Emerging evidence suggests psychedelic-assisted therapies ameliorate symptoms of psychopathology. However, less is known about how psychedelics influence positive psychological functioning (e.g., compassionate love, self-compassion, and life satisfaction). These constructs may be relevant in understanding how psychedelics exert their therapeutic effects, as they are central to both intra- and...
Abstract Introduction While the relationship between substance use disorders (SUD) and mental health conditions is well established, treatment for these co-occurring conditions is difficult to manage. Research on the potential for psychedelic treatments to address SUD and mental health conditions has recently seen a resurgence. This study aimed to explore narratives on the influence of...
Background: Psilocybin-assisted therapy (PAT) has shown promise for alcohol use disorder (AUD) in randomized controlled trials (RCTs). However, the effects of open-label administration following blinded treatment are unclear. Here, we present safety and efficacy data from an open-label extension of a Phase II RCT (NCT02061293) examining PAT for AUD. Methods: Adults with AUD (N = 59) received a...
Classic psychedelics typically act at the serotonin 5-HT2A receptor to profoundly alter brain function and consciousness. Research on these compounds has accelerated. Major strides have been made in understanding their unique mechanisms of action and clinical potential. This Review outlines the state of psychedelic science, spanning cellular mechanisms, systems neuroscience and clinical...
A recent randomized, double-blind, placebo-controlled, parallel-group trial (NCT02061293) found that psilocybin-assisted therapy significantly improved drinking outcomes compared to an active placebo in adults with alcohol use disorder (AUD). In this secondary analysis, we assessed whether psilocybin-assisted therapy improved self-compassion and whether these changes predicted drinking...
The durability of ayahuasca's effects on mental health and the influence of clinical diagnoses on therapeutic response is unclear. Adults with no prior exposure to ayahuasca (n = 66) participating in neo-shamanic ayahuasca ceremonies completed questionnaires at baseline, 7 days, and 1, 6, and 12 months. Mixed models were used to characterize temporal trajectories in mental health, alcohol and...
Introduction: Serotonergic psychedelics, serotonin 2A receptor agonists such as psilocybin that can result in substantially altered states of consciousness, are used in recreational and research settings. The safety of psychedelic experiences in research settings is supported by controlled physical environments, presence of clinical and medical staff to address emergent issues, screening for...
The opioid crisis continues to exert a tremendous toll in North America, with existing interventions often falling short of addressing ongoing needs. Psychedelics are emerging as a possible alternative therapy for mental health and substance use disorders. This study aimed to gather insights on how people use or are considering using psychedelics to manage opioid use disorder (OUD), how these...
PAT elicited durable shifts in personality, suggesting normalization of abnormal personality trait expression in AUD. Further study is needed to clarify whether PAT exerts its beneficial effects by reducing impulsiveness or whether impulsive individuals inherently respond better to PAT.
Background: Psilocybin can produce long-term changes in personality, personal values, and behavior. Although psilocybin-assisted therapy (PAT) is being actively studied for various psychiatric conditions, its effects on personal values in patients with alcohol use disorder (AUD) remain unexplored. This study examined the effects of PAT on personal values in patients with AUD and assessed...
In the version of the article initially published, some members of the MAPP2 Study Collaborator Group were listed only in the Supplementary Information. Charlotte Harrison, Berra Yazar-Klosinski, Wael Garas, Darrick May, Cole Marta, Susan Walker, Elizabeth Nielson, Gregory Wells, Randall Brown, Revital Amiaz, Yair Wallach, Ray Worthy, Alia Lilienstein and Amy Emerson have now been added to the...
Psilocybin-assisted psychotherapy (PAP) has shown promise in treating mood and anxiety disorders in patients with cancer. However, patients with cancer often suffer from more than just depression and anxiety, and so far, PAP's effect on other psychiatric symptoms remains largely unknown. To address this gap, we pooled previously unpublished data from two phase II, randomized, placebo-controlled...
Recent experience with off-label use of ketamine and recent challenges experienced in research with MDMA and psilocybin provide additional perspectives on how best to continue development of experimental psychedelic medications. Andrews et al. [1] provide a valuable perspective by noting the parallels between the ongoing deregulation of cannabis and what is now happening with psychedelics. The...
OBJECTIVES/GOALS: This pilot study investigated psilocybin-induced changes in neural reactivity to alcohol and emotional cues in patients with alcohol use disorder (AUD). METHODS/STUDY POPULATION: Participants were recruited from a phase II, randomized, double-blind, placebo-controlled clinical trial investigating psilocybin-assisted therapy (PAT) for the treatment of AUD (NCT02061293). Eleven...
Abstract This pilot study investigated psilocybin-induced changes in neural reactivity to alcohol and emotional cues in patients with alcohol use disorder (AUD). Participants were recruited from a phase II, randomized, double-blind, placebo-controlled clinical trial investigating psilocybin-assisted therapy (PAT) for the treatment of AUD (NCT02061293). Eleven adult patients completed task-based...
Abstract Interest in possible clinical uses for psychedelic drugs has grown steadily over the past decade. Although impressive findings from small studies stimulated considerable speculation and provided a strong justification for further study of psychedelic treatments, until very recently there was a dearth of high-quality evidence for their efficacy, mechanisms of action, and appropriate...
This multi-site, randomized, double-blind, confirmatory phase 3 study evaluated the efficacy and safety of 3,4-methylenedioxymethamphetamine-assisted therapy (MDMA-AT) versus placebo with identical therapy in participants with moderate to severe post-traumatic stress disorder (PTSD). Changes in Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) total severity score (primary endpoint) and...
Background: Amyotrophic lateral sclerosis (ALS) is an aggressive, terminal neurodegenerative disease that causes death of motor neurons and has an average survival time of 3-4 years. ALS is the most common motor neuron degenerative disease and is increasing in prevalence. There is a pressing need for more effective ALS treatments as available pharmacotherapies do not reverse disease progression...
Post-traumatic stress disorder (PTSD) presents a major public health problem for which currently available treatments are modestly effective. We report the findings of a randomized, double-blind, placebo-controlled, multi-site phase 3 clinical trial (NCT03537014) to test the efficacy and safety of 3,4-methylenedioxymethamphetamine (MDMA)-assisted therapy for the treatment of patients with...
OBJECTIVE: The primary aim of this qualitative study was to delineate psychological mechanisms of change in the first randomized controlled trial of psilocybin-assisted psychotherapy to treat alcohol use disorder (AUD). Theories regarding psychological processes involved in psychedelic therapy remain underdeveloped. METHOD: Participants (N = 13) mostly identified as non-Hispanic and White, with...
More than 50 million people in the United States serve as uncompensated informal caregivers to chronically ill friends or family members. Providing care to a sick loved one can contribute to personal growth but can also cause significant strain. Caregiver distress refers to a constellation of physiological, psychological, interpersonal, and spiritual impairments that typically result when an...
Novel treatments for opioid use disorder (OUD) are needed to address both the ongoing opioid epidemic and long-standing barriers to existing OUD treatments that target the endogenous μ-opioid receptor (MOR) system. The goal of this review is to highlight unique clinical trial design considerations for the study of emerging treatments for OUD that address targets beyond the MOR system. In...
Several lines of evidence suggest that classic psychedelics (5-HT2A receptor agonists or partial agonists) such as psilocybin might facilitate behavior change in individuals with substance use disorders. We conducted a multi-site, double-blind, randomized controlled trial (RCT) to assess the effects of psilocybin-assisted psychotherapy in alcohol-dependent volunteers. In addition to a...
Importance Although classic psychedelic medications have shown promise in the treatment of alcohol use disorder (AUD), the efficacy of psilocybin remains unknown. Objective To evaluate whether 2 administrations of high-dose psilocybin improve the percentage of heavy drinking days in patients with AUD undergoing psychotherapy relative to outcomes observed with active placebo medication and...
Post-traumatic stress disorder (PTSD) presents a major public health problem for which currently available treatments are modestly effective. We report the findings of a randomized, double-blind, placebo-controlled, multi-site phase 3 clinical trial (NCT03537014) to test the efficacy and safety of 3,4-methylenedioxymethamphetamine (MDMA)-assisted therapy for the treatment of patients with...