Psychological distress, such as anxiety and depression, is common among people with cancer and is often worsened by existential worries about mortality, loss of meaning, and decreased quality of life. Standard treatments, including medication and psychotherapy, often offer limited or short-term relief, highlighting the need for new, integrative psychosocial ...
Psilocybin, the chemical component of "magic mushrooms", has been administered with psychotherapy in several randomized clinical trials (RCTs) showing large and sustained antidepressant effects. There is interest to see if similar effects may be provided in those with obsessive compulsive disorder (OCD). The purpose of this study is to evaluate the safety, f...
Interest in psychedelic-assisted therapy (PAT) is surging across research and medical communities, prompting the discussion of policy shifts that reflect growing openness to implementing psychedelics in clinical practice. State-level psychedelic reform in the United States has accelerated since 2019, with legalization projected to reach most states within th...
Psilocybin, the chemical component of "magic mushrooms", has been administered with psychotherapy in several randomized clinical trials (RCTs) showing large and sustained antidepressant effects. In healthy volunteers, the psychedelic effects of psilocybin have been shown to be blocked by administration of serotonin (5HT)2A receptor antagonists such as risper...
This study is a 12-week (in addition to up to 30 days of screening) randomized, double-blind, placebo-controlled, parallel-group trial. The primary objective of this study is to assess the effectiveness, safety, and tolerability of single-dose psilocybin (25 mg)-assisted therapy in comparison to active placebo (1 mg micro-dose) psilocybin-assisted therapy in...
Background: -methamphetamine (MDMA). Objectives: The study provided an overview of PAT as currently provided in Switzerland under the regulatory framework of the Federal Office of Public Health (FOPH). Design: Swiss PAT practices were examined using an anonymous survey of physicians providing PAT. Questions included physicians' backgrounds, training, therape...
BACKGROUND AND AIMS: Australia recently down-scheduled and authorised psychedelic-assisted therapies, including psilocybin, for certain mental health conditions. Evidence is emerging for potential application in substance use disorder treatment. However, regulatory developments have outpaced implementation readiness. While service leaders and clinicians are ...
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:...
We propose a first-of-its-kind open-label clinical trial to investigate the feasibility, tolerability, and safety of administering psilocybin in autistic adults with treatment-resistant depression (TRD). In this study, 20 participants (intellectually able and fluent-speech adults) with autism and co-occurring TRD will receive around 20 hours of manualized ps...
The overall objective of this study is to assess the feasibility, safety and preliminary efficacy of psilocybin-assisted therapy to alleviate opioid-refractory pain in patients with advanced-cancer. The name of the study intervention used in this research study is: Psilocybin (a tryptamine derivative) This study is a phase 2 open label, single center, concur...
This is an open-label pilot trial to assess the safety and feasibility of a novel 8-week psilocybin-assisted psychotherapy intervention to facilitate successful tapering/discontinuation of opioid pain medication in adult patients receiving long-term opioid therapy for chronic pain. Participation will last approximately 8 months and includes one or two psiloc...
Obsessive-compulsive disorder (OCD) is a neuropsychiatric disorder characterized by recurrent distressing thoughts and substantial anxiety, accompanied by repetitive behaviors or mental rituals. Individuals with OCD often have diminished quality of life, and functional impairment. The disorder cause high personal, societal and economic costs. Current availab...
Investigators will recruit 36 individuals on MAT for OUD for a double-blind, placebo-controlled design to determine whether PEX010 (25-mg/d) shows preliminary efficacy on neural correlates of neurocognition and on clinical outcomes. Participants will be randomized to either (single dose) 25-mg (PEX010-25 group) or 1-mg (PPEX010-1 group) PEX010 in a 2:1 ratio...
Psychedelic-assisted therapies are re-emerging as credible options in psychological care amid a high global burden of mental ill-health and limited response to first-line treatments. Once marginal, psychedelics are now part of mainstream research and policy debate, while remaining illegal or tightly restricted in many jurisdictions. Classic and atypical comp...
This is an open-label psilocybin-assisted therapy study that will examine the safety and tolerability of psilocybin-assisted therapy in the offspring of genocide survivors with mood and anxiety disorders. The study will also investigate the efficacy of psilocybin-assisted therapy in reducing symptoms such as depression, anxiety and stress, as well as changes...
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...