Single dose of inhaled 5-MeO-DMT plus therapy in 13 people with alcohol use disorder

The question

Can a single intranasal dose of 5-MeO-DMT, given alongside a course of talk therapy, be given safely to people with moderate to severe alcohol use disorder, and does drinking change afterwards?

What they did

Thirteen adults with moderate to severe alcohol use disorder were enrolled at two clinics in England between March 2023 and July 2024. Each received one 10 mg intranasal dose of BPL-003, a powder formulation of 5-MeO-DMT, in a controlled setting with psychological support, plus three preparation and three integration sessions. All were also enrolled in a 10-week relapse-prevention cognitive behavioural therapy (CBT) programme. Safety was the main outcome; drinking, craving and wellbeing were tracked to Week 12. Twelve people completed the study.

What they found

Over 12 weeks, 41 treatment-emergent adverse events were reported, all mild or moderate, affecting 11 of 12 participants; no one withdrew because of them. The most common were pain at the site where the drug was given (4 participants) and short-lived rises in blood pressure after dosing (4 participants); flashbacks, nightmares and nausea each affected 2 participants. Mean abstinent days rose from 33.2% at baseline to 80.8% at Week 12, and heavy drinking days fell from 56.2% to 13.2%. Six of 12 (50%) were continuously abstinent, 3 (25%) cut down meaningfully, and 3 (25%) showed little or no change. Craving, alcohol-related problems, wellbeing and quality-of-life measures all pointed in a favourable direction.

The fine print

This was a very small, open-label trial: everyone knew what they received, there was no placebo or comparison group, and only 12 people were analyzed for drinking outcomes. Because all participants also completed a 10-week CBT programme, the effects of the drug cannot be separated from therapy, expectation or the natural course of the condition. The drinking outcomes were exploratory, follow-up ended at 12 weeks, and the sample was mostly male and almost entirely White-UK. This summary is based on the abstract only.

What it means

In a first small trial, a single dose of intranasal 5-MeO-DMT given with psychological support and CBT was tolerated without severe side effects, and drinking fell over 12 weeks. Whether the drug itself drove that change can only be answered by larger randomized trials with a control group.

Evidence grade: Very low. A small, open-label single-dose trial with no control group and only 12 people in the efficacy analysis, so improvements cannot be separated from the therapy programme or from expectation.

This summary is based on the study’s published abstract.