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

An Open-Label, Phase 2a Single Dose Study in Patients With Alcohol Use Disorder

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.

Study Overview

• Status: Completed
• Conditions: Alcohol Use Disorder
• Intervention / Treatment: Drug: BPL-003

Detailed 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

• Study Type: Interventional
• Enrollment (Actual): 13
• Phase: Phase 2

Contacts and Locations

Study Locations

• United Kingdom
  • London, United Kingdom
    • King's College London
  • London, United Kingdom, W1G 8DR
    • Clerkenwell Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 64 years (Adult)
• Accepts Healthy Volunteers: No

Description

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 of detoxification, with no HDD in the 72 hours prior to dosing and no alcohol at all in the 24 hours prior to dosing
6. Willing to abstain from using recreational drugs from Screening until end of the study
7. Willing to abstain from smoking during their time in the clinic on the day of dosing.
8. Willing to refrain from psychedelic drug use from Screening until the end of the study.
9. Living in stable/secure accommodation in the community.
10. 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:

1. Personal or first-degree family history of schizophrenia, bipolar disorder, psychotic disorder, delusional disorder, paranoid disorder or schizoaffective disorder.
2. Any major psychiatric disorders, with the exception of mild or moderate anxiety and/or depression.
3. A clinical diagnosis of post-traumatic stress disorder.
4. Suicide ideation or behaviour or self-injurious behaviours within the 12 months before 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 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.
14. Uncontrolled or insulin-dependent diabetes.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: BPL-003 arm	Drug: BPL-003; A single dose administered intranasally

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Effects on the Mystical Experience Questionnaire (MEQ-30)	The MEQ-30 was performed to assess the extent of a participant's mystical experience after receiving BPL-003 on Day 0 (dosing day). The questionnaire comprises a list of 30 phenomena, with subscales to measure mystical, positive mood, transcendence of space and time, and ineffability factors, measured on a 0 to 5 scale (0=none; not at all to 5=extreme). A 'total MEQ-30 score' was calculated for each participant as the average of all their responses. The total MEQ-30 score is presented. The higher the score, the greater the mystical experience. A total score of ≥3 was considered to be a significant mystical experience.	1 Day
Effects on the Ego Dissolution Inventory (EDI)	The EDI was performed to assess the extent of a participant's dissolution of ego after receiving BPL-003 on Day 0 (dosing day). The inventory comprises 8 statements. Participants rated their agreement to each statement by marking on a visual analogue scale from 0 ("no, not more than usually") to 100 ("yes, entirely or completely"). Higher scores are indicative of more intense ego dissolution. In practice, this means participants with higher scores could have a reduced sense of having a distinct, separate self; greater feelings of unity with the environment or universe; a loss of self-referential thoughts or identity; or altered boundaries between 'self' and 'other'. A 'total EDI score' was calculated for each participant as the average of their individual-item scores. The total EDI score is presented.	1 Day
Percentage of Participants With a Complete Mystical Experience Using the MEQ-30	The MEQ-30 was performed to assess the extent of a participant's mystical experience after receiving BPL-003 on Day 0 (dosing day). The questionnaire comprises a list of 30 phenomena, with subscales to measure mystical, positive mood, transcendence, and ineffability factors, measured on a 0 to 5 scale (0=none; not at all to 5=extreme). A 'total MEQ-30 score' was calculated for each participant as the average of all their responses. A complete mystical experience was defined as reaching or exceeding a score of 3 on all four sub-domains (mystical, positive mood, transcendence of time and space, and ineffability) of the MEQ-30 scale.	1 Day
Percentage of Participants Experiencing an Ego Dissolution Using the EDI	The EDI was performed to assess the extent of a participant's dissolution of ego after receiving BPL-003 on Day 0 (dosing day). The inventory comprises 8 statements. Participants rated their agreement to each statement by marking on a visual analogue scale from 0 ("no, not more than usually") to 100 ("yes, entirely or completely"). Participants were classed as experiencing an ego dissolution if they had a total score of >50.0 out of 100 on the EDI scale.	1 Day
Description of the BPL-003 Subjective Experience Data, From a Qualitative Interview	After BPL-003 dosing, participants had the option to participate in a one-to-one guided interview with independent researchers trained in microphenomenology methods to describe their psychedelic experience. Temporal aspects of drug effects (e.g., sensory, cognitive, metacognitive, and sense of self/other/connectedness) were elicited through open-ended interview questions.	Interviews were conducted approximately 2 hours after dosing
Feedback From Therapists on the Frequency and Duration of Psychotherapy Sessions, Therapy Manual and Overall Therapy Model	Key themes from qualitative feedback on the treatment model was sought from therapists on frequency and duration of psychotherapy sessions, implementation of therapy manual, and overall therapy model. Feedback was obtained in a qualitative interview with each therapist after each participant's last integration session (between Day 15 and Day 42).	1 Day
Semi-structured Interview to Assess Psychological Changes Following BPL-003 Treatment	After BPL-003 dosing, participants had the option to participate in a semi-structured interview. The interviews were topic-guided, qualitative interviews to understand psychological changes shortly after dosing on Day 1, and on Day 84.	Up to 12 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Timeline Follow-Back (TLFB) Interview to Assess the Percentage of Abstinent Days (PAD)	Using the TLFB interview, the PAD in the 85 days before Day -3 (or start of detox) vs the PAD post-dosing measured on Days 14, 28, 56, and 84 were determined to assess alcohol use.	Up to 12 weeks
TLFB Interview to Assess the Percentage of Heavy Drinking Days (PHDD)	Using the TLFB interview, the PHDD in the 85 days before Day -3 (or start of detox) vs PHDD post-dosing measured on Days 14, 28, 56, and 84 were determined to assess alcohol use.	Up to 12 weeks
TLFB Interview to Assess the Percentage of Drinking Days (PDD)	Using the TLFB interview, the PDD in the 85 days before Day -3 (or start of detox) vs PDD post-dosing measured on Days 14, 28, 56, and 84 were determined to assess alcohol use.	Up to 12 weeks

Collaborators and Investigators

• Sponsor: Beckley Psytech Limited
• Investigators: Study Director: Kevin Craig, M.D., Beckley Psytech Ltd

Study record dates

Study Major Dates

• Study Start (Actual): May 30, 2023
• Primary Completion (Actual): October 2, 2024
• Study Completion (Actual): October 2, 2024

Study Registration Dates

• First Submitted: December 13, 2022
• First Submitted That Met QC Criteria: December 21, 2022
• First Posted (Actual): January 9, 2023

Study Record Updates

• Last Update Posted (Actual): May 22, 2026
• Last Update Submitted That Met QC Criteria: May 21, 2026
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Alcohol-Related Disorders; Alcoholism
• Other Study ID Numbers: BPL-003-203

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Due to the UK GDPR, individual participant data will not be shared publicly. Group data will be presented in publication after study completion.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No