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

NCT05674929 | Completed Phase 2

• 1 other identifier: BPL-003-203
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 2

Brief Summary

An open-label, Phase 2a 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.

Conditions

Alcohol Use Disorder

Outcome Measures

Primary Outcomes (6)

• Percentage of patients with treatment emergent adverse events

  Up to12 weeks

• Percentage of patients with clinically significant abnormal laboratory tests

  Up to12 weeks

• Percentage of patients with clinically significant abnormal vital signs

  Up to12 weeks

• Percentage of patients with suicidal ideation and changes in Columbia Suicidality Rating Scores (CSSRS)

  Up to12 weeks

• Readiness for discharge questionnaire

  1 Day

• Reactivation Questionnaire

  Measure the frequency, emotional valence and functional impact of any re-activation events in the study

  Up to 12 weeks

Secondary Outcomes (6)

• Effects on the Mystical Experience Questionnaire (MEQ30)

  1 Day

• Effects on the Ego Dissolution Inventory (EDI)

  1 Day

• Percentage of patients experiencing a complete mystical experience, as assessed by the Mystical Experience Questionnaire (MEQ30)

  1 Day

• Percentage of patients experiencing a an ego dissolution, as assessed by the Ego Dissolution Inventory (EDI)

  1 Day

• Description of the BPL-003 subjective experience data, from a qualitative interview

  1 Day

Other Outcomes (3)

• Timeline Follow-Back (TLFB) interview to assess the Percentage of Abstinent days (PAD) in 85d prior D-3 (or start of detox) vs PAD on d14, d28, d56, d84 (with biomarker verification).

  Up to 12 weeks

• Timeline Follow-Back (TLFB) interview to assess Percentage of Heavy Drinking Days (PHDD) in 85d prior D-3 (or start of detox) vs PHDD post-dosing measured on d14, d28, d56, d84

  Up to 12 weeks

• Timeline Follow-Back (TLFB) interview to assess Percentage of Drinking Days (PDD) in 85d prior D-3 (or start of detox) vs PDD post-dosing measured on d14, d28, d56, d84

  Up to 12 weeks

Study Arms (1)

BPL-003 arm

EXPERIMENTAL

Drug: BPL-003

Interventions

BPL-003 DRUG

A single dose administered intranasally

BPL-003 arm

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Willing and able to give informed consent.
• Age 18 to 64 years at Screening.
• Diagnosed with moderate to severe AUD.
• Minimum of 4 heavy drinking days in the 28 days before Screening.
• No more than 14 days have elapsed since the last HDD or completion of detoxification, with no HDD in the 72 hours prior to dosing and no alcohol at all in the 24 hours prior to dosing
• Willing to abstain from using recreational drugs from Screening until end of the study
• Willing to abstain from smoking during their time in the clinic on the day of dosing.
• Willing to refrain from psychedelic drug use from Screening until the end of the study.
• Living in stable/secure accommodation in the community.
• In possession of a personal mobile phone and able to nominate at least one locator individual (eg, a family member, friend, or recovery mentor), with a verifiable address and a telephone number to assist with the arrangement of follow-up appointments.

You may not qualify if:

• Personal or first-degree family history of schizophrenia, bipolar disorder, psychotic disorder, delusional disorder, paranoid disorder or schizoaffective disorder.
• Any major psychiatric disorders, with the exception of mild or moderate anxiety and/or depression.
• A clinical diagnosis of post-traumatic stress disorder.
• Suicide ideation or behaviour or self-injurious behaviours within the 12 months before screening
• Regular use of or dependence on other drugs other than caffeine or nicotine.
• Any self-reported use of psychedelic compounds in the past 6 months.
• History of seizures.
• Patients who are exhibiting any signs of alcohol withdrawal on dosing day.
• Positive for alcohol on dosing day.
• Positive urine drug screen for illicit drugs or drugs of abuse.
• Any nasal obstruction, blockage, or symptoms of congestion.
• Any personal or family history of malignant hyperthermia.
• Patients with an uncontrolled cardiovascular disorder that, in the opinion of the Investigator, may interfere with the interpretation of study results or constitute a health risk for the patient if he/she takes part in the study.
• Uncontrolled or insulin-dependent diabetes.

Sponsors & Collaborators

• Beckley Psytech Limited: lead

Study Sites (2)

Clerkenwell Health

London, W1G 8DR, United Kingdom

Location

King's College London

London, United Kingdom

Location

MeSH Terms

Conditions

Alcoholism

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Study Officials

• VP & Head of Clinical Development, PhD

  Beckley Psytech Ltd

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Open label

Study Record Dates

• First Submitted: December 13, 2022
• First Posted: January 9, 2023
• Study Start: May 30, 2023
• Primary Completion: October 2, 2024
• Study Completion: October 2, 2024
• Last Updated: August 14, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

GB (2)