses: a randomized pilot study

Abstract The success of modern medicine creates a growing population of those suffering from life-threatening illnesses (LTI) who often experience anxiety, depression, and existential distress. We present a novel approach; investigating MDMA-assisted psychotherapy for the treatment of anxiety in peo...

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Autores principales:	Philip E. Wolfson, Julane Andries, Allison A. Feduccia, Lisa Jerome, Julie B. Wang, Emily Williams, Shannon C. Carlin, Evan Sola, Scott Hamilton, Berra Yazar-Klosinski, Amy Emerson, Michael C. Mithoefer, Rick Doblin
Formato:	article
Lenguaje:	EN
Publicado:	Nature Portfolio 2020
Materias:	Medicine R Science Q
Acceso en línea:	https://doaj.org/article/1d8c9d23513e47d292c58730dbf6fde5
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spelling	oai:doaj.org-article:1d8c9d23513e47d292c58730dbf6fde52021-12-02T16:08:54ZMDMA-assisted psychotherapy for treatment of anxiety and other psychological distress related to life-threatening illnesses: a randomized pilot study10.1038/s41598-020-75706-12045-2322https://doaj.org/article/1d8c9d23513e47d292c58730dbf6fde52020-11-01T00:00:00Zhttps://doi.org/10.1038/s41598-020-75706-1https://doaj.org/toc/2045-2322Abstract The success of modern medicine creates a growing population of those suffering from life-threatening illnesses (LTI) who often experience anxiety, depression, and existential distress. We present a novel approach; investigating MDMA-assisted psychotherapy for the treatment of anxiety in people with an LTI. Participants with anxiety from an LTI were randomized in a double-blind study to receive MDMA (125 mg, n = 13) or placebo (n = 5) in combination with two 8-h psychotherapy sessions. The primary outcome was change in State-Trait Anxiety Inventory (STAI) Trait scores from baseline to one month post the second experimental session. After unblinding, participants in the MDMA group had one open-label MDMA session and placebo participants crossed over to receive three open-label MDMA sessions. Additional follow-up assessments occurred six and twelve months after a participant’s last experimental session. At the primary endpoint, the MDMA group had a greater mean (SD) reduction in STAI-Trait scores, − 23.5 (13.2), indicating less anxiety, compared to placebo group, − 8.8 (14.7); results did not reach a significant group difference (p = .056). Hedges’ g between-group effect size was 1.03 (95% CI: − 5.25, 7.31). Overall, MDMA was well-tolerated in this sample. These preliminary findings can inform development of larger clinical trials to further examine MDMA-assisted psychotherapy as a novel approach to treat individuals with LTI-related anxiety. Trial Registration: clinicaltrials.gov Identifier: NCT02427568, first registered April 28, 2015.Philip E. WolfsonJulane AndriesAllison A. FeducciaLisa JeromeJulie B. WangEmily WilliamsShannon C. CarlinEvan SolaScott HamiltonBerra Yazar-KlosinskiAmy EmersonMichael C. MithoeferRick DoblinNature PortfolioarticleMedicineRScienceQENScientific Reports, Vol 10, Iss 1, Pp 1-15 (2020)
institution	DOAJ
collection	DOAJ
language	EN
topic	Medicine R Science Q
spellingShingle	Medicine R Science Q Philip E. Wolfson Julane Andries Allison A. Feduccia Lisa Jerome Julie B. Wang Emily Williams Shannon C. Carlin Evan Sola Scott Hamilton Berra Yazar-Klosinski Amy Emerson Michael C. Mithoefer Rick Doblin MDMA-assisted psychotherapy for treatment of anxiety and other psychological distress related to life-threatening illnesses: a randomized pilot study
description	Abstract The success of modern medicine creates a growing population of those suffering from life-threatening illnesses (LTI) who often experience anxiety, depression, and existential distress. We present a novel approach; investigating MDMA-assisted psychotherapy for the treatment of anxiety in people with an LTI. Participants with anxiety from an LTI were randomized in a double-blind study to receive MDMA (125 mg, n = 13) or placebo (n = 5) in combination with two 8-h psychotherapy sessions. The primary outcome was change in State-Trait Anxiety Inventory (STAI) Trait scores from baseline to one month post the second experimental session. After unblinding, participants in the MDMA group had one open-label MDMA session and placebo participants crossed over to receive three open-label MDMA sessions. Additional follow-up assessments occurred six and twelve months after a participant’s last experimental session. At the primary endpoint, the MDMA group had a greater mean (SD) reduction in STAI-Trait scores, − 23.5 (13.2), indicating less anxiety, compared to placebo group, − 8.8 (14.7); results did not reach a significant group difference (p = .056). Hedges’ g between-group effect size was 1.03 (95% CI: − 5.25, 7.31). Overall, MDMA was well-tolerated in this sample. These preliminary findings can inform development of larger clinical trials to further examine MDMA-assisted psychotherapy as a novel approach to treat individuals with LTI-related anxiety. Trial Registration: clinicaltrials.gov Identifier: NCT02427568, first registered April 28, 2015.
format	article
author	Philip E. Wolfson Julane Andries Allison A. Feduccia Lisa Jerome Julie B. Wang Emily Williams Shannon C. Carlin Evan Sola Scott Hamilton Berra Yazar-Klosinski Amy Emerson Michael C. Mithoefer Rick Doblin
author_facet	Philip E. Wolfson Julane Andries Allison A. Feduccia Lisa Jerome Julie B. Wang Emily Williams Shannon C. Carlin Evan Sola Scott Hamilton Berra Yazar-Klosinski Amy Emerson Michael C. Mithoefer Rick Doblin
author_sort	Philip E. Wolfson
title	MDMA-assisted psychotherapy for treatment of anxiety and other psychological distress related to life-threatening illnesses: a randomized pilot study
title_short	MDMA-assisted psychotherapy for treatment of anxiety and other psychological distress related to life-threatening illnesses: a randomized pilot study
title_full	MDMA-assisted psychotherapy for treatment of anxiety and other psychological distress related to life-threatening illnesses: a randomized pilot study
title_fullStr	MDMA-assisted psychotherapy for treatment of anxiety and other psychological distress related to life-threatening illnesses: a randomized pilot study
title_full_unstemmed	MDMA-assisted psychotherapy for treatment of anxiety and other psychological distress related to life-threatening illnesses: a randomized pilot study
title_sort	mdma-assisted psychotherapy for treatment of anxiety and other psychological distress related to life-threatening illnesses: a randomized pilot study
publisher	Nature Portfolio
publishDate	2020
url	https://doaj.org/article/1d8c9d23513e47d292c58730dbf6fde5
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MDMA-assisted psychotherapy for treatment of anxiety and other psychological distress related to life-threatening illnesses: a randomized pilot study

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