Small Pharma receives regulatory approval for clinical trial to explore DMT for depression, which it claims is the world’s first patient clinical trial of the psychedelic.

London-based Small Pharma has been given the green light by UK regulators for a trial assessing the safety, and later efficacy, of N,N-dimethyltryptamine (DMT) in depression. The company believes that DMT can offer a shorter psychedelic therapy session, given that it “delivers a psychedelic experience in 20 minutes” according to CEO Peter Rand.

Rand explained that, given the fast-acting nature of the drug, a DMT session could take less than two hours. This could present obvious benefits in terms of cost-effectiveness and convenience when compared to similar psychedelics like psilocybin.

Small Pharma’s Chief Medical & Scientific Officer Carol Routledge likened the high-dose psychedelic experience to “shaking up a snow globe, disrupting unhealthy patterns of thought an providing an opportunity for them to resettle differently.”

The psychedelic experience occasioned by DMT is generally accepted to be more intense than that of peer drugs like psilocybin and is different in its nature according to Routledge.

DMT is the primary active ingredient in ayahuasca, a ceremonial brew used for spiritual and religious purposes by many tribes. Routledge suggested that, despite showing efficacy in treating patients with depression, ayahuasca “contains a bit of a cocktail of active components and so has a much poorer safety profile and is a significantly longer psychedelic experience compared to DMT.”

Preliminary clinical and nonclinical evidence suggests that DMT may encourage neuroplasticity and the expansion of connections in the brain, which is important in augmenting the efficacy of therapy. Small Pharma is seeking to build on this evidence in this new trial.

The company is working with Imperial College London’s Centre for Psychedelic Research to launch the study and hopes to begin dosing in January 2021. 32 healthy volunteers, who have never taken psychedelics, will participate in the Phase 1 trial in order to understand the lowest possible dose that results in a psychedelic experience.

Assuming the first phase returns conclusive results, the second phase would involve 36 participants. In a Phase 2a trial, researchers at Robin Carhart-Harris’ research centre would seek to ascertain the efficacy of DMT-assisted therapy for major depressive disorder (MDD) – the same indication the Usona Institute is targeting in its psilocybin-assisted therapy research.

The company has received approval from the Medicines and Healthcare products Regulatory Agency, an executive agency of the UK Government’s Department for Health and Social Care. Now, Small Pharma is in discussion with the Home Office, with the aim of receiving permission to use the controlled substance in these trials. A source at Small Pharma told Psilocybin Alpha that they expect to receive such approval imminently.

The DMT itself is manufactured through a contract manufacturing organisation, to GMP standards.

Last week the Financial Times reported that the UK government is set to receive a seven-figure return on an investment it made in Small Pharma via Angel CoFund, a state-backed investor that owns a 5.5% share in the company. Importantly, the fund invested in the company before it delved into psychedelic research.

Small Pharma plans to list on a Canadian exchange via a reverse takeover (RTO).