Phase 2
N=13
An Open-Label, Single Dose Study in Patients With Alcohol Use Disorder
Alcohol Use Disorder
Bottom Line
View on ClinicalTrials.gov: NCT05674929 ↗Enrolled (actual)
13
Serious AEs
0.0%
Results posted
May 2026
Primary outcome: Primary: Percentage of Participants With Treatment Emergent Adverse Events — 11 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- BPL-003 (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Beckley Psytech Limited
- Primary completion
- Oct 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Treatment Emergent Adverse Events |
11 | — |
| PRIMARY Percentage of Participants With Clinically Significant Abnormal Laboratory Tests |
— | — |
| PRIMARY Percentage of Participants With Clinically Significant Abnormal Vital Signs |
4 | — |
| PRIMARY Number of Participants With Post-baseline Suicidal Ideation or Behaviour Based on C-SSRS Score |
1 | — |
| PRIMARY Time to Readiness for Discharge Post-dose Using the Readiness for Discharge Questionnaire (RDQ) |
2.1 | — |
| PRIMARY Percentage of Participants With Occurrence of Reactivation Using the Reactivation Questionnaire (ReAQ) |
— | — |
| SECONDARY Effects on the Mystical Experience Questionnaire (MEQ-30) |
3.07; 2.60; 3.50; 3.92; 3.84 | — |
| SECONDARY Effects on the Ego Dissolution Inventory (EDI) |
52.4 | — |
| SECONDARY Percentage of Participants With a Complete Mystical Experience Using the MEQ-30 |
4 | — |
| SECONDARY Percentage of Participants Experiencing an Ego Dissolution Using the EDI |
7 | — |
| SECONDARY Description of the BPL-003 Subjective Experience Data, From a Qualitative Interview |
5; 5; 8; 6; 7; 5 | — |
| SECONDARY Feedback From Therapists on the Frequency and Duration of Psychotherapy Sessions, Therapy Manual and Overall Therapy Model |
4; 4; 3; 3 | — |
| SECONDARY Semi-structured Interview to Assess Psychological Changes Following BPL-003 Treatment |
6; 5; 8; 6; 7; 6 | — |
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 Criteria
- 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.
Exclusion Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT05674929). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.