The primary purpose of this study is to evaluate the feasibility and estimate the efficacy of psilocybin-facilitated treatment for cocaine use. We also will monitor the impact of psilocybin-facilitated treatment on the use of other drugs and outcomes relevant to cocaine involvement. MRI assessment is a unique aspect of this study. As a potential biological m...
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...
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:...
OBJECTIVE: The goals of this study were to examine the therapeutic effects and safety of psilocybin given as a pulsed regimen for the prevention of migraine and to consider the blinding integrity of an active control agent. BACKGROUND: The administration of a single low dose of psilocybin was observed to have lasting therapeutic effects in one small pilot tr...
Psychedelics have been studied since the 1950s as a potential treatment for alcohol use disorder (AUD), with over a dozen clinical trials of lysergic acid diethylamide (LSD), and several contemporary trials of psilocybin and ayahuasca for this indication. Herein, we characterize foundational studies from the 1950s to the present, with emphasis on key design ...
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 thes...
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 thes...
OBJECTIVE: Evidence suggests that psilocybin-assisted therapy (PAT) leads to durable shifts in personality structure. However, such changes have yet to be characterized in disorders of addiction. In this secondary analysis from a randomized controlled trial, the authors examined the effect of PAT on personality dimensions in patients with alcohol use disorde...
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 p...
Several lines of evidence suggest that classic hallucinogens such as psilocybin can facilitate behavior change in addictions such as alcohol dependence. The proposed investigation is a multi-site, double-blind active-controlled trial (n = 180, 90 per group) contrasting the acute and persisting effects of psilocybin to those of diphenhydramine in the context ...
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 v...
ImportanceAlthough classic psychedelic medications have shown promise in the treatment of alcohol use disorder (AUD), the efficacy of psilocybin remains unknown.ObjectiveTo 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 a...
Anticholinergic toxicity is a relatively uncommon occurrence. When it does occur, it is usually attributed to an overdose of anticholinergic agents, especially in the elderly population. In younger patients, anticholingeric toxicity is usually due to an intentional overdose in a suicide attempt, accidental exposure to jimson weed or deadly nightshade plant, ...
