Psychedelic-assisted therapy (PAT) is gaining recognition as a promising intervention for treatment-refractory mental health conditions in adults. While interest in its applications for adolescents is growing, critical gaps remain in understanding safe and effective delivery of PAT to this vulnerable population, including implications for caregiver/family (used interchangeably) involvement in...
This trial aimed to assess the efficacy of lysergic acid diethylamide (LSD)-assisted therapy in patients with moderate-to-severe major depressive disorder. This was a randomized, parallel, double-blind, low-dose controlled trial (Clinicaltrials.gov: NCT03866252). Patients were randomly assigned in a 1:1 ratio to receive supportive psychotherapy and either 100 μg + 200 μg LSD or 25 μg + 25 μg...
Psychedelic substances exhibit complex interactions with the 'set and setting' of use, that is, the mental state of the user and the environment in which a psychedelic experience takes place. Despite these contextual variables' known importance, psychedelic research has lacked methodological rigor in reporting extra-pharmacological factors. This study aimed to generate consensus-based...
The incidence of psychiatric disorders, such as post-traumatic stress disorder (PTSD), anxiety, and depression, has been steadily increasing, while current treatment approaches remain limited in efficacy. As a result, there is an urgent need to explore more effective therapeutic interventions. In recent years, MDMA (3,4- methylenedioxymethamphetamine)-assisted therapy (MDMA-AT) has emerged as a...
With several classical psychedelics being designated as breakthrough therapies and the recent review of a New Drug Application for 3,4-Methylenedioxymethamphetamine in the treatment of posttraumatic stress disorder, the likelihood of psychedelic medication becoming approved for clinical use in the United States is high. Psychedelic-assisted therapy (PAT) may have a high demand in rural America,...
Black Americans are significantly underrepresented in psychedelic trials despite significant mental health disparities. Growing research suggests that psychedelic-assisted therapy (PAT) is an effective treatment for post-traumatic stress disorder and depression. It is important to understand perceptions of PAT among populations with unmet mental health needs. We conducted four focus groups to...
Psilocybin, a serotonergic psychedelic, may have therapeutic benefits for Substance Use Disorders (SUDs), but its overall efficacy and safety remain uncertain. This systematic review assessed the safety and efficacy of psilocybin for SUDs through a systematic database search conducted via OVID on May 22, 2024, and summarized 26 ongoing clinical trials registered on clinicaltrials.gov. Among 16...
ABSTRACT Psychedelic-assisted therapy is an emerging and promising field for the treatment of various psychological disorders. The concept of integration is integral to the success of such interventions. While the term integration is used frequently and in numerous ways within clinical literature, it remains poorly defined, and inconsistency in its use has led to confusion in practice. This...
Current antidepressants have shown certain limitations in the treatment of unipolar depression. Their long onset of action, interactions, and side effects are obstacles to achieving lasting remission of this prevalent, often chronic or recurrent, pathology. Faced with this clinical necessity, research efforts have intensified in recent years around psychedelic drugs, with a particular focus on...
The therapeutic use of psychedelics for mental health issues holds considerable promise. However, systematic assessment of adverse events associated with these substances has received relatively little attention. Here, we discuss several considerations concerning the assessment of adverse events in psychedelic-assisted therapies. We discuss the preference for using the term "adverse effects"...
Abstract Music is integral to Psilocybin-assisted psychotherapy (PAP), believed to enhance therapeutic outcomes by structuring experiences and facilitating emotional expression. However, the effects of conducting PAP without music are underexplored. This study examines the experiences of two breast cancer patients undergoing psilocybin therapy under Canada's compassionate access program,...
Safety and tolerability data from the first open-label feasibility study of 3,4-methylenedioxymethamphetamine (MDMA)-assisted psychotherapy for alcohol use disorder was recently published. This paper presents a Bayesian analysis of the impact of MDMA-assisted psychotherapy on treatment success, defined as 2-level reduction in the World Health Organization (WHO) drinking risk at the 3 months...
Psychedelics offer promising outcomes in psychiatry. However, the preparation of participants (set) and the environmental conditions of taking a psychedelic (setting) are not standardized. We describe the set and setting for therapeutic use of psychedelic drugs in people with psychiatric disorders. In this systematic review, articles were identified in the PubMed and Web of Science databases...
DMT induces rapid antidepressant effects, but acute sympathomimetic side effects, particularly hypertension and tachycardia, limit its use. This study describes coformulations with short-acting beta-blockers or nitrates, matched to DMT's pharmacokinetics, to mitigate peripheral cardiovascular risks without compromising central therapeutic action, facilitating safer psychedelic therapy in...
Australia has become the first country to approve the use of psychedelics, namely MDMA and psilocybin, for clinical treatment of post-traumatic stress disorder and treatment-resistant depression. Here, we briefly explore the history of its use, how it works, and the hope it may provide people receiving end-of-life care.
This paper is an edited transcript of a plenary panel held at the 2024 Annual Meeting of the International Society for Traumatic Stress Studies (ISTSS) in Boston, Massachusetts, United States. The panel comprised Drs. Mark Creamer (moderator), Richard Bryant (convenor), Amy Lehrner, Barbara O. Rothbaum, Joseph I. Ruzek, and Paula P. Schnurr. Bringing together clinicians and researchers with a...
Psychedelic therapies are promising new treatment options in psychiatry. Including the use of physical touch as part of treatment is an area of debate. This study aimed to characterize the viewpoints of practitioners on the use of touch in psychedelic therapy. An anonymous survey was distributed via e-mail to the contacts listed on ClinicalTrials.gov for trials of psilocybin and lysergic acid...
Abstract Purpose of the review Treatment-resistant depression (TRD) is a challenging condition characterized by minimal improvement despite two or more antidepressant trials. Ketamine-assisted psychotherapy (KAP) integrates the rapid antidepressant effects of ketamine with psychotherapy to enhance and sustain therapeutic outcomes. This systematic review evaluates the effectiveness of KAP in...
ABSTRACT Background Alcohol Use Disorder (AUD) is a widespread condition with serious health, social, and economic impacts, often marked by relapse despite the availability of FDA-approved treatments. Recent studies suggest that psychedelic substances, such as psilocybin, Lysergic acid diethylamide (LSD), ayahuasca, etc. may offer novel therapeutic potential in treating AUD by modulating...
Socioeconomic status (SES) substantially influences mental health outcomes and treatment access, yet its reporting in psychedelic-assisted therapy trials remains underexplored. Here we systematically reviewed 98 articles (49 primary trials and 49 secondary analyses) published between 2006 and 2024 examining classic psychedelics and MDMA for mental health conditions. Only 12% of primary trials...