Psilocybin has received increased attention as a potential therapeutic intervention, but it is unclear whether news media reporting reflects the strengths and limitations of the clinical trial evidence. To describe the annual counts of published clinical trials of therapeutic psilocybin and contemporaneous media articles and compare tone, efficacy, and safety messaging. This systematic review...
This cross-sectional study describes health outcomes attributed to recent use of psilocybin, lysergic acid diethylamide (LSD), 3,4-methylenedioxymethamphetamine (MDMA), ibogaine, and 5-methoxy-N,N-dimethyltryptamine (5-MeO-DMT) in a nationally representative survey of US adults.
Ketamine exerts rapid antidepressant effects. However, currently available ketamine-based treatments are associated with dissociative and cardiovascular adverse effects. To evaluate the antidepressant efficacy and tolerability of KET01, a novel, oral, prolonged-release racemic ketamine tablet formulation. KET01-03 was an active-comparator, double-blind, double-dummy, crossover phase 1...
Importance: Psilocybin has been proposed as a rapid-acting antidepressant (onset 6 weeks), but evidence from randomized clinical trials remains limited, particularly in the broader major depressive disorder (MDD) population. Objective: To assess short-term and long-term antidepressant effects of psilocybin therapy in patients with MDD. Design, Setting, and Participants: This double-blind,...
Importance: Cocaine use disorder is a serious public health problem and no medications have been proven effective for its treatment. Objective: To evaluate psilocybin in the treatment of cocaine use disorder. It was hypothesized that psilocybin, compared with placebo, would yield a higher percentage of cocaine abstinent days, a greater likelihood of complete abstinence from cocaine, and a...
Simultaneous cannabis and alcohol use (co-use) is a public safety concern. Controlled data on the effects of co-ingestion of oral cannabis products (edibles) with alcohol are lacking, despite an increased prevalence of this behavior. To evaluate the individual and interactive effects of cannabis edibles and alcohol on simulated driving and subjective and objective impairment measures. This...
Importance: Annual tobacco-related death estimates are 480 000 in the US and 8 million worldwide, surpassing mortality for other abused substances. Most smoking cessation interventions result in modest long-term success. Objective: To compare prolonged smoking abstinence rates in smokers receiving psilocybin plus cognitive behavioral therapy (CBT) with those receiving the nicotine patch plus...
JAMA Network OpenJanuary 2, 2026Gianluca Andri Florineth, Isabell Klima, Anna Laura Boeker et al.5 citations
Psychedelic-assisted therapy (PAT) is a novel intervention for depressive symptoms, typically delivered with additional psychological therapy sessions. Quantitative evidence on how this concomitant therapy contributes to treatment outcomes is limited, highlighting the need for a systematic synthesis. To evaluate whether the quantity of psychological therapy is associated with symptom reduction...
Importance: The availability of psychedelic retreats has grown to meet the demand for access to these substances. Despite centuries of use among Indigenous communities, psychedelics can pose serious risks for some users. Objective: To determine safety precautions that retreat organizations that offer psychedelic substances currently use. Design, Setting, and Participants: This qualitative study...
Importance Psilocybin has demonstrated rapid and sustained antidepressant efficacy, with acute-phase effect sizes often more than double those for conventional antidepressants. However, concerns have been raised that high rates of functional unblinding in combination with trial participants with positive expectations of psychedelic use might bias treatment outcomes. Objective To compare...
There are few effective pharmacotherapies for treating eating disorders (EDs). High rates of substance use among individuals with EDs suggest potential self-medication of symptoms. To explore the experiences of individuals with EDs regarding use of prescribed and nonprescribed drugs. This survey study assessed responses to the Medications and Other Drugs for Eating Disorders (MED-FED) survey,...
Rapidly acting therapeutics like 3,4-methylenedioxymethamphetamine (MDMA) are promising treatments for disorders such as posttraumatic stress disorder (PTSD). However, understanding who benefits most and the underlying neural mechanisms remains a critical gap. Stratifying individuals by neural circuit profiles could help differentiate neural, behavioral, and affective responses to MDMA,...
Importance There is growing societal interest in and use of psilocybin. While psilocybin in Canada is illegal outside of clinical trials, there have been anecdotal reports of increasing access via unregulated online purchases and retail dispensaries. Objective To describe access to and the characteristics of psilocybin dispensaries across Canada and the health claims and warnings made on...
Key Points Question What is the comparative effectiveness of mindfulness-based therapy (MBT) and standard-of-care cognitive behavioral therapy (CBT) among adults with opioid-treated chronic low back pain (CLBP)? Findings In this randomized clinical trial of 770 adults with opioid-treated CLBP, although there were no differences between groups, both the MBT and CBT groups experienced improved...
Esketamine has been found to reduce the incidence of postpartum depression (PPD) in randomized clinical trials. However, current evidence from randomized clinical trials does not reflect esketamine's efficacy in clinical settings. To assess the clinical efficacy of intraoperative esketamine administration for preventing PPD among women who underwent cesarean delivery. This randomized clinical...
Key Points Question Were the liberalization of medical cannabis and the legalization of nonmedical cannabis in Canada associated with changes in the population-attributable fraction of cannabis use disorders associated with schizophrenia? Findings In this population-based cohort study comprising 13 588 681 individuals, the population-attributable fraction of cannabis use disorder associated...
Mindfulness meditation may improve well-being among employees; however, effects of digital meditation programs are poorly understood. To evaluate the effects of digital meditation vs a waiting list condition on general and work-specific stress and whether greater engagement in the intervention moderates these effects. This randomized clinical trial included a volunteer sample of adults (aged...
Key Points Question During buprenorphine treatment, does group-based mindfulness training reduce opioid use, craving, and anxiety compared with group recovery support? Findings In this randomized clinical trial including 196 adults prescribed buprenorphine for opioid use disorder, mindfulness was not superior at reducing illicit opioid use compared with an active group intervention with an...
Importance The psychological morbidity experienced by physicians, advanced practice practitioners (APPs), and nurses from working during the COVID-19 pandemic includes burnout, depression, and posttraumatic stress disorder (PTSD). Objective To investigate whether psilocybin therapy could improve symptoms of depression, burnout, and PTSD in US clinicians who developed these symptoms from...
3,4-Methylenedioxymethamphetamine (MDMA, or ecstasy) is a recreational drug being investigated for the treatment of posttraumatic stress disorder. Acute hyponatremia is a potentially serious complication after even a single dose of MDMA. The assumed etiology has been a vasopressin release inducing the syndrome of inappropriate antidiuresis combined with increased thirst, causing polydipsia and...
This secondary analysis of a randomized clinical trial assesses patient-reported anxiety, depression, and quality of life among patients receiving mindfulness-based stress reduction vs escitalopram for the treatment of anxiety disorders.