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

NCT05674929 | Completed Phase 2 Results

• 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 Participants With Treatment Emergent Adverse Events

  The number (%) of participants with at least one treatment-emergent adverse event is presented. More detailed information is provided in the dedicated 'Adverse Events' section

  Up to 12 weeks

• Percentage of Participants With Clinically Significant Abnormal Laboratory Tests

  The number (%) of participants with any clinically significant abnormal laboratory tests (routine haematology, clinical chemistry and coagulation) is presented

  Up to 12 weeks

• Percentage of Participants With Clinically Significant Abnormal Vital Signs

  The number (%) of participants with any clinically significant abnormal vital signs (blood pressure, heart rate and temperature) result is presented

  Up to 12 weeks

• Number of Participants With Post-baseline Suicidal Ideation or Behaviour Based on C-SSRS Score

  The C-SSRS was performed at screening, on Day 0 (dosing day), and on Days 1, 7, and 84 post-dose. Participants were counted if they answered 'yes' to any question. At baseline, the C-SSRS assessed the worst-point suicidal ideation experienced during the participant's lifetime. Beyond baseline, suicidal ideation and behaviour since last visit was assessed.

  Up to 12 weeks

• Time to Readiness for Discharge Post-dose Using the Readiness for Discharge Questionnaire (RDQ)

  The RDQ was a brief assessment scale to ensure that ahead of discharge after BPL-003 dosing, participants: * Were fully responsive, aware of their surroundings, and reacted adequately * The acute psychedelic effects of the drug had completely subsided * Were fully orientated (name, location, time) * Had normal (or only slightly elevated) blood pressure and pulse rate, and normal breathing frequency and body temperature * Had a stable gate, normal muscle coordination, and could walk safely * Had only mild to moderate potential side affects that did not need to be medically monitored * Had no acute suicidal ideations or suicidal intentions * Possible distress or feelings of overwhelm had sufficiently subsided and the participant felt safe to be discharged. Readiness for discharge was assessed at 90 minutes post-dose and then every 30 minutes until the participant was deemed ready for discharge (eg, the answer was 'yes' to all of the above items).

  1 Day

• Percentage of Participants With Occurrence of Reactivation Using the Reactivation Questionnaire (ReAQ)

  The occurrence and (if applicable) frequency, emotional valence, and functional impact of any reactivation events was determined. To determine if reactivation had occurred, participants were asked if they had any flashbacks or recurrence of any effects of the study drug experience.

  Up to 12 weeks

Secondary Outcomes (7)

• Effects on the Mystical Experience Questionnaire (MEQ-30)

  1 Day

• Effects on the Ego Dissolution Inventory (EDI)

  1 Day

• Percentage of Participants With a Complete Mystical Experience Using the MEQ-30

  1 Day

• Percentage of Participants Experiencing an Ego Dissolution Using the EDI

  1 Day

• Description of the BPL-003 Subjective Experience Data, From a Qualitative Interview

  Interviews were conducted approximately 2 hours after dosing

Other Outcomes (3)

• Timeline Follow-Back (TLFB) Interview to Assess the Percentage of Abstinent Days (PAD)

  Up to 12 weeks

• TLFB Interview to Assess the Percentage of Heavy Drinking Days (PHDD)

  Up to 12 weeks

• TLFB Interview to Assess the Percentage of Drinking Days (PDD)

  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

Results Point of Contact

• Title: Claire Roberts (VP & Head of Clinical Development and Regulatory Affairs)
• Organization: Beckley Psytech Ltd.

Medinfo@beckleypsytech.com

+44 (0)1865 987633

Study Officials

• Kevin Craig, M.D.

  Beckley Psytech Ltd

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

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: May 22, 2026
• Results First Posted: May 22, 2026

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

GB (2)