Evidence map›Paper›PMID 33235285›Full record

Trial reportScientific reports2020

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

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 and 3 more

2 registry-linked trialsOpen access · goldAbstract readClinical Trial, Phase IIRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Scientific reports, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 60 papers, 13 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
60citing papers in PubMed, 13 pooled it
5.1field-weighted citation impact, top 3% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT02427568 phase2completednot on this map

A Randomized, Double-Blind, Placebo-Controlled Phase 2 Pilot Study of MDMA-Assisted Psychotherapy for Anxiety Associated With a Life-Threatening Illness

TypeinterventionalSponsorResilient PharmaceuticalsRan2015 to 2018Enrolled18ConditionsAnxietyArmsMidomafetamine HCl, Placebo, Therapy
NCT05214417 phase2unknown statusnot on this mapstarted 2022, after this paper: background citation

Conscious Dying/Conscious Living: Ketamine-Assisted Psychotherapy (KAP) for Patients at End of Life-A Pilot Study for Palliative and Hospice Care

TypeinterventionalSponsorThe Ketamine Research FoundationRan2022 to 2024Enrolled120ConditionsIllness TerminalArmsKetamine Injectable Solution, Naturalistic Control
3 · Its place in the literature

Who cites it

60 citing papers in PubMed, 13 syntheses or guidelines pooled it, 165 citations in OpenAlex.

  1. Pooled it
  2. Magnitude of response in treatment and control groups within psychedelic trials for psychiatric disorders: A meta-analysis.European psychiatry : the journal of the Association of European Psychiatrists · 2026
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  8. Side-effects of mdma-assisted psychotherapy: a systematic review and meta-analysis.Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology · 2024
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  14. Trial
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  16. Oncology Providers' Perspectives on Psychedelic-Assisted Therapy.The American journal of hospice & palliative care · 2026
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

13 authors at 5 institutions in 1 country.

Philip E WolfsonCenter for Transformational Psychotherapy, San Anselmo, CA, USA.
Julane AndriesCenter for Transformational Psychotherapy, San Anselmo, CA, USA.
Allison A FeducciaMAPS Public Benefit Corporation, Santa Cruz, CA, USA.
Lisa JeromeMAPS Public Benefit Corporation, Santa Cruz, CA, USA.
Julie B WangMAPS Public Benefit Corporation, Santa Cruz, CA, USA. juliewang@mapsbcorp.com.
Emily WilliamsDepartment of Psychiatry, University of California, San Francisco, CA, USA.
Shannon C CarlinMAPS Public Benefit Corporation, Santa Cruz, CA, USA.
Evan SolaPrivate Practice, San Francisco, CA, USA.
Scott HamiltonStanford School of Medicine, Stanford Stroke Center, Palo Alto, CA, USA.
Berra Yazar-KlosinskiMultidisciplinary Association for Psychedelic Studies, Santa Cruz, CA, USA.
Amy EmersonMAPS Public Benefit Corporation, Santa Cruz, CA, USA.
Michael C MithoeferMedical University of South Carolina, Charleston, SC, USA.
Rick DoblinMultidisciplinary Association for Psychedelic Studies, Santa Cruz, CA, USA.
Public Service Electric and Gas (United States) · USMultidisciplinary Association for Psychedelic Studies · USMedical University of South Carolina · USStanford Medicine · USUniversity of California, San Francisco · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

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.

Indexed as

AdultAnxietyCombined Modality TherapyCross-Over StudiesDouble-Blind MethodFemaleHumansMaleMiddle AgedNeoplasmsNervous System DiseasesN-Methyl-3,4-methylenedioxyamphetaminePilot ProjectsPsychiatric Status Rating ScalesPsychotherapyTreatment OutcomeN-Methyl-3,4-methylenedioxyamphetamine

Identifiers

PMID33235285
PMCPMC7686344
OpenAlexW3107917596

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.