Research & Trials

We receive many enquiries about participation in our clinical trials. However, we do not accept participants directly through the Small Pharma website or company email addresses. For more information about our clinical trials, please click on the links below. Please note that Small Pharma is not able to diagnose, advise, provide care or make treatment referrals. If you need urgent medical help, please contact the emergency services or your doctor as soon as possible.

 

Clinical Trial

Location

Status

SPL026 with supportive therapy Phase I in psychedelic-naive healthy volunteers 

London, UK 

SPL026 with supportive therapy Phase IIa in patients with Major Depressive Disorder 

London and Liverpool, UK 

Recruitment closed

SPL026 with supportive therapy Phase IIb in patients with Major Depressive Disorder 

Multiple sites (global)

Not yet recruiting

 

Liverpool & Manchester, UK

Actively recruiting

Ultra-short programs: SPL026 with supportive therapy for Major Depressive Disorder

Small Pharma was awarded an Innovation Passport designation by the MHRA for this program. The designation provides Small Pharma with access to the ILAP (the Innovative Licensing and Access Pathway) which aims to accelerate the time to market for SPL026, facilitating patient access to this potential new treatment.

Phase I: Complete

Status: Completed

No. of participants: 32

Indication: Psychedelic naive healthy volunteers

Location: Hammersmith Medical Research, London

Phase IIA: In Progress

Status: In Progress, Recruitment Closed

No. of participants: up to 42

Indication Patients with moderate/ severe Major Depressive Disorder

Location: Hammersmith Medical Research, London and MAC Clinical Research, Liverpool

Phase IIB: Not Actively Recruiting

Status:  We are not yet actively recruiting for Phase IIb. We will update this page with details about the sites that will be involved in our Phase IIb trial once they have been approved.

 

 

SSRI Drug Interaction Study: Actively Recruiting

This study will assess the interaction between serotonin reuptake inhibitors (SSRIs) and SPL026 with supportive therapy in patients with MDD.

Status: Actively Recruiting

Indication: Patients with moderate/severe MDD

No. of participants: Up to 24

Location: Two MAC Clinical Research sites – Liverpool and Manchester

View Eligibility Requirements: For more information on how to apply to this study CLICK HERE

Play Video about Dr David Erritzoe

Short-acting psychedelic for depression

We are evaluating short acting psychedelics, like SPL026, with supportive therapy as a potential new approach to the treatment of depression.

“It needs to be competitive in public health systems; it needs to be kind of cost-effective. If a more condensed, powerful experience could have therapeutic effects... then it's totally worth exploring.” Dr David Erritzoe, Psychiatrist at Imperial College London

Partners

Anticipated treatment journey

Preparation

The therapist helps patients feel comfortable about the dosing experience, explore their life history, their intentions and ultimately help them build a patient-therapist relationship.

Dosing Session

The patient is supervised by the therapy team as the medicine is administered in a calm room. The patient is encouraged to lie down, listen to music and use eye shades to enhance the experience.

Integration

The therapist works with the individual to interpret and identify insights from the psychedelic experience with the goal of achieving meaningful long-term change.

Self Healing

Individuals are encouraged to use additional approaches to reflect and continue their healing outside of the clinic setting.

Psychedelic therapist training

Overview

To support our clinical programs, we run a training program for therapists to support the delivery of short-acting psychedelic therapy protocols, such as with our lead program SPL026.

Designed by experts

Our training program has been designed in collaboration with leading experts in psychedelic therapy methods and approaches.

Multi-method approach

Our program uses multiple methods including theory, experimental learning and observational work, ensuring therapists feel comfortable and empowered to deliver the protocol in a clinical trial setting.

Recruitment process

We are actively recruiting and registering the interest of therapists interested in our training. Successful completion of the therapy training will make you eligible to participate as a therapist in our future clinical trials.

To find out more, or to register your interest in upcoming therapist training programs, please email Dr Tiffanie Benway at:

tiffanie.benway@smallpharma.com

About Small Pharma

We’re a biotechnology company researching and developing short-acting psychedelics with supportive therapy for mental health conditions.

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