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

Last updated: April 28, 2025
Sponsor: Beckley Psytech Limited
Overall Status: Completed

Phase

2

Condition

Alcohol Use Disorder

Substance Abuse

Alcohol Dependence

Treatment

BPL-003

Clinical Study ID

NCT05674929
BPL-003-203
  • Ages 18-64
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Willing and able to give informed consent.

  2. Age 18 to 64 years at Screening.

  3. Diagnosed with moderate to severe AUD.

  4. Minimum of 4 heavy drinking days in the 28 days before Screening.

  5. No more than 14 days have elapsed since the last HDD or completion ofdetoxification, with no HDD in the 72 hours prior to dosing and no alcohol at all inthe 24 hours prior to dosing

  6. Willing to abstain from using recreational drugs from Screening until end of thestudy

  7. Willing to abstain from smoking during their time in the clinic on the day ofdosing.

  8. Willing to refrain from psychedelic drug use from Screening until the end of thestudy.

  9. Living in stable/secure accommodation in the community.

  10. In possession of a personal mobile phone and able to nominate at least one locatorindividual (eg, a family member, friend, or recovery mentor), with a verifiableaddress and a telephone number to assist with the arrangement of follow-upappointments.

Exclusion

Exclusion Criteria:

  1. Personal or first-degree family history of schizophrenia, bipolar disorder,psychotic disorder, delusional disorder, paranoid disorder or schizoaffectivedisorder.

  2. Any major psychiatric disorders, with the exception of mild or moderate anxietyand/or depression.

  3. A clinical diagnosis of post-traumatic stress disorder.

  4. Suicide ideation or behaviour or self-injurious behaviours within the 12 monthsbefore screening

  5. Regular use of or dependence on other drugs other than caffeine or nicotine.

  6. Any self-reported use of psychedelic compounds in the past 6 months.

  7. History of seizures.

  8. Patients who are exhibiting any signs of alcohol withdrawal on dosing day.

  9. Positive for alcohol on dosing day.

  10. Positive urine drug screen for illicit drugs or drugs of abuse.

  11. Any nasal obstruction, blockage, or symptoms of congestion.

  12. Any personal or family history of malignant hyperthermia.

  13. Patients with an uncontrolled cardiovascular disorder that, in the opinion of theInvestigator, may interfere with the interpretation of study results or constitute ahealth risk for the patient if he/she takes part in the study.

  14. Uncontrolled or insulin-dependent diabetes.

Study Design

Total Participants: 13
Treatment Group(s): 1
Primary Treatment: BPL-003
Phase: 2
Study Start date:
May 30, 2023
Estimated Completion Date:
October 02, 2024

Study Description

Approximately 12 eligible participants will be receive a single dose of BPL-003, given intranasally, with 12 weeks of follow-up assessments. Psychological support will be given before, during and after dosing

Connect with a study center

  • Clerkenwell Health

    London, W1G 8DR
    United Kingdom

    Site Not Available

  • King's College London

    London,
    United Kingdom

    Site Not Available

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