The American journal of psychiatry
January 1, 2025
Aaron Wolfgang, Gregory A. Fonzo, Joshua C. Gray et al.
47 citations
MDMA-assisted therapy (MDMA-AT) using pharmaceutical-grade MDMA in controlled clinical settings is a safe and efficacious treatment for PTSD. After three MDMA administrations supported by psychotherapy, 67%–71% of individuals with PTSD no longer meet diagnostic criteria, compared with 32%–48% for placebo-assisted therapy, and effects persist at long-term follow-up. Unlike recreational use, which is confounded by adulterants and lack of precautions, MDMA-AT uniquely induces prosocial effects of trust and self-compassion while maintaining cognitive clarity. The review distinguishes evidence from recreational and therapeutic settings, describes neurobiological mechanisms, clinical evidence, public health and policy considerations, and future research directions.
Current Psychiatry Reports
October 1, 2023
Aaron Wolfgang, Charles W Hoge
15 citations
MDMA- and psilocybin-assisted therapy have shown promising outcomes for PTSD and depression, respectively. MDMA-assisted therapy is already FDA-approved on a compassionate use basis for PTSD, with full approval projected for 2024; psilocybin-assisted therapy is projected to be approved for depression soon after. The VA is conducting clinical trials, but implementation barriers include high clinical hours per patient, resource requirements, military-specific considerations, and the need for strong evidence before inclusion in clinical guidelines. Policymakers in the DoD and VA must prepare clear policies for these treatments as FDA approval approaches.
American Journal of Psychiatry
January 1, 2025
Adrienne Grzenda, Gregory A. Fonzo, Aaron Wolfgang et al.
14 citations
Current evidence does not support recommending psilocybin combined with psychological support (PST) as a psychiatric treatment. More rigorous clinical trials are needed to confirm its effectiveness in larger and more diverse patient groups, determine appropriate dosing, improve blinding methods, and understand how it works and for whom it works best. Comparing it directly with other proven treatments will clarify its potential future role in treating major psychiatric disorders.
Military Medicine
December 24, 2022
Joshua C. Gray, Mikela A. Murphy, Sierra Carter et al.
10 citations
Service members and veterans with traumatic brain injury and co-occurring symptoms initially held neutral views of psychedelic drugs and psychedelic-assisted therapies (PAT). After a brief psychoeducation session, their views of psychedelic drugs and interest in PAT became significantly more positive. Most participants supported making PAT available in medical settings if proven beneficial and would support a loved one engaging in PAT. The most common health concerns were long-term effects (43%), fear of losing one's mind (33%), fear of personality changes (33%), and fear of traumatic brain injury complications (24%). Logistical barriers included time, transportation, finances, work, and childcare, though 48% reported no barriers.
Am J Psychiatry
January 1, 2025
Aaron Wolfgang, Vetisha L. McClair, Paula P. Schnurr et al.
6 citations
The Veterans Health Administration (VHA) is exploring the integration of psychedelic-assisted therapy as a potential treatment for veterans with mental health conditions, particularly PTSD. The text outlines the need for careful research and implementation strategies within the VHA system, emphasizing safe integration, care pathways, and the development of clinical protocols. It highlights the importance of addressing regulatory, ethical, and logistical challenges to ensure veteran well-being and recovery. The work suggests that psychedelic-assisted therapies could offer innovative treatment options, but rigorous study and structured implementation are necessary before widespread adoption.
Journal of Medical Ethics
May 30, 2023
Scott Hoener, Aaron Wolfgang, David A. Nissan et al.
6 citations
Psychedelic-assisted therapies, particularly with MDMA and psilocybin, show rapid, durable, and cost-effective results for conditions like PTSD and major depression in clinical trials. Researchers are now interested in applying these treatments to active-duty US military personnel with treatment-resistant mental health issues, though psychedelics remain unapproved for general use. Unique ethical concerns arise for service members, including informed consent, confidentiality, deployability, and unanticipated psychological risks. The authors argue that MDMA-assisted therapy is a promising option that warrants accelerated investigation for military use, while cautioning that military-specific uncertainties must be carefully addressed.
Cureus
June 28, 2022
Ann M. Inouye, Aaron Wolfgang
5 citations
The Food and Drug Administration granted breakthrough therapy status to MDMA-assisted therapy in 2017 based on early evidence for treating PTSD. Across six phase-II trials, 54% of participants receiving a full dose no longer met PTSD diagnosis after two sessions, compared to 23% in the control group. In the first phase-III trial, 67% no longer met criteria after three sessions. Effects persisted: 67% remained undiagnosable after one year and 74% after nearly four years. The therapy was being fast-tracked for potential FDA approval by 2023. Hawaii's 2021 Senate Bill 738, which unsuccessfully sought to reschedule psilocybin for major depressive disorder, highlighted that MDMA, also a Schedule I substance, could benefit Hawaii residents.
Biol Psychiatry
August 1, 2021
Luke G. Petry, Monica Sharma, Aaron Wolfgang et al.
4 citations
The text critically examines the use of MDMA in therapeutic contexts, arguing that the current enthusiasm for MDMA-assisted therapy may overlook significant risks and methodological shortcomings. It questions the robustness of evidence supporting its efficacy for conditions like PTSD, highlighting issues such as small sample sizes, lack of long-term safety data, and potential for adverse effects. The author suggests that a sober, evidence-based evaluation is necessary before embracing MDMA as a treatment, emphasizing the need for rigorous research and caution against premature adoption.
Cleve Clin J Med
April 1, 2025
Nicole Cornish, Tara Coles, M. Jennifer Cheng et al.
3 citations
Recent clinical trials on psychedelic-assisted therapy have sparked interest in using psychedelics to address nonphysical suffering, particularly spiritual and existential distress at the end of life. The authors examine the medical, ethical, and legal dimensions of employing psychedelics to relieve such suffering, aiming to encourage further discussion and research on this clinically promising approach.
Journal of Psychedelic Studies
February 5, 2024
Ann M. Inouye, Aaron Wolfgang, Lianne T. Philhower
1 citation
In 2021, phase 3 clinical trials of MDMA-assisted therapy for treatment-resistant PTSD found that 71.2% of full-dose participants no longer met PTSD criteria. Although MDMA-assisted therapy is not FDA-approved for borderline personality disorder, its beneficial effects might be applicable. An exploratory, qualitative, interview-based study examined clinicians' perspectives by interviewing two dialectical behavioral therapy clinicians and two MDMA-assisted therapy clinicians. The study assessed underlying therapeutic mechanisms, pharmacological factors, and treatment context to improve clinical responses. Participants' codes revealed a chronological narrative with three treatment phases.
Journal of Psychedelic Studies
December 14, 2023
Ann M. Inouye, Aaron Wolfgang, Lianne T. Philhower
1 citation
Borderline personality disorder (BPD) is often misunderstood, misdiagnosed, and stigmatized, with 25–58% of individuals also having post-traumatic stress disorder (PTSD). In Phase 3 clinical trials, up to 71.2% of full-dose MDMA participants for treatment-resistant PTSD no longer met PTSD criteria. This qualitative study interviewed two clinicians treating BPD and two MDMA-assisted therapy clinicians, exploring overlaps in etiology and conceptualization. Through eight interviews, perspectives revealed similarities and limitations of both dialectical behavioral therapy and MDMA-assisted therapy.