Malcolm Boyce

2 papers in the library · 20 citations · publishing 2023-2026

Papers

Safety, tolerability, pharmacodynamic and wellbeing effects of SPL026 (dimethyltryptamine fumarate) in healthy participants: a randomized, placebo-controlled phase 1 trial.

Frontiers in psychiatry January 1, 2023 Ellen James, David Erritzøe, Tiffanie Benway et al. 16 citations

A phase 1 trial tested escalating intravenous doses of the psychedelic DMT (SPL026) in healthy volunteers who had never used psychedelics, to find a safe, tolerable dose for a future trial in people with major depressive disorder. Participants were randomly assigned to placebo or one of four doses (9, 12, 17, or 21.5 mg). The drug was well tolerated with no serious adverse events. Higher blood levels of DMT correlated with stronger ratings of mystical experience, ego dissolution, and intensity, though these trends need confirmation in larger studies. Based on safety and pharmacodynamic results, 21.5 mg given as a two-phase infusion was chosen for the patient trial.

DOI: 10.3389/fpsyt.2023.1305796 Full text Dimethyltryptamine Major depressive disorder Depression DMT +8

A short-acting psychedelic intervention for major depressive disorder: a phase IIa randomized placebo-controlled trial.

Nat Med February 16, 2026 David Erritzøe, Tommaso Barba, Tiffanie Benway et al. 4 citations

A single 21.5-mg intravenous dose of the psychedelic DMT, given with psychotherapeutic support, produced a rapid and significant reduction in depressive symptoms in adults with moderate-to-severe major depressive disorder. In a double-blind, placebo-controlled trial with 34 participants, those receiving DMT showed a greater decrease in depression scores at two weeks compared to placebo. Antidepressant effects persisted up to three months in an open-label phase. Adverse events were mostly mild to moderate, and no serious adverse events occurred.

DOI: 10.1038/s41591-025-04154-z Full text