An Open-Label, Single Dose Study in Patients With Alcohol Use Disorder

This open-label, Phase IIa study (n=12) evaluates the safety, tolerability, and pharmacodynamic effects of a single intranasal dose of BPL-003 (5-MeO-DMT) combined with relapse prevention psychological support for patients with Alcohol Use Disorder (AUD).

Conducted by Beckley Psytech Ltd, the trial aims to explore the potential effects of BPL-003 on alcohol use and related symptoms. Approximately 12 eligible participants will receive a single intranasal dose of BPL-003, with 12 weeks of follow-up assessments. Psychological support will be provided before, during, and after dosing.

The study started on May 30, 2023, and was estimated to be completed by October 2023.

Topic Alcohol Use Disorder Addiction
Compound 5-MeO-DMT
Country United Kingdom
Visit trial
Status Recruiting
Results Published No
Start date 30 May 2023
End date 01 October 2023
Phase Phase II
Design Open
Type Interventional
Generation Second
Participants 12
Sex All
Age 18- 64
Therapy Yes

Trial Details

An open-label, Phase IIa study to evaluate the safety, tolerability, and pharmacodynamic effects of a single intranasal dose of BPL-003 combined with relapse prevention psychological support, to explore the potential effects on alcohol use and related symptoms in patients with Alcohol Use Disorder.

NCT Number NCT05674929

Sponsors & Collaborators

Beckley Psytech
Beckley Psytech is working on getting 5-MeO-DMT to market as the first of a variety of psychedelic medicines.

Data attribution

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