There is growing interest in incorporating MDMA (3,4-Methylenedioxymethamphetamine) into structured, evidence-based cognitive-behavioral treatment protocols for post-traumatic stress disorder. Yet this risks overlooking the distinctive qualities of MDMA-assisted therapy, which has already demonstrated strong clinical effects, high response rates, and low dropout using a principle-guided,...
The original MAPS manual for MDMA-assisted therapy (MDMA-AT) opened a therapeutic frontier for PTSD. However, it drew critique for concepts—such as “inner healing intelligence” – that originated in transpersonal traditions rather than academic or empirically grounded clinical models. While many patients found the therapies helpful, these constructs were difficult to interpret and standardize....
Post-traumatic stress disorder (PTSD) is a debilitating condition leading to significant personal and societal burden. Standard treatments frequently demonstrate limited efficacy, leading to persistent symptoms and high dropout rates. Psilocybin has shown promise in treating depression, a condition that is often comorbid with PTSD. We aimed to explore participant experiences of psilocybin...
Background: Post-traumatic stress disorder (PTSD) is a debilitating condition for which there are few efficacious treatments. Psilocybin is being studied for use in treatment-resistant depression but has not yet been investigated in PTSD. Aims: The trial’s primary outcome was to investigate the safety and tolerability of single-dose psilocybin in participants with PTSD. Methods: This was a...
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Objective: This open-label clinical trial examined the preliminary efficacy of combining a course of 6 ketamine infusions with a brief, evidence-based exposure-based psychotherapy-written exposure therapy (WET)-in patients with chronic posttraumatic stress disorder (PTSD). Methods: The trial was conducted between June 2021 and October 2023. Patients with chronic PTSD and high-moderate to severe...
There is notable controversy about the role of psychotherapy in clinical trials of psychedelic-assisted therapy (PAT). This heated and perpetually evolving debate informs questions such as how much therapy should accompany a psychedelic intervention (Marseille et al. , 2022), what type of therapy most effectively complements psychedelic administration (Cavarra et al. , 2022;Yaden et al. ,...
We sought to identify patterns of psychedelic use among United States military veterans, compare demographic variables and perspectives of those who did and did not report use, and characterize benefits and adverse outcomes associated with use. Respondents (N = 426) were recruited to complete an online cross-sectional survey. Approximately one-half (51%) reported using psychedelics. Most did so...
Introduction There is a resurgence of interest in the therapeutic potential of psychedelic substances such as 3,4-methylenedioxymethamphetamine (MDMA). Primary findings from our randomized, double-blind, placebo-controlled, multi-site Phase 3 clinical trial of participants with severe PTSD (NCT03537014) showed that MDMA-assisted therapy induced significant attenuation in the...
Abstract: Post-traumatic stress disorder (PTSD) is a mental health condition that can occur following exposure to a traumatic experience. An estimated 12 million U.S. adults are presently affected by this disorder. Current treatments include psychological therapies (e.g., exposure-based interventions) and pharmacological treatments (e.g., selective serotonin reuptake inhibitors (SSRIs))....
The reemergence of psychedelic medicines as clinical treatments has generated considerable interest in both professional and popular arenas. Although evidence is promising for psychedelic-assisted therapy (PAT), there is much that is not yet known and needs to be researched so as to understand how to safely and effectively utilize PAT in clinical populations and to most effectively deploy PAT...
Introduction: The field of psychedelic research and therapy is growing at an unprecedented rate, as is the need for shared terminology to allow for coherent conversations about these medicines. However, proclaiming consensus definitions at the present time may be a premature closure, limiting the possibility of what psychedelics can teach about the mind and brain. Objective: Our goal in this...
An increasing number of clinicians and researchers have become interested in the potential of psychedelic drugs for the treatment of mental health disorders, including depression, anxiety, posttraumatic stress disorder, eating disorders, and addictions.1,2
As psychedelic compounds gain traction in psychiatry, there is a need to consider the active mechanism to explain the effect observed in randomized clinical trials. Traditionally, biological psychiatry has asked how compounds affect the causal pathways of illness to reduce symptoms and therefore focus on analysis of the pharmacologic properties. In psychedelic-assisted psychotherapy (PAP),...
Introduction: A resurgence of interest in the use of psychedelics for mental health and wellness has stimulated greater experimentation with psychedelics in society. Although clinical psychedelic trials protect research participants by offering a safe setting, thorough preparation, and containment during and after ingestion of psychedelic medicines, many try these substances without the benefit...
BackgroundPrevious research has demonstrated that epigenetic changes in specific hypothalamic-pituitary-adrenal (HPA) genes may predict successful psychotherapy in post-traumatic stress disorder (PTSD). A recent Phase 3 clinical trial reported high efficacy of 3,4-methylenedioxymethamphetamine (MDMA)-assisted therapy for treating patients with severe PTSD compared to a therapy with placebo...
In recent years there has been a resurgence of interest in the therapeutic potential of psychedelic substances such as 3,4-methylenedioxymethamphetamine (MDMA). This renaissance of psychedelic studies opens the door for a new paradigm in psychiatric medicine: drug-facilitated psychotherapy. In this study we report the findings of a randomized, double-blind, placebo-controlled, multi-site Phase...
As psychedelic compounds gain traction in psychiatry, there is a need to consider the active mechanism to explain the effect observed in randomized clinical trials. Traditionally, biological psychiatry has asked how compounds affect the causal pathways of illness to reduce symptoms and therefore focus on analysis of the pharmacologic properties. In psychedelic-assisted psychotherapy (PAP),...
Many biological systems are altered in association with Posttraumatic Stress Disorder (PTSD) and resilience. However, there are only few approved pharmacological treatments for PTSD, and no approved medications to enhance resilience. This paper provides a critical review of select neurobiological findings in PTSD and resilience, and also of pharmacologic approaches that have emerged from this...