Completed Trials

The effects of psilocybin on cognitive function in healthy participants

In partnership with COMPASS Pathways researchers from King’s College London have established that psilocybin can be safely administered at doses of either 10mg or 25mg to up to six participants simultaneously.

The trial is now finished and results were published in The Journal of Psychopharmacology in March 2022. They represent an essential first step in demonstrating the safety and feasibility of psilocybin for use within controlled settings alongside talking therapy as a potential treatment for a range of mental health conditions.

Status	Completed, not recruiting
Participants	Adults
Clinical area	Healthy participants
Intervention	Psilocybin
Recruitment period	2018-2020
Funder	Compass Pathways
Sponsor	Compass Pathways

The Safety and Efficacy of Psilocybin in Participants with Treatment-Resistant Depression (P-TRD) Study

King’s College London were part of a multi-centre trial led by COMPASS Pathways that is called P-TRD. The trial was conducted across 22 sites in 10 countries from Europe and the US. Adults with treatment resistant depression were given psilocybin at a dose of 25 mg, 10 mg, or 1 mg. The drug was administered together with psychological support and researchers measured changes in depression symptoms.

Status	Completed, not recruiting
Participants	Adults
Clinical area	Treatment resistant depression
Intervention	Psilocybin therapy
Recruitment period	2020-2021
Funder	Compass Pathways
Sponsor	Compass Pathways

An Exploratory Open-Label, Phase 1b, Ascending Dose Study to Evaluate the Effects of Oral 3 [2 (dimethylamino)ethyl]-1h-indol-4-yl Dihydrogen Phosphate (Psilocybin, BPL PSILO) on Cognition in Patients with Chronic Short-Lasting Unilateral Neuralgiform Headache Attacks (SUNHA)

Short-Lasting Unilateral Neuralgiform Headache Attacks (SUNHA) are debilitating and there are few treatment options. With funding from Beckley PsyTech researchers from King’s investigated the efficacy of psilocybin at three doses for treating these headache attacks, particularly looking at its impact on thought processes.

Status	Completed, not recruiting
Participants	Adults
Clinical area	SUNHA
Intervention	3 doses of psilocybin
Recruitment period	2022
Funder	Beckley PsyTech
Sponsor	Beckley PsyTech

A Double-Blind, Randomized, Phase 1, First-in-Human, Single Ascending Dose Study to Evaluate the Safety, Tolerability and Pharmacokinetic Profile of Intranasal 5 Methoxy N,N-dimethyltryptamine (5-MeO-DMT) in Healthy Subjects

In partnership with Beckley PsyTech, King’s researchers evaluated the safety and tolerability of the psychedelic 5 Methoxy N,N-dimethyltryptamine (5-MeO-DMT) which is found in a variety of plant species and secreted by one species of toad. It was administered nasally to healthy participants at one dosage and researchers assessed the percentage of participants that experienced any unfavourable and unintended signs, alongside various measures to assess what is happening to the drug when it is taken.

Status	Completed, not recruiting
Participants	Adults
Clinical area	Healthy participants
Intervention	5-Methoxy-N,N-Dimethyltryptamine
Recruitment period	2021 – 2022
Funder	Beckley PsyTech
Sponsor	Beckley PsyTech

Publications:

https://journals.sagepub.com/doi/full/10.1177/02698811211064720

An Open-Label, Phase 2, Multicenter Feasibility Study of Manualized MDMA- Assisted Psychotherapy with an Optional fMRI Sub-Study Assessing Changes in Brain Activity in Subjects with Posttraumatic Stress Disorder

With support from the Multidisciplinary Association of Psychedelic Studies (MAPS) we trialled MDMA therapy for PTSD for veterans.

Status	Completed, not recruiting
Participants	Adults
Clinical area	PTSD
Intervention	MDMA
Recruitment period	2022 – 2023
Funder	MAPS
Sponsor	MAPS

The Safety and Tolerability of COMP360 in Participants with Post-traumatic Stress Disorder

With support from Compass Pathways, we explored the safety and tolerability of of COMP360 (psilocybin) given alongside psychological support to participants suffering from post-traumatic stress disorder. This trial was undertaken alongside colleagues in the United States.

Status	Completed, not recruiting
Participants	Adults
Clinical area	PTSD
Intervention	Psilocybin
Recruitment period	2022 – 2023
Funder	Compass Pathways
Sponsor	Compass Pathways

An Open-Label, Phase 2a Single Dose Study of 5-MeO-DMT in Patients With Alcohol Use Disorder

With the support of Beckley PsyTech we trialled 5-MeO-DMT given with structured psychological support for alcohol use disorder. 5-MeO-DMT is a short-acting psychedelic drug, which means that it induces an altered state of consciousness that can be characterised by mystical experiences, strong emotions, visions and distorted perceptions.

Status	Completed, not recruiting
Participants	Adults
Clinical area	Alcohol use disorder
Intervention	5-MeO-DMT with Structured Psychological Support
Recruitment period	2023-24
Contact	AUD-5MEODMT@kcl.ac.uk
Funder	Beckley PsyTech
Sponsor	Beckley PsyTech

'IMPACT-1 Study – methylone therapy for the treatment of posttraumatic stress disorder'

With support from Transcend Therapeutics, we explored the safety and efficacy of methylone treatment in patients suffering from post-traumatic stress disorder.

Status	Completed, not recruiting
Participants	Adults
Clinical area	Post-traumatic stress disorder
Intervention	Methylone therapy
Recruitment period	2024
Contact	methylone@kcl.ac.uk
Funder	Transcend Therapeutics
Sponsor	Transcend Therapeutics

Psilocybin in Depression Resistant to Standard Treatments (PsiDeR) feasibility study

This study evaluated the feasibility, safety and effectiveness of psilocybin-assisted therapy for treatment-resistant depression. Participants received either a single dose of 25mg psilocybin or a placebo and all participants received psychological support. The study assessed changes in the level of depression at three and six weeks. With further informed consent, this study collected neuroimaging and omics data to analyse possible mechanisms behind effects and biomarkers.

Status	Completed, not recruiting
Participants	Adults
Clinical area	Treatment resistant depression
Intervention	Psilocybin-assisted therapy
Recruitment period	2021-2024
Funder	National Institute for Health and Care Research
Sponsor	King’s College London & South London & Maudsley NHS Foundation Trust

BPL-003-201 Study - 5-MeO-DMT Therapy for Treatment Resistant Depression

With support from Beckley Psytech Ltd. we trialled 5-MeO-DMT (BPL-003-201) therapy for treatment resistant depression.

Status	Completed, not recruiting
Participants	Adults
Clinical area	Treatment resistant depression
Intervention	5-MeO-DMT therapy
Recruitment period	2024-2025
Funder	Beckley Psytech Ltd.
Sponsor	Beckley Psytech Ltd.

Raphael Rifkin-Zybutz

Research

Research

Psychoactive Trials Group

Research

Psychoactive Trials Group